Shoulder & Elbow

Take-Home Points

• RTSA is projected to triple by 2020.
• RTSA for fracture indication anticipates a 4.9% compound quarterly growth rate.

• RTSA is gaining in popularity likely due to unpredictable results of hemiarthroplasty in select patients.

Reverse total shoulder arthroplasty (RTSA) is an accepted treatment option for the pain and dysfunction associated with glenohumeral arthritis and severe rotator cuff pathology.^1-3 Recently, it has been gaining acceptance as an alternative to hemiarthroplasty (HA) and open reduction and internal fixation (ORIF) in the surgical management of complex proximal humerus fractures (PHFs) in elderly patients.^4-6 The advantages of RTSA over other PHF treatment options include a lower revision rate and superior range of motion.^4,5

PHF remains one of the most common fracture pathologies in the United States.⁷ Given the country’s aging patient population, the popularity of RTSA likely will continue to increase.^4-6 The release of supercomputer data from individual private-payer insurance providers provides an opportunity to investigate trends in the surgical management of PHFs and to formulate models for predicting use. In this study, we used a large private-payer database to analyze these trends over the period 2010 to 2014 and project RTSA use through 2020.

Methods

We used PearlDiver’s supercomputer application to search the Humana private-payer database to retrospectively identify cases of PHF treated with the index procedure of RTSA. PearlDiver, a publicly available national database compliant with HIPAA (Health Insurance Portability and Accountability Act of 1996), compiles private-payer records submitted by Humana. These records represent 100% of the orthopedics-related payer records within the dataset. The database includes International Classification of Diseases, Ninth Revision (ICD-9) codes and Current Procedural Terminology (CPT) codes from 2007 to 2014.

RTSA cases were identified by ICD-9 codes 81.80 and 81.88 and CPT code 23472. PHFs were identified by ICD-9, Clinical Modification (ICD-9-CM) codes 812.00, 812.01, 812.02, 812.03, 812.09, 812.10, 812.11, 812.12, 812.13, 812.19, and 812.20. Holt-Winters quarterly (Q) projection analysis was performed on the RTSA-PHF data from Q1-2010 through Q4-2020 (Figure).

Compound quarterly growth rate (CQGR) was calculated as well. Linear regression analysis was performed to determine the goodness of fit (R²) of the known and projected study data. Age-based subgroup analysis was performed and the results reported as incidence.

Results

For the known study period Q1-2010 through Q3-2014, our search yielded 46,106 PHF cases, 4057 (8.8%) of which were surgically treated with RTSAs (Table 1).

Mean (SD) age of these RTSA patients was 75 (7) years. For the period Q4-2014 through Q4-2020, RTSAs for the surgical treatment of PHFs were projected to total 12,898. Combining the data for the known and projected periods (Q1-2010 through Q4-2020) produced an overall total of 16,955 cases. The known period’s CQGR was 6.5%, and the projected period’s CQGR was 2.8%, giving an overall CQGR of 4.6%.

Linear regression analysis revealed an R² (coefficient of determination) of 0.94 for the known period and an R² of 0.98 for the projected period, demonstrating strong goodness of fit for projection.

Age-based subgroup analysis revealed RTSA was performed primarily in the older-than-65 years patient population, with the highest percentage in the 70-to-74 years age group (24.4%), followed by the 75-to-79 years age group (21.6%) (Table 2).

Discussion

Use of RTSA for the management of complex PHFs has increased tremendously over the past several years. The primary results of our study showed an upward trend in RTSA use in the Humana population. CQGR was 6.5% from Q1-2010 through Q3-2014 (the number of RTSAs increased to 294 from 95). Based on the Holt-Winters projection analysis, CQGR was projected to be 2.8% through 2020 (339 RTSAs in Q4-2014 increasing to 664 RTSAs in Q4-2020), resulting in an overall 10-year CQGR of 4.6%.

Recent studies have shown RTSA to be a viable alternative to HA in patients with PHFs. It has been suggested that RTSAs may have more reliable clinical outcomes without a comparative increase in complication rates.^1,8,9 HA has been associated with unpredictable motion, higher complication rates, and high rates of unsatisfactory results in patients older than 65 years.^10-12 In addition, studies have found that, compared with HA and ORIF, RTSA produces superior range of motion.^8,9 The reliability of clinical outcomes in the early transition to use of RTSA for complex fractures suggests that use of RTSA for PHF management is trending upward. Results of the present study showed a steady increase in RTSA use. This trend is further supported by a recent study finding on national trends in RTSA use in PHF cases: 12.3% annual growth during the period 2000 to 2008.⁶Our study results showed a continued steady quarterly increase in use of RTSA for PHFs, projected to triple by Q4-2020 (Table 1). The increasing popularity of RTSA may be attributable to its better clinical outcomes and to the procedural instruction given to newly trained orthopedic surgeons during residency. A recent study found a substantial increase in the use of RTSA for PHFs—from 2% in 2005 to 38% in 2012—among newly trained orthopedic surgeons.¹³ Another possible driver of the increase is cost. Although RTSA implant costs are often a multiple of the costs of other treatment options, different findings were reported in 2 recent studies that used quality-adjusted life-years (QALY) to determine RTSA cost-effectiveness. Coe and colleagues¹⁴ compared RTSA with HA and found RTSA to be cost-effective but highly dependent on implant cost. They determined that an implant cost of over $13,000 put RTSA cost-effectiveness at just under $100,000 QALY, whereas an implant cost of under $7000 brought QALY down to under $50,000. Renfree and colleagues¹⁵ used the same QALY benchmark but found RTSA to be at the highly cost-effective threshold of under $25,000 QALY.

Current literature recommends RTSA be performed primarily for elderly patients.^1,2,16,17 Guery and colleagues² suggested limiting RTSA to patients who are older than 70 years and have low functional demands. In 2 studies of RTSA use in complex humeral fractures, Gallinet and colleagues^16,18 found an increased rate of scapular notching in younger patients and recommended restricting RTSA to patients 70 years or older. PHFs in patients older than 70 years often have more complex fracture patterns and poor-quality bone, which makes fracture healing more challenging in HA and ORIF settings. As tuberosity healing is crucial to functional outcomes of surgically treated PHFs, RTSA has been advanced as a more reliable option in patients in whom tuberosity healing is expected to be unreliable. The present study’s finding that 68.5% of the RTSA patients in the Humana population were older than 70 years further supports the literature’s emphasis on reserving RTSA for patients over 70 years.

This study had its limitations. The PearlDiver database depends on accurate ICD-9 and CPT coding, and there was potential for reporting bias. In addition, a new, specific ICD-9 code for RTSA was introduced in 2010 and may not have been immediately used; data reported during this time could have been affected. Furthermore, the data were primarily represented by a single private-payer organization (Humana) and therefore may not have fully encapsulated the entire US trend. Projection in this study did not account for US Census–predicted population growth and therefore may have underestimated the true projected use of RTSA for PHFs.

This study benefited from the completeness of the data used. PearlDiver represents 100% of Humana claims data, providing a large patient population for analysis and capturing data as recent as 2014. To our knowledge, no other large database studies have used such up-to-date data.

 

Conclusion

RTSA is becoming an increasingly popular treatment option for PHFs. Modest overall quarterly growth in use of RTSA for PHFs (CQGR, 4.6%) is predicted through Q4-2020. Number of RTSAs performed for PHF management is projected to more than triple by 2020.

Am J Orthop. 2017;46(1):E28-E31. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Take-Home Points

• RTSA is projected to triple by 2020.
• RTSA for fracture indication anticipates a 4.9% compound quarterly growth rate.

• RTSA is gaining in popularity likely due to unpredictable results of hemiarthroplasty in select patients.

Reverse total shoulder arthroplasty (RTSA) is an accepted treatment option for the pain and dysfunction associated with glenohumeral arthritis and severe rotator cuff pathology.^1-3 Recently, it has been gaining acceptance as an alternative to hemiarthroplasty (HA) and open reduction and internal fixation (ORIF) in the surgical management of complex proximal humerus fractures (PHFs) in elderly patients.^4-6 The advantages of RTSA over other PHF treatment options include a lower revision rate and superior range of motion.^4,5

PHF remains one of the most common fracture pathologies in the United States.⁷ Given the country’s aging patient population, the popularity of RTSA likely will continue to increase.^4-6 The release of supercomputer data from individual private-payer insurance providers provides an opportunity to investigate trends in the surgical management of PHFs and to formulate models for predicting use. In this study, we used a large private-payer database to analyze these trends over the period 2010 to 2014 and project RTSA use through 2020.

Methods

We used PearlDiver’s supercomputer application to search the Humana private-payer database to retrospectively identify cases of PHF treated with the index procedure of RTSA. PearlDiver, a publicly available national database compliant with HIPAA (Health Insurance Portability and Accountability Act of 1996), compiles private-payer records submitted by Humana. These records represent 100% of the orthopedics-related payer records within the dataset. The database includes International Classification of Diseases, Ninth Revision (ICD-9) codes and Current Procedural Terminology (CPT) codes from 2007 to 2014.

RTSA cases were identified by ICD-9 codes 81.80 and 81.88 and CPT code 23472. PHFs were identified by ICD-9, Clinical Modification (ICD-9-CM) codes 812.00, 812.01, 812.02, 812.03, 812.09, 812.10, 812.11, 812.12, 812.13, 812.19, and 812.20. Holt-Winters quarterly (Q) projection analysis was performed on the RTSA-PHF data from Q1-2010 through Q4-2020 (Figure).

Compound quarterly growth rate (CQGR) was calculated as well. Linear regression analysis was performed to determine the goodness of fit (R²) of the known and projected study data. Age-based subgroup analysis was performed and the results reported as incidence.

Results

For the known study period Q1-2010 through Q3-2014, our search yielded 46,106 PHF cases, 4057 (8.8%) of which were surgically treated with RTSAs (Table 1).

Mean (SD) age of these RTSA patients was 75 (7) years. For the period Q4-2014 through Q4-2020, RTSAs for the surgical treatment of PHFs were projected to total 12,898. Combining the data for the known and projected periods (Q1-2010 through Q4-2020) produced an overall total of 16,955 cases. The known period’s CQGR was 6.5%, and the projected period’s CQGR was 2.8%, giving an overall CQGR of 4.6%.

Linear regression analysis revealed an R² (coefficient of determination) of 0.94 for the known period and an R² of 0.98 for the projected period, demonstrating strong goodness of fit for projection.

Age-based subgroup analysis revealed RTSA was performed primarily in the older-than-65 years patient population, with the highest percentage in the 70-to-74 years age group (24.4%), followed by the 75-to-79 years age group (21.6%) (Table 2).

Discussion

Use of RTSA for the management of complex PHFs has increased tremendously over the past several years. The primary results of our study showed an upward trend in RTSA use in the Humana population. CQGR was 6.5% from Q1-2010 through Q3-2014 (the number of RTSAs increased to 294 from 95). Based on the Holt-Winters projection analysis, CQGR was projected to be 2.8% through 2020 (339 RTSAs in Q4-2014 increasing to 664 RTSAs in Q4-2020), resulting in an overall 10-year CQGR of 4.6%.

Recent studies have shown RTSA to be a viable alternative to HA in patients with PHFs. It has been suggested that RTSAs may have more reliable clinical outcomes without a comparative increase in complication rates.^1,8,9 HA has been associated with unpredictable motion, higher complication rates, and high rates of unsatisfactory results in patients older than 65 years.^10-12 In addition, studies have found that, compared with HA and ORIF, RTSA produces superior range of motion.^8,9 The reliability of clinical outcomes in the early transition to use of RTSA for complex fractures suggests that use of RTSA for PHF management is trending upward. Results of the present study showed a steady increase in RTSA use. This trend is further supported by a recent study finding on national trends in RTSA use in PHF cases: 12.3% annual growth during the period 2000 to 2008.⁶Our study results showed a continued steady quarterly increase in use of RTSA for PHFs, projected to triple by Q4-2020 (Table 1). The increasing popularity of RTSA may be attributable to its better clinical outcomes and to the procedural instruction given to newly trained orthopedic surgeons during residency. A recent study found a substantial increase in the use of RTSA for PHFs—from 2% in 2005 to 38% in 2012—among newly trained orthopedic surgeons.¹³ Another possible driver of the increase is cost. Although RTSA implant costs are often a multiple of the costs of other treatment options, different findings were reported in 2 recent studies that used quality-adjusted life-years (QALY) to determine RTSA cost-effectiveness. Coe and colleagues¹⁴ compared RTSA with HA and found RTSA to be cost-effective but highly dependent on implant cost. They determined that an implant cost of over $13,000 put RTSA cost-effectiveness at just under $100,000 QALY, whereas an implant cost of under $7000 brought QALY down to under $50,000. Renfree and colleagues¹⁵ used the same QALY benchmark but found RTSA to be at the highly cost-effective threshold of under $25,000 QALY.

Current literature recommends RTSA be performed primarily for elderly patients.^1,2,16,17 Guery and colleagues² suggested limiting RTSA to patients who are older than 70 years and have low functional demands. In 2 studies of RTSA use in complex humeral fractures, Gallinet and colleagues^16,18 found an increased rate of scapular notching in younger patients and recommended restricting RTSA to patients 70 years or older. PHFs in patients older than 70 years often have more complex fracture patterns and poor-quality bone, which makes fracture healing more challenging in HA and ORIF settings. As tuberosity healing is crucial to functional outcomes of surgically treated PHFs, RTSA has been advanced as a more reliable option in patients in whom tuberosity healing is expected to be unreliable. The present study’s finding that 68.5% of the RTSA patients in the Humana population were older than 70 years further supports the literature’s emphasis on reserving RTSA for patients over 70 years.

This study had its limitations. The PearlDiver database depends on accurate ICD-9 and CPT coding, and there was potential for reporting bias. In addition, a new, specific ICD-9 code for RTSA was introduced in 2010 and may not have been immediately used; data reported during this time could have been affected. Furthermore, the data were primarily represented by a single private-payer organization (Humana) and therefore may not have fully encapsulated the entire US trend. Projection in this study did not account for US Census–predicted population growth and therefore may have underestimated the true projected use of RTSA for PHFs.

This study benefited from the completeness of the data used. PearlDiver represents 100% of Humana claims data, providing a large patient population for analysis and capturing data as recent as 2014. To our knowledge, no other large database studies have used such up-to-date data.

 

Conclusion

RTSA is becoming an increasingly popular treatment option for PHFs. Modest overall quarterly growth in use of RTSA for PHFs (CQGR, 4.6%) is predicted through Q4-2020. Number of RTSAs performed for PHF management is projected to more than triple by 2020.

Am J Orthop. 2017;46(1):E28-E31. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Take-Home Points

• RTSA is projected to triple by 2020.
• RTSA for fracture indication anticipates a 4.9% compound quarterly growth rate.

• RTSA is gaining in popularity likely due to unpredictable results of hemiarthroplasty in select patients.

Reverse total shoulder arthroplasty (RTSA) is an accepted treatment option for the pain and dysfunction associated with glenohumeral arthritis and severe rotator cuff pathology.^1-3 Recently, it has been gaining acceptance as an alternative to hemiarthroplasty (HA) and open reduction and internal fixation (ORIF) in the surgical management of complex proximal humerus fractures (PHFs) in elderly patients.^4-6 The advantages of RTSA over other PHF treatment options include a lower revision rate and superior range of motion.^4,5

PHF remains one of the most common fracture pathologies in the United States.⁷ Given the country’s aging patient population, the popularity of RTSA likely will continue to increase.^4-6 The release of supercomputer data from individual private-payer insurance providers provides an opportunity to investigate trends in the surgical management of PHFs and to formulate models for predicting use. In this study, we used a large private-payer database to analyze these trends over the period 2010 to 2014 and project RTSA use through 2020.

Methods

We used PearlDiver’s supercomputer application to search the Humana private-payer database to retrospectively identify cases of PHF treated with the index procedure of RTSA. PearlDiver, a publicly available national database compliant with HIPAA (Health Insurance Portability and Accountability Act of 1996), compiles private-payer records submitted by Humana. These records represent 100% of the orthopedics-related payer records within the dataset. The database includes International Classification of Diseases, Ninth Revision (ICD-9) codes and Current Procedural Terminology (CPT) codes from 2007 to 2014.

RTSA cases were identified by ICD-9 codes 81.80 and 81.88 and CPT code 23472. PHFs were identified by ICD-9, Clinical Modification (ICD-9-CM) codes 812.00, 812.01, 812.02, 812.03, 812.09, 812.10, 812.11, 812.12, 812.13, 812.19, and 812.20. Holt-Winters quarterly (Q) projection analysis was performed on the RTSA-PHF data from Q1-2010 through Q4-2020 (Figure).

Compound quarterly growth rate (CQGR) was calculated as well. Linear regression analysis was performed to determine the goodness of fit (R²) of the known and projected study data. Age-based subgroup analysis was performed and the results reported as incidence.

Results

For the known study period Q1-2010 through Q3-2014, our search yielded 46,106 PHF cases, 4057 (8.8%) of which were surgically treated with RTSAs (Table 1).

Mean (SD) age of these RTSA patients was 75 (7) years. For the period Q4-2014 through Q4-2020, RTSAs for the surgical treatment of PHFs were projected to total 12,898. Combining the data for the known and projected periods (Q1-2010 through Q4-2020) produced an overall total of 16,955 cases. The known period’s CQGR was 6.5%, and the projected period’s CQGR was 2.8%, giving an overall CQGR of 4.6%.

Linear regression analysis revealed an R² (coefficient of determination) of 0.94 for the known period and an R² of 0.98 for the projected period, demonstrating strong goodness of fit for projection.

Age-based subgroup analysis revealed RTSA was performed primarily in the older-than-65 years patient population, with the highest percentage in the 70-to-74 years age group (24.4%), followed by the 75-to-79 years age group (21.6%) (Table 2).

Discussion

Use of RTSA for the management of complex PHFs has increased tremendously over the past several years. The primary results of our study showed an upward trend in RTSA use in the Humana population. CQGR was 6.5% from Q1-2010 through Q3-2014 (the number of RTSAs increased to 294 from 95). Based on the Holt-Winters projection analysis, CQGR was projected to be 2.8% through 2020 (339 RTSAs in Q4-2014 increasing to 664 RTSAs in Q4-2020), resulting in an overall 10-year CQGR of 4.6%.

Recent studies have shown RTSA to be a viable alternative to HA in patients with PHFs. It has been suggested that RTSAs may have more reliable clinical outcomes without a comparative increase in complication rates.^1,8,9 HA has been associated with unpredictable motion, higher complication rates, and high rates of unsatisfactory results in patients older than 65 years.^10-12 In addition, studies have found that, compared with HA and ORIF, RTSA produces superior range of motion.^8,9 The reliability of clinical outcomes in the early transition to use of RTSA for complex fractures suggests that use of RTSA for PHF management is trending upward. Results of the present study showed a steady increase in RTSA use. This trend is further supported by a recent study finding on national trends in RTSA use in PHF cases: 12.3% annual growth during the period 2000 to 2008.⁶Our study results showed a continued steady quarterly increase in use of RTSA for PHFs, projected to triple by Q4-2020 (Table 1). The increasing popularity of RTSA may be attributable to its better clinical outcomes and to the procedural instruction given to newly trained orthopedic surgeons during residency. A recent study found a substantial increase in the use of RTSA for PHFs—from 2% in 2005 to 38% in 2012—among newly trained orthopedic surgeons.¹³ Another possible driver of the increase is cost. Although RTSA implant costs are often a multiple of the costs of other treatment options, different findings were reported in 2 recent studies that used quality-adjusted life-years (QALY) to determine RTSA cost-effectiveness. Coe and colleagues¹⁴ compared RTSA with HA and found RTSA to be cost-effective but highly dependent on implant cost. They determined that an implant cost of over $13,000 put RTSA cost-effectiveness at just under $100,000 QALY, whereas an implant cost of under $7000 brought QALY down to under $50,000. Renfree and colleagues¹⁵ used the same QALY benchmark but found RTSA to be at the highly cost-effective threshold of under $25,000 QALY.

Current literature recommends RTSA be performed primarily for elderly patients.^1,2,16,17 Guery and colleagues² suggested limiting RTSA to patients who are older than 70 years and have low functional demands. In 2 studies of RTSA use in complex humeral fractures, Gallinet and colleagues^16,18 found an increased rate of scapular notching in younger patients and recommended restricting RTSA to patients 70 years or older. PHFs in patients older than 70 years often have more complex fracture patterns and poor-quality bone, which makes fracture healing more challenging in HA and ORIF settings. As tuberosity healing is crucial to functional outcomes of surgically treated PHFs, RTSA has been advanced as a more reliable option in patients in whom tuberosity healing is expected to be unreliable. The present study’s finding that 68.5% of the RTSA patients in the Humana population were older than 70 years further supports the literature’s emphasis on reserving RTSA for patients over 70 years.

This study had its limitations. The PearlDiver database depends on accurate ICD-9 and CPT coding, and there was potential for reporting bias. In addition, a new, specific ICD-9 code for RTSA was introduced in 2010 and may not have been immediately used; data reported during this time could have been affected. Furthermore, the data were primarily represented by a single private-payer organization (Humana) and therefore may not have fully encapsulated the entire US trend. Projection in this study did not account for US Census–predicted population growth and therefore may have underestimated the true projected use of RTSA for PHFs.

This study benefited from the completeness of the data used. PearlDiver represents 100% of Humana claims data, providing a large patient population for analysis and capturing data as recent as 2014. To our knowledge, no other large database studies have used such up-to-date data.

 

Conclusion

RTSA is becoming an increasingly popular treatment option for PHFs. Modest overall quarterly growth in use of RTSA for PHFs (CQGR, 4.6%) is predicted through Q4-2020. Number of RTSAs performed for PHF management is projected to more than triple by 2020.

Am J Orthop. 2017;46(1):E28-E31. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

The ulnar collateral ligament (UCL) is the primary restraint to valgus stress between 20° and 125° of motion.^1-5 Overhead athletes, most commonly baseball pitchers, are at risk of developing UCL insufficiency, and dysfunction presents as pain with loss of velocity and control. Some injuries may present acutely while throwing, but many patients, when questioned, report a preceding period of either pain or loss of velocity and control.

Authors have documented a significant rise in elbow injuries in young athletes, especially pitchers.⁶ Extended seasons, higher pitch counts, year-round pitching, pitching while fatigued, and pitching for multiple teams are risk factors for elbow injuries.⁷ Pitchers in the southern United States are more likely to undergo UCL reconstruction than those from the northern states.⁸ Pitchers who also play catcher are at a higher risk due to more total throws than those who pitch and play other positions or pitch only. Throwers with higher velocity are more likely to pitch in showcases, pitch for multiple teams, and pitch with pain and fatigue, and these are all risk factors.⁶ Also, in one study of youth baseball injuries, individuals in the injured group were found to be taller and heavier than those in the uninjured group.⁶ Pitch counts, rest from pitching during the off-season, adequate rest, and ensuring pain-free pitching can lessen the risk of injury.⁶ As expected with the rise in throwing injuries, the rise in medial elbow procedures has risen.⁹

While throwing, stress across the medial elbow has been measured to be nearly 300 N. A maximum varus force during pitching was measured to be 64 N-m at 95° ± 14°.¹⁰ Morrey and An⁴ determined that the UCL generated 54% of the varus force at 90° of flexion. During active pitching, this value is likely reduced due to simultaneous muscle contraction, but if one assumes the UCL bears 54% of the maximal load, the UCL must be able to withstand 34 N-m. The UCL can withstand a maximum valgus torque between 22.7 and 34 N-m^11-13; therefore, during pitching, the UCL is at or above its failure load. After thousands of cycles over many years, one can imagine how the UCL might be injured.

Multiple techniques have been proposed in the surgical treatment of UCL injuries. Jobe¹⁴ pioneered UCL reconstruction in 1974 in Tommy John, a Major League Baseball pitcher. John returned to pitch successfully, and both the UCL and the reconstruction are commonly called by his name. Jobe¹⁴ reported his technique in 1986, and it has remained, with a few modifications, the primary method for reconstruction of the UCL (Figure 1).

Primary repair has been reported, and the best results have been in younger pitchers with acute injuries.¹⁵ Cain and colleagues¹⁶ reported a 70% return to same or higher level with repair alone, which was an improvement on Azar’s series¹⁷ with 63% return to same or higher level. Recent advancements have included primary repair with augmentation using grafts or anchored suture or tape¹⁸ (Figure 2).

The modified Jobe and docking techniques remain the most commonly used techniques with reproducible and reliable results.^19,20

Evaluation

A standard evaluation with physical examination and imaging is completed in all throwers with elbow pain. In our prior study,¹⁶ we found that 100% of patients experienced pain during athletic activity and that 96% of throwers complained of pain during late cocking and acceleration phases of the throwing motion. Nearly half reported an acute onset of pain, while 53% were unable to identify a single inciting event. Seventy-five percent of the acute injuries were during competition. Delayed diagnosis was very common, with an average time to diagnosis after onset of symptoms of 6.4 months. Neurologic symptoms were seen in 23% of athletes, most of which were ulnar nerve paresthesias during throwing.¹⁶

Physical examination includes inspection for swelling, hand intrinsic atrophy, neurovascular examination, range of motion, shoulder examination, and elbow stress examination. Range of motion at presentation averaged 5° to 135° with 85° of supination and pronation.¹⁶ All patients need neurologic evaluation for ulnar nerve dysfunction. Tinel test of the cubital tunnel was positive in 21%.¹⁶ Significant ulnar nerve dysfunction, including hand weakness, is much less common but must be well examined and documented. The shoulder must also be evaluated for loss of rotation, which can lead to increased stress on the elbow. An evaluation of mechanics may point out flaws in technique, which may be contributing to elbow stress. The UCL stress examination includes static stress at 30° of flexion, the milking test at 90°, and the moving valgus stress test. The presence of pain directly over the UCL or laxity compared to the uninvolved side is suggestive of UCL injury.

Radiographic evaluation is completed in all patients with concern for UCL injury. Standard x-rays of the elbow, including anteroposterior, medial, and lateral obliques, axial olecranon, and lateral views, are obtained to evaluate bony abnormalities. Fifty-seven percent of our series showed some abnormality, most commonly olecranon osteophyte formation or ectopic calcification within the UCL substance. Stress radiography rarely changed the treatment course and is somewhat difficult to interpret because of the reports documenting normal increased medial elbow opening in the dominant arm of throwing athletes.²¹ Magnetic resonance imaging (MRI) is obtained very commonly in this patient population, and intra-articular contrast is crucial. Partial, undersurface tears are common, and a contrasted study better demonstrates undersurface tears or avulsions. The T-sign as described by Timmerman and colleagues²² using computed tomography (CT) arthrography shows partial undersurface detachment, which can be difficult to see without intra-articular contrast.²² This finding is very well visualized on MRI arthrogram as well (Figure 3).

Sensitivity in partial tears is also highly favorable for CT arthrogram over noncontrasted MRI, detecting 71% vs 14%.²² MRI with arthrogram provides further detail to better detect tears and to determine the condition of the ligament, and is currently the gold standard diagnostic test for UCL evaluation.

 

Nonoperative Management

Nonoperative treatment is recommended for 3 months prior to performing reconstruction. Patients are given complete rest from throwing, but rehabilitation is initiated immediately. Rehabilitation exercises and nonsteroidal anti-inflammatory medications are prescribed, and activities that place valgus stress across the elbow are avoided. After resolution of symptoms, an interval throwing program is initiated, and the athlete is gradually returned to sport. Unfortunately, due to season-specific schedules and time-sensitive demands in high-level throwers, operative treatment is often chosen without an extended period of conservative treatment.

Platelet-rich plasma (PRP) therapy has recently been shown to improve healing rates and promote healing in partial UCL tears,²³ and as orthobiologics are advanced, they will likely play a larger role in the treatment of UCL injuries.

Surgical Technique

At our institution, UCL reconstruction is performed with the modified Jobe technique as described by Azar and colleagues.¹⁷ Arthroscopy prior to reconstruction was routinely performed at our institution until we recognized that arthroscopy rarely changed the preoperative plan.¹⁶ Currently, the presence of anterior pathology such as loose bodies or osteochondral defect is our only indication for arthroscopy before reconstruction.

Ipsilateral palmaris autograft is our current graft of choice. This must be examined preoperatively because 16% of patients have unilateral absence and 9% have bilateral absence.²⁴ In revision cases or in patients with insufficient or absent palmaris, contralateral palmaris followed by contralateral gracilis tendon is used. The contralateral gracilis is chosen because of ease of setup and position of the surgeon during the harvest. Gracilis tendon is also used in cases with bony involvement of the ligament based on the results from Dugas and colleagues.²⁵ Toe extensors, plantaris, and patellar tendon grafts have also been used. One recent study showed that neither graft choice nor diameter affected resistance to valgus stress, and that all reconstruction types restored strength at 60° to 120° of flexion.²⁶

Ulnar nerve transposition is performed in all cases regardless of the presence of preoperative nerve symptoms. A complete decompression is completed proximally to the Arcade of Struthers and distally to the deep portion of the flexor carpi ulnaris. A single fascial sling of medial intermuscular septum originating from the epicondylar attachment is used to stabilize the nerve without compression. At wound closure, the deep fascia on the posterior skin flap is also sewn into the cubital tunnel to prevent the nerve from subluxating back into the groove. A single suture is placed distally closing the muscle fascia to prevent propagation of the fascial incision, which can lead to herniation. Transposition is necessary because of the ulnar nerve exposure required in the modified Jobe technique to allow elevation of the deep flexor muscle mass for ligament exposure.

The reconstruction is completed as described by Jobe¹⁴ but with a few modifications as described by Azar and colleagues¹⁷ and slight adaptations implemented since that time. The flexor-pronator mass is retracted laterally instead of detachment or splitting as described by Thompson and colleagues.²⁷ A subcutaneous rather than a submuscular ulnar nerve transposition is used.

The patient is positioned supine using an arm board. If gracilis tendon is chosen, the contralateral leg is prepped and draped simultaneously. A tourniquet is inflated after exsanguination. A medial approach is performed, and the medial antebrachial nerve is located and protected. The ulnar nerve is then located in the cubital tunnel and mobilized. The neurolysis extends to the deep portion of the flexor carpi ulnaris distally and proximally to the Arcade of Struthers, and the nerve is retracted with a vessel loop. The flexor muscle mass is not elevated from the medial epicondyle; rather, it is retracted anteriorly by small Hohmann retractors. The dissection is carried down to the UCL and found at its attachments to the medial epicondyle and sublime tubercle. If no tear is seen on the superficial surface of the ligament, a longitudinal incision is made through the ligament. Undersurface tears, partial tears, and avulsions can then be identified (Figure 4).

Often, a portion of the ligament is degenerative and is excised, leaving only healthy-appearing ligament.

The autologous graft of choice is then harvested. Our technique for palmaris harvest is performed with three 1-cm transverse incisions. The palmaris is palpated and marked with the first incision made near the distal wrist crease, and the second incision is made 3 to 4 cm proximal to the first. The tendon is found in both distal incisions and cut distally with the wrist flexed to maximize tendon length. The tendon is then pulled through the second incision and tensioned to identify the most proximal location the tendon can be palpated. A third incision is made directly over this point and carried down to cut the tendon. This usually provides a graft length of 15 to 20 cm; 13 cm is the minimum graft length to ensure good graft fixation. Muscle is removed from the tendon and each end is secured with a No. 1 nonabsorbable suture in a locking fashion.

If posterior osteophytes are present, they are removed through a posterior, vertical arthrotomy. Over-resection of the olecranon must be avoided, as this can further destabilize the elbow and place increased stress on the reconstruction. Posterior loose bodies can also be removed through this arthrotomy. The arthrotomy is then closed with absorbable suture.

Tunnel placement is critical to success. A 3.2-mm drill bit is used with palmaris grafts and a 4-mm drill bit is used with gracilis grafts. Two convergent tunnels are drilled in the medial epicondyle in a Y fashion and 2 convergent tunnels are drilled at the sublime tubercle in a U or V fashion. After drilling the first tunnel on each side, a hemostat is placed in the tunnel as an aiming point to ensure a complete tunnel is made. The junction is smoothed with a curette, leaving a 5-mm bone bridge between the articular surface and the tunnels. A bent Hewson suture passer is used to pass one end of the graft through the ulna. The 2 limbs of the tendon graft are then passed through the humeral tunnels, creating a figure-of-eight. A varus stress is applied with the elbow at roughly 30° and the 2 limbs are tied together with a No. 1 nonabsorbable suture. If enough graft remains, one or both limbs are passed back through the tunnels and secured again with No. 1 nonabsorbable suture. The 2 limbs are then tied side-to-side, incorporating the native ligament to further secure and tighten the reconstruction.

The ulnar nerve is then secured using a strip of medial intermuscular septum left intact to its insertion at the medial epicondyle. This is attached to the flexor-pronator muscle fascia with a 3-0 nonabsorbable suture. Enough length should be harvested from the septum to ensure there is no compression on the nerve. The deep posterior fascial tissue is then sewn to the periosteum of the medial epicondyle to further prevent subluxation of the nerve back into the groove. The skin is then closed in layered fashion over a superficial drain. The patient is placed in a well-padded posterior splint for 1 week, then the rehabilitation protocol is initiated as discussed below.

 

Postoperative Rehabilitation

A standardized postoperative 4-phase rehabilitation program for ulnar collateral reconstruction is followed as described by Wilk and colleagues.^28-30 The first phase begins immediately after surgery and continues for 4 weeks. During surgery, the patient’s elbow is placed in a compression dressing with a posterior splint to immobilize the elbow in 90° of flexion with wrist motion for 1 week to allow initial healing. Full range of motion of the elbow joint is restored by the end of the fifth to sixth week after surgery.

During phase II (weeks 4-10), a progressive isotonic strengthening program is initiated. Exercises are focused on scapular, rotator cuff, deltoid, and arm musculature. Shoulder range of motion and stretching exercises are performed during this phase and the Thrower’s Ten exercise program is initiated. Any adaptations or strength deficits are addressed during this phase.

During the advanced strengthening phase (phase III), from weeks 10 to 16, a sport-specific exercise/rehabilitation program is initiated. During this phase, stretching and flexibility exercises are performed to enhance strength, power, and endurance. During this phase the patient is placed on the advanced Thrower’s Ten program. Isotonic strengthening exercises are progressed, and at week 12, the athlete is allowed to begin an isotonic lifting program, including bench press, seated rowing, latissimus dorsi pull downs, triceps push downs, and biceps curls. In addition, the athlete performs specific exercises to emphasize sport-specific movements. At week 12, overhead athletes begin a 2-hand plyometric throwing program, and at 14 weeks, a 1-hand plyometric throwing program. Furthermore, endurance exercises, core stability, and leg strengthening are emphasized during phase III. Phase IV, the return to activity phase (week 16 and beyond), is characterized by the initiation of an interval throwing program. The patient is instructed to continue his stretching and strengthening program. An interval throwing program off the mound is gradually initiated at 5 to 6 months postoperative and a gradual return to competition is initiated for pitchers at 9 months and for position players 6 to 7 months postoperative.

Discussion

Results after ulnar collateral reconstruction have been good. In our series of 743 patients, 83% returned to the same or higher level at an average of 11.6 months.¹⁶ There was a 4% major complication rate and 16% minor complication rate. Major complications included medial epicondyle fracture (0.5%), significant ulnar nerve dysfunction (1 patient), rupture of graft (1%), and graft site infection. Sixteen percent of patients had ulnar nerve dysfunction, and 82% of these resolved within 6 weeks. All but 1 patient’s paresthesias resolved within 1 year.¹⁶ The 10-year follow-up of this group of patients included 256 patients and was reported by Osbahr and colleagues³¹ in 2014. Retirement from baseball was due to reasons other than the elbow in 86%, and 98% were still able to throw on at least a recreational level. The overall longevity was 3.6 years, with 2.9 years at pre-injury level or higher. Statistically, pitchers performed at a higher level after reconstruction.³¹

A recent review by Erickson and colleagues⁹ showed an overall 82% excellent and 8% good result when evaluating different techniques, including the American Sports Medicine Institute (ASMI) modification of Jobe’s technique, docking technique, and Jobe’s technique. With an overall complication rate of 10% (75% of which was transient ulnar neuritis), the procedure was deemed overall a safe surgical option. Collegiate athletes had the highest return to sport (95%) compared with high school athletes (89%) and professional athletes (86%). The docking technique had the highest rate of return to play (97%) compared with ASMI technique (93%) and Jobe technique (66%).⁹ Results after repair have not been as good as reconstruction, as reported in 2 studies.^16,32 Savoie and colleagues,¹⁵ however, reported 93% good/excellent results after primary UCL repair alone.

Another recent review of outcomes showed an overall return to same or higher level was best with docking or modified docking techniques (90.4% and 91.3%, respectively).¹⁹ Overall return with modified Jobe technique was 77%.¹⁹ O’Brien and colleagues²⁰ performed a review of 33 patients with either modified Jobe or docking technique that showed 81% return to same or higher level with modified Jobe vs 92% with docking technique. The Kerlan-Jobe Orthopaedic Clinic scores were higher in the modified Jobe group (79 vs 74) and the docking technique group returned to play nearly 1 month sooner (12.4 months vs 11.8 months).²⁰ However, comparing different techniques in a heterogenous patient population over 40 years is difficult. Many of the modified Jobe technique cases were performed in the early evolution of the rehabilitation and return-to-play programs. We believe that the current modified Jobe technique has results equal to any other variation.

Despite good results with reconstructions, the recovery is lengthy and most pitchers cannot fully return to competition level for 12 to 18 months. Extensive research has been performed in exploring alternatives to the traditional reconstruction. Advancements in orthobiologics and development of new surgical options seem to provide an alternative to reconstruction, and may allow faster return to competition with less morbidity.

PRP has been at the forefront of orthopedic research for the last 2 decades, mostly focused in tendon and bone healing. Due to the release of many inflammatory mediators, PRP is theorized to initiate a healing response with growth factors that can direct healing towards normal tissue.³³ Two main types of PRP are reported based on the presence or absence of leukocytes. PRP has been studied in many applications, but only one clinical study on the UCL has been published to date. Podesta and colleagues²³ injected PRP into the elbow of 34 baseball players with MRI-confirmed partial UCL tear. The athletes then underwent a rehabilitation program, which limited stress across the UCL. Type 1A PRP was used (leukocyte-rich, unactivated, 5x or greater platelet concentration³³). Athletes were allowed to return to sport based on symptoms and examination findings. Eighty-eight percent returned to same level of play without complaints at average 70 week follow-up, and average return to play ranged from 10 to 15 weeks.²³ No specific data were given on the 16 pitchers in the group, but with such a high rate of return, PRP needs to be further evaluated in the treatment of UCL injuries.

Another recent study from Dugas and colleagues¹⁸ presented primary UCL repair using a tape augment (InternalBrace, Arthrex). Nine matched cadaver elbows underwent UCL sectioning and then either modified Jobe reconstruction or primary repair of the UCL with placement of the InternalBrace. The biomechanical data showed the repair with internal brace to have slightly less gap, more stiffness, and higher failure strength, although these findings were not statistically significant.¹⁸ This bone-preserving technique with less exposure and healing of the native ligament may be another step towards good results with a quicker return to throwing.

 

Conclusion

UCL injuries can be disabling in throwers. Reconstruction has afforded throwers a high rate of return to preinjury function or better, and several techniques have been presented that produce acceptable results. Overall complication rates range from 10% to 15%, and the majority of complications are transient ulnar neuropraxias. Orthobiologics and repair with augmentation have more recently offered additional options that may improve success of nonoperative treatment or allow less-invasive surgical treatment. Increased involvement in youth sports and early specialization is driving injury rates in young athletes. The orthopedic community must continue to look for better ways to prevent these injuries and investigate better methods to return athletes to high-level competition.

Am J Orthop. 2016;45(7):E534-E540. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

The ulnar collateral ligament (UCL) is the primary restraint to valgus stress between 20° and 125° of motion.^1-5 Overhead athletes, most commonly baseball pitchers, are at risk of developing UCL insufficiency, and dysfunction presents as pain with loss of velocity and control. Some injuries may present acutely while throwing, but many patients, when questioned, report a preceding period of either pain or loss of velocity and control.

Authors have documented a significant rise in elbow injuries in young athletes, especially pitchers.⁶ Extended seasons, higher pitch counts, year-round pitching, pitching while fatigued, and pitching for multiple teams are risk factors for elbow injuries.⁷ Pitchers in the southern United States are more likely to undergo UCL reconstruction than those from the northern states.⁸ Pitchers who also play catcher are at a higher risk due to more total throws than those who pitch and play other positions or pitch only. Throwers with higher velocity are more likely to pitch in showcases, pitch for multiple teams, and pitch with pain and fatigue, and these are all risk factors.⁶ Also, in one study of youth baseball injuries, individuals in the injured group were found to be taller and heavier than those in the uninjured group.⁶ Pitch counts, rest from pitching during the off-season, adequate rest, and ensuring pain-free pitching can lessen the risk of injury.⁶ As expected with the rise in throwing injuries, the rise in medial elbow procedures has risen.⁹

While throwing, stress across the medial elbow has been measured to be nearly 300 N. A maximum varus force during pitching was measured to be 64 N-m at 95° ± 14°.¹⁰ Morrey and An⁴ determined that the UCL generated 54% of the varus force at 90° of flexion. During active pitching, this value is likely reduced due to simultaneous muscle contraction, but if one assumes the UCL bears 54% of the maximal load, the UCL must be able to withstand 34 N-m. The UCL can withstand a maximum valgus torque between 22.7 and 34 N-m^11-13; therefore, during pitching, the UCL is at or above its failure load. After thousands of cycles over many years, one can imagine how the UCL might be injured.

Multiple techniques have been proposed in the surgical treatment of UCL injuries. Jobe¹⁴ pioneered UCL reconstruction in 1974 in Tommy John, a Major League Baseball pitcher. John returned to pitch successfully, and both the UCL and the reconstruction are commonly called by his name. Jobe¹⁴ reported his technique in 1986, and it has remained, with a few modifications, the primary method for reconstruction of the UCL (Figure 1).

Primary repair has been reported, and the best results have been in younger pitchers with acute injuries.¹⁵ Cain and colleagues¹⁶ reported a 70% return to same or higher level with repair alone, which was an improvement on Azar’s series¹⁷ with 63% return to same or higher level. Recent advancements have included primary repair with augmentation using grafts or anchored suture or tape¹⁸ (Figure 2).

The modified Jobe and docking techniques remain the most commonly used techniques with reproducible and reliable results.^19,20

Evaluation

A standard evaluation with physical examination and imaging is completed in all throwers with elbow pain. In our prior study,¹⁶ we found that 100% of patients experienced pain during athletic activity and that 96% of throwers complained of pain during late cocking and acceleration phases of the throwing motion. Nearly half reported an acute onset of pain, while 53% were unable to identify a single inciting event. Seventy-five percent of the acute injuries were during competition. Delayed diagnosis was very common, with an average time to diagnosis after onset of symptoms of 6.4 months. Neurologic symptoms were seen in 23% of athletes, most of which were ulnar nerve paresthesias during throwing.¹⁶

Physical examination includes inspection for swelling, hand intrinsic atrophy, neurovascular examination, range of motion, shoulder examination, and elbow stress examination. Range of motion at presentation averaged 5° to 135° with 85° of supination and pronation.¹⁶ All patients need neurologic evaluation for ulnar nerve dysfunction. Tinel test of the cubital tunnel was positive in 21%.¹⁶ Significant ulnar nerve dysfunction, including hand weakness, is much less common but must be well examined and documented. The shoulder must also be evaluated for loss of rotation, which can lead to increased stress on the elbow. An evaluation of mechanics may point out flaws in technique, which may be contributing to elbow stress. The UCL stress examination includes static stress at 30° of flexion, the milking test at 90°, and the moving valgus stress test. The presence of pain directly over the UCL or laxity compared to the uninvolved side is suggestive of UCL injury.

Radiographic evaluation is completed in all patients with concern for UCL injury. Standard x-rays of the elbow, including anteroposterior, medial, and lateral obliques, axial olecranon, and lateral views, are obtained to evaluate bony abnormalities. Fifty-seven percent of our series showed some abnormality, most commonly olecranon osteophyte formation or ectopic calcification within the UCL substance. Stress radiography rarely changed the treatment course and is somewhat difficult to interpret because of the reports documenting normal increased medial elbow opening in the dominant arm of throwing athletes.²¹ Magnetic resonance imaging (MRI) is obtained very commonly in this patient population, and intra-articular contrast is crucial. Partial, undersurface tears are common, and a contrasted study better demonstrates undersurface tears or avulsions. The T-sign as described by Timmerman and colleagues²² using computed tomography (CT) arthrography shows partial undersurface detachment, which can be difficult to see without intra-articular contrast.²² This finding is very well visualized on MRI arthrogram as well (Figure 3).

Sensitivity in partial tears is also highly favorable for CT arthrogram over noncontrasted MRI, detecting 71% vs 14%.²² MRI with arthrogram provides further detail to better detect tears and to determine the condition of the ligament, and is currently the gold standard diagnostic test for UCL evaluation.

 

Nonoperative Management

Nonoperative treatment is recommended for 3 months prior to performing reconstruction. Patients are given complete rest from throwing, but rehabilitation is initiated immediately. Rehabilitation exercises and nonsteroidal anti-inflammatory medications are prescribed, and activities that place valgus stress across the elbow are avoided. After resolution of symptoms, an interval throwing program is initiated, and the athlete is gradually returned to sport. Unfortunately, due to season-specific schedules and time-sensitive demands in high-level throwers, operative treatment is often chosen without an extended period of conservative treatment.

Platelet-rich plasma (PRP) therapy has recently been shown to improve healing rates and promote healing in partial UCL tears,²³ and as orthobiologics are advanced, they will likely play a larger role in the treatment of UCL injuries.

Surgical Technique

At our institution, UCL reconstruction is performed with the modified Jobe technique as described by Azar and colleagues.¹⁷ Arthroscopy prior to reconstruction was routinely performed at our institution until we recognized that arthroscopy rarely changed the preoperative plan.¹⁶ Currently, the presence of anterior pathology such as loose bodies or osteochondral defect is our only indication for arthroscopy before reconstruction.

Ipsilateral palmaris autograft is our current graft of choice. This must be examined preoperatively because 16% of patients have unilateral absence and 9% have bilateral absence.²⁴ In revision cases or in patients with insufficient or absent palmaris, contralateral palmaris followed by contralateral gracilis tendon is used. The contralateral gracilis is chosen because of ease of setup and position of the surgeon during the harvest. Gracilis tendon is also used in cases with bony involvement of the ligament based on the results from Dugas and colleagues.²⁵ Toe extensors, plantaris, and patellar tendon grafts have also been used. One recent study showed that neither graft choice nor diameter affected resistance to valgus stress, and that all reconstruction types restored strength at 60° to 120° of flexion.²⁶

Ulnar nerve transposition is performed in all cases regardless of the presence of preoperative nerve symptoms. A complete decompression is completed proximally to the Arcade of Struthers and distally to the deep portion of the flexor carpi ulnaris. A single fascial sling of medial intermuscular septum originating from the epicondylar attachment is used to stabilize the nerve without compression. At wound closure, the deep fascia on the posterior skin flap is also sewn into the cubital tunnel to prevent the nerve from subluxating back into the groove. A single suture is placed distally closing the muscle fascia to prevent propagation of the fascial incision, which can lead to herniation. Transposition is necessary because of the ulnar nerve exposure required in the modified Jobe technique to allow elevation of the deep flexor muscle mass for ligament exposure.

The reconstruction is completed as described by Jobe¹⁴ but with a few modifications as described by Azar and colleagues¹⁷ and slight adaptations implemented since that time. The flexor-pronator mass is retracted laterally instead of detachment or splitting as described by Thompson and colleagues.²⁷ A subcutaneous rather than a submuscular ulnar nerve transposition is used.

The patient is positioned supine using an arm board. If gracilis tendon is chosen, the contralateral leg is prepped and draped simultaneously. A tourniquet is inflated after exsanguination. A medial approach is performed, and the medial antebrachial nerve is located and protected. The ulnar nerve is then located in the cubital tunnel and mobilized. The neurolysis extends to the deep portion of the flexor carpi ulnaris distally and proximally to the Arcade of Struthers, and the nerve is retracted with a vessel loop. The flexor muscle mass is not elevated from the medial epicondyle; rather, it is retracted anteriorly by small Hohmann retractors. The dissection is carried down to the UCL and found at its attachments to the medial epicondyle and sublime tubercle. If no tear is seen on the superficial surface of the ligament, a longitudinal incision is made through the ligament. Undersurface tears, partial tears, and avulsions can then be identified (Figure 4).

Often, a portion of the ligament is degenerative and is excised, leaving only healthy-appearing ligament.

The autologous graft of choice is then harvested. Our technique for palmaris harvest is performed with three 1-cm transverse incisions. The palmaris is palpated and marked with the first incision made near the distal wrist crease, and the second incision is made 3 to 4 cm proximal to the first. The tendon is found in both distal incisions and cut distally with the wrist flexed to maximize tendon length. The tendon is then pulled through the second incision and tensioned to identify the most proximal location the tendon can be palpated. A third incision is made directly over this point and carried down to cut the tendon. This usually provides a graft length of 15 to 20 cm; 13 cm is the minimum graft length to ensure good graft fixation. Muscle is removed from the tendon and each end is secured with a No. 1 nonabsorbable suture in a locking fashion.

If posterior osteophytes are present, they are removed through a posterior, vertical arthrotomy. Over-resection of the olecranon must be avoided, as this can further destabilize the elbow and place increased stress on the reconstruction. Posterior loose bodies can also be removed through this arthrotomy. The arthrotomy is then closed with absorbable suture.

Tunnel placement is critical to success. A 3.2-mm drill bit is used with palmaris grafts and a 4-mm drill bit is used with gracilis grafts. Two convergent tunnels are drilled in the medial epicondyle in a Y fashion and 2 convergent tunnels are drilled at the sublime tubercle in a U or V fashion. After drilling the first tunnel on each side, a hemostat is placed in the tunnel as an aiming point to ensure a complete tunnel is made. The junction is smoothed with a curette, leaving a 5-mm bone bridge between the articular surface and the tunnels. A bent Hewson suture passer is used to pass one end of the graft through the ulna. The 2 limbs of the tendon graft are then passed through the humeral tunnels, creating a figure-of-eight. A varus stress is applied with the elbow at roughly 30° and the 2 limbs are tied together with a No. 1 nonabsorbable suture. If enough graft remains, one or both limbs are passed back through the tunnels and secured again with No. 1 nonabsorbable suture. The 2 limbs are then tied side-to-side, incorporating the native ligament to further secure and tighten the reconstruction.

The ulnar nerve is then secured using a strip of medial intermuscular septum left intact to its insertion at the medial epicondyle. This is attached to the flexor-pronator muscle fascia with a 3-0 nonabsorbable suture. Enough length should be harvested from the septum to ensure there is no compression on the nerve. The deep posterior fascial tissue is then sewn to the periosteum of the medial epicondyle to further prevent subluxation of the nerve back into the groove. The skin is then closed in layered fashion over a superficial drain. The patient is placed in a well-padded posterior splint for 1 week, then the rehabilitation protocol is initiated as discussed below.

 

Postoperative Rehabilitation

A standardized postoperative 4-phase rehabilitation program for ulnar collateral reconstruction is followed as described by Wilk and colleagues.^28-30 The first phase begins immediately after surgery and continues for 4 weeks. During surgery, the patient’s elbow is placed in a compression dressing with a posterior splint to immobilize the elbow in 90° of flexion with wrist motion for 1 week to allow initial healing. Full range of motion of the elbow joint is restored by the end of the fifth to sixth week after surgery.

During phase II (weeks 4-10), a progressive isotonic strengthening program is initiated. Exercises are focused on scapular, rotator cuff, deltoid, and arm musculature. Shoulder range of motion and stretching exercises are performed during this phase and the Thrower’s Ten exercise program is initiated. Any adaptations or strength deficits are addressed during this phase.

During the advanced strengthening phase (phase III), from weeks 10 to 16, a sport-specific exercise/rehabilitation program is initiated. During this phase, stretching and flexibility exercises are performed to enhance strength, power, and endurance. During this phase the patient is placed on the advanced Thrower’s Ten program. Isotonic strengthening exercises are progressed, and at week 12, the athlete is allowed to begin an isotonic lifting program, including bench press, seated rowing, latissimus dorsi pull downs, triceps push downs, and biceps curls. In addition, the athlete performs specific exercises to emphasize sport-specific movements. At week 12, overhead athletes begin a 2-hand plyometric throwing program, and at 14 weeks, a 1-hand plyometric throwing program. Furthermore, endurance exercises, core stability, and leg strengthening are emphasized during phase III. Phase IV, the return to activity phase (week 16 and beyond), is characterized by the initiation of an interval throwing program. The patient is instructed to continue his stretching and strengthening program. An interval throwing program off the mound is gradually initiated at 5 to 6 months postoperative and a gradual return to competition is initiated for pitchers at 9 months and for position players 6 to 7 months postoperative.

Discussion

Results after ulnar collateral reconstruction have been good. In our series of 743 patients, 83% returned to the same or higher level at an average of 11.6 months.¹⁶ There was a 4% major complication rate and 16% minor complication rate. Major complications included medial epicondyle fracture (0.5%), significant ulnar nerve dysfunction (1 patient), rupture of graft (1%), and graft site infection. Sixteen percent of patients had ulnar nerve dysfunction, and 82% of these resolved within 6 weeks. All but 1 patient’s paresthesias resolved within 1 year.¹⁶ The 10-year follow-up of this group of patients included 256 patients and was reported by Osbahr and colleagues³¹ in 2014. Retirement from baseball was due to reasons other than the elbow in 86%, and 98% were still able to throw on at least a recreational level. The overall longevity was 3.6 years, with 2.9 years at pre-injury level or higher. Statistically, pitchers performed at a higher level after reconstruction.³¹

A recent review by Erickson and colleagues⁹ showed an overall 82% excellent and 8% good result when evaluating different techniques, including the American Sports Medicine Institute (ASMI) modification of Jobe’s technique, docking technique, and Jobe’s technique. With an overall complication rate of 10% (75% of which was transient ulnar neuritis), the procedure was deemed overall a safe surgical option. Collegiate athletes had the highest return to sport (95%) compared with high school athletes (89%) and professional athletes (86%). The docking technique had the highest rate of return to play (97%) compared with ASMI technique (93%) and Jobe technique (66%).⁹ Results after repair have not been as good as reconstruction, as reported in 2 studies.^16,32 Savoie and colleagues,¹⁵ however, reported 93% good/excellent results after primary UCL repair alone.

Another recent review of outcomes showed an overall return to same or higher level was best with docking or modified docking techniques (90.4% and 91.3%, respectively).¹⁹ Overall return with modified Jobe technique was 77%.¹⁹ O’Brien and colleagues²⁰ performed a review of 33 patients with either modified Jobe or docking technique that showed 81% return to same or higher level with modified Jobe vs 92% with docking technique. The Kerlan-Jobe Orthopaedic Clinic scores were higher in the modified Jobe group (79 vs 74) and the docking technique group returned to play nearly 1 month sooner (12.4 months vs 11.8 months).²⁰ However, comparing different techniques in a heterogenous patient population over 40 years is difficult. Many of the modified Jobe technique cases were performed in the early evolution of the rehabilitation and return-to-play programs. We believe that the current modified Jobe technique has results equal to any other variation.

Despite good results with reconstructions, the recovery is lengthy and most pitchers cannot fully return to competition level for 12 to 18 months. Extensive research has been performed in exploring alternatives to the traditional reconstruction. Advancements in orthobiologics and development of new surgical options seem to provide an alternative to reconstruction, and may allow faster return to competition with less morbidity.

PRP has been at the forefront of orthopedic research for the last 2 decades, mostly focused in tendon and bone healing. Due to the release of many inflammatory mediators, PRP is theorized to initiate a healing response with growth factors that can direct healing towards normal tissue.³³ Two main types of PRP are reported based on the presence or absence of leukocytes. PRP has been studied in many applications, but only one clinical study on the UCL has been published to date. Podesta and colleagues²³ injected PRP into the elbow of 34 baseball players with MRI-confirmed partial UCL tear. The athletes then underwent a rehabilitation program, which limited stress across the UCL. Type 1A PRP was used (leukocyte-rich, unactivated, 5x or greater platelet concentration³³). Athletes were allowed to return to sport based on symptoms and examination findings. Eighty-eight percent returned to same level of play without complaints at average 70 week follow-up, and average return to play ranged from 10 to 15 weeks.²³ No specific data were given on the 16 pitchers in the group, but with such a high rate of return, PRP needs to be further evaluated in the treatment of UCL injuries.

Another recent study from Dugas and colleagues¹⁸ presented primary UCL repair using a tape augment (InternalBrace, Arthrex). Nine matched cadaver elbows underwent UCL sectioning and then either modified Jobe reconstruction or primary repair of the UCL with placement of the InternalBrace. The biomechanical data showed the repair with internal brace to have slightly less gap, more stiffness, and higher failure strength, although these findings were not statistically significant.¹⁸ This bone-preserving technique with less exposure and healing of the native ligament may be another step towards good results with a quicker return to throwing.

 

Conclusion

UCL injuries can be disabling in throwers. Reconstruction has afforded throwers a high rate of return to preinjury function or better, and several techniques have been presented that produce acceptable results. Overall complication rates range from 10% to 15%, and the majority of complications are transient ulnar neuropraxias. Orthobiologics and repair with augmentation have more recently offered additional options that may improve success of nonoperative treatment or allow less-invasive surgical treatment. Increased involvement in youth sports and early specialization is driving injury rates in young athletes. The orthopedic community must continue to look for better ways to prevent these injuries and investigate better methods to return athletes to high-level competition.

Am J Orthop. 2016;45(7):E534-E540. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

The ulnar collateral ligament (UCL) is the primary restraint to valgus stress between 20° and 125° of motion.^1-5 Overhead athletes, most commonly baseball pitchers, are at risk of developing UCL insufficiency, and dysfunction presents as pain with loss of velocity and control. Some injuries may present acutely while throwing, but many patients, when questioned, report a preceding period of either pain or loss of velocity and control.

Authors have documented a significant rise in elbow injuries in young athletes, especially pitchers.⁶ Extended seasons, higher pitch counts, year-round pitching, pitching while fatigued, and pitching for multiple teams are risk factors for elbow injuries.⁷ Pitchers in the southern United States are more likely to undergo UCL reconstruction than those from the northern states.⁸ Pitchers who also play catcher are at a higher risk due to more total throws than those who pitch and play other positions or pitch only. Throwers with higher velocity are more likely to pitch in showcases, pitch for multiple teams, and pitch with pain and fatigue, and these are all risk factors.⁶ Also, in one study of youth baseball injuries, individuals in the injured group were found to be taller and heavier than those in the uninjured group.⁶ Pitch counts, rest from pitching during the off-season, adequate rest, and ensuring pain-free pitching can lessen the risk of injury.⁶ As expected with the rise in throwing injuries, the rise in medial elbow procedures has risen.⁹

While throwing, stress across the medial elbow has been measured to be nearly 300 N. A maximum varus force during pitching was measured to be 64 N-m at 95° ± 14°.¹⁰ Morrey and An⁴ determined that the UCL generated 54% of the varus force at 90° of flexion. During active pitching, this value is likely reduced due to simultaneous muscle contraction, but if one assumes the UCL bears 54% of the maximal load, the UCL must be able to withstand 34 N-m. The UCL can withstand a maximum valgus torque between 22.7 and 34 N-m^11-13; therefore, during pitching, the UCL is at or above its failure load. After thousands of cycles over many years, one can imagine how the UCL might be injured.

Multiple techniques have been proposed in the surgical treatment of UCL injuries. Jobe¹⁴ pioneered UCL reconstruction in 1974 in Tommy John, a Major League Baseball pitcher. John returned to pitch successfully, and both the UCL and the reconstruction are commonly called by his name. Jobe¹⁴ reported his technique in 1986, and it has remained, with a few modifications, the primary method for reconstruction of the UCL (Figure 1).

Primary repair has been reported, and the best results have been in younger pitchers with acute injuries.¹⁵ Cain and colleagues¹⁶ reported a 70% return to same or higher level with repair alone, which was an improvement on Azar’s series¹⁷ with 63% return to same or higher level. Recent advancements have included primary repair with augmentation using grafts or anchored suture or tape¹⁸ (Figure 2).

The modified Jobe and docking techniques remain the most commonly used techniques with reproducible and reliable results.^19,20

Evaluation

A standard evaluation with physical examination and imaging is completed in all throwers with elbow pain. In our prior study,¹⁶ we found that 100% of patients experienced pain during athletic activity and that 96% of throwers complained of pain during late cocking and acceleration phases of the throwing motion. Nearly half reported an acute onset of pain, while 53% were unable to identify a single inciting event. Seventy-five percent of the acute injuries were during competition. Delayed diagnosis was very common, with an average time to diagnosis after onset of symptoms of 6.4 months. Neurologic symptoms were seen in 23% of athletes, most of which were ulnar nerve paresthesias during throwing.¹⁶

Physical examination includes inspection for swelling, hand intrinsic atrophy, neurovascular examination, range of motion, shoulder examination, and elbow stress examination. Range of motion at presentation averaged 5° to 135° with 85° of supination and pronation.¹⁶ All patients need neurologic evaluation for ulnar nerve dysfunction. Tinel test of the cubital tunnel was positive in 21%.¹⁶ Significant ulnar nerve dysfunction, including hand weakness, is much less common but must be well examined and documented. The shoulder must also be evaluated for loss of rotation, which can lead to increased stress on the elbow. An evaluation of mechanics may point out flaws in technique, which may be contributing to elbow stress. The UCL stress examination includes static stress at 30° of flexion, the milking test at 90°, and the moving valgus stress test. The presence of pain directly over the UCL or laxity compared to the uninvolved side is suggestive of UCL injury.

Radiographic evaluation is completed in all patients with concern for UCL injury. Standard x-rays of the elbow, including anteroposterior, medial, and lateral obliques, axial olecranon, and lateral views, are obtained to evaluate bony abnormalities. Fifty-seven percent of our series showed some abnormality, most commonly olecranon osteophyte formation or ectopic calcification within the UCL substance. Stress radiography rarely changed the treatment course and is somewhat difficult to interpret because of the reports documenting normal increased medial elbow opening in the dominant arm of throwing athletes.²¹ Magnetic resonance imaging (MRI) is obtained very commonly in this patient population, and intra-articular contrast is crucial. Partial, undersurface tears are common, and a contrasted study better demonstrates undersurface tears or avulsions. The T-sign as described by Timmerman and colleagues²² using computed tomography (CT) arthrography shows partial undersurface detachment, which can be difficult to see without intra-articular contrast.²² This finding is very well visualized on MRI arthrogram as well (Figure 3).

Sensitivity in partial tears is also highly favorable for CT arthrogram over noncontrasted MRI, detecting 71% vs 14%.²² MRI with arthrogram provides further detail to better detect tears and to determine the condition of the ligament, and is currently the gold standard diagnostic test for UCL evaluation.

 

Nonoperative Management

Nonoperative treatment is recommended for 3 months prior to performing reconstruction. Patients are given complete rest from throwing, but rehabilitation is initiated immediately. Rehabilitation exercises and nonsteroidal anti-inflammatory medications are prescribed, and activities that place valgus stress across the elbow are avoided. After resolution of symptoms, an interval throwing program is initiated, and the athlete is gradually returned to sport. Unfortunately, due to season-specific schedules and time-sensitive demands in high-level throwers, operative treatment is often chosen without an extended period of conservative treatment.

Platelet-rich plasma (PRP) therapy has recently been shown to improve healing rates and promote healing in partial UCL tears,²³ and as orthobiologics are advanced, they will likely play a larger role in the treatment of UCL injuries.

Surgical Technique

At our institution, UCL reconstruction is performed with the modified Jobe technique as described by Azar and colleagues.¹⁷ Arthroscopy prior to reconstruction was routinely performed at our institution until we recognized that arthroscopy rarely changed the preoperative plan.¹⁶ Currently, the presence of anterior pathology such as loose bodies or osteochondral defect is our only indication for arthroscopy before reconstruction.

Ipsilateral palmaris autograft is our current graft of choice. This must be examined preoperatively because 16% of patients have unilateral absence and 9% have bilateral absence.²⁴ In revision cases or in patients with insufficient or absent palmaris, contralateral palmaris followed by contralateral gracilis tendon is used. The contralateral gracilis is chosen because of ease of setup and position of the surgeon during the harvest. Gracilis tendon is also used in cases with bony involvement of the ligament based on the results from Dugas and colleagues.²⁵ Toe extensors, plantaris, and patellar tendon grafts have also been used. One recent study showed that neither graft choice nor diameter affected resistance to valgus stress, and that all reconstruction types restored strength at 60° to 120° of flexion.²⁶

Ulnar nerve transposition is performed in all cases regardless of the presence of preoperative nerve symptoms. A complete decompression is completed proximally to the Arcade of Struthers and distally to the deep portion of the flexor carpi ulnaris. A single fascial sling of medial intermuscular septum originating from the epicondylar attachment is used to stabilize the nerve without compression. At wound closure, the deep fascia on the posterior skin flap is also sewn into the cubital tunnel to prevent the nerve from subluxating back into the groove. A single suture is placed distally closing the muscle fascia to prevent propagation of the fascial incision, which can lead to herniation. Transposition is necessary because of the ulnar nerve exposure required in the modified Jobe technique to allow elevation of the deep flexor muscle mass for ligament exposure.

The reconstruction is completed as described by Jobe¹⁴ but with a few modifications as described by Azar and colleagues¹⁷ and slight adaptations implemented since that time. The flexor-pronator mass is retracted laterally instead of detachment or splitting as described by Thompson and colleagues.²⁷ A subcutaneous rather than a submuscular ulnar nerve transposition is used.

The patient is positioned supine using an arm board. If gracilis tendon is chosen, the contralateral leg is prepped and draped simultaneously. A tourniquet is inflated after exsanguination. A medial approach is performed, and the medial antebrachial nerve is located and protected. The ulnar nerve is then located in the cubital tunnel and mobilized. The neurolysis extends to the deep portion of the flexor carpi ulnaris distally and proximally to the Arcade of Struthers, and the nerve is retracted with a vessel loop. The flexor muscle mass is not elevated from the medial epicondyle; rather, it is retracted anteriorly by small Hohmann retractors. The dissection is carried down to the UCL and found at its attachments to the medial epicondyle and sublime tubercle. If no tear is seen on the superficial surface of the ligament, a longitudinal incision is made through the ligament. Undersurface tears, partial tears, and avulsions can then be identified (Figure 4).

Often, a portion of the ligament is degenerative and is excised, leaving only healthy-appearing ligament.

The autologous graft of choice is then harvested. Our technique for palmaris harvest is performed with three 1-cm transverse incisions. The palmaris is palpated and marked with the first incision made near the distal wrist crease, and the second incision is made 3 to 4 cm proximal to the first. The tendon is found in both distal incisions and cut distally with the wrist flexed to maximize tendon length. The tendon is then pulled through the second incision and tensioned to identify the most proximal location the tendon can be palpated. A third incision is made directly over this point and carried down to cut the tendon. This usually provides a graft length of 15 to 20 cm; 13 cm is the minimum graft length to ensure good graft fixation. Muscle is removed from the tendon and each end is secured with a No. 1 nonabsorbable suture in a locking fashion.

If posterior osteophytes are present, they are removed through a posterior, vertical arthrotomy. Over-resection of the olecranon must be avoided, as this can further destabilize the elbow and place increased stress on the reconstruction. Posterior loose bodies can also be removed through this arthrotomy. The arthrotomy is then closed with absorbable suture.

Tunnel placement is critical to success. A 3.2-mm drill bit is used with palmaris grafts and a 4-mm drill bit is used with gracilis grafts. Two convergent tunnels are drilled in the medial epicondyle in a Y fashion and 2 convergent tunnels are drilled at the sublime tubercle in a U or V fashion. After drilling the first tunnel on each side, a hemostat is placed in the tunnel as an aiming point to ensure a complete tunnel is made. The junction is smoothed with a curette, leaving a 5-mm bone bridge between the articular surface and the tunnels. A bent Hewson suture passer is used to pass one end of the graft through the ulna. The 2 limbs of the tendon graft are then passed through the humeral tunnels, creating a figure-of-eight. A varus stress is applied with the elbow at roughly 30° and the 2 limbs are tied together with a No. 1 nonabsorbable suture. If enough graft remains, one or both limbs are passed back through the tunnels and secured again with No. 1 nonabsorbable suture. The 2 limbs are then tied side-to-side, incorporating the native ligament to further secure and tighten the reconstruction.

The ulnar nerve is then secured using a strip of medial intermuscular septum left intact to its insertion at the medial epicondyle. This is attached to the flexor-pronator muscle fascia with a 3-0 nonabsorbable suture. Enough length should be harvested from the septum to ensure there is no compression on the nerve. The deep posterior fascial tissue is then sewn to the periosteum of the medial epicondyle to further prevent subluxation of the nerve back into the groove. The skin is then closed in layered fashion over a superficial drain. The patient is placed in a well-padded posterior splint for 1 week, then the rehabilitation protocol is initiated as discussed below.

 

Postoperative Rehabilitation

A standardized postoperative 4-phase rehabilitation program for ulnar collateral reconstruction is followed as described by Wilk and colleagues.^28-30 The first phase begins immediately after surgery and continues for 4 weeks. During surgery, the patient’s elbow is placed in a compression dressing with a posterior splint to immobilize the elbow in 90° of flexion with wrist motion for 1 week to allow initial healing. Full range of motion of the elbow joint is restored by the end of the fifth to sixth week after surgery.

During phase II (weeks 4-10), a progressive isotonic strengthening program is initiated. Exercises are focused on scapular, rotator cuff, deltoid, and arm musculature. Shoulder range of motion and stretching exercises are performed during this phase and the Thrower’s Ten exercise program is initiated. Any adaptations or strength deficits are addressed during this phase.

During the advanced strengthening phase (phase III), from weeks 10 to 16, a sport-specific exercise/rehabilitation program is initiated. During this phase, stretching and flexibility exercises are performed to enhance strength, power, and endurance. During this phase the patient is placed on the advanced Thrower’s Ten program. Isotonic strengthening exercises are progressed, and at week 12, the athlete is allowed to begin an isotonic lifting program, including bench press, seated rowing, latissimus dorsi pull downs, triceps push downs, and biceps curls. In addition, the athlete performs specific exercises to emphasize sport-specific movements. At week 12, overhead athletes begin a 2-hand plyometric throwing program, and at 14 weeks, a 1-hand plyometric throwing program. Furthermore, endurance exercises, core stability, and leg strengthening are emphasized during phase III. Phase IV, the return to activity phase (week 16 and beyond), is characterized by the initiation of an interval throwing program. The patient is instructed to continue his stretching and strengthening program. An interval throwing program off the mound is gradually initiated at 5 to 6 months postoperative and a gradual return to competition is initiated for pitchers at 9 months and for position players 6 to 7 months postoperative.

Discussion

Results after ulnar collateral reconstruction have been good. In our series of 743 patients, 83% returned to the same or higher level at an average of 11.6 months.¹⁶ There was a 4% major complication rate and 16% minor complication rate. Major complications included medial epicondyle fracture (0.5%), significant ulnar nerve dysfunction (1 patient), rupture of graft (1%), and graft site infection. Sixteen percent of patients had ulnar nerve dysfunction, and 82% of these resolved within 6 weeks. All but 1 patient’s paresthesias resolved within 1 year.¹⁶ The 10-year follow-up of this group of patients included 256 patients and was reported by Osbahr and colleagues³¹ in 2014. Retirement from baseball was due to reasons other than the elbow in 86%, and 98% were still able to throw on at least a recreational level. The overall longevity was 3.6 years, with 2.9 years at pre-injury level or higher. Statistically, pitchers performed at a higher level after reconstruction.³¹

A recent review by Erickson and colleagues⁹ showed an overall 82% excellent and 8% good result when evaluating different techniques, including the American Sports Medicine Institute (ASMI) modification of Jobe’s technique, docking technique, and Jobe’s technique. With an overall complication rate of 10% (75% of which was transient ulnar neuritis), the procedure was deemed overall a safe surgical option. Collegiate athletes had the highest return to sport (95%) compared with high school athletes (89%) and professional athletes (86%). The docking technique had the highest rate of return to play (97%) compared with ASMI technique (93%) and Jobe technique (66%).⁹ Results after repair have not been as good as reconstruction, as reported in 2 studies.^16,32 Savoie and colleagues,¹⁵ however, reported 93% good/excellent results after primary UCL repair alone.

Another recent review of outcomes showed an overall return to same or higher level was best with docking or modified docking techniques (90.4% and 91.3%, respectively).¹⁹ Overall return with modified Jobe technique was 77%.¹⁹ O’Brien and colleagues²⁰ performed a review of 33 patients with either modified Jobe or docking technique that showed 81% return to same or higher level with modified Jobe vs 92% with docking technique. The Kerlan-Jobe Orthopaedic Clinic scores were higher in the modified Jobe group (79 vs 74) and the docking technique group returned to play nearly 1 month sooner (12.4 months vs 11.8 months).²⁰ However, comparing different techniques in a heterogenous patient population over 40 years is difficult. Many of the modified Jobe technique cases were performed in the early evolution of the rehabilitation and return-to-play programs. We believe that the current modified Jobe technique has results equal to any other variation.

Despite good results with reconstructions, the recovery is lengthy and most pitchers cannot fully return to competition level for 12 to 18 months. Extensive research has been performed in exploring alternatives to the traditional reconstruction. Advancements in orthobiologics and development of new surgical options seem to provide an alternative to reconstruction, and may allow faster return to competition with less morbidity.

PRP has been at the forefront of orthopedic research for the last 2 decades, mostly focused in tendon and bone healing. Due to the release of many inflammatory mediators, PRP is theorized to initiate a healing response with growth factors that can direct healing towards normal tissue.³³ Two main types of PRP are reported based on the presence or absence of leukocytes. PRP has been studied in many applications, but only one clinical study on the UCL has been published to date. Podesta and colleagues²³ injected PRP into the elbow of 34 baseball players with MRI-confirmed partial UCL tear. The athletes then underwent a rehabilitation program, which limited stress across the UCL. Type 1A PRP was used (leukocyte-rich, unactivated, 5x or greater platelet concentration³³). Athletes were allowed to return to sport based on symptoms and examination findings. Eighty-eight percent returned to same level of play without complaints at average 70 week follow-up, and average return to play ranged from 10 to 15 weeks.²³ No specific data were given on the 16 pitchers in the group, but with such a high rate of return, PRP needs to be further evaluated in the treatment of UCL injuries.

Another recent study from Dugas and colleagues¹⁸ presented primary UCL repair using a tape augment (InternalBrace, Arthrex). Nine matched cadaver elbows underwent UCL sectioning and then either modified Jobe reconstruction or primary repair of the UCL with placement of the InternalBrace. The biomechanical data showed the repair with internal brace to have slightly less gap, more stiffness, and higher failure strength, although these findings were not statistically significant.¹⁸ This bone-preserving technique with less exposure and healing of the native ligament may be another step towards good results with a quicker return to throwing.

 

Conclusion

UCL injuries can be disabling in throwers. Reconstruction has afforded throwers a high rate of return to preinjury function or better, and several techniques have been presented that produce acceptable results. Overall complication rates range from 10% to 15%, and the majority of complications are transient ulnar neuropraxias. Orthobiologics and repair with augmentation have more recently offered additional options that may improve success of nonoperative treatment or allow less-invasive surgical treatment. Increased involvement in youth sports and early specialization is driving injury rates in young athletes. The orthopedic community must continue to look for better ways to prevent these injuries and investigate better methods to return athletes to high-level competition.

Am J Orthop. 2016;45(7):E534-E540. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Healing after rotator cuff repair (RCR) can be challenging, especially in cases of large and massive tears, revision repairs, and tendons with poor tissue quality.^1-3 Poor tissue quality is associated with increased risk for recurrent tears, independent of age and tear size.³ Various techniques have been used to improve tendon fixation strength in these difficult situations, including augmented suture configurations (eg, massive cuff stitches, rip-stop stitches) and tissue grafts (eg, acellular dermal matrix).^4-9 Clinical studies have found improved healing rates for larger tears and revision repairs using acellular dermal matrix grafts.^6,10 Synthetic patches are another option for RCR augmentation, but limited clinical data and biomechanical evidence support use of synthetic grafts as an augment for RCRs.^11-13

Polyhydroxyalkanoates (PHAs) are a class of biodegradable polymers that have been used as orthopedic devices, tissue scaffolds, patches, and other applications with increasing frequency over the past decade.¹⁴ In the laboratory, these implanted materials have been shown to support cell migration and growth.¹⁵ The PHA family of polymers typically degrades by hydrolytic and bacterial depolymerase mechanisms over 52-plus weeks in vivo.¹⁴PHA grafts have been studied in the setting of RCR. An expanded polytetrafluoroethylene scaffold was shown to improve repair mechanics when used as a bursal side graft in an in vitro ovine model.¹¹ The graft increased tendon footprint contact pressure and failure loads by almost 180 N. In clinical studies, poly-L-lactic acid augmentations have been used to reinforce massive RCRs. Lenart and colleagues¹⁶ found that 38% of 16 patients with such tears had an intact rotator cuff at 1.2-year follow-up, and improvement in clinical scores. Proctor¹³ reported on use of a poly-L-lactic acid retrograde patch for reinforcement of massive tears with both single- and double-row repairs in 18 patients. The cohort had more favorable rates of intact cuffs at 12 months (83%) and 42 months (78%), and ASES (American Shoulder and Elbow Surgeons) scores improved from 25 before surgery to 82 at latest follow-up after surgery.

RCR augmentation traditionally has been performed with an open or mini-open technique.⁶ Recently, several authors have reported on arthroscopic techniques for augmentation with either acellular dermal matrix or synthetic grafts.^13,17,18 Most techniques have involved “bridging” with a graft or patch used to stress-shield a single-row repair.^8,9,13 This bridging typically involves placing several sutures medial to where the anchor repair stitches pass through the tendon. An alternative is to pass the repair stitches through both the tendon and the graft.^17-19 The overall volume of tissue incorporated into the repair stitches (rotator cuff plus graft) is increased with the augmented technique relative to the bridging technique. Both can be technically challenging, but the augmented technique may be easier to perform arthroscopically.^9,19 Regardless, these techniques are complicated and require a higher level of arthroscopic skills compared with those required in arthroscopic RCR without a graft. Simplifying arthroscopic graft augmentation likely will increase its utility because, even for skilled surgeons, adding a graft can increase operative time by 20 to 30 minutes. Simplification will also extend use of the technique to surgeons with less experience and proficiency with arthroscopic repair.

We developed a simple method for augmenting single-row RCR with a strip of bioresorbable soft-tissue scaffold. We also conducted a study to evaluate the initial biomechanical properties of single-row RCR in cadaveric shoulder specimens augmented with PHA mesh (BioFiber; Tornier) graft as compared with single-row RCR without augmentation. Both cyclic gap formation and ultimate failure loads and displacement were quantified. We hypothesized that the augmented RCRs would have decreased gap formation and increased ultimate failure loads compared with nonaugmented RCRs. This study was exempt from having to obtain Institutional Review Board approval.

Methods

Eight pairs of fresh-frozen cadaver humeri (6 male, 2 female; mean [SD] age, 61 [9] years) were dissected of all soft tissue (except rotator cuff) by Dr. Tashjian, a board-certified, fellowship-trained orthopedic surgeon. There were no qualitative differences in tendon condition between tendons within a pair. The supraspinatus muscle and tendon were separated from the other rotator cuff muscles. The infraspinatus, subscapularis, and teres minor were removed from the humerus. Last, the supraspinatus was resected at its insertion. Humeral pairs were then randomized into augmented and nonaugmented RCRs within each pair.

In the nonaugmented group, the supraspinatus was reattached to its insertion in a single-row RCR with 2 triple-loaded suture anchors (5.5-mm Insite FT Ti, No. 2 Force Fiber suture; Tornier) and 6 simple stitches (Figure 1A). Anchors were placed midway between the articular margin and the lateral edge of the greater tuberosity at about 45° to the bone surface.

Anchors were separated by 15 mm, with the anterior anchor 5 mm posterior to the biceps groove. Stitches were passed through the supraspinatus tendon, taking a 15-mm bite of tissue, with each stitch separated by 5 mm. Each suture was then tied with a Revo knot.

In the contralateral shoulders, augmented RCRs were performed. Specimens were prepared exactly as they were for the nonaugmented RCRs, including anchor placement and suture passage. Before knot tying, RCRs were augmented with 2 strips of 13-mm × 23-mm PHA mesh (BioFiber) (Figure 1B). One strip was used to augment the 3 sutures of each anchor, overlying the residual tendon, to reinforce the tendon–knot interface. After each suture was passed through the supraspinatus tendon from the intra-articular surface, the stitch was passed through the strip of PHA mesh. Stitches were separated by 5 mm in each mesh strip. All 6 sutures were then tied with a Revo knot between the free end of each suture leg and the leg that passed through the tendon and mesh.

Each humerus was transected at the midshaft and potted and mounted in an Instron 1331 load frame with Model 8800 controller (Instron). A cryoclamp was used to grasp the supraspinatus muscle belly above the musculotendinous junction (Figure 2).

The humerus was aligned in the mounting fixture such that loading was performed at a 135° angle with the humeral shaft (Figure 2).²⁰ The Instron, which was equipped with a 1-kN load cell (Dynacell Model 2527-130; Instron) to monitor applied force, measured applied displacement.

Three rows of 2-mm fiducial markers were affixed to the bone, tendon, and muscle belly with cyanoacrylate for tracking with a digital video system (DMAS Version 6.5; Spicatek) (Figure 3).21

Camera resolution was 1360 pixels × 1024 pixels, and DMAS accuracy for marker centroid tracking was rated at ± 0.005 mm. Construct gapping was defined as the difference in displacement between the markers at the tissue–suture interface and the markers on the bone. Tissue deformation was then defined as the displacement between the markers at the tissue–suture interface and the markers on the muscle belly. Mean gapping was defined from anterior to posterior across the construct using 3 sets of fiducial markers.

A 0.1-MPa pre-stress (applied force/tendon cross-sectional area) was applied to each construct to determine the starting position for the deformation profile. Each repair underwent 1000 cycles of uniaxial load-controlled displacement between 0.1 and 1.0 MPa of effective stress at 1 Hz. Effective stress was determined as the ratio of applied force to cross-sectional area of the tendon at harvest to normalize the applied loads between tendons of varying size. During cyclic testing, gapping of more than 5 mm was defined as construct failure.²² After cyclic loading, each construct was loaded to failure at 1.0 mm/s. Ultimate failure load was defined as the highest load achieved at the maximum displacement before rapid decline in load supported by the construct.

 

Statistical Analysis

Paired t tests were used to compare the matched pairs of constructs. For all tests, significance was set at P ≤ .05. Post hoc power was calculated for significant results using G*Power Version 3.1.6.²³ All data are presented as means (SDs).

Results

After 1000 cycles of displacement, mean (SD) gapping was 3.8 (0.9) mm for the nonaugmented repairs and 3.9 (1.1) mm for the PHA mesh–augmented repairs (P = .879) (Figure 4).

Mean (SD) tissue elongation above the construct was comparable (P = .276) between nonaugmented repairs, 0.5 (0.4) mm, and augmented repairs, 0.7 (0.4) mm. No specimens failed during cyclic load, as mean gapping was <4 mm²² in all constructs. Mean (SD) applied force was 11.8 (1.8) N at 0.1 MPa of effective stress and 117.8 (18.1) N at 1.0 MPa of effective stress. Applied force did not vary between constructs (P = .727).

For the nonaugmented repairs, mean (SD) failure displacement was 6.3 (1.7) mm, and mean (SD) ultimate failure load was 472.1 (120.3) N. For the PHA-augmented repairs, failure displacement was 5.5 (1.9) mm, and ultimate failure load was 571.2 (173.0) N. There was no difference in failure displacement (P = .393), but there was a difference in ultimate failure load (P = .042; power = 0.57). During failure testing, mean (SD) tissue deformation was higher (P = .012; power = 0.83) for the PHA-augmented repairs, 1.2 (0.7) mm, than for the nonaugmented repairs, 0.8 (0.5) mm. Failures, which were consistent within pairs, were caused by tissue failure, with sutures pulling through the tissue (4 pairs) or single anchor pullout before ultimate tissue failure (4 pairs). Of the 4 failures with anchor pullout, 3 had anterior anchor pullout, and 1 had posterior anchor pullout. In all specimens with anchor pullout, the second anchor remained stable, and ultimate failure occurred with tissue tearing at the suture interface. There were no significant differences in any metrics between specimens that failed with intact anchors and specimens with single anchor pullout (P ≥ .122). Therefore, both groups were pooled for the failure analysis.

Discussion

RCR augmentation with a synthetic graft is a viable option for improving fixation strength of supraspinatus repairs, as shown in otherwise healthy tendon in the present study. Our hypothesis that there would be decreased gap formation with graft augmentation was not supported, whereas the hypothesis of increased failure loads with graft augmentation was supported. These findings may also be applicable in cases of large tears, revisions, and tendons with poor tissue quality. Simplification of graft application techniques will allow quick and easy arthroscopic augmentation.

Studies of RCRs for large or massive tears have reported retear rates of 25% to 79%.^24-26 Latissimus dorsi tendon transfers also show promise in posterosuperior RCRs, with failure rates near 10%.^27,28 Although use of PHA patches in RCR augmentation is relatively new, short-term and midterm failure rates are in the range of 20% to 60% in the few small cohorts currently being studied.^13,16 It is possible that these rates may improve as indications, surgical experience, and techniques for use of PHA patches are further refined. Regardless, with PHA currently being used in practice, it is important to quantify the biomechanics of the augmentation as a baseline for its performance in reinforcing the tendon–suture interface.

We determined that the initial fixation strength of single-row repairs was higher with the addition of PHA synthetic grafts using a very simple technique. Single-row triple-loaded anchor repairs already provide high initial mechanical strength, and our results are similar to those of another study of this technique.²⁹ Despite the already high mechanical strength of a triple-loaded anchor repair, PHA mesh increased ultimate strength by about 100 N (~25%). Of note, tissue elongation during failure was higher (P = .012; power = 0.83) in the PHA-augmented group (1.2 mm) than in the nonaugmented group (0.8 mm). This was not surprising—failure loads were almost 100 N higher in the PHA-augmented group than in the nonaugmented group. Consequently, much higher forces were placed on the muscle belly, likely resulting in additional elongation of the intact tissue medial to the repair construct.

The ultimate failure loads in our study compare favorably with the biomechanical strength of augmented repairs reported by others.^8,9,18 Barber and colleagues¹⁸ evaluated an augmented single-row repair with 2 double-loaded suture anchors and an acellular dermal matrix graft. The ultimate failure load of the augmented repairs was 325 N. In contrast, Omae and colleagues⁸ tested a bridging single-row repair using 2 double-loaded suture anchors and an acellular dermal matrix graft. Ultimate failure load of the augmented repairs was 560 N, similar to our finding. Last, Shea and colleagues⁹ evaluated a bridging single-row repair using 2 double-loaded suture anchors and an acellular dermal matrix graft, with ultimate failure load of 429 N. The techniques in all 3 studies can be performed arthroscopically but are challenging and require multiple extra sutures and anchors that need management and tying. Our technique provides similar initial fixation strength, has no requirement for extra sutures or anchors, and is very simple to perform.

The supraspinatus tendon is estimated to fail between 800 N and 1000 N.^30,31 Biomechanical shoulder simulators use supraspinatus forces in the range of 20 N to 200 N for scapular plane abduction.^32-36 Therefore, the single-row repair failures in our study fell between functional and full-thickness failure loads. Studies on the mechanics of degenerated human supraspinatus tendon are limited, but there is evidence the mechanical properties of these tissues are inferior to those of healthy tendon.³⁷ A 100-N increase in failure loads with PHA augmentation may prove highly significant in reinforcing the suture–tendon interface in degenerated tendons.

Adding the mesh did not have any effect on gapping at the repair site after cyclic loading. This finding suggests that construct gapping under cyclic loading is not a function of a reinforced knot–tendon interface but is instead caused by microtearing and cinching of the suture constructs in relation to the underlying bone. Tissue elongation likely was not a strong contributor to overall cyclic gapping, as elongation did not differ between the nonaugmented and augmented repairs (0.5 mm vs 0.7 mm; P = .276) and was small relative to the nearly 4 mm of construct gapping. Gapping may be affected by healing and integration of the mesh into the repaired tendon over time, but this effect could not be captured in the present study. Patients are initially immobilized and passive shoulder motion gradually introduced, in stark contrast to the immediate loading protocol in the present study. Regardless, the 25% increase in overall strength may be clinically important, especially in cases of difficult repair or poor tissue quality.

Our technique simplifies arthroscopic augmentation—stitches are passed through the rotator cuff in simple fashion. Before being tied, the limbs that were passed through the rotator cuff are removed through a cannula and then passed through the synthetic graft.

The graft is then shuttled into the subacromial space, and all the suture limbs are tied simply (Figures 5A, 5B). Even though this implementation is simple, our data showed the construct increases overall failure loads by about 25% with no effect on construct elongation.

 

Study Limitations

This study had several limitations. First, it was a cadaveric biomechanical study that evaluated only time-zero biomechanical properties. Loads were normalized to tendon size, specimens were randomized between sides, and paired specimens were used to minimize the effects of tendon and bone quality on outcome metrics. In addition, donor tendons were representative of otherwise healthy tissue. Chronic tears and associated resorption/atrophy could have affected the magnitude of forces and gapping detected in this study. Theoretically, over time the tendon tissue will adhere to and grow into the mesh, which could minimize potential differences. Studies are needed to determine the effects of healing on long-term repair strength in affected patients. Last, all constructs were performed in open fashion to improve repeatability of construct placement and provide accessibility for Instron testing. Our technique did not directly replicate the arthroscopic approach, but, unlike other augmentation techniques, it is so simple that transition to all-arthroscopic augmentation is realistic.

Patch augmentation increases the cost of materials and operative time and should be considered a limitation of its utility. We do not recommend augmentation in all RCRs, as it likely is cost-ineffective. Instead, we recommend augmentation in cases of poor tissue quality, which could lead to healing failure, revision surgery, and higher overall patient costs beyond the cost of adding augmentation. Similarly, we recommend augmentation for revision cases in which tendon healing has failed and tissue quality is poor. The goal is to prevent another failure.

Conclusion

PHA graft augmentation of single-row triple-loaded anchor repairs of the supraspinatus tendon improves the overall ultimate load to failure by 25%. There was no difference in gap formation after cyclic loading between augmented and nonaugmented repairs. This technique for arthroscopic augmentation can be used to improve initial biomechanical repair strength in tears at risk for failure.

Am J Orthop. 2016;45(7):E527-E533. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Healing after rotator cuff repair (RCR) can be challenging, especially in cases of large and massive tears, revision repairs, and tendons with poor tissue quality.^1-3 Poor tissue quality is associated with increased risk for recurrent tears, independent of age and tear size.³ Various techniques have been used to improve tendon fixation strength in these difficult situations, including augmented suture configurations (eg, massive cuff stitches, rip-stop stitches) and tissue grafts (eg, acellular dermal matrix).^4-9 Clinical studies have found improved healing rates for larger tears and revision repairs using acellular dermal matrix grafts.^6,10 Synthetic patches are another option for RCR augmentation, but limited clinical data and biomechanical evidence support use of synthetic grafts as an augment for RCRs.^11-13

Polyhydroxyalkanoates (PHAs) are a class of biodegradable polymers that have been used as orthopedic devices, tissue scaffolds, patches, and other applications with increasing frequency over the past decade.¹⁴ In the laboratory, these implanted materials have been shown to support cell migration and growth.¹⁵ The PHA family of polymers typically degrades by hydrolytic and bacterial depolymerase mechanisms over 52-plus weeks in vivo.¹⁴PHA grafts have been studied in the setting of RCR. An expanded polytetrafluoroethylene scaffold was shown to improve repair mechanics when used as a bursal side graft in an in vitro ovine model.¹¹ The graft increased tendon footprint contact pressure and failure loads by almost 180 N. In clinical studies, poly-L-lactic acid augmentations have been used to reinforce massive RCRs. Lenart and colleagues¹⁶ found that 38% of 16 patients with such tears had an intact rotator cuff at 1.2-year follow-up, and improvement in clinical scores. Proctor¹³ reported on use of a poly-L-lactic acid retrograde patch for reinforcement of massive tears with both single- and double-row repairs in 18 patients. The cohort had more favorable rates of intact cuffs at 12 months (83%) and 42 months (78%), and ASES (American Shoulder and Elbow Surgeons) scores improved from 25 before surgery to 82 at latest follow-up after surgery.

RCR augmentation traditionally has been performed with an open or mini-open technique.⁶ Recently, several authors have reported on arthroscopic techniques for augmentation with either acellular dermal matrix or synthetic grafts.^13,17,18 Most techniques have involved “bridging” with a graft or patch used to stress-shield a single-row repair.^8,9,13 This bridging typically involves placing several sutures medial to where the anchor repair stitches pass through the tendon. An alternative is to pass the repair stitches through both the tendon and the graft.^17-19 The overall volume of tissue incorporated into the repair stitches (rotator cuff plus graft) is increased with the augmented technique relative to the bridging technique. Both can be technically challenging, but the augmented technique may be easier to perform arthroscopically.^9,19 Regardless, these techniques are complicated and require a higher level of arthroscopic skills compared with those required in arthroscopic RCR without a graft. Simplifying arthroscopic graft augmentation likely will increase its utility because, even for skilled surgeons, adding a graft can increase operative time by 20 to 30 minutes. Simplification will also extend use of the technique to surgeons with less experience and proficiency with arthroscopic repair.

We developed a simple method for augmenting single-row RCR with a strip of bioresorbable soft-tissue scaffold. We also conducted a study to evaluate the initial biomechanical properties of single-row RCR in cadaveric shoulder specimens augmented with PHA mesh (BioFiber; Tornier) graft as compared with single-row RCR without augmentation. Both cyclic gap formation and ultimate failure loads and displacement were quantified. We hypothesized that the augmented RCRs would have decreased gap formation and increased ultimate failure loads compared with nonaugmented RCRs. This study was exempt from having to obtain Institutional Review Board approval.

Methods

Eight pairs of fresh-frozen cadaver humeri (6 male, 2 female; mean [SD] age, 61 [9] years) were dissected of all soft tissue (except rotator cuff) by Dr. Tashjian, a board-certified, fellowship-trained orthopedic surgeon. There were no qualitative differences in tendon condition between tendons within a pair. The supraspinatus muscle and tendon were separated from the other rotator cuff muscles. The infraspinatus, subscapularis, and teres minor were removed from the humerus. Last, the supraspinatus was resected at its insertion. Humeral pairs were then randomized into augmented and nonaugmented RCRs within each pair.

In the nonaugmented group, the supraspinatus was reattached to its insertion in a single-row RCR with 2 triple-loaded suture anchors (5.5-mm Insite FT Ti, No. 2 Force Fiber suture; Tornier) and 6 simple stitches (Figure 1A). Anchors were placed midway between the articular margin and the lateral edge of the greater tuberosity at about 45° to the bone surface.

Anchors were separated by 15 mm, with the anterior anchor 5 mm posterior to the biceps groove. Stitches were passed through the supraspinatus tendon, taking a 15-mm bite of tissue, with each stitch separated by 5 mm. Each suture was then tied with a Revo knot.

In the contralateral shoulders, augmented RCRs were performed. Specimens were prepared exactly as they were for the nonaugmented RCRs, including anchor placement and suture passage. Before knot tying, RCRs were augmented with 2 strips of 13-mm × 23-mm PHA mesh (BioFiber) (Figure 1B). One strip was used to augment the 3 sutures of each anchor, overlying the residual tendon, to reinforce the tendon–knot interface. After each suture was passed through the supraspinatus tendon from the intra-articular surface, the stitch was passed through the strip of PHA mesh. Stitches were separated by 5 mm in each mesh strip. All 6 sutures were then tied with a Revo knot between the free end of each suture leg and the leg that passed through the tendon and mesh.

Each humerus was transected at the midshaft and potted and mounted in an Instron 1331 load frame with Model 8800 controller (Instron). A cryoclamp was used to grasp the supraspinatus muscle belly above the musculotendinous junction (Figure 2).

The humerus was aligned in the mounting fixture such that loading was performed at a 135° angle with the humeral shaft (Figure 2).²⁰ The Instron, which was equipped with a 1-kN load cell (Dynacell Model 2527-130; Instron) to monitor applied force, measured applied displacement.

Three rows of 2-mm fiducial markers were affixed to the bone, tendon, and muscle belly with cyanoacrylate for tracking with a digital video system (DMAS Version 6.5; Spicatek) (Figure 3).21

Camera resolution was 1360 pixels × 1024 pixels, and DMAS accuracy for marker centroid tracking was rated at ± 0.005 mm. Construct gapping was defined as the difference in displacement between the markers at the tissue–suture interface and the markers on the bone. Tissue deformation was then defined as the displacement between the markers at the tissue–suture interface and the markers on the muscle belly. Mean gapping was defined from anterior to posterior across the construct using 3 sets of fiducial markers.

A 0.1-MPa pre-stress (applied force/tendon cross-sectional area) was applied to each construct to determine the starting position for the deformation profile. Each repair underwent 1000 cycles of uniaxial load-controlled displacement between 0.1 and 1.0 MPa of effective stress at 1 Hz. Effective stress was determined as the ratio of applied force to cross-sectional area of the tendon at harvest to normalize the applied loads between tendons of varying size. During cyclic testing, gapping of more than 5 mm was defined as construct failure.²² After cyclic loading, each construct was loaded to failure at 1.0 mm/s. Ultimate failure load was defined as the highest load achieved at the maximum displacement before rapid decline in load supported by the construct.

 

Statistical Analysis

Paired t tests were used to compare the matched pairs of constructs. For all tests, significance was set at P ≤ .05. Post hoc power was calculated for significant results using G*Power Version 3.1.6.²³ All data are presented as means (SDs).

Results

After 1000 cycles of displacement, mean (SD) gapping was 3.8 (0.9) mm for the nonaugmented repairs and 3.9 (1.1) mm for the PHA mesh–augmented repairs (P = .879) (Figure 4).

Mean (SD) tissue elongation above the construct was comparable (P = .276) between nonaugmented repairs, 0.5 (0.4) mm, and augmented repairs, 0.7 (0.4) mm. No specimens failed during cyclic load, as mean gapping was <4 mm²² in all constructs. Mean (SD) applied force was 11.8 (1.8) N at 0.1 MPa of effective stress and 117.8 (18.1) N at 1.0 MPa of effective stress. Applied force did not vary between constructs (P = .727).

For the nonaugmented repairs, mean (SD) failure displacement was 6.3 (1.7) mm, and mean (SD) ultimate failure load was 472.1 (120.3) N. For the PHA-augmented repairs, failure displacement was 5.5 (1.9) mm, and ultimate failure load was 571.2 (173.0) N. There was no difference in failure displacement (P = .393), but there was a difference in ultimate failure load (P = .042; power = 0.57). During failure testing, mean (SD) tissue deformation was higher (P = .012; power = 0.83) for the PHA-augmented repairs, 1.2 (0.7) mm, than for the nonaugmented repairs, 0.8 (0.5) mm. Failures, which were consistent within pairs, were caused by tissue failure, with sutures pulling through the tissue (4 pairs) or single anchor pullout before ultimate tissue failure (4 pairs). Of the 4 failures with anchor pullout, 3 had anterior anchor pullout, and 1 had posterior anchor pullout. In all specimens with anchor pullout, the second anchor remained stable, and ultimate failure occurred with tissue tearing at the suture interface. There were no significant differences in any metrics between specimens that failed with intact anchors and specimens with single anchor pullout (P ≥ .122). Therefore, both groups were pooled for the failure analysis.

Discussion

RCR augmentation with a synthetic graft is a viable option for improving fixation strength of supraspinatus repairs, as shown in otherwise healthy tendon in the present study. Our hypothesis that there would be decreased gap formation with graft augmentation was not supported, whereas the hypothesis of increased failure loads with graft augmentation was supported. These findings may also be applicable in cases of large tears, revisions, and tendons with poor tissue quality. Simplification of graft application techniques will allow quick and easy arthroscopic augmentation.

Studies of RCRs for large or massive tears have reported retear rates of 25% to 79%.^24-26 Latissimus dorsi tendon transfers also show promise in posterosuperior RCRs, with failure rates near 10%.^27,28 Although use of PHA patches in RCR augmentation is relatively new, short-term and midterm failure rates are in the range of 20% to 60% in the few small cohorts currently being studied.^13,16 It is possible that these rates may improve as indications, surgical experience, and techniques for use of PHA patches are further refined. Regardless, with PHA currently being used in practice, it is important to quantify the biomechanics of the augmentation as a baseline for its performance in reinforcing the tendon–suture interface.

We determined that the initial fixation strength of single-row repairs was higher with the addition of PHA synthetic grafts using a very simple technique. Single-row triple-loaded anchor repairs already provide high initial mechanical strength, and our results are similar to those of another study of this technique.²⁹ Despite the already high mechanical strength of a triple-loaded anchor repair, PHA mesh increased ultimate strength by about 100 N (~25%). Of note, tissue elongation during failure was higher (P = .012; power = 0.83) in the PHA-augmented group (1.2 mm) than in the nonaugmented group (0.8 mm). This was not surprising—failure loads were almost 100 N higher in the PHA-augmented group than in the nonaugmented group. Consequently, much higher forces were placed on the muscle belly, likely resulting in additional elongation of the intact tissue medial to the repair construct.

The ultimate failure loads in our study compare favorably with the biomechanical strength of augmented repairs reported by others.^8,9,18 Barber and colleagues¹⁸ evaluated an augmented single-row repair with 2 double-loaded suture anchors and an acellular dermal matrix graft. The ultimate failure load of the augmented repairs was 325 N. In contrast, Omae and colleagues⁸ tested a bridging single-row repair using 2 double-loaded suture anchors and an acellular dermal matrix graft. Ultimate failure load of the augmented repairs was 560 N, similar to our finding. Last, Shea and colleagues⁹ evaluated a bridging single-row repair using 2 double-loaded suture anchors and an acellular dermal matrix graft, with ultimate failure load of 429 N. The techniques in all 3 studies can be performed arthroscopically but are challenging and require multiple extra sutures and anchors that need management and tying. Our technique provides similar initial fixation strength, has no requirement for extra sutures or anchors, and is very simple to perform.

The supraspinatus tendon is estimated to fail between 800 N and 1000 N.^30,31 Biomechanical shoulder simulators use supraspinatus forces in the range of 20 N to 200 N for scapular plane abduction.^32-36 Therefore, the single-row repair failures in our study fell between functional and full-thickness failure loads. Studies on the mechanics of degenerated human supraspinatus tendon are limited, but there is evidence the mechanical properties of these tissues are inferior to those of healthy tendon.³⁷ A 100-N increase in failure loads with PHA augmentation may prove highly significant in reinforcing the suture–tendon interface in degenerated tendons.

Adding the mesh did not have any effect on gapping at the repair site after cyclic loading. This finding suggests that construct gapping under cyclic loading is not a function of a reinforced knot–tendon interface but is instead caused by microtearing and cinching of the suture constructs in relation to the underlying bone. Tissue elongation likely was not a strong contributor to overall cyclic gapping, as elongation did not differ between the nonaugmented and augmented repairs (0.5 mm vs 0.7 mm; P = .276) and was small relative to the nearly 4 mm of construct gapping. Gapping may be affected by healing and integration of the mesh into the repaired tendon over time, but this effect could not be captured in the present study. Patients are initially immobilized and passive shoulder motion gradually introduced, in stark contrast to the immediate loading protocol in the present study. Regardless, the 25% increase in overall strength may be clinically important, especially in cases of difficult repair or poor tissue quality.

Our technique simplifies arthroscopic augmentation—stitches are passed through the rotator cuff in simple fashion. Before being tied, the limbs that were passed through the rotator cuff are removed through a cannula and then passed through the synthetic graft.

The graft is then shuttled into the subacromial space, and all the suture limbs are tied simply (Figures 5A, 5B). Even though this implementation is simple, our data showed the construct increases overall failure loads by about 25% with no effect on construct elongation.

 

Study Limitations

This study had several limitations. First, it was a cadaveric biomechanical study that evaluated only time-zero biomechanical properties. Loads were normalized to tendon size, specimens were randomized between sides, and paired specimens were used to minimize the effects of tendon and bone quality on outcome metrics. In addition, donor tendons were representative of otherwise healthy tissue. Chronic tears and associated resorption/atrophy could have affected the magnitude of forces and gapping detected in this study. Theoretically, over time the tendon tissue will adhere to and grow into the mesh, which could minimize potential differences. Studies are needed to determine the effects of healing on long-term repair strength in affected patients. Last, all constructs were performed in open fashion to improve repeatability of construct placement and provide accessibility for Instron testing. Our technique did not directly replicate the arthroscopic approach, but, unlike other augmentation techniques, it is so simple that transition to all-arthroscopic augmentation is realistic.

Patch augmentation increases the cost of materials and operative time and should be considered a limitation of its utility. We do not recommend augmentation in all RCRs, as it likely is cost-ineffective. Instead, we recommend augmentation in cases of poor tissue quality, which could lead to healing failure, revision surgery, and higher overall patient costs beyond the cost of adding augmentation. Similarly, we recommend augmentation for revision cases in which tendon healing has failed and tissue quality is poor. The goal is to prevent another failure.

Conclusion

PHA graft augmentation of single-row triple-loaded anchor repairs of the supraspinatus tendon improves the overall ultimate load to failure by 25%. There was no difference in gap formation after cyclic loading between augmented and nonaugmented repairs. This technique for arthroscopic augmentation can be used to improve initial biomechanical repair strength in tears at risk for failure.

Am J Orthop. 2016;45(7):E527-E533. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Healing after rotator cuff repair (RCR) can be challenging, especially in cases of large and massive tears, revision repairs, and tendons with poor tissue quality.^1-3 Poor tissue quality is associated with increased risk for recurrent tears, independent of age and tear size.³ Various techniques have been used to improve tendon fixation strength in these difficult situations, including augmented suture configurations (eg, massive cuff stitches, rip-stop stitches) and tissue grafts (eg, acellular dermal matrix).^4-9 Clinical studies have found improved healing rates for larger tears and revision repairs using acellular dermal matrix grafts.^6,10 Synthetic patches are another option for RCR augmentation, but limited clinical data and biomechanical evidence support use of synthetic grafts as an augment for RCRs.^11-13

Polyhydroxyalkanoates (PHAs) are a class of biodegradable polymers that have been used as orthopedic devices, tissue scaffolds, patches, and other applications with increasing frequency over the past decade.¹⁴ In the laboratory, these implanted materials have been shown to support cell migration and growth.¹⁵ The PHA family of polymers typically degrades by hydrolytic and bacterial depolymerase mechanisms over 52-plus weeks in vivo.¹⁴PHA grafts have been studied in the setting of RCR. An expanded polytetrafluoroethylene scaffold was shown to improve repair mechanics when used as a bursal side graft in an in vitro ovine model.¹¹ The graft increased tendon footprint contact pressure and failure loads by almost 180 N. In clinical studies, poly-L-lactic acid augmentations have been used to reinforce massive RCRs. Lenart and colleagues¹⁶ found that 38% of 16 patients with such tears had an intact rotator cuff at 1.2-year follow-up, and improvement in clinical scores. Proctor¹³ reported on use of a poly-L-lactic acid retrograde patch for reinforcement of massive tears with both single- and double-row repairs in 18 patients. The cohort had more favorable rates of intact cuffs at 12 months (83%) and 42 months (78%), and ASES (American Shoulder and Elbow Surgeons) scores improved from 25 before surgery to 82 at latest follow-up after surgery.

RCR augmentation traditionally has been performed with an open or mini-open technique.⁶ Recently, several authors have reported on arthroscopic techniques for augmentation with either acellular dermal matrix or synthetic grafts.^13,17,18 Most techniques have involved “bridging” with a graft or patch used to stress-shield a single-row repair.^8,9,13 This bridging typically involves placing several sutures medial to where the anchor repair stitches pass through the tendon. An alternative is to pass the repair stitches through both the tendon and the graft.^17-19 The overall volume of tissue incorporated into the repair stitches (rotator cuff plus graft) is increased with the augmented technique relative to the bridging technique. Both can be technically challenging, but the augmented technique may be easier to perform arthroscopically.^9,19 Regardless, these techniques are complicated and require a higher level of arthroscopic skills compared with those required in arthroscopic RCR without a graft. Simplifying arthroscopic graft augmentation likely will increase its utility because, even for skilled surgeons, adding a graft can increase operative time by 20 to 30 minutes. Simplification will also extend use of the technique to surgeons with less experience and proficiency with arthroscopic repair.

We developed a simple method for augmenting single-row RCR with a strip of bioresorbable soft-tissue scaffold. We also conducted a study to evaluate the initial biomechanical properties of single-row RCR in cadaveric shoulder specimens augmented with PHA mesh (BioFiber; Tornier) graft as compared with single-row RCR without augmentation. Both cyclic gap formation and ultimate failure loads and displacement were quantified. We hypothesized that the augmented RCRs would have decreased gap formation and increased ultimate failure loads compared with nonaugmented RCRs. This study was exempt from having to obtain Institutional Review Board approval.

Methods

Eight pairs of fresh-frozen cadaver humeri (6 male, 2 female; mean [SD] age, 61 [9] years) were dissected of all soft tissue (except rotator cuff) by Dr. Tashjian, a board-certified, fellowship-trained orthopedic surgeon. There were no qualitative differences in tendon condition between tendons within a pair. The supraspinatus muscle and tendon were separated from the other rotator cuff muscles. The infraspinatus, subscapularis, and teres minor were removed from the humerus. Last, the supraspinatus was resected at its insertion. Humeral pairs were then randomized into augmented and nonaugmented RCRs within each pair.

In the nonaugmented group, the supraspinatus was reattached to its insertion in a single-row RCR with 2 triple-loaded suture anchors (5.5-mm Insite FT Ti, No. 2 Force Fiber suture; Tornier) and 6 simple stitches (Figure 1A). Anchors were placed midway between the articular margin and the lateral edge of the greater tuberosity at about 45° to the bone surface.

Anchors were separated by 15 mm, with the anterior anchor 5 mm posterior to the biceps groove. Stitches were passed through the supraspinatus tendon, taking a 15-mm bite of tissue, with each stitch separated by 5 mm. Each suture was then tied with a Revo knot.

In the contralateral shoulders, augmented RCRs were performed. Specimens were prepared exactly as they were for the nonaugmented RCRs, including anchor placement and suture passage. Before knot tying, RCRs were augmented with 2 strips of 13-mm × 23-mm PHA mesh (BioFiber) (Figure 1B). One strip was used to augment the 3 sutures of each anchor, overlying the residual tendon, to reinforce the tendon–knot interface. After each suture was passed through the supraspinatus tendon from the intra-articular surface, the stitch was passed through the strip of PHA mesh. Stitches were separated by 5 mm in each mesh strip. All 6 sutures were then tied with a Revo knot between the free end of each suture leg and the leg that passed through the tendon and mesh.

Each humerus was transected at the midshaft and potted and mounted in an Instron 1331 load frame with Model 8800 controller (Instron). A cryoclamp was used to grasp the supraspinatus muscle belly above the musculotendinous junction (Figure 2).

The humerus was aligned in the mounting fixture such that loading was performed at a 135° angle with the humeral shaft (Figure 2).²⁰ The Instron, which was equipped with a 1-kN load cell (Dynacell Model 2527-130; Instron) to monitor applied force, measured applied displacement.

Three rows of 2-mm fiducial markers were affixed to the bone, tendon, and muscle belly with cyanoacrylate for tracking with a digital video system (DMAS Version 6.5; Spicatek) (Figure 3).21

Camera resolution was 1360 pixels × 1024 pixels, and DMAS accuracy for marker centroid tracking was rated at ± 0.005 mm. Construct gapping was defined as the difference in displacement between the markers at the tissue–suture interface and the markers on the bone. Tissue deformation was then defined as the displacement between the markers at the tissue–suture interface and the markers on the muscle belly. Mean gapping was defined from anterior to posterior across the construct using 3 sets of fiducial markers.

A 0.1-MPa pre-stress (applied force/tendon cross-sectional area) was applied to each construct to determine the starting position for the deformation profile. Each repair underwent 1000 cycles of uniaxial load-controlled displacement between 0.1 and 1.0 MPa of effective stress at 1 Hz. Effective stress was determined as the ratio of applied force to cross-sectional area of the tendon at harvest to normalize the applied loads between tendons of varying size. During cyclic testing, gapping of more than 5 mm was defined as construct failure.²² After cyclic loading, each construct was loaded to failure at 1.0 mm/s. Ultimate failure load was defined as the highest load achieved at the maximum displacement before rapid decline in load supported by the construct.

 

Statistical Analysis

Paired t tests were used to compare the matched pairs of constructs. For all tests, significance was set at P ≤ .05. Post hoc power was calculated for significant results using G*Power Version 3.1.6.²³ All data are presented as means (SDs).

Results

After 1000 cycles of displacement, mean (SD) gapping was 3.8 (0.9) mm for the nonaugmented repairs and 3.9 (1.1) mm for the PHA mesh–augmented repairs (P = .879) (Figure 4).

Mean (SD) tissue elongation above the construct was comparable (P = .276) between nonaugmented repairs, 0.5 (0.4) mm, and augmented repairs, 0.7 (0.4) mm. No specimens failed during cyclic load, as mean gapping was <4 mm²² in all constructs. Mean (SD) applied force was 11.8 (1.8) N at 0.1 MPa of effective stress and 117.8 (18.1) N at 1.0 MPa of effective stress. Applied force did not vary between constructs (P = .727).

For the nonaugmented repairs, mean (SD) failure displacement was 6.3 (1.7) mm, and mean (SD) ultimate failure load was 472.1 (120.3) N. For the PHA-augmented repairs, failure displacement was 5.5 (1.9) mm, and ultimate failure load was 571.2 (173.0) N. There was no difference in failure displacement (P = .393), but there was a difference in ultimate failure load (P = .042; power = 0.57). During failure testing, mean (SD) tissue deformation was higher (P = .012; power = 0.83) for the PHA-augmented repairs, 1.2 (0.7) mm, than for the nonaugmented repairs, 0.8 (0.5) mm. Failures, which were consistent within pairs, were caused by tissue failure, with sutures pulling through the tissue (4 pairs) or single anchor pullout before ultimate tissue failure (4 pairs). Of the 4 failures with anchor pullout, 3 had anterior anchor pullout, and 1 had posterior anchor pullout. In all specimens with anchor pullout, the second anchor remained stable, and ultimate failure occurred with tissue tearing at the suture interface. There were no significant differences in any metrics between specimens that failed with intact anchors and specimens with single anchor pullout (P ≥ .122). Therefore, both groups were pooled for the failure analysis.

Discussion

RCR augmentation with a synthetic graft is a viable option for improving fixation strength of supraspinatus repairs, as shown in otherwise healthy tendon in the present study. Our hypothesis that there would be decreased gap formation with graft augmentation was not supported, whereas the hypothesis of increased failure loads with graft augmentation was supported. These findings may also be applicable in cases of large tears, revisions, and tendons with poor tissue quality. Simplification of graft application techniques will allow quick and easy arthroscopic augmentation.

Studies of RCRs for large or massive tears have reported retear rates of 25% to 79%.^24-26 Latissimus dorsi tendon transfers also show promise in posterosuperior RCRs, with failure rates near 10%.^27,28 Although use of PHA patches in RCR augmentation is relatively new, short-term and midterm failure rates are in the range of 20% to 60% in the few small cohorts currently being studied.^13,16 It is possible that these rates may improve as indications, surgical experience, and techniques for use of PHA patches are further refined. Regardless, with PHA currently being used in practice, it is important to quantify the biomechanics of the augmentation as a baseline for its performance in reinforcing the tendon–suture interface.

We determined that the initial fixation strength of single-row repairs was higher with the addition of PHA synthetic grafts using a very simple technique. Single-row triple-loaded anchor repairs already provide high initial mechanical strength, and our results are similar to those of another study of this technique.²⁹ Despite the already high mechanical strength of a triple-loaded anchor repair, PHA mesh increased ultimate strength by about 100 N (~25%). Of note, tissue elongation during failure was higher (P = .012; power = 0.83) in the PHA-augmented group (1.2 mm) than in the nonaugmented group (0.8 mm). This was not surprising—failure loads were almost 100 N higher in the PHA-augmented group than in the nonaugmented group. Consequently, much higher forces were placed on the muscle belly, likely resulting in additional elongation of the intact tissue medial to the repair construct.

The ultimate failure loads in our study compare favorably with the biomechanical strength of augmented repairs reported by others.^8,9,18 Barber and colleagues¹⁸ evaluated an augmented single-row repair with 2 double-loaded suture anchors and an acellular dermal matrix graft. The ultimate failure load of the augmented repairs was 325 N. In contrast, Omae and colleagues⁸ tested a bridging single-row repair using 2 double-loaded suture anchors and an acellular dermal matrix graft. Ultimate failure load of the augmented repairs was 560 N, similar to our finding. Last, Shea and colleagues⁹ evaluated a bridging single-row repair using 2 double-loaded suture anchors and an acellular dermal matrix graft, with ultimate failure load of 429 N. The techniques in all 3 studies can be performed arthroscopically but are challenging and require multiple extra sutures and anchors that need management and tying. Our technique provides similar initial fixation strength, has no requirement for extra sutures or anchors, and is very simple to perform.

The supraspinatus tendon is estimated to fail between 800 N and 1000 N.^30,31 Biomechanical shoulder simulators use supraspinatus forces in the range of 20 N to 200 N for scapular plane abduction.^32-36 Therefore, the single-row repair failures in our study fell between functional and full-thickness failure loads. Studies on the mechanics of degenerated human supraspinatus tendon are limited, but there is evidence the mechanical properties of these tissues are inferior to those of healthy tendon.³⁷ A 100-N increase in failure loads with PHA augmentation may prove highly significant in reinforcing the suture–tendon interface in degenerated tendons.

Adding the mesh did not have any effect on gapping at the repair site after cyclic loading. This finding suggests that construct gapping under cyclic loading is not a function of a reinforced knot–tendon interface but is instead caused by microtearing and cinching of the suture constructs in relation to the underlying bone. Tissue elongation likely was not a strong contributor to overall cyclic gapping, as elongation did not differ between the nonaugmented and augmented repairs (0.5 mm vs 0.7 mm; P = .276) and was small relative to the nearly 4 mm of construct gapping. Gapping may be affected by healing and integration of the mesh into the repaired tendon over time, but this effect could not be captured in the present study. Patients are initially immobilized and passive shoulder motion gradually introduced, in stark contrast to the immediate loading protocol in the present study. Regardless, the 25% increase in overall strength may be clinically important, especially in cases of difficult repair or poor tissue quality.

Our technique simplifies arthroscopic augmentation—stitches are passed through the rotator cuff in simple fashion. Before being tied, the limbs that were passed through the rotator cuff are removed through a cannula and then passed through the synthetic graft.

The graft is then shuttled into the subacromial space, and all the suture limbs are tied simply (Figures 5A, 5B). Even though this implementation is simple, our data showed the construct increases overall failure loads by about 25% with no effect on construct elongation.

 

Study Limitations

This study had several limitations. First, it was a cadaveric biomechanical study that evaluated only time-zero biomechanical properties. Loads were normalized to tendon size, specimens were randomized between sides, and paired specimens were used to minimize the effects of tendon and bone quality on outcome metrics. In addition, donor tendons were representative of otherwise healthy tissue. Chronic tears and associated resorption/atrophy could have affected the magnitude of forces and gapping detected in this study. Theoretically, over time the tendon tissue will adhere to and grow into the mesh, which could minimize potential differences. Studies are needed to determine the effects of healing on long-term repair strength in affected patients. Last, all constructs were performed in open fashion to improve repeatability of construct placement and provide accessibility for Instron testing. Our technique did not directly replicate the arthroscopic approach, but, unlike other augmentation techniques, it is so simple that transition to all-arthroscopic augmentation is realistic.

Patch augmentation increases the cost of materials and operative time and should be considered a limitation of its utility. We do not recommend augmentation in all RCRs, as it likely is cost-ineffective. Instead, we recommend augmentation in cases of poor tissue quality, which could lead to healing failure, revision surgery, and higher overall patient costs beyond the cost of adding augmentation. Similarly, we recommend augmentation for revision cases in which tendon healing has failed and tissue quality is poor. The goal is to prevent another failure.

Conclusion

PHA graft augmentation of single-row triple-loaded anchor repairs of the supraspinatus tendon improves the overall ultimate load to failure by 25%. There was no difference in gap formation after cyclic loading between augmented and nonaugmented repairs. This technique for arthroscopic augmentation can be used to improve initial biomechanical repair strength in tears at risk for failure.

Am J Orthop. 2016;45(7):E527-E533. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Pathology of the biceps-labrum complex (BLC) can be an important source of shoulder pain. Discussion of pathoanatomy, imaging, and surgical intervention is facilitated by distinguishing the anatomical zones of the BLC: inside, junction, and bicipital tunnel (extra-articular), parts of which cannot be visualized with standard diagnostic arthroscopy.

The recent literature indicates that bicipital tunnel lesions are common and perhaps overlooked. Systematic reviews suggest improvement in outcomes of BLC operations when the bicipital tunnel is decompressed. Higher-level clinical and basic science studies are needed to fully elucidate the role of the bicipital tunnel, but it is evident that a comprehensive physical examination and an understanding of the limits of advanced imaging are necessary to correctly diagnose and treat BLC-related shoulder pain.

Anatomy of Biceps-Labrum Complex

The long head of the biceps tendon (LHBT) and the glenoid labrum work as an interdependent functional unit, the biceps-labrum complex (BLC). The BLC is divided into 3 distinct anatomical zones: inside, junction, and bicipital tunnel.^1,2

Inside

The inside includes the superior labrum and biceps attachment. The LHBT most commonly originates in the superior labrum.^3-5 Vangsness and colleagues³ described 4 types of LHBT origins: Type I biceps attaches solely to the posterior labrum, type II predominantly posterior, type III equally to the anterior and posterior labrum, and type IV mostly to the anterior labrum. The LHBT can also originate in the supraglenoid tubercle or the inferior border of the supraspinatus.^3,6

Junction

Junction is the intra-articular segment of the LHBT and the biceps pulley. The LHBT traverses the glenohumeral joint en route to the extra-articular bicipital tunnel.² The LHBT is enveloped in synovium that extends into part of the bicipital tunnel.² The intra-articular segment of the LHBT is about 25 mm in length⁷ and has a diameter of 5 mm to 6 mm.⁸

A cadaveric study found that the average length of the LHBT that can be arthroscopically visualized at rest is 35.6 mm, or only 40% of the total length of the LHBT with respect to the proximal margin of the pectoralis major tendon.¹ When the LHBT was pulled into the joint, more tendon (another 14 mm) was visualized.¹ Therefore, diagnostic arthroscopy of the glenohumeral joint visualizes about 50% of the LHBT.⁹The morphology of the LHBT varies by location. The intra-articular portion of the LHBT is wide and flat, whereas the extra-articular portion is round.⁸ The tendon becomes smoother and more avascular as it exits the joint to promote gliding within its sheath in the bicipital groove.¹⁰ The proximal LHBT receives its vascular supply from superior labrum tributaries, and distally the LHBT is supplied by ascending branches of the anterior humeral circumflex artery.⁴ There is a hypovascular zone, created by this dual blood supply, about 12 mm to 30 mm from the LHBT origin, predisposing the tendon to rupture or fray in this region.¹¹The LHBT makes a 30° turn into the biceps pulley system as it exits the glenohumeral joint. The fibrous pulley system that stabilizes the LHBT in this region has contributions from the coracohumeral ligament, the superior glenohumeral ligament, and the supraspinatus tendon.^12-14

The floor of the pulley consists of the superior glenohumeral ligament with reinforcing fibers from the superior border of the subscapularis tendon.¹⁵ The roof consists of the coracohumeral ligament fibers with supraspinatus fibers contributing posteriorly (Figure 1).¹²

Bicipital Tunnel

The bicipital tunnel, the third portion of the BLC, remains largely hidden from standard diagnostic glenohumeral arthroscopy. The bicipital tunnel is an extra-articular, closed space that constrains the LHBT from the articular margin through the subpectoral region.²

The bicipital tunnel itself can be divided into 3 zones (Figure 2).²

Zone 1 is the traditional bicipital groove or “bony groove” that extends from the articular margin to the distal margin of the subscapularis tendon. The floor consists of a deep osseous groove covered by a continuation of subscapularis tendon fibers and periosteum.²Zone 2, “no man’s land,” extends from the distal margin of the subscapularis tendon to the proximal margin of the pectoralis major (PMPM). The LHBT in this zone cannot be visualized during a pull test at arthroscopy, yet lesions commonly occur here.¹ Zones 1 and 2 have a similar histology and contain synovium.²Zone 3 is the subpectoral region distal to the PMPM. Fibers of the latissimus dorsi form the flat floor of zone 3, and the pectoralis major inserts lateral to the LHBT on the humerus in this zone. The synovium encapsulating the LHBT in zones 1 and 2 rarely extends past the PMPM. Taylor and colleagues² found a higher percentage of unoccupied tunnel space in zone 3 than in zones 1 and 2, which results in a “functional bottleneck” between zones 2 and 3 represented by the PMPM.

 

Pathoanatomy

BLC lesions may occur in isolation or concomitantly across multiple anatomical zones. In a series of 277 chronically symptomatic shoulders that underwent transfer of the LHBT to the conjoint tendon with subdeltoid arthroscopy, Taylor and colleagues¹ found 47% incidence of bicipital tunnel lesions, 44% incidence of junctional lesions, and 35% incidence of inside lesions. In their series, 37% of patients had concomitant lesions involving more than 1 anatomical zone.

Inside Lesions

Inside lesions involve the superior labrum, the LHBT origin, or both. Superior labrum anterior-posterior (SLAP) tears are included as inside BLC lesions. Snyder and colleagues¹⁶ originally identified 4 broad categories of SLAP tears, but Powell and colleagues¹⁷ described up to 10 variations. Type II lesions, which are the most common, destabilize the biceps anchor.

Dynamic incarceration of the biceps between the humeral head and the glenoid labrum is another inside lesion that can be identified during routine diagnostic glenohumeral arthroscopy. The arthroscopic active compression test, as described by Verma and colleagues,¹⁸ can be used during surgery to demonstrate incarceration of the biceps tendon.

Medial biceps chondromalacia, attritional chondral wear along the anteromedial aspect of the humeral head, occurs secondary to a windshield wiper effect of the LHBT in the setting of an incarcerating LHBT or may be associated with destabilization of the biceps pulley.

Junctional Lesions

Junctional lesions, which include lesions that affect the intra-articular LHBT, can be visualized during routine glenohumeral arthroscopy. They include partial and complete biceps tears, biceps pulley lesions, and junctional biceps chondromalacia.

Biceps pulley injuries and/or tears of the upper subscapularis tendon can destabilize the biceps as it exits the joint, and this destabilization may result in medial subluxation of the tendon and the aforementioned medial biceps chondromalacia.^10,19 Junctional biceps chondromalacia is attritional chondral wear of the humeral head from abnormal tracking of the LHBT deep to the LHBT near the articular margin.

Recently elucidated is the limited ability of diagnostic glenohumeral arthroscopy to fully identify the extent of BLC pathology.^1,20-22 Gilmer and colleagues²⁰ found that diagnostic arthroscopy identified only 67% of biceps pathology and underestimated its extent in 56% of patients in their series. Similarly, Moon and colleagues²¹ found that 79% of proximal LHBT tears propagated distally into the bicipital tunnel and were incompletely visualized with standard arthroscopy.

Bicipital Tunnel Lesions

Recent evidence indicates that the bicipital tunnel is a closed space that often conceals space-occupying lesions, including scar, synovitis, loose bodies, and osteophytes, which can become trapped in the tunnel. The functional bottleneck between zones 2 and 3 of the bicipital tunnel explains the aggregation of loose bodies in this region.² Similarly, as the percentage of free space within the bicipital tunnel increases, space-occupying lesions (eg scar, loose bodies, osteophytes) may exude a compressive and/or abrasive force within zones 1 and 2, but not as commonly within zone 3.²

Physical Examination of Biceps-Labrum Complex

Accurate diagnosis of BLC disease is crucial in selecting an optimal intervention, but challenging. Beyond identifying biceps pathology, specific examination maneuvers may help distinguish between lesions of the intra-articular BLC and lesions of the extra-articular bicipital tunnel.²³

Traditional examination maneuvers for biceps-related shoulder pain include the Speed test, the full can test, and the Yergason test.^24,25 For the Speed test, the patient forward-flexes the shoulder to 60° to 90°, extends the arm at the elbow, and supinates the forearm. The clinician applies a downward force as the patient resists. The reported sensitivity of the Speed test ranges from 37% to 63%, and specificity is 60% to 88%.^25,26 In the full can test, with the patient’s arm in the plane of the scapula, the shoulder abducted to 90°, and the forearm in neutral rotation, a downward force is applied against resistance. Sensitivity of the full can test is 60% to 67%, and specificity is 76% to 84%.²⁴ The Yergason test is performed with the patient’s arm at his or her side, the elbow flexed to 90°, and the forearm pronated. The patient supinates the forearm against the clinician’s resistance. Sensitivity of the Yergason test is 19% to 32%, and specificity is 70% to 100%.^25,26 The Yergason test has a positive predictive value of 92% for bicipital tunnel disease.

O’Brien and colleagues^23,26 introduced a “3-pack” physical examination designed to elicit BLC symptoms. In this examination, the LHBT is palpated along its course within the bicipital tunnel. Reproduction of the patient’s pain by palpation had a sensitivity of 98% for bicipital tunnel disease but was less specific (70%). Gill and colleagues²⁷ reported low sensitivity (53%) and low specificity (54%) for biceps palpation, and they used arthroscopy as a gold standard. Since then, multiple studies have demonstrated that glenohumeral arthroscopy fails to identify lesions concealed within the bicipital tunnel.^20-22The second part of the 3-pack examination is the active compression test. A downward force is applied as the patient resists with his or her arm forward-flexed to 90° and adducted 10° to 15° with the thumb pointing downward.²⁸ This action is repeated with the humerus externally rotated and the forearm supinated. A positive test is indicated by reproduction of symptoms with the thumb down, and elimination or reduction of symptoms with the palm up. Test sensitivity is 88% to 96%, and specificity is 46% to 64% for BLC lesions, but for bicipital tunnel disease sensitivity is higher (96%), and the negative predictive value is 93%.²⁶The third component of the 3-pack examination is the throwing test. A late-cocking throwing position is re-created with the shoulder externally rotated and abducted to 90° and the elbow flexed to 90°. The patient steps forward with the contralateral leg and moves into the acceleration phase of throwing while the clinician provides isometric resistance. If this maneuver reproduces pain, the test is positive. As Taylor and colleagues²⁶ reported, the throwing test has sensitivity of 73% to 77% and specificity of 65% to 79% for BLC pathology. This test has moderate sensitivity and negative predictive value for bicipital tunnel disease but may be the only positive test on physical examination in the setting of LHBT instability.

 

Imaging of Biceps-Labrum Complex

Plain anteroposterior, lateral, and axillary radiographs of the shoulder should be obtained for all patients having an orthopedic examination for shoulder pain. Magnetic resonance imaging (MRI) and ultrasound are the advanced modalities most commonly used for diagnostic imaging. These modalities should be considered in conjunction with, not in place of, a comprehensive history and physical examination.

The literature suggests MRI fails to accurately detect many LHBT lesions (Table).^29-37

MRI has sensitivity of 9% to 89% for LHBT pathology^29-37 and 38% to 98% for SLAP pathology.^35,38-41 The wide range of reported sensitivity and specificity might be attributed to the varying criteria for what constitutes a BLC lesion. Some authors include biceps chondromalacia, dynamic incarceration of LHBT, and extra-articular bicipital tunnel lesions, while others historically have included only intra-articular LHBT lesions that can be directly visualized arthroscopically.

In their retrospective review of 277 shoulders with chronic refractory BLC symptoms treated with subdeltoid transfer of the LHBT to the conjoint tendon, Taylor and colleagues³⁰ reported MRI was more sensitive for inside BLC lesions than for junctional or bicipital tunnel lesions (77% vs 43% and 50%, respectively).

Treatment Options for Biceps-Labrum Complex Lesions

A diagnosis of BLC disease warrants a trial of conservative (nonoperative) management for at least 3 months. Many patients improve with activity modification, use of oral anti-inflammatory medication, and structured physical therapy focused on dynamic stabilizers and range of motion. If pain persists, local anesthetic and corticosteroid can be injected under ultrasound guidance into the bicipital tunnel; this injection has the advantage of being both diagnostic and therapeutic. Hashiuchi and colleagues⁴² found ultrasound-guided injections are 87% successful in achieving intra-sheath placement (injections without ultrasound guidance are only 27% successful).

If the 3-month trial of conservative management fails, surgical intervention should be considered. The goal in treating BLC pain is to maximize clinical function and alleviate pain in a predictable manner while minimizing technical demands and morbidity. A singular solution has not been identified. Furthermore, 3 systematic reviews failed to identify a difference between the most commonly used techniques, biceps tenodesis and tenotomy.^43-45 These reviews grouped all tenotomy procedures together and compared them with all tenodesis procedures. A limitation of these systematic reviews is that they did not differentiate tenodesis techniques. We prefer to classify techniques according to whether or not they decompress zones 1 and 2 of the bicipital tunnel.

Bicipital Tunnel Nondecompressing Techniques

Release of the biceps tendon, a biceps tenotomy, is a simple procedure that potentially avoids open surgery and provides patients with a quick return to activity. Disadvantages of tenotomy include cosmetic (Popeye) deformity after surgery, potential cramping and fatigue, and biomechanical changes in the humeral head,^46-48 particularly among patients younger than 65 years. High rates of revision after tenotomy have been reported.^43,49 Incomplete retraction of the LHBT and/or residual synovium may be responsible for refractory pain following biceps tenotomy.⁴⁹ We hypothesize that failure of tenotomy may be related to unaddressed bicipital tunnel disease.

Proximal nondecompressing tenodesis techniques may be performed either on soft tissue in the interval or rotator cuff or on bone at the articular margin or within zone 1 of the bicipital tunnel.^50-52 These techniques can be performed with standard glenohumeral arthroscopy and generally are fast and well tolerated and have limited operative morbidity. Advantages of these techniques over simple tenotomy are lower rates of cosmetic deformity and lower rates of cramping and fatigue pain, likely resulting from maintenance of the muscle tension relationship of the LHBT. Disadvantages of proximal tenodesis techniques include introduction of hardware for bony fixation, longer postoperative rehabilitation to protect repairs, and failure to address hidden bicipital tunnel disease. Furthermore, the rate of stiffness in patients who undergo proximal tenodesis without decompression of the bicipital tunnel may be as high as 18%.⁵³

Bicipital Tunnel Decompressing Techniques

Surgical techniques that decompress the bicipital tunnel include proximal techniques that release the bicipital sheath within zones 1 and 2 of the bicipital tunnel (to the level of the proximal margin of the pectoralis major tendon) and certain arthroscopic suprapectoral techniques,⁵⁴ open subpectoral tenodeses,^55-57 and arthroscopic transfer of the LHBT to the conjoint tendon.^58,59

Open subpectoral tenodesis techniques have the advantage of maintaining the length-tension relationship of the LHBT and preventing Popeye deformity. However, these techniques require making an incision near the axilla, which may introduce an unnecessary source of infection. Furthermore, open subpectoral tenodesis requires drilling the humerus and placing a screw for bony fixation of the LHBT, which can create a risk of neurovascular injury, given the proximity of neurovascular structures,^60-62 and humeral shaft fracture, particularly in athletes.^63,64Our preferred method is transfer of the LHBT to the conjoint tendon (Figure 3).⁵⁹

The subdeltoid space is a large, relatively avascular fascial plane bounded superiorly by the acromion and coracoacromial ligament, medially by the coracoid and conjoint tendon, inferiorly by the musculotendinous insertion of the pectoralis major, and laterally by the border of the humerus.⁶⁵ After the LHBT is released from the superior labrum, it is transferred to the subdeltoid space and sutured to the conjoint tendon in side-to-side fashion with nonabsorbable sutures.^58,59 This technique allows for isometric tensioning of the LHBT, which preserves the strength of the biceps muscle, and fixation of soft tissue to soft tissue obviates the need for bone tunnels, mitigating fracture risk. A histologic study that compared healing between LHBT tenodesis with bone and soft-tissue transfer to the conjoint tendon found a more robust response of tenomodulin in the soft-tissue transfer, suggesting tendon regeneration in this technique.⁶⁶ Perhaps the most significant advantage is the ability of this approach to effectively decompress the bicipital tunnel. Early-term results were promising, and recent midterm results demonstrated durability of clinical outcomes.^58,59Sanders and colleagues⁴⁹ compared revision rates of biceps procedures and found a 6.8% rate for techniques that released the biceps sheath and a 20.6% rate for operations in which the sheath was not released. Subsequent meta-analysis of 30 studies (1881 patients) found improved Constant scores in the cohort that underwent bicipital tunnel decompression in comparison with the cohort that did not have the bicipital tunnel decompressed, but there was no significant difference in UCLA (University of California Los Angeles) scores between cohorts.67 

In light of recent literature that confirms the prevalence of bicipital tunnel lesions that have been overlooked, and the power of physical examination, we have proposed an evidence-based approach to diagnosing and managing BLC disease (Figure 4).

 

Am J Orthop. 2016;45(7):E503-E511. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Pathology of the biceps-labrum complex (BLC) can be an important source of shoulder pain. Discussion of pathoanatomy, imaging, and surgical intervention is facilitated by distinguishing the anatomical zones of the BLC: inside, junction, and bicipital tunnel (extra-articular), parts of which cannot be visualized with standard diagnostic arthroscopy.

The recent literature indicates that bicipital tunnel lesions are common and perhaps overlooked. Systematic reviews suggest improvement in outcomes of BLC operations when the bicipital tunnel is decompressed. Higher-level clinical and basic science studies are needed to fully elucidate the role of the bicipital tunnel, but it is evident that a comprehensive physical examination and an understanding of the limits of advanced imaging are necessary to correctly diagnose and treat BLC-related shoulder pain.

Anatomy of Biceps-Labrum Complex

The long head of the biceps tendon (LHBT) and the glenoid labrum work as an interdependent functional unit, the biceps-labrum complex (BLC). The BLC is divided into 3 distinct anatomical zones: inside, junction, and bicipital tunnel.^1,2

Inside

The inside includes the superior labrum and biceps attachment. The LHBT most commonly originates in the superior labrum.^3-5 Vangsness and colleagues³ described 4 types of LHBT origins: Type I biceps attaches solely to the posterior labrum, type II predominantly posterior, type III equally to the anterior and posterior labrum, and type IV mostly to the anterior labrum. The LHBT can also originate in the supraglenoid tubercle or the inferior border of the supraspinatus.^3,6

Junction

Junction is the intra-articular segment of the LHBT and the biceps pulley. The LHBT traverses the glenohumeral joint en route to the extra-articular bicipital tunnel.² The LHBT is enveloped in synovium that extends into part of the bicipital tunnel.² The intra-articular segment of the LHBT is about 25 mm in length⁷ and has a diameter of 5 mm to 6 mm.⁸

A cadaveric study found that the average length of the LHBT that can be arthroscopically visualized at rest is 35.6 mm, or only 40% of the total length of the LHBT with respect to the proximal margin of the pectoralis major tendon.¹ When the LHBT was pulled into the joint, more tendon (another 14 mm) was visualized.¹ Therefore, diagnostic arthroscopy of the glenohumeral joint visualizes about 50% of the LHBT.⁹The morphology of the LHBT varies by location. The intra-articular portion of the LHBT is wide and flat, whereas the extra-articular portion is round.⁸ The tendon becomes smoother and more avascular as it exits the joint to promote gliding within its sheath in the bicipital groove.¹⁰ The proximal LHBT receives its vascular supply from superior labrum tributaries, and distally the LHBT is supplied by ascending branches of the anterior humeral circumflex artery.⁴ There is a hypovascular zone, created by this dual blood supply, about 12 mm to 30 mm from the LHBT origin, predisposing the tendon to rupture or fray in this region.¹¹The LHBT makes a 30° turn into the biceps pulley system as it exits the glenohumeral joint. The fibrous pulley system that stabilizes the LHBT in this region has contributions from the coracohumeral ligament, the superior glenohumeral ligament, and the supraspinatus tendon.^12-14

The floor of the pulley consists of the superior glenohumeral ligament with reinforcing fibers from the superior border of the subscapularis tendon.¹⁵ The roof consists of the coracohumeral ligament fibers with supraspinatus fibers contributing posteriorly (Figure 1).¹²

Bicipital Tunnel

The bicipital tunnel, the third portion of the BLC, remains largely hidden from standard diagnostic glenohumeral arthroscopy. The bicipital tunnel is an extra-articular, closed space that constrains the LHBT from the articular margin through the subpectoral region.²

The bicipital tunnel itself can be divided into 3 zones (Figure 2).²

Zone 1 is the traditional bicipital groove or “bony groove” that extends from the articular margin to the distal margin of the subscapularis tendon. The floor consists of a deep osseous groove covered by a continuation of subscapularis tendon fibers and periosteum.²Zone 2, “no man’s land,” extends from the distal margin of the subscapularis tendon to the proximal margin of the pectoralis major (PMPM). The LHBT in this zone cannot be visualized during a pull test at arthroscopy, yet lesions commonly occur here.¹ Zones 1 and 2 have a similar histology and contain synovium.²Zone 3 is the subpectoral region distal to the PMPM. Fibers of the latissimus dorsi form the flat floor of zone 3, and the pectoralis major inserts lateral to the LHBT on the humerus in this zone. The synovium encapsulating the LHBT in zones 1 and 2 rarely extends past the PMPM. Taylor and colleagues² found a higher percentage of unoccupied tunnel space in zone 3 than in zones 1 and 2, which results in a “functional bottleneck” between zones 2 and 3 represented by the PMPM.

 

Pathoanatomy

BLC lesions may occur in isolation or concomitantly across multiple anatomical zones. In a series of 277 chronically symptomatic shoulders that underwent transfer of the LHBT to the conjoint tendon with subdeltoid arthroscopy, Taylor and colleagues¹ found 47% incidence of bicipital tunnel lesions, 44% incidence of junctional lesions, and 35% incidence of inside lesions. In their series, 37% of patients had concomitant lesions involving more than 1 anatomical zone.

Inside Lesions

Inside lesions involve the superior labrum, the LHBT origin, or both. Superior labrum anterior-posterior (SLAP) tears are included as inside BLC lesions. Snyder and colleagues¹⁶ originally identified 4 broad categories of SLAP tears, but Powell and colleagues¹⁷ described up to 10 variations. Type II lesions, which are the most common, destabilize the biceps anchor.

Dynamic incarceration of the biceps between the humeral head and the glenoid labrum is another inside lesion that can be identified during routine diagnostic glenohumeral arthroscopy. The arthroscopic active compression test, as described by Verma and colleagues,¹⁸ can be used during surgery to demonstrate incarceration of the biceps tendon.

Medial biceps chondromalacia, attritional chondral wear along the anteromedial aspect of the humeral head, occurs secondary to a windshield wiper effect of the LHBT in the setting of an incarcerating LHBT or may be associated with destabilization of the biceps pulley.

Junctional Lesions

Junctional lesions, which include lesions that affect the intra-articular LHBT, can be visualized during routine glenohumeral arthroscopy. They include partial and complete biceps tears, biceps pulley lesions, and junctional biceps chondromalacia.

Biceps pulley injuries and/or tears of the upper subscapularis tendon can destabilize the biceps as it exits the joint, and this destabilization may result in medial subluxation of the tendon and the aforementioned medial biceps chondromalacia.^10,19 Junctional biceps chondromalacia is attritional chondral wear of the humeral head from abnormal tracking of the LHBT deep to the LHBT near the articular margin.

Recently elucidated is the limited ability of diagnostic glenohumeral arthroscopy to fully identify the extent of BLC pathology.^1,20-22 Gilmer and colleagues²⁰ found that diagnostic arthroscopy identified only 67% of biceps pathology and underestimated its extent in 56% of patients in their series. Similarly, Moon and colleagues²¹ found that 79% of proximal LHBT tears propagated distally into the bicipital tunnel and were incompletely visualized with standard arthroscopy.

Bicipital Tunnel Lesions

Recent evidence indicates that the bicipital tunnel is a closed space that often conceals space-occupying lesions, including scar, synovitis, loose bodies, and osteophytes, which can become trapped in the tunnel. The functional bottleneck between zones 2 and 3 of the bicipital tunnel explains the aggregation of loose bodies in this region.² Similarly, as the percentage of free space within the bicipital tunnel increases, space-occupying lesions (eg scar, loose bodies, osteophytes) may exude a compressive and/or abrasive force within zones 1 and 2, but not as commonly within zone 3.²

Physical Examination of Biceps-Labrum Complex

Accurate diagnosis of BLC disease is crucial in selecting an optimal intervention, but challenging. Beyond identifying biceps pathology, specific examination maneuvers may help distinguish between lesions of the intra-articular BLC and lesions of the extra-articular bicipital tunnel.²³

Traditional examination maneuvers for biceps-related shoulder pain include the Speed test, the full can test, and the Yergason test.^24,25 For the Speed test, the patient forward-flexes the shoulder to 60° to 90°, extends the arm at the elbow, and supinates the forearm. The clinician applies a downward force as the patient resists. The reported sensitivity of the Speed test ranges from 37% to 63%, and specificity is 60% to 88%.^25,26 In the full can test, with the patient’s arm in the plane of the scapula, the shoulder abducted to 90°, and the forearm in neutral rotation, a downward force is applied against resistance. Sensitivity of the full can test is 60% to 67%, and specificity is 76% to 84%.²⁴ The Yergason test is performed with the patient’s arm at his or her side, the elbow flexed to 90°, and the forearm pronated. The patient supinates the forearm against the clinician’s resistance. Sensitivity of the Yergason test is 19% to 32%, and specificity is 70% to 100%.^25,26 The Yergason test has a positive predictive value of 92% for bicipital tunnel disease.

O’Brien and colleagues^23,26 introduced a “3-pack” physical examination designed to elicit BLC symptoms. In this examination, the LHBT is palpated along its course within the bicipital tunnel. Reproduction of the patient’s pain by palpation had a sensitivity of 98% for bicipital tunnel disease but was less specific (70%). Gill and colleagues²⁷ reported low sensitivity (53%) and low specificity (54%) for biceps palpation, and they used arthroscopy as a gold standard. Since then, multiple studies have demonstrated that glenohumeral arthroscopy fails to identify lesions concealed within the bicipital tunnel.^20-22The second part of the 3-pack examination is the active compression test. A downward force is applied as the patient resists with his or her arm forward-flexed to 90° and adducted 10° to 15° with the thumb pointing downward.²⁸ This action is repeated with the humerus externally rotated and the forearm supinated. A positive test is indicated by reproduction of symptoms with the thumb down, and elimination or reduction of symptoms with the palm up. Test sensitivity is 88% to 96%, and specificity is 46% to 64% for BLC lesions, but for bicipital tunnel disease sensitivity is higher (96%), and the negative predictive value is 93%.²⁶The third component of the 3-pack examination is the throwing test. A late-cocking throwing position is re-created with the shoulder externally rotated and abducted to 90° and the elbow flexed to 90°. The patient steps forward with the contralateral leg and moves into the acceleration phase of throwing while the clinician provides isometric resistance. If this maneuver reproduces pain, the test is positive. As Taylor and colleagues²⁶ reported, the throwing test has sensitivity of 73% to 77% and specificity of 65% to 79% for BLC pathology. This test has moderate sensitivity and negative predictive value for bicipital tunnel disease but may be the only positive test on physical examination in the setting of LHBT instability.

 

Imaging of Biceps-Labrum Complex

Plain anteroposterior, lateral, and axillary radiographs of the shoulder should be obtained for all patients having an orthopedic examination for shoulder pain. Magnetic resonance imaging (MRI) and ultrasound are the advanced modalities most commonly used for diagnostic imaging. These modalities should be considered in conjunction with, not in place of, a comprehensive history and physical examination.

The literature suggests MRI fails to accurately detect many LHBT lesions (Table).^29-37

MRI has sensitivity of 9% to 89% for LHBT pathology^29-37 and 38% to 98% for SLAP pathology.^35,38-41 The wide range of reported sensitivity and specificity might be attributed to the varying criteria for what constitutes a BLC lesion. Some authors include biceps chondromalacia, dynamic incarceration of LHBT, and extra-articular bicipital tunnel lesions, while others historically have included only intra-articular LHBT lesions that can be directly visualized arthroscopically.

In their retrospective review of 277 shoulders with chronic refractory BLC symptoms treated with subdeltoid transfer of the LHBT to the conjoint tendon, Taylor and colleagues³⁰ reported MRI was more sensitive for inside BLC lesions than for junctional or bicipital tunnel lesions (77% vs 43% and 50%, respectively).

Treatment Options for Biceps-Labrum Complex Lesions

A diagnosis of BLC disease warrants a trial of conservative (nonoperative) management for at least 3 months. Many patients improve with activity modification, use of oral anti-inflammatory medication, and structured physical therapy focused on dynamic stabilizers and range of motion. If pain persists, local anesthetic and corticosteroid can be injected under ultrasound guidance into the bicipital tunnel; this injection has the advantage of being both diagnostic and therapeutic. Hashiuchi and colleagues⁴² found ultrasound-guided injections are 87% successful in achieving intra-sheath placement (injections without ultrasound guidance are only 27% successful).

If the 3-month trial of conservative management fails, surgical intervention should be considered. The goal in treating BLC pain is to maximize clinical function and alleviate pain in a predictable manner while minimizing technical demands and morbidity. A singular solution has not been identified. Furthermore, 3 systematic reviews failed to identify a difference between the most commonly used techniques, biceps tenodesis and tenotomy.^43-45 These reviews grouped all tenotomy procedures together and compared them with all tenodesis procedures. A limitation of these systematic reviews is that they did not differentiate tenodesis techniques. We prefer to classify techniques according to whether or not they decompress zones 1 and 2 of the bicipital tunnel.

Bicipital Tunnel Nondecompressing Techniques

Release of the biceps tendon, a biceps tenotomy, is a simple procedure that potentially avoids open surgery and provides patients with a quick return to activity. Disadvantages of tenotomy include cosmetic (Popeye) deformity after surgery, potential cramping and fatigue, and biomechanical changes in the humeral head,^46-48 particularly among patients younger than 65 years. High rates of revision after tenotomy have been reported.^43,49 Incomplete retraction of the LHBT and/or residual synovium may be responsible for refractory pain following biceps tenotomy.⁴⁹ We hypothesize that failure of tenotomy may be related to unaddressed bicipital tunnel disease.

Proximal nondecompressing tenodesis techniques may be performed either on soft tissue in the interval or rotator cuff or on bone at the articular margin or within zone 1 of the bicipital tunnel.^50-52 These techniques can be performed with standard glenohumeral arthroscopy and generally are fast and well tolerated and have limited operative morbidity. Advantages of these techniques over simple tenotomy are lower rates of cosmetic deformity and lower rates of cramping and fatigue pain, likely resulting from maintenance of the muscle tension relationship of the LHBT. Disadvantages of proximal tenodesis techniques include introduction of hardware for bony fixation, longer postoperative rehabilitation to protect repairs, and failure to address hidden bicipital tunnel disease. Furthermore, the rate of stiffness in patients who undergo proximal tenodesis without decompression of the bicipital tunnel may be as high as 18%.⁵³

Bicipital Tunnel Decompressing Techniques

Surgical techniques that decompress the bicipital tunnel include proximal techniques that release the bicipital sheath within zones 1 and 2 of the bicipital tunnel (to the level of the proximal margin of the pectoralis major tendon) and certain arthroscopic suprapectoral techniques,⁵⁴ open subpectoral tenodeses,^55-57 and arthroscopic transfer of the LHBT to the conjoint tendon.^58,59

Open subpectoral tenodesis techniques have the advantage of maintaining the length-tension relationship of the LHBT and preventing Popeye deformity. However, these techniques require making an incision near the axilla, which may introduce an unnecessary source of infection. Furthermore, open subpectoral tenodesis requires drilling the humerus and placing a screw for bony fixation of the LHBT, which can create a risk of neurovascular injury, given the proximity of neurovascular structures,^60-62 and humeral shaft fracture, particularly in athletes.^63,64Our preferred method is transfer of the LHBT to the conjoint tendon (Figure 3).⁵⁹

The subdeltoid space is a large, relatively avascular fascial plane bounded superiorly by the acromion and coracoacromial ligament, medially by the coracoid and conjoint tendon, inferiorly by the musculotendinous insertion of the pectoralis major, and laterally by the border of the humerus.⁶⁵ After the LHBT is released from the superior labrum, it is transferred to the subdeltoid space and sutured to the conjoint tendon in side-to-side fashion with nonabsorbable sutures.^58,59 This technique allows for isometric tensioning of the LHBT, which preserves the strength of the biceps muscle, and fixation of soft tissue to soft tissue obviates the need for bone tunnels, mitigating fracture risk. A histologic study that compared healing between LHBT tenodesis with bone and soft-tissue transfer to the conjoint tendon found a more robust response of tenomodulin in the soft-tissue transfer, suggesting tendon regeneration in this technique.⁶⁶ Perhaps the most significant advantage is the ability of this approach to effectively decompress the bicipital tunnel. Early-term results were promising, and recent midterm results demonstrated durability of clinical outcomes.^58,59Sanders and colleagues⁴⁹ compared revision rates of biceps procedures and found a 6.8% rate for techniques that released the biceps sheath and a 20.6% rate for operations in which the sheath was not released. Subsequent meta-analysis of 30 studies (1881 patients) found improved Constant scores in the cohort that underwent bicipital tunnel decompression in comparison with the cohort that did not have the bicipital tunnel decompressed, but there was no significant difference in UCLA (University of California Los Angeles) scores between cohorts.67 

In light of recent literature that confirms the prevalence of bicipital tunnel lesions that have been overlooked, and the power of physical examination, we have proposed an evidence-based approach to diagnosing and managing BLC disease (Figure 4).

 

Am J Orthop. 2016;45(7):E503-E511. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Pathology of the biceps-labrum complex (BLC) can be an important source of shoulder pain. Discussion of pathoanatomy, imaging, and surgical intervention is facilitated by distinguishing the anatomical zones of the BLC: inside, junction, and bicipital tunnel (extra-articular), parts of which cannot be visualized with standard diagnostic arthroscopy.

The recent literature indicates that bicipital tunnel lesions are common and perhaps overlooked. Systematic reviews suggest improvement in outcomes of BLC operations when the bicipital tunnel is decompressed. Higher-level clinical and basic science studies are needed to fully elucidate the role of the bicipital tunnel, but it is evident that a comprehensive physical examination and an understanding of the limits of advanced imaging are necessary to correctly diagnose and treat BLC-related shoulder pain.

Anatomy of Biceps-Labrum Complex

The long head of the biceps tendon (LHBT) and the glenoid labrum work as an interdependent functional unit, the biceps-labrum complex (BLC). The BLC is divided into 3 distinct anatomical zones: inside, junction, and bicipital tunnel.^1,2

Inside

The inside includes the superior labrum and biceps attachment. The LHBT most commonly originates in the superior labrum.^3-5 Vangsness and colleagues³ described 4 types of LHBT origins: Type I biceps attaches solely to the posterior labrum, type II predominantly posterior, type III equally to the anterior and posterior labrum, and type IV mostly to the anterior labrum. The LHBT can also originate in the supraglenoid tubercle or the inferior border of the supraspinatus.^3,6

Junction

Junction is the intra-articular segment of the LHBT and the biceps pulley. The LHBT traverses the glenohumeral joint en route to the extra-articular bicipital tunnel.² The LHBT is enveloped in synovium that extends into part of the bicipital tunnel.² The intra-articular segment of the LHBT is about 25 mm in length⁷ and has a diameter of 5 mm to 6 mm.⁸

A cadaveric study found that the average length of the LHBT that can be arthroscopically visualized at rest is 35.6 mm, or only 40% of the total length of the LHBT with respect to the proximal margin of the pectoralis major tendon.¹ When the LHBT was pulled into the joint, more tendon (another 14 mm) was visualized.¹ Therefore, diagnostic arthroscopy of the glenohumeral joint visualizes about 50% of the LHBT.⁹The morphology of the LHBT varies by location. The intra-articular portion of the LHBT is wide and flat, whereas the extra-articular portion is round.⁸ The tendon becomes smoother and more avascular as it exits the joint to promote gliding within its sheath in the bicipital groove.¹⁰ The proximal LHBT receives its vascular supply from superior labrum tributaries, and distally the LHBT is supplied by ascending branches of the anterior humeral circumflex artery.⁴ There is a hypovascular zone, created by this dual blood supply, about 12 mm to 30 mm from the LHBT origin, predisposing the tendon to rupture or fray in this region.¹¹The LHBT makes a 30° turn into the biceps pulley system as it exits the glenohumeral joint. The fibrous pulley system that stabilizes the LHBT in this region has contributions from the coracohumeral ligament, the superior glenohumeral ligament, and the supraspinatus tendon.^12-14

The floor of the pulley consists of the superior glenohumeral ligament with reinforcing fibers from the superior border of the subscapularis tendon.¹⁵ The roof consists of the coracohumeral ligament fibers with supraspinatus fibers contributing posteriorly (Figure 1).¹²

Bicipital Tunnel

The bicipital tunnel, the third portion of the BLC, remains largely hidden from standard diagnostic glenohumeral arthroscopy. The bicipital tunnel is an extra-articular, closed space that constrains the LHBT from the articular margin through the subpectoral region.²

The bicipital tunnel itself can be divided into 3 zones (Figure 2).²

Zone 1 is the traditional bicipital groove or “bony groove” that extends from the articular margin to the distal margin of the subscapularis tendon. The floor consists of a deep osseous groove covered by a continuation of subscapularis tendon fibers and periosteum.²Zone 2, “no man’s land,” extends from the distal margin of the subscapularis tendon to the proximal margin of the pectoralis major (PMPM). The LHBT in this zone cannot be visualized during a pull test at arthroscopy, yet lesions commonly occur here.¹ Zones 1 and 2 have a similar histology and contain synovium.²Zone 3 is the subpectoral region distal to the PMPM. Fibers of the latissimus dorsi form the flat floor of zone 3, and the pectoralis major inserts lateral to the LHBT on the humerus in this zone. The synovium encapsulating the LHBT in zones 1 and 2 rarely extends past the PMPM. Taylor and colleagues² found a higher percentage of unoccupied tunnel space in zone 3 than in zones 1 and 2, which results in a “functional bottleneck” between zones 2 and 3 represented by the PMPM.

 

Pathoanatomy

BLC lesions may occur in isolation or concomitantly across multiple anatomical zones. In a series of 277 chronically symptomatic shoulders that underwent transfer of the LHBT to the conjoint tendon with subdeltoid arthroscopy, Taylor and colleagues¹ found 47% incidence of bicipital tunnel lesions, 44% incidence of junctional lesions, and 35% incidence of inside lesions. In their series, 37% of patients had concomitant lesions involving more than 1 anatomical zone.

Inside Lesions

Inside lesions involve the superior labrum, the LHBT origin, or both. Superior labrum anterior-posterior (SLAP) tears are included as inside BLC lesions. Snyder and colleagues¹⁶ originally identified 4 broad categories of SLAP tears, but Powell and colleagues¹⁷ described up to 10 variations. Type II lesions, which are the most common, destabilize the biceps anchor.

Dynamic incarceration of the biceps between the humeral head and the glenoid labrum is another inside lesion that can be identified during routine diagnostic glenohumeral arthroscopy. The arthroscopic active compression test, as described by Verma and colleagues,¹⁸ can be used during surgery to demonstrate incarceration of the biceps tendon.

Medial biceps chondromalacia, attritional chondral wear along the anteromedial aspect of the humeral head, occurs secondary to a windshield wiper effect of the LHBT in the setting of an incarcerating LHBT or may be associated with destabilization of the biceps pulley.

Junctional Lesions

Junctional lesions, which include lesions that affect the intra-articular LHBT, can be visualized during routine glenohumeral arthroscopy. They include partial and complete biceps tears, biceps pulley lesions, and junctional biceps chondromalacia.

Biceps pulley injuries and/or tears of the upper subscapularis tendon can destabilize the biceps as it exits the joint, and this destabilization may result in medial subluxation of the tendon and the aforementioned medial biceps chondromalacia.^10,19 Junctional biceps chondromalacia is attritional chondral wear of the humeral head from abnormal tracking of the LHBT deep to the LHBT near the articular margin.

Recently elucidated is the limited ability of diagnostic glenohumeral arthroscopy to fully identify the extent of BLC pathology.^1,20-22 Gilmer and colleagues²⁰ found that diagnostic arthroscopy identified only 67% of biceps pathology and underestimated its extent in 56% of patients in their series. Similarly, Moon and colleagues²¹ found that 79% of proximal LHBT tears propagated distally into the bicipital tunnel and were incompletely visualized with standard arthroscopy.

Bicipital Tunnel Lesions

Recent evidence indicates that the bicipital tunnel is a closed space that often conceals space-occupying lesions, including scar, synovitis, loose bodies, and osteophytes, which can become trapped in the tunnel. The functional bottleneck between zones 2 and 3 of the bicipital tunnel explains the aggregation of loose bodies in this region.² Similarly, as the percentage of free space within the bicipital tunnel increases, space-occupying lesions (eg scar, loose bodies, osteophytes) may exude a compressive and/or abrasive force within zones 1 and 2, but not as commonly within zone 3.²

Physical Examination of Biceps-Labrum Complex

Accurate diagnosis of BLC disease is crucial in selecting an optimal intervention, but challenging. Beyond identifying biceps pathology, specific examination maneuvers may help distinguish between lesions of the intra-articular BLC and lesions of the extra-articular bicipital tunnel.²³

Traditional examination maneuvers for biceps-related shoulder pain include the Speed test, the full can test, and the Yergason test.^24,25 For the Speed test, the patient forward-flexes the shoulder to 60° to 90°, extends the arm at the elbow, and supinates the forearm. The clinician applies a downward force as the patient resists. The reported sensitivity of the Speed test ranges from 37% to 63%, and specificity is 60% to 88%.^25,26 In the full can test, with the patient’s arm in the plane of the scapula, the shoulder abducted to 90°, and the forearm in neutral rotation, a downward force is applied against resistance. Sensitivity of the full can test is 60% to 67%, and specificity is 76% to 84%.²⁴ The Yergason test is performed with the patient’s arm at his or her side, the elbow flexed to 90°, and the forearm pronated. The patient supinates the forearm against the clinician’s resistance. Sensitivity of the Yergason test is 19% to 32%, and specificity is 70% to 100%.^25,26 The Yergason test has a positive predictive value of 92% for bicipital tunnel disease.

O’Brien and colleagues^23,26 introduced a “3-pack” physical examination designed to elicit BLC symptoms. In this examination, the LHBT is palpated along its course within the bicipital tunnel. Reproduction of the patient’s pain by palpation had a sensitivity of 98% for bicipital tunnel disease but was less specific (70%). Gill and colleagues²⁷ reported low sensitivity (53%) and low specificity (54%) for biceps palpation, and they used arthroscopy as a gold standard. Since then, multiple studies have demonstrated that glenohumeral arthroscopy fails to identify lesions concealed within the bicipital tunnel.^20-22The second part of the 3-pack examination is the active compression test. A downward force is applied as the patient resists with his or her arm forward-flexed to 90° and adducted 10° to 15° with the thumb pointing downward.²⁸ This action is repeated with the humerus externally rotated and the forearm supinated. A positive test is indicated by reproduction of symptoms with the thumb down, and elimination or reduction of symptoms with the palm up. Test sensitivity is 88% to 96%, and specificity is 46% to 64% for BLC lesions, but for bicipital tunnel disease sensitivity is higher (96%), and the negative predictive value is 93%.²⁶The third component of the 3-pack examination is the throwing test. A late-cocking throwing position is re-created with the shoulder externally rotated and abducted to 90° and the elbow flexed to 90°. The patient steps forward with the contralateral leg and moves into the acceleration phase of throwing while the clinician provides isometric resistance. If this maneuver reproduces pain, the test is positive. As Taylor and colleagues²⁶ reported, the throwing test has sensitivity of 73% to 77% and specificity of 65% to 79% for BLC pathology. This test has moderate sensitivity and negative predictive value for bicipital tunnel disease but may be the only positive test on physical examination in the setting of LHBT instability.

 

Imaging of Biceps-Labrum Complex

Plain anteroposterior, lateral, and axillary radiographs of the shoulder should be obtained for all patients having an orthopedic examination for shoulder pain. Magnetic resonance imaging (MRI) and ultrasound are the advanced modalities most commonly used for diagnostic imaging. These modalities should be considered in conjunction with, not in place of, a comprehensive history and physical examination.

The literature suggests MRI fails to accurately detect many LHBT lesions (Table).^29-37

MRI has sensitivity of 9% to 89% for LHBT pathology^29-37 and 38% to 98% for SLAP pathology.^35,38-41 The wide range of reported sensitivity and specificity might be attributed to the varying criteria for what constitutes a BLC lesion. Some authors include biceps chondromalacia, dynamic incarceration of LHBT, and extra-articular bicipital tunnel lesions, while others historically have included only intra-articular LHBT lesions that can be directly visualized arthroscopically.

In their retrospective review of 277 shoulders with chronic refractory BLC symptoms treated with subdeltoid transfer of the LHBT to the conjoint tendon, Taylor and colleagues³⁰ reported MRI was more sensitive for inside BLC lesions than for junctional or bicipital tunnel lesions (77% vs 43% and 50%, respectively).

Treatment Options for Biceps-Labrum Complex Lesions

A diagnosis of BLC disease warrants a trial of conservative (nonoperative) management for at least 3 months. Many patients improve with activity modification, use of oral anti-inflammatory medication, and structured physical therapy focused on dynamic stabilizers and range of motion. If pain persists, local anesthetic and corticosteroid can be injected under ultrasound guidance into the bicipital tunnel; this injection has the advantage of being both diagnostic and therapeutic. Hashiuchi and colleagues⁴² found ultrasound-guided injections are 87% successful in achieving intra-sheath placement (injections without ultrasound guidance are only 27% successful).

If the 3-month trial of conservative management fails, surgical intervention should be considered. The goal in treating BLC pain is to maximize clinical function and alleviate pain in a predictable manner while minimizing technical demands and morbidity. A singular solution has not been identified. Furthermore, 3 systematic reviews failed to identify a difference between the most commonly used techniques, biceps tenodesis and tenotomy.^43-45 These reviews grouped all tenotomy procedures together and compared them with all tenodesis procedures. A limitation of these systematic reviews is that they did not differentiate tenodesis techniques. We prefer to classify techniques according to whether or not they decompress zones 1 and 2 of the bicipital tunnel.

Bicipital Tunnel Nondecompressing Techniques

Release of the biceps tendon, a biceps tenotomy, is a simple procedure that potentially avoids open surgery and provides patients with a quick return to activity. Disadvantages of tenotomy include cosmetic (Popeye) deformity after surgery, potential cramping and fatigue, and biomechanical changes in the humeral head,^46-48 particularly among patients younger than 65 years. High rates of revision after tenotomy have been reported.^43,49 Incomplete retraction of the LHBT and/or residual synovium may be responsible for refractory pain following biceps tenotomy.⁴⁹ We hypothesize that failure of tenotomy may be related to unaddressed bicipital tunnel disease.

Proximal nondecompressing tenodesis techniques may be performed either on soft tissue in the interval or rotator cuff or on bone at the articular margin or within zone 1 of the bicipital tunnel.^50-52 These techniques can be performed with standard glenohumeral arthroscopy and generally are fast and well tolerated and have limited operative morbidity. Advantages of these techniques over simple tenotomy are lower rates of cosmetic deformity and lower rates of cramping and fatigue pain, likely resulting from maintenance of the muscle tension relationship of the LHBT. Disadvantages of proximal tenodesis techniques include introduction of hardware for bony fixation, longer postoperative rehabilitation to protect repairs, and failure to address hidden bicipital tunnel disease. Furthermore, the rate of stiffness in patients who undergo proximal tenodesis without decompression of the bicipital tunnel may be as high as 18%.⁵³

Bicipital Tunnel Decompressing Techniques

Surgical techniques that decompress the bicipital tunnel include proximal techniques that release the bicipital sheath within zones 1 and 2 of the bicipital tunnel (to the level of the proximal margin of the pectoralis major tendon) and certain arthroscopic suprapectoral techniques,⁵⁴ open subpectoral tenodeses,^55-57 and arthroscopic transfer of the LHBT to the conjoint tendon.^58,59

Open subpectoral tenodesis techniques have the advantage of maintaining the length-tension relationship of the LHBT and preventing Popeye deformity. However, these techniques require making an incision near the axilla, which may introduce an unnecessary source of infection. Furthermore, open subpectoral tenodesis requires drilling the humerus and placing a screw for bony fixation of the LHBT, which can create a risk of neurovascular injury, given the proximity of neurovascular structures,^60-62 and humeral shaft fracture, particularly in athletes.^63,64Our preferred method is transfer of the LHBT to the conjoint tendon (Figure 3).⁵⁹

The subdeltoid space is a large, relatively avascular fascial plane bounded superiorly by the acromion and coracoacromial ligament, medially by the coracoid and conjoint tendon, inferiorly by the musculotendinous insertion of the pectoralis major, and laterally by the border of the humerus.⁶⁵ After the LHBT is released from the superior labrum, it is transferred to the subdeltoid space and sutured to the conjoint tendon in side-to-side fashion with nonabsorbable sutures.^58,59 This technique allows for isometric tensioning of the LHBT, which preserves the strength of the biceps muscle, and fixation of soft tissue to soft tissue obviates the need for bone tunnels, mitigating fracture risk. A histologic study that compared healing between LHBT tenodesis with bone and soft-tissue transfer to the conjoint tendon found a more robust response of tenomodulin in the soft-tissue transfer, suggesting tendon regeneration in this technique.⁶⁶ Perhaps the most significant advantage is the ability of this approach to effectively decompress the bicipital tunnel. Early-term results were promising, and recent midterm results demonstrated durability of clinical outcomes.^58,59Sanders and colleagues⁴⁹ compared revision rates of biceps procedures and found a 6.8% rate for techniques that released the biceps sheath and a 20.6% rate for operations in which the sheath was not released. Subsequent meta-analysis of 30 studies (1881 patients) found improved Constant scores in the cohort that underwent bicipital tunnel decompression in comparison with the cohort that did not have the bicipital tunnel decompressed, but there was no significant difference in UCLA (University of California Los Angeles) scores between cohorts.67 

In light of recent literature that confirms the prevalence of bicipital tunnel lesions that have been overlooked, and the power of physical examination, we have proposed an evidence-based approach to diagnosing and managing BLC disease (Figure 4).

 

Am J Orthop. 2016;45(7):E503-E511. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Risk factors for dislocation after reverse total shoulder arthroplasty (RTSA) are not clearly defined. Prosthetic dislocation can result in poor patient satisfaction, worse functional outcomes, and return to the operating room.^1-3 As a result, identification of modifiable risk factors for complications represents an important research initiative for shoulder surgeons.

There is a paucity of literature devoted to the study of dislocation after RTSA. Chalmers and colleagues⁴ found a 2.9% (11/385) incidence of early dislocation within 3 months after index surgery—an improvement over the 15.8% reported for early instability over the period 2004–2006.⁵ As prosthesis design has improved and surgeons have become more comfortable with the RTSA prosthesis, surgical indications have expanded,^6,7 and dislocation rates appear to have decreased. Although the most common indication for RTSA continues to be cuff tear arthropathy (CTA),⁶ there has been increased use in rheumatoid arthritis^8-10; proximal humerus fractures, especially in cases of poor bone quality and unreliable fixation of tuberosities^11-13; and failed previous shoulder reconstruction.^14,15 As RTSA is performed more often, limiting the complications will become more important for both patient care and economics.

We conducted a study to analyze dislocation rates at our institution and to identify both modifiable and nonmodifiable risk factors for dislocation after RTSA. By identifying risk factors for dislocation, we will be able to implement additional perioperative clinical measures to reduce the incidence of dislocation.

Materials and Methods

This retrospective study of dislocation after RTSA was conducted at the Rothman Institute of Orthopedics and Methodist Hospital (Thomas Jefferson University Hospitals, Philadelphia, PA). After obtaining Institutional Review Board approval for the study, we searched our institution’s electronic database of shoulder arthroplasties to identify all RTSAs performed at our 2 large-volume urban institutions between September 27, 2010 and December 31, 2013. For the record search, International Classification of Diseases, Ninth Revision (ICD-9) codes were used (Table 1).

These unique procedure codes are used by the hospital system for billing, but are not always specific to assigned procedures. Therefore, the individual operative reports identified were reviewed to identify the patients who actually underwent RTSA. From this database, all patients who underwent RTSA were selected. Using the subpopulation of patients who underwent RTSA, we searched individual medical records to identify patients who had a dislocation after RTSA. This information was cross-referenced with ICD-9 codes for shoulder dislocation (831.0, 831.01, 831.02, 831.03) to ensure that all patients were identified.

The medical records of each patient were used to identify independent variables that could be associated with dislocation rate. Demographic variables included sex, age, and race. Preoperative clinical data included body mass index (BMI), etiology of shoulder disease leading to RTSA, individual comorbidities, and Charlson Comorbidity Index (CCI)¹⁶ modified to be used with ICD-9 codes.¹⁷ In addition, prior shoulder surgery history and arthroplasty type (primary or revision) were determined. Postoperative considerations were time to dislocation, mechanism of dislocation, and intervention(s) needed for dislocation. Although the institutional database did not include operative variables such as prosthesis type and surgical approach, all 6 surgeons in this study were using a standard deltopectoral approach in beach-chair position with a Grammont style prosthesis for RTSA cases.

Descriptive statistics for RTSA patients and the dislocation subpopulation were compiled. Bivariate analysis was used to evaluate which of the previously described variables influenced dislocation rates. Last, multivariate logistic regression analysis was performed to evaluate which factors were independent predictors of dislocation. We included demographic variables (age, sex, ethnicity), clinical variables (BMI, individual comorbidities, CCI), and surgical variables (primary vs revision, diagnosis at time of surgery). All statistical analyses were performed with Excel 2013 (Microsoft) and SPSS Statistics Version 20.0 (SPSS Inc.).

Results

From the database, we identified 487 patients who underwent 510 RTSAs during the study period. These surgeries were performed by 6 shoulder and elbow fellowship–trained surgeons. Of the 510 RTSAs, 393 (77.1%) were primary cases, and 117 (22.9%) were revision cases.

Of the 510 shoulders that underwent RTSA, 15 (2.9%; 14 patients) dislocated. Of these 15 cases, 5 were primary (1.3% of all primary cases) and 10 were revision (8.5% of all revision cases). Mean time from index surgery to diagnosis of dislocation was 58.2 days (range, 0-319 days). One dislocation occurred immediately after surgery, 2 after falls, 4 from patient-identified low-energy mechanisms of injury, and 8 without known inciting events. Nine dislocations (60%) did not have a subscapularis repair (7 were irreparable, 2 underwent subscapularis peel without repair), and the other 6 were repaired primarily (Table 2).

In addition, 11 dislocations (73.3%) previously underwent open or arthroscopic shoulder surgery. All patients who had a dislocation after RTSA returned to the operating room at least once; no dislocation was successfully treated with closed reduction in the clinic. The 15 dislocations underwent 17 surgeries: 7 isolated polyethylene exchanges, 2 isolated closed reductions, 1 hematoma aspiration with closed reduction, 1 open reduction, 2 humeral component revisions with polyethylene exchange, 1 humeral augmentation with polyethylene exchange, 2 glenosphere exchanges with polyethylene exchange, and 1 polyethylene exchange with concurrent subscapularis repair.

Male patients accounted for 32.2% of the study population but 60.0% of the dislocations (P = .019) (Table 3).

In addition, mean BMI was 33.2 for patients with dislocation and 29.5 for patients without dislocation (P = .039) (Table 3). Revision arthroplasty was found to be a risk factor for dislocation in univariate analysis: 66.7% of the dislocations occurred after revision RTSA, and only 21.6% of nondislocated shoulders were revision cases (P < .001) (Table 4).

Patients who underwent RTSA for CTA had a very low incidence of dislocation (0.35%, 1/285), accounting for 6.7% of the dislocated group and 57.6% of the nondislocated group (P < .001) (Table 4). The 1 patient with a dislocation after primary RTSA for CTA had an indolent infection at time of surgery after dislocation.

Multivariate logistic regression analysis revealed revision arthroplasty (OR = 7.515; P = .042) and increased BMI (OR = 1.09; P = .047) to be independent risk factors for dislocation after RTSA. Analysis also found a diagnosis of primary CTA to be independently associated with lower risk of dislocation after RTSA (OR = 0.025; P = .008). Last, the previously described risk factor of male sex was found not to be a significant independent risk factor, though it did trend positively (OR = 3.011; P = .071).

 

Discussion

With more RTSAs being performed, evaluation of their common complications becomes increasingly important.¹⁸ We found a 3.0% rate of dislocation after RTSA, which is consistent with the most recently reported incidence⁴ and falls within the previously described range of 0% to 8.6%.^19-26 Of the clinical risk factors identified in this study, those previously described were prior surgery, subscapularis insufficiency, higher BMI, and male sex.⁴ However, our finding of lower risk of dislocation after RTSA for primary rotator cuff pathology was not previously described. Although Chalmers and colleagues⁴ did not report this lower risk, 3 (27.3%) of their 11 patients with dislocation had primary CTA, compared with 1 (6.7%) of 15 patients in the present study.⁴ Our literature review did not identify any studies that independently reported the dislocation rate in patients who underwent RTSA for rotator cuff failure.

The risk factors of subscapularis irreparability and revision surgery suggest the importance of the soft-tissue envelope and bony anatomy in dislocation prevention. Previous analyses have suggested implant malpositioning,^27,28 poor subscapularis quality,²⁹ and inadequate muscle tensioning^5,30-32 as risk factors for RTSA. Patients with an irreparable subscapularis tendon have often had multiple surgeries with compromise to the muscle/soft-tissue envelope or bony anatomy of the shoulder. A biomechanical study by Gutiérrez and colleagues³¹ found the compressive forces of the soft tissue at the glenohumeral joint to be the most important contributor to stability in the RTSA prosthesis. In clinical studies, the role of the subscapularis in preventing instability after RTSA remains unclear. Edwards and colleagues²⁹ prospectively compared dislocation rates in patients with reparable and irreparable subscapularis tendons during RTSA and found a higher rate of dislocation in the irreparable subscapularis group. Of note, patients in the irreparable subscapularis group also had more complex diagnoses, including proximal humeral nonunion, fixed glenohumeral dislocation, and failed prior arthroplasty. Clark and colleagues³³ retrospectively analyzed subscapularis repair in 2 RTSA groups and found no appreciable effect on complication rate, dislocation events, range-of-motion gains, or pain relief.

Our finding that higher BMI is an independent risk factor was previously described.⁴ The association is unclear but could be related to implant positioning, difficulty in intraoperative assessment of muscle tensioning, or body habitus that may generate a lever arm for impingement and dislocation when the arm is in adduction. Last, our finding that male sex is a risk factor for dislocation approached significance, and this relationship was previously reported.⁴ This could be attributable to a higher rate of activity or of indolent infection in male patients.^34,35Besides studying risk factors for dislocation after RTSA, we investigated treatment. None of our patients were treated successfully and definitively with closed reduction in the clinic. This finding diverges from findings in studies by Teusink and colleagues² and Chalmers and colleagues,⁴who respectively reported 62% and 44% rates of success with closed reduction. Our cohort of 14 patients with 15 dislocations required a total of 17 trips to the operating room after dislocation. This significantly higher rate of return to the operating room suggests that dislocation after RTSA may be a more costly and morbid problem than has been previously described.

This study had several weaknesses. Despite its large consecutive series of patients, the study was retrospective, and several variables that would be documented and controlled in a prospective study could not be measured here. Specifically, neither preoperative physical examination nor patient-specific assessments of pain or function were consistently obtained. Similarly, postoperative patient-specific instruments of outcomes evaluation were not obtained consistently, so results of patients with dislocation could not be compared with those of a control group. In addition, preoperative and postoperative radiographs were not consistently present in our electronic medical records, so the influence of preoperative bony anatomy, intraoperative limb lengthening, and any implant malpositioning could not be determined. Furthermore, operative details, such as reparability of the subscapularis, were not fully available for the control group and could not be included in statistical analysis. In addition, that the known dislocation risk factor of male sex⁴ was identified here but was not significant in multivariate regression analysis suggests that this study may not have been adequately powered to identify a significant difference in dislocation rate between the sexes. Last, though our results suggested associations between the aforementioned variables and dislocation after RTSA, a truly causative relationship could not be confirmed with this study design or analysis. Therefore, our study findings are hypothesis-generating and may indicate a benefit to greater deltoid tensioning, use of retentive liners, or more conservative rehabilitation protocols for high-risk patients.

Conclusion

Dislocation after RTSA is an uncommon complication that often requires a return to the operating room. This study identified a modifiable risk factor (higher BMI) and 3 nonmodifiable risk factors (male sex, subscapularis insufficiency, revision surgery) for dislocation after RTSA. In contrast, patients who undergo RTSA for primary rotator cuff pathology are unlikely to dislocate after surgery. This low risk of dislocation after RTSA for primary cuff pathology was not previously described. Patients in the higher risk category may benefit from preoperative lifestyle modification, intraoperative techniques for increasing stability, and more conservative therapy after surgery. In addition, unlike previous investigations, this study did not find closed reduction in the clinic alone to be successful in definitively treating this patient population.

Am J Orthop. 2016;45(7):E444-E450. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Risk factors for dislocation after reverse total shoulder arthroplasty (RTSA) are not clearly defined. Prosthetic dislocation can result in poor patient satisfaction, worse functional outcomes, and return to the operating room.^1-3 As a result, identification of modifiable risk factors for complications represents an important research initiative for shoulder surgeons.

There is a paucity of literature devoted to the study of dislocation after RTSA. Chalmers and colleagues⁴ found a 2.9% (11/385) incidence of early dislocation within 3 months after index surgery—an improvement over the 15.8% reported for early instability over the period 2004–2006.⁵ As prosthesis design has improved and surgeons have become more comfortable with the RTSA prosthesis, surgical indications have expanded,^6,7 and dislocation rates appear to have decreased. Although the most common indication for RTSA continues to be cuff tear arthropathy (CTA),⁶ there has been increased use in rheumatoid arthritis^8-10; proximal humerus fractures, especially in cases of poor bone quality and unreliable fixation of tuberosities^11-13; and failed previous shoulder reconstruction.^14,15 As RTSA is performed more often, limiting the complications will become more important for both patient care and economics.

We conducted a study to analyze dislocation rates at our institution and to identify both modifiable and nonmodifiable risk factors for dislocation after RTSA. By identifying risk factors for dislocation, we will be able to implement additional perioperative clinical measures to reduce the incidence of dislocation.

Materials and Methods

This retrospective study of dislocation after RTSA was conducted at the Rothman Institute of Orthopedics and Methodist Hospital (Thomas Jefferson University Hospitals, Philadelphia, PA). After obtaining Institutional Review Board approval for the study, we searched our institution’s electronic database of shoulder arthroplasties to identify all RTSAs performed at our 2 large-volume urban institutions between September 27, 2010 and December 31, 2013. For the record search, International Classification of Diseases, Ninth Revision (ICD-9) codes were used (Table 1).

These unique procedure codes are used by the hospital system for billing, but are not always specific to assigned procedures. Therefore, the individual operative reports identified were reviewed to identify the patients who actually underwent RTSA. From this database, all patients who underwent RTSA were selected. Using the subpopulation of patients who underwent RTSA, we searched individual medical records to identify patients who had a dislocation after RTSA. This information was cross-referenced with ICD-9 codes for shoulder dislocation (831.0, 831.01, 831.02, 831.03) to ensure that all patients were identified.

The medical records of each patient were used to identify independent variables that could be associated with dislocation rate. Demographic variables included sex, age, and race. Preoperative clinical data included body mass index (BMI), etiology of shoulder disease leading to RTSA, individual comorbidities, and Charlson Comorbidity Index (CCI)¹⁶ modified to be used with ICD-9 codes.¹⁷ In addition, prior shoulder surgery history and arthroplasty type (primary or revision) were determined. Postoperative considerations were time to dislocation, mechanism of dislocation, and intervention(s) needed for dislocation. Although the institutional database did not include operative variables such as prosthesis type and surgical approach, all 6 surgeons in this study were using a standard deltopectoral approach in beach-chair position with a Grammont style prosthesis for RTSA cases.

Descriptive statistics for RTSA patients and the dislocation subpopulation were compiled. Bivariate analysis was used to evaluate which of the previously described variables influenced dislocation rates. Last, multivariate logistic regression analysis was performed to evaluate which factors were independent predictors of dislocation. We included demographic variables (age, sex, ethnicity), clinical variables (BMI, individual comorbidities, CCI), and surgical variables (primary vs revision, diagnosis at time of surgery). All statistical analyses were performed with Excel 2013 (Microsoft) and SPSS Statistics Version 20.0 (SPSS Inc.).

Results

From the database, we identified 487 patients who underwent 510 RTSAs during the study period. These surgeries were performed by 6 shoulder and elbow fellowship–trained surgeons. Of the 510 RTSAs, 393 (77.1%) were primary cases, and 117 (22.9%) were revision cases.

Of the 510 shoulders that underwent RTSA, 15 (2.9%; 14 patients) dislocated. Of these 15 cases, 5 were primary (1.3% of all primary cases) and 10 were revision (8.5% of all revision cases). Mean time from index surgery to diagnosis of dislocation was 58.2 days (range, 0-319 days). One dislocation occurred immediately after surgery, 2 after falls, 4 from patient-identified low-energy mechanisms of injury, and 8 without known inciting events. Nine dislocations (60%) did not have a subscapularis repair (7 were irreparable, 2 underwent subscapularis peel without repair), and the other 6 were repaired primarily (Table 2).

In addition, 11 dislocations (73.3%) previously underwent open or arthroscopic shoulder surgery. All patients who had a dislocation after RTSA returned to the operating room at least once; no dislocation was successfully treated with closed reduction in the clinic. The 15 dislocations underwent 17 surgeries: 7 isolated polyethylene exchanges, 2 isolated closed reductions, 1 hematoma aspiration with closed reduction, 1 open reduction, 2 humeral component revisions with polyethylene exchange, 1 humeral augmentation with polyethylene exchange, 2 glenosphere exchanges with polyethylene exchange, and 1 polyethylene exchange with concurrent subscapularis repair.

Male patients accounted for 32.2% of the study population but 60.0% of the dislocations (P = .019) (Table 3).

In addition, mean BMI was 33.2 for patients with dislocation and 29.5 for patients without dislocation (P = .039) (Table 3). Revision arthroplasty was found to be a risk factor for dislocation in univariate analysis: 66.7% of the dislocations occurred after revision RTSA, and only 21.6% of nondislocated shoulders were revision cases (P < .001) (Table 4).

Patients who underwent RTSA for CTA had a very low incidence of dislocation (0.35%, 1/285), accounting for 6.7% of the dislocated group and 57.6% of the nondislocated group (P < .001) (Table 4). The 1 patient with a dislocation after primary RTSA for CTA had an indolent infection at time of surgery after dislocation.

Multivariate logistic regression analysis revealed revision arthroplasty (OR = 7.515; P = .042) and increased BMI (OR = 1.09; P = .047) to be independent risk factors for dislocation after RTSA. Analysis also found a diagnosis of primary CTA to be independently associated with lower risk of dislocation after RTSA (OR = 0.025; P = .008). Last, the previously described risk factor of male sex was found not to be a significant independent risk factor, though it did trend positively (OR = 3.011; P = .071).

 

Discussion

With more RTSAs being performed, evaluation of their common complications becomes increasingly important.¹⁸ We found a 3.0% rate of dislocation after RTSA, which is consistent with the most recently reported incidence⁴ and falls within the previously described range of 0% to 8.6%.^19-26 Of the clinical risk factors identified in this study, those previously described were prior surgery, subscapularis insufficiency, higher BMI, and male sex.⁴ However, our finding of lower risk of dislocation after RTSA for primary rotator cuff pathology was not previously described. Although Chalmers and colleagues⁴ did not report this lower risk, 3 (27.3%) of their 11 patients with dislocation had primary CTA, compared with 1 (6.7%) of 15 patients in the present study.⁴ Our literature review did not identify any studies that independently reported the dislocation rate in patients who underwent RTSA for rotator cuff failure.

The risk factors of subscapularis irreparability and revision surgery suggest the importance of the soft-tissue envelope and bony anatomy in dislocation prevention. Previous analyses have suggested implant malpositioning,^27,28 poor subscapularis quality,²⁹ and inadequate muscle tensioning^5,30-32 as risk factors for RTSA. Patients with an irreparable subscapularis tendon have often had multiple surgeries with compromise to the muscle/soft-tissue envelope or bony anatomy of the shoulder. A biomechanical study by Gutiérrez and colleagues³¹ found the compressive forces of the soft tissue at the glenohumeral joint to be the most important contributor to stability in the RTSA prosthesis. In clinical studies, the role of the subscapularis in preventing instability after RTSA remains unclear. Edwards and colleagues²⁹ prospectively compared dislocation rates in patients with reparable and irreparable subscapularis tendons during RTSA and found a higher rate of dislocation in the irreparable subscapularis group. Of note, patients in the irreparable subscapularis group also had more complex diagnoses, including proximal humeral nonunion, fixed glenohumeral dislocation, and failed prior arthroplasty. Clark and colleagues³³ retrospectively analyzed subscapularis repair in 2 RTSA groups and found no appreciable effect on complication rate, dislocation events, range-of-motion gains, or pain relief.

Our finding that higher BMI is an independent risk factor was previously described.⁴ The association is unclear but could be related to implant positioning, difficulty in intraoperative assessment of muscle tensioning, or body habitus that may generate a lever arm for impingement and dislocation when the arm is in adduction. Last, our finding that male sex is a risk factor for dislocation approached significance, and this relationship was previously reported.⁴ This could be attributable to a higher rate of activity or of indolent infection in male patients.^34,35Besides studying risk factors for dislocation after RTSA, we investigated treatment. None of our patients were treated successfully and definitively with closed reduction in the clinic. This finding diverges from findings in studies by Teusink and colleagues² and Chalmers and colleagues,⁴who respectively reported 62% and 44% rates of success with closed reduction. Our cohort of 14 patients with 15 dislocations required a total of 17 trips to the operating room after dislocation. This significantly higher rate of return to the operating room suggests that dislocation after RTSA may be a more costly and morbid problem than has been previously described.

This study had several weaknesses. Despite its large consecutive series of patients, the study was retrospective, and several variables that would be documented and controlled in a prospective study could not be measured here. Specifically, neither preoperative physical examination nor patient-specific assessments of pain or function were consistently obtained. Similarly, postoperative patient-specific instruments of outcomes evaluation were not obtained consistently, so results of patients with dislocation could not be compared with those of a control group. In addition, preoperative and postoperative radiographs were not consistently present in our electronic medical records, so the influence of preoperative bony anatomy, intraoperative limb lengthening, and any implant malpositioning could not be determined. Furthermore, operative details, such as reparability of the subscapularis, were not fully available for the control group and could not be included in statistical analysis. In addition, that the known dislocation risk factor of male sex⁴ was identified here but was not significant in multivariate regression analysis suggests that this study may not have been adequately powered to identify a significant difference in dislocation rate between the sexes. Last, though our results suggested associations between the aforementioned variables and dislocation after RTSA, a truly causative relationship could not be confirmed with this study design or analysis. Therefore, our study findings are hypothesis-generating and may indicate a benefit to greater deltoid tensioning, use of retentive liners, or more conservative rehabilitation protocols for high-risk patients.

Conclusion

Dislocation after RTSA is an uncommon complication that often requires a return to the operating room. This study identified a modifiable risk factor (higher BMI) and 3 nonmodifiable risk factors (male sex, subscapularis insufficiency, revision surgery) for dislocation after RTSA. In contrast, patients who undergo RTSA for primary rotator cuff pathology are unlikely to dislocate after surgery. This low risk of dislocation after RTSA for primary cuff pathology was not previously described. Patients in the higher risk category may benefit from preoperative lifestyle modification, intraoperative techniques for increasing stability, and more conservative therapy after surgery. In addition, unlike previous investigations, this study did not find closed reduction in the clinic alone to be successful in definitively treating this patient population.

Am J Orthop. 2016;45(7):E444-E450. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Risk factors for dislocation after reverse total shoulder arthroplasty (RTSA) are not clearly defined. Prosthetic dislocation can result in poor patient satisfaction, worse functional outcomes, and return to the operating room.^1-3 As a result, identification of modifiable risk factors for complications represents an important research initiative for shoulder surgeons.

There is a paucity of literature devoted to the study of dislocation after RTSA. Chalmers and colleagues⁴ found a 2.9% (11/385) incidence of early dislocation within 3 months after index surgery—an improvement over the 15.8% reported for early instability over the period 2004–2006.⁵ As prosthesis design has improved and surgeons have become more comfortable with the RTSA prosthesis, surgical indications have expanded,^6,7 and dislocation rates appear to have decreased. Although the most common indication for RTSA continues to be cuff tear arthropathy (CTA),⁶ there has been increased use in rheumatoid arthritis^8-10; proximal humerus fractures, especially in cases of poor bone quality and unreliable fixation of tuberosities^11-13; and failed previous shoulder reconstruction.^14,15 As RTSA is performed more often, limiting the complications will become more important for both patient care and economics.

We conducted a study to analyze dislocation rates at our institution and to identify both modifiable and nonmodifiable risk factors for dislocation after RTSA. By identifying risk factors for dislocation, we will be able to implement additional perioperative clinical measures to reduce the incidence of dislocation.

Materials and Methods

This retrospective study of dislocation after RTSA was conducted at the Rothman Institute of Orthopedics and Methodist Hospital (Thomas Jefferson University Hospitals, Philadelphia, PA). After obtaining Institutional Review Board approval for the study, we searched our institution’s electronic database of shoulder arthroplasties to identify all RTSAs performed at our 2 large-volume urban institutions between September 27, 2010 and December 31, 2013. For the record search, International Classification of Diseases, Ninth Revision (ICD-9) codes were used (Table 1).

These unique procedure codes are used by the hospital system for billing, but are not always specific to assigned procedures. Therefore, the individual operative reports identified were reviewed to identify the patients who actually underwent RTSA. From this database, all patients who underwent RTSA were selected. Using the subpopulation of patients who underwent RTSA, we searched individual medical records to identify patients who had a dislocation after RTSA. This information was cross-referenced with ICD-9 codes for shoulder dislocation (831.0, 831.01, 831.02, 831.03) to ensure that all patients were identified.

The medical records of each patient were used to identify independent variables that could be associated with dislocation rate. Demographic variables included sex, age, and race. Preoperative clinical data included body mass index (BMI), etiology of shoulder disease leading to RTSA, individual comorbidities, and Charlson Comorbidity Index (CCI)¹⁶ modified to be used with ICD-9 codes.¹⁷ In addition, prior shoulder surgery history and arthroplasty type (primary or revision) were determined. Postoperative considerations were time to dislocation, mechanism of dislocation, and intervention(s) needed for dislocation. Although the institutional database did not include operative variables such as prosthesis type and surgical approach, all 6 surgeons in this study were using a standard deltopectoral approach in beach-chair position with a Grammont style prosthesis for RTSA cases.

Descriptive statistics for RTSA patients and the dislocation subpopulation were compiled. Bivariate analysis was used to evaluate which of the previously described variables influenced dislocation rates. Last, multivariate logistic regression analysis was performed to evaluate which factors were independent predictors of dislocation. We included demographic variables (age, sex, ethnicity), clinical variables (BMI, individual comorbidities, CCI), and surgical variables (primary vs revision, diagnosis at time of surgery). All statistical analyses were performed with Excel 2013 (Microsoft) and SPSS Statistics Version 20.0 (SPSS Inc.).

Results

From the database, we identified 487 patients who underwent 510 RTSAs during the study period. These surgeries were performed by 6 shoulder and elbow fellowship–trained surgeons. Of the 510 RTSAs, 393 (77.1%) were primary cases, and 117 (22.9%) were revision cases.

Of the 510 shoulders that underwent RTSA, 15 (2.9%; 14 patients) dislocated. Of these 15 cases, 5 were primary (1.3% of all primary cases) and 10 were revision (8.5% of all revision cases). Mean time from index surgery to diagnosis of dislocation was 58.2 days (range, 0-319 days). One dislocation occurred immediately after surgery, 2 after falls, 4 from patient-identified low-energy mechanisms of injury, and 8 without known inciting events. Nine dislocations (60%) did not have a subscapularis repair (7 were irreparable, 2 underwent subscapularis peel without repair), and the other 6 were repaired primarily (Table 2).

In addition, 11 dislocations (73.3%) previously underwent open or arthroscopic shoulder surgery. All patients who had a dislocation after RTSA returned to the operating room at least once; no dislocation was successfully treated with closed reduction in the clinic. The 15 dislocations underwent 17 surgeries: 7 isolated polyethylene exchanges, 2 isolated closed reductions, 1 hematoma aspiration with closed reduction, 1 open reduction, 2 humeral component revisions with polyethylene exchange, 1 humeral augmentation with polyethylene exchange, 2 glenosphere exchanges with polyethylene exchange, and 1 polyethylene exchange with concurrent subscapularis repair.

Male patients accounted for 32.2% of the study population but 60.0% of the dislocations (P = .019) (Table 3).

In addition, mean BMI was 33.2 for patients with dislocation and 29.5 for patients without dislocation (P = .039) (Table 3). Revision arthroplasty was found to be a risk factor for dislocation in univariate analysis: 66.7% of the dislocations occurred after revision RTSA, and only 21.6% of nondislocated shoulders were revision cases (P < .001) (Table 4).

Patients who underwent RTSA for CTA had a very low incidence of dislocation (0.35%, 1/285), accounting for 6.7% of the dislocated group and 57.6% of the nondislocated group (P < .001) (Table 4). The 1 patient with a dislocation after primary RTSA for CTA had an indolent infection at time of surgery after dislocation.

Multivariate logistic regression analysis revealed revision arthroplasty (OR = 7.515; P = .042) and increased BMI (OR = 1.09; P = .047) to be independent risk factors for dislocation after RTSA. Analysis also found a diagnosis of primary CTA to be independently associated with lower risk of dislocation after RTSA (OR = 0.025; P = .008). Last, the previously described risk factor of male sex was found not to be a significant independent risk factor, though it did trend positively (OR = 3.011; P = .071).

 

Discussion

With more RTSAs being performed, evaluation of their common complications becomes increasingly important.¹⁸ We found a 3.0% rate of dislocation after RTSA, which is consistent with the most recently reported incidence⁴ and falls within the previously described range of 0% to 8.6%.^19-26 Of the clinical risk factors identified in this study, those previously described were prior surgery, subscapularis insufficiency, higher BMI, and male sex.⁴ However, our finding of lower risk of dislocation after RTSA for primary rotator cuff pathology was not previously described. Although Chalmers and colleagues⁴ did not report this lower risk, 3 (27.3%) of their 11 patients with dislocation had primary CTA, compared with 1 (6.7%) of 15 patients in the present study.⁴ Our literature review did not identify any studies that independently reported the dislocation rate in patients who underwent RTSA for rotator cuff failure.

The risk factors of subscapularis irreparability and revision surgery suggest the importance of the soft-tissue envelope and bony anatomy in dislocation prevention. Previous analyses have suggested implant malpositioning,^27,28 poor subscapularis quality,²⁹ and inadequate muscle tensioning^5,30-32 as risk factors for RTSA. Patients with an irreparable subscapularis tendon have often had multiple surgeries with compromise to the muscle/soft-tissue envelope or bony anatomy of the shoulder. A biomechanical study by Gutiérrez and colleagues³¹ found the compressive forces of the soft tissue at the glenohumeral joint to be the most important contributor to stability in the RTSA prosthesis. In clinical studies, the role of the subscapularis in preventing instability after RTSA remains unclear. Edwards and colleagues²⁹ prospectively compared dislocation rates in patients with reparable and irreparable subscapularis tendons during RTSA and found a higher rate of dislocation in the irreparable subscapularis group. Of note, patients in the irreparable subscapularis group also had more complex diagnoses, including proximal humeral nonunion, fixed glenohumeral dislocation, and failed prior arthroplasty. Clark and colleagues³³ retrospectively analyzed subscapularis repair in 2 RTSA groups and found no appreciable effect on complication rate, dislocation events, range-of-motion gains, or pain relief.

Our finding that higher BMI is an independent risk factor was previously described.⁴ The association is unclear but could be related to implant positioning, difficulty in intraoperative assessment of muscle tensioning, or body habitus that may generate a lever arm for impingement and dislocation when the arm is in adduction. Last, our finding that male sex is a risk factor for dislocation approached significance, and this relationship was previously reported.⁴ This could be attributable to a higher rate of activity or of indolent infection in male patients.^34,35Besides studying risk factors for dislocation after RTSA, we investigated treatment. None of our patients were treated successfully and definitively with closed reduction in the clinic. This finding diverges from findings in studies by Teusink and colleagues² and Chalmers and colleagues,⁴who respectively reported 62% and 44% rates of success with closed reduction. Our cohort of 14 patients with 15 dislocations required a total of 17 trips to the operating room after dislocation. This significantly higher rate of return to the operating room suggests that dislocation after RTSA may be a more costly and morbid problem than has been previously described.

This study had several weaknesses. Despite its large consecutive series of patients, the study was retrospective, and several variables that would be documented and controlled in a prospective study could not be measured here. Specifically, neither preoperative physical examination nor patient-specific assessments of pain or function were consistently obtained. Similarly, postoperative patient-specific instruments of outcomes evaluation were not obtained consistently, so results of patients with dislocation could not be compared with those of a control group. In addition, preoperative and postoperative radiographs were not consistently present in our electronic medical records, so the influence of preoperative bony anatomy, intraoperative limb lengthening, and any implant malpositioning could not be determined. Furthermore, operative details, such as reparability of the subscapularis, were not fully available for the control group and could not be included in statistical analysis. In addition, that the known dislocation risk factor of male sex⁴ was identified here but was not significant in multivariate regression analysis suggests that this study may not have been adequately powered to identify a significant difference in dislocation rate between the sexes. Last, though our results suggested associations between the aforementioned variables and dislocation after RTSA, a truly causative relationship could not be confirmed with this study design or analysis. Therefore, our study findings are hypothesis-generating and may indicate a benefit to greater deltoid tensioning, use of retentive liners, or more conservative rehabilitation protocols for high-risk patients.

Conclusion

Dislocation after RTSA is an uncommon complication that often requires a return to the operating room. This study identified a modifiable risk factor (higher BMI) and 3 nonmodifiable risk factors (male sex, subscapularis insufficiency, revision surgery) for dislocation after RTSA. In contrast, patients who undergo RTSA for primary rotator cuff pathology are unlikely to dislocate after surgery. This low risk of dislocation after RTSA for primary cuff pathology was not previously described. Patients in the higher risk category may benefit from preoperative lifestyle modification, intraoperative techniques for increasing stability, and more conservative therapy after surgery. In addition, unlike previous investigations, this study did not find closed reduction in the clinic alone to be successful in definitively treating this patient population.

Am J Orthop. 2016;45(7):E444-E450. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

The rate of medical visits for rotator cuff pathology and the US incidence of arthroscopic rotator cuff repair (RCR) have increased over the past 10 years.¹ The increased use of RCR has been justified with improved patient outcomes.^2,3 Advances in surgical techniques and instrumentation have contributed to better outcomes for patients with rotator cuff pathology.^3-5 Several studies have validated RCR with functional outcome measures, cost–benefit analysis, and health-related quality-of-life measurements.^6-9

Healthcare reimbursement models are being changed to include capitated care, pay for performance, and penalties.¹⁰ Given the changing healthcare climate and the increasing incidence of RCR, it is becoming increasingly important for orthopedic surgeons to critically evaluate and modify their practice and procedures to decrease costs without compromising outcomes.¹¹ RCR outcome studies have focused on comparing open/mini-open with arthroscopic techniques, and single-row with double-row techniques, among others.^4,12-18 Furthermore, several studies on the cost-effectiveness of these surgical techniques have been conducted.^19-21Arthroscopic anchorless (transosseous [TO]) RCR, which is increasingly popular,²² combines the minimal invasiveness of arthroscopic procedures with the biomechanical strength of open TO repair. In addition, this technique avoids the potential complications and costs associated with suture anchors, such as anchor pullout and greater tuberosity osteolysis.^22,23 Several studies have documented the effectiveness of this technique.^24-26 Biomechanical and clinical outcome data supporting arthroscopic TO-RCR have been published, but there are no reports of studies that have analyzed the cost savings associated with this technique.

In this study, we compared implant costs associated with arthroscopic TO-RCR and arthroscopic TO-equivalent (TOE) RCR. We also evaluated these techniques’ operative time and outcomes. Our hypothesis was that arthroscopic TO-RCR can be performed at lower cost and without increasing operative time or compromising outcomes.

Materials and Methods

Our Institutional Review Board approved this study. Between February 2013 and January 2014, participating surgeons performed 43 arthroscopic TO-RCRs that met the study’s inclusion criteria. Twenty-one of the 43 patients enrolled and became the study group. The control group of 21 patients, who underwent arthroscopic TOE-RCR the preceding year (between January 2012 and January 2013), was matched to the study group on tear size and concomitant procedures, including biceps treatment, labral treatment, acromioplasty, and distal clavicle excision (Table 1).

Males or nonpregnant females, age 18 years or older, with full-thickness rotator cuff tear treated with arthroscopic RCR at one regional healthcare system were eligible for the study. Exclusion criteria were revision repair, irreparable tear, worker compensation claim, and subscapularis repair.

The primary outcome measure was implant cost (amount paid by institution). Cost was determined and reported by an independent third party using Cerner Surginet as the operating room documentation system and McKessen Pathways Materials Management System for item pricing.

All arthroscopic RCRs were performed by 1 of 3 orthopedic surgeons fellowship-trained in either sports medicine or shoulder and elbow surgery. Using the Cofield classification,²⁷ the treating surgeon recorded the size of the rotator cuff tear: small (<1 cm), medium (1-3 cm), large (3-5 cm), massive (>5 cm). The surgeon also recorded the number of suture anchors used, repair technique, biceps treatment, execution of subacromial decompression, execution of distal clavicle excision, and intraoperative complications. TO repair surgical technique is described in the next section. TOE repair was double-row repair with suture anchors. The number of suture anchors varied by tear size: small (3 anchors), medium (2-5 anchors), large (4-6 anchors), massive (4-5 anchors).

Secondary outcome measures were operative time (time from cut to close) and scores on pain VAS (visual analog scale), SANE (Single Assessment Numeric Evaluation), and SST (Simple Shoulder Test). Demographic information was also obtained: age, sex, body mass index, smoking status (Table 1). All patients were asked to fill out questionnaires before surgery and 3, 6, and >12 months after surgery. Outcome surveys were scored by a single research coordinator, who recorded each patient’s outcome scores at the preoperative and postoperative intervals. Follow-up of >12 months was reached by 17 (81%) of the 21 TO patients and 14 (67%) of the 21 TOE patients. For >12 months, the overall rate of follow-up was 74%.

All patients followed the same postoperative rehabilitation protocol: sling immobilization with pendulums for 6 weeks starting at 2 weeks, passive range of motion starting at 6 weeks, and active range of motion starting at 8 weeks. At 3 months, they were allowed progressive resistant exercises with a 10-pound limit, and at 4.5 months they progressed to a 20-pound limit. At 6 months, they were cleared for discharge.

 

Surgical Technique: Arthroscopic Transosseous Repair

Surgery was performed with the patient in either the beach-chair position or the lateral decubitus position, based on surgeon preference. Our technique is similar to what has been described in the past.^22,28 The glenohumeral joint is accessed through a standard posterior portal, followed by an anterior accessory portal through the rotator interval. Standard diagnostic arthroscopy is performed and intra-articular pathology addressed. Next, the scope is placed in the subacromial space through the posterior portal. A lateral subacromial portal is established and cannulated, and a bursectomy performed. The scope is then placed in a posterolateral portal for better visualization of the rotator cuff tear. The greater tuberosity is débrided with a curette to prepare the bed for repair. An ArthroTunneler (Tornier) is used to pass sutures through the greater tuberosity. For standard 2-tunnel repair, 3 sutures are placed through each tunnel. All 6 sutures are next passed (using a suture passer) through the rotator cuff. The second and fifth suture ends that are passed through the cuff are brought out through the cannula and tied together. They are then brought into the shoulder by pulling on the opposite ends and tied alongside the greater tuberosity to create a box stitch. The box stitch acts as a medial row fixation and as a rip stitch that strengthens the vertical mattress sutures against pullout. The other 4 sutures are tied in vertical mattress configuration.

Statistical Analysis

After obtaining the TO and TOE implant costs, we compared them using a generalized linear model with negative binomial distribution and an identity link function so returned parameters were in additive dollars. This comparison included evaluation of tear size and concomitant procedures. Operative times for TO and TOE were obtained and evaluated, and then compared using time-to-event analysis and the log-rank test. Outcome scores were obtained from patients at baseline and 3, 6, and >12 months after surgery and were compared using a linear mixed model that identified change in outcome scores over time, and difference in outcome scores between the TO and TOE groups.

Results

Table 1 lists patient demographics, including age, sex, body mass index, smoking status, and concomitant procedures. The TO and TOE groups had identical tear-size distributions. In addition, they had similar numbers of concomitant procedures, though our study was underpowered to confirm equivalence. Treatment techniques differed: more biceps tenodesis cases in the TO group (n = 12) than in the TOE group (n = 2) and more biceps tenotomy cases in the TOE group (n = 8) than in the TO group (n = 1).

TO implant cost was significantly lower than TOE implant cost for all tear sizes and independent of concomitant procedures (Figure 1).

Mean (SD) implant cost was $563.10 ($29.65) for the TO group and $1489.00 ($331.05) for the TOE group. With all other factors controlled, mean (SD) implant cost was $946.91 ($100.70) more expensive for the TOE group (P < .0001).

Operative time was not significantly different between the TO and TOE groups. Mean (SD) operative time was 82.38 (24.09) minutes for the TO group and 81.71 (17.27) minutes for the TOE group. With all other factors controlled, mean operative time was 5.96 minutes shorter for the TOE group, but the difference was not significant (P = .549).

There was no significant difference in preoperative pain VAS (P = .93), SANE (P = .35), or SST (P = .36) scores between the TO and TOE groups.

At all postoperative follow-ups (3, 6, and >12 months), there was significant (P < .0001) improvement in outcome scores (VAS, SANE, SST) for both groups (Table 2).

There was no significant difference in pain VAS (P = .688), SANE (P = .882), or SST (P = .272) scores (Figure 2) between the groups across all time points.

Discussion

RCR is one of the most common orthopedic surgical procedures, and its use has increased over the past decade.^9,21 This increase coincides with the emergence of new repair techniques and implants. These advancements come at a cost. Given the increasingly cost-conscious healthcare environment and its changing reimbursement models, now surgeons must evaluate the economics of their surgical procedures in an attempt to decrease costs without compromising outcomes. We hypothesized that arthroscopic TO-RCR can be performed at lower cost relative to arthroscopic TOE-RCR and without increasing operative time or compromising short-term outcomes.

Studies on the cost-effectiveness of different RCR techniques have been conducted.^19-21 Adla and colleagues¹⁹ found that open RCR was more cost-effective than arthroscopic RCR, with most of the difference attributable to disposables and suture anchors. Genuario and colleagues²¹ found that double-row RCR was not as cost-effective as single-row RCR in treating tears of any size. They attributed the difference to 2 more anchors and about 15 more minutes in the operating room.

The increased interest in healthcare costs and the understanding that a substantial part of the cost of arthroscopic RCR is attributable to implants (suture anchors, specifically) led to recent efforts to eliminate the need for anchors. Newly available instrumentation was designed to assist in arthroscopic anchorless repair constructs using the concepts of traditional TO repair.²² Although still considered to be the RCR gold standard, TO fixation has been used less often in recent years, owing to the shift from open to arthroscopic surgery.²⁴ Arthroscopic TO-RCR allows for all the benefits of arthroscopic surgery, plus the biological and mechanical benefits of traditional open or mini-open TO repair. In addition, this technique eliminates the cost of anchors. Kummer and colleagues²⁵ confirmed with biomechanical testing that arthroscopic TO repair and double-row TOE repair are similar in strength, with a trend of less tendon displacement in the TO group.

Our study results support the hypothesis that arthroscopic TO repair provides significant cost savings over tear size–matched arthroscopic TOE repair. Implant cost was substantially higher for TOE repair than for TO repair. Mean (SD) total savings of $946.91 ($100.70) (P < .0001) can be realized performing TO rather than TOE repair. In the United States, where about 250,000 RCRs are performed each year, the use of TO repair would result in an annual savings of almost $250 million.⁶Operative time was analyzed as well. Running an operating room in the United States costs an estimated $62 per minute (range, $22-$133 per minute).²⁹ Much of this cost is indirect, unrelated to the surgery (eg, capital investment, personnel, insurance), and is being paid even when the operating room is not in use. Therefore, for the hospital’s bottom line, operative time savings are less important than direct cost savings (supplies, implants). However, operative time has more of an effect on the surgeon’s bottom line, and longer procedures reduce the number of surgeries that can be performed and billed. We found no significant difference in operative time between TO and TOE repairs. Critical evaluation revealed that operative time was 5.96 minutes shorter for TOE repairs, but this difference was not significant (P = .677).

Our study results showed no significant difference in clinical outcomes between TO and TOE repair patients. Both groups’ outcome scores improved. At all follow-ups, both groups’ VAS, SANE, and SST scores were significantly improved. Overall, this is the first study to validate the proposed cost benefit of arthroscopic TO repair and confirm no compromise in patient outcomes.

This study had limitations. First, it enrolled relatively few patients, particularly those with small tears. In addition, despite the fact that patients were matched on tear size and concomitant procedures, the groups differed in their biceps pathology treatments. Of the 13 TO patients who had biceps treatment, 12 underwent tenodesis (1 had tenotomy); in contrast, of the 10 TOE patients who had biceps treatment, only 2 underwent tenodesis (8 had tenotomy). The difference is explained by the consecutive course of this study and the increasing popularity of tenodesis over tenotomy. The TOE group underwent surgery before the TO group did, at a time when the involved surgeons were routinely performing tenotomy more than tenodesis. We did not include the costs of implants related to biceps treatment in our analysis, as our focus was on the implant cost of RCR. As for operative time, biceps tenodesis would be expected to extend surgery and potentially affect the comparison of operative times between the TO and TOE groups. However, despite the fact that 12 of the 13 TO patients underwent biceps tenodesis, there was no significant difference in overall operative time. Last, regarding the effect of biceps treatment on clinical outcomes, there are no data showing improved outcomes with tenodesis over tenotomy in the setting of RCR.

A final limitation is lack of data from longer term (>12 months) follow-up for all patients. Our analysis included cost and operative time data for all 42 enrolled patients, but our clinical outcome data represent only 74% of the patients enrolled. Eleven of the 42 patients were lost to follow-up at >12 months, and outcome scores could not be obtained, despite multiple attempts at contact (phone, mail, email). The study design and primary outcome variable focused on cost analysis rather than clinical outcomes. Nevertheless, our data support our hypothesis that there is no difference in clinical outcomes between TO and TOE repairs.

 

Conclusion

Arthroscopic TO-RCR provides significant cost savings over arthroscopic TOE-RCR without increasing operative time or compromising outcomes. Arthroscopic TO-RCR may have an important role in the evolving healthcare environment and its changing reimbursement models.

Am J Orthop. 2016;45(7):E415-E420. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

The rate of medical visits for rotator cuff pathology and the US incidence of arthroscopic rotator cuff repair (RCR) have increased over the past 10 years.¹ The increased use of RCR has been justified with improved patient outcomes.^2,3 Advances in surgical techniques and instrumentation have contributed to better outcomes for patients with rotator cuff pathology.^3-5 Several studies have validated RCR with functional outcome measures, cost–benefit analysis, and health-related quality-of-life measurements.^6-9

Healthcare reimbursement models are being changed to include capitated care, pay for performance, and penalties.¹⁰ Given the changing healthcare climate and the increasing incidence of RCR, it is becoming increasingly important for orthopedic surgeons to critically evaluate and modify their practice and procedures to decrease costs without compromising outcomes.¹¹ RCR outcome studies have focused on comparing open/mini-open with arthroscopic techniques, and single-row with double-row techniques, among others.^4,12-18 Furthermore, several studies on the cost-effectiveness of these surgical techniques have been conducted.^19-21Arthroscopic anchorless (transosseous [TO]) RCR, which is increasingly popular,²² combines the minimal invasiveness of arthroscopic procedures with the biomechanical strength of open TO repair. In addition, this technique avoids the potential complications and costs associated with suture anchors, such as anchor pullout and greater tuberosity osteolysis.^22,23 Several studies have documented the effectiveness of this technique.^24-26 Biomechanical and clinical outcome data supporting arthroscopic TO-RCR have been published, but there are no reports of studies that have analyzed the cost savings associated with this technique.

In this study, we compared implant costs associated with arthroscopic TO-RCR and arthroscopic TO-equivalent (TOE) RCR. We also evaluated these techniques’ operative time and outcomes. Our hypothesis was that arthroscopic TO-RCR can be performed at lower cost and without increasing operative time or compromising outcomes.

Materials and Methods

Our Institutional Review Board approved this study. Between February 2013 and January 2014, participating surgeons performed 43 arthroscopic TO-RCRs that met the study’s inclusion criteria. Twenty-one of the 43 patients enrolled and became the study group. The control group of 21 patients, who underwent arthroscopic TOE-RCR the preceding year (between January 2012 and January 2013), was matched to the study group on tear size and concomitant procedures, including biceps treatment, labral treatment, acromioplasty, and distal clavicle excision (Table 1).

Males or nonpregnant females, age 18 years or older, with full-thickness rotator cuff tear treated with arthroscopic RCR at one regional healthcare system were eligible for the study. Exclusion criteria were revision repair, irreparable tear, worker compensation claim, and subscapularis repair.

The primary outcome measure was implant cost (amount paid by institution). Cost was determined and reported by an independent third party using Cerner Surginet as the operating room documentation system and McKessen Pathways Materials Management System for item pricing.

All arthroscopic RCRs were performed by 1 of 3 orthopedic surgeons fellowship-trained in either sports medicine or shoulder and elbow surgery. Using the Cofield classification,²⁷ the treating surgeon recorded the size of the rotator cuff tear: small (<1 cm), medium (1-3 cm), large (3-5 cm), massive (>5 cm). The surgeon also recorded the number of suture anchors used, repair technique, biceps treatment, execution of subacromial decompression, execution of distal clavicle excision, and intraoperative complications. TO repair surgical technique is described in the next section. TOE repair was double-row repair with suture anchors. The number of suture anchors varied by tear size: small (3 anchors), medium (2-5 anchors), large (4-6 anchors), massive (4-5 anchors).

Secondary outcome measures were operative time (time from cut to close) and scores on pain VAS (visual analog scale), SANE (Single Assessment Numeric Evaluation), and SST (Simple Shoulder Test). Demographic information was also obtained: age, sex, body mass index, smoking status (Table 1). All patients were asked to fill out questionnaires before surgery and 3, 6, and >12 months after surgery. Outcome surveys were scored by a single research coordinator, who recorded each patient’s outcome scores at the preoperative and postoperative intervals. Follow-up of >12 months was reached by 17 (81%) of the 21 TO patients and 14 (67%) of the 21 TOE patients. For >12 months, the overall rate of follow-up was 74%.

All patients followed the same postoperative rehabilitation protocol: sling immobilization with pendulums for 6 weeks starting at 2 weeks, passive range of motion starting at 6 weeks, and active range of motion starting at 8 weeks. At 3 months, they were allowed progressive resistant exercises with a 10-pound limit, and at 4.5 months they progressed to a 20-pound limit. At 6 months, they were cleared for discharge.

 

Surgical Technique: Arthroscopic Transosseous Repair

Surgery was performed with the patient in either the beach-chair position or the lateral decubitus position, based on surgeon preference. Our technique is similar to what has been described in the past.^22,28 The glenohumeral joint is accessed through a standard posterior portal, followed by an anterior accessory portal through the rotator interval. Standard diagnostic arthroscopy is performed and intra-articular pathology addressed. Next, the scope is placed in the subacromial space through the posterior portal. A lateral subacromial portal is established and cannulated, and a bursectomy performed. The scope is then placed in a posterolateral portal for better visualization of the rotator cuff tear. The greater tuberosity is débrided with a curette to prepare the bed for repair. An ArthroTunneler (Tornier) is used to pass sutures through the greater tuberosity. For standard 2-tunnel repair, 3 sutures are placed through each tunnel. All 6 sutures are next passed (using a suture passer) through the rotator cuff. The second and fifth suture ends that are passed through the cuff are brought out through the cannula and tied together. They are then brought into the shoulder by pulling on the opposite ends and tied alongside the greater tuberosity to create a box stitch. The box stitch acts as a medial row fixation and as a rip stitch that strengthens the vertical mattress sutures against pullout. The other 4 sutures are tied in vertical mattress configuration.

Statistical Analysis

After obtaining the TO and TOE implant costs, we compared them using a generalized linear model with negative binomial distribution and an identity link function so returned parameters were in additive dollars. This comparison included evaluation of tear size and concomitant procedures. Operative times for TO and TOE were obtained and evaluated, and then compared using time-to-event analysis and the log-rank test. Outcome scores were obtained from patients at baseline and 3, 6, and >12 months after surgery and were compared using a linear mixed model that identified change in outcome scores over time, and difference in outcome scores between the TO and TOE groups.

Results

Table 1 lists patient demographics, including age, sex, body mass index, smoking status, and concomitant procedures. The TO and TOE groups had identical tear-size distributions. In addition, they had similar numbers of concomitant procedures, though our study was underpowered to confirm equivalence. Treatment techniques differed: more biceps tenodesis cases in the TO group (n = 12) than in the TOE group (n = 2) and more biceps tenotomy cases in the TOE group (n = 8) than in the TO group (n = 1).

TO implant cost was significantly lower than TOE implant cost for all tear sizes and independent of concomitant procedures (Figure 1).

Mean (SD) implant cost was $563.10 ($29.65) for the TO group and $1489.00 ($331.05) for the TOE group. With all other factors controlled, mean (SD) implant cost was $946.91 ($100.70) more expensive for the TOE group (P < .0001).

Operative time was not significantly different between the TO and TOE groups. Mean (SD) operative time was 82.38 (24.09) minutes for the TO group and 81.71 (17.27) minutes for the TOE group. With all other factors controlled, mean operative time was 5.96 minutes shorter for the TOE group, but the difference was not significant (P = .549).

There was no significant difference in preoperative pain VAS (P = .93), SANE (P = .35), or SST (P = .36) scores between the TO and TOE groups.

At all postoperative follow-ups (3, 6, and >12 months), there was significant (P < .0001) improvement in outcome scores (VAS, SANE, SST) for both groups (Table 2).

There was no significant difference in pain VAS (P = .688), SANE (P = .882), or SST (P = .272) scores (Figure 2) between the groups across all time points.

Discussion

RCR is one of the most common orthopedic surgical procedures, and its use has increased over the past decade.^9,21 This increase coincides with the emergence of new repair techniques and implants. These advancements come at a cost. Given the increasingly cost-conscious healthcare environment and its changing reimbursement models, now surgeons must evaluate the economics of their surgical procedures in an attempt to decrease costs without compromising outcomes. We hypothesized that arthroscopic TO-RCR can be performed at lower cost relative to arthroscopic TOE-RCR and without increasing operative time or compromising short-term outcomes.

Studies on the cost-effectiveness of different RCR techniques have been conducted.^19-21 Adla and colleagues¹⁹ found that open RCR was more cost-effective than arthroscopic RCR, with most of the difference attributable to disposables and suture anchors. Genuario and colleagues²¹ found that double-row RCR was not as cost-effective as single-row RCR in treating tears of any size. They attributed the difference to 2 more anchors and about 15 more minutes in the operating room.

The increased interest in healthcare costs and the understanding that a substantial part of the cost of arthroscopic RCR is attributable to implants (suture anchors, specifically) led to recent efforts to eliminate the need for anchors. Newly available instrumentation was designed to assist in arthroscopic anchorless repair constructs using the concepts of traditional TO repair.²² Although still considered to be the RCR gold standard, TO fixation has been used less often in recent years, owing to the shift from open to arthroscopic surgery.²⁴ Arthroscopic TO-RCR allows for all the benefits of arthroscopic surgery, plus the biological and mechanical benefits of traditional open or mini-open TO repair. In addition, this technique eliminates the cost of anchors. Kummer and colleagues²⁵ confirmed with biomechanical testing that arthroscopic TO repair and double-row TOE repair are similar in strength, with a trend of less tendon displacement in the TO group.

Our study results support the hypothesis that arthroscopic TO repair provides significant cost savings over tear size–matched arthroscopic TOE repair. Implant cost was substantially higher for TOE repair than for TO repair. Mean (SD) total savings of $946.91 ($100.70) (P < .0001) can be realized performing TO rather than TOE repair. In the United States, where about 250,000 RCRs are performed each year, the use of TO repair would result in an annual savings of almost $250 million.⁶Operative time was analyzed as well. Running an operating room in the United States costs an estimated $62 per minute (range, $22-$133 per minute).²⁹ Much of this cost is indirect, unrelated to the surgery (eg, capital investment, personnel, insurance), and is being paid even when the operating room is not in use. Therefore, for the hospital’s bottom line, operative time savings are less important than direct cost savings (supplies, implants). However, operative time has more of an effect on the surgeon’s bottom line, and longer procedures reduce the number of surgeries that can be performed and billed. We found no significant difference in operative time between TO and TOE repairs. Critical evaluation revealed that operative time was 5.96 minutes shorter for TOE repairs, but this difference was not significant (P = .677).

Our study results showed no significant difference in clinical outcomes between TO and TOE repair patients. Both groups’ outcome scores improved. At all follow-ups, both groups’ VAS, SANE, and SST scores were significantly improved. Overall, this is the first study to validate the proposed cost benefit of arthroscopic TO repair and confirm no compromise in patient outcomes.

This study had limitations. First, it enrolled relatively few patients, particularly those with small tears. In addition, despite the fact that patients were matched on tear size and concomitant procedures, the groups differed in their biceps pathology treatments. Of the 13 TO patients who had biceps treatment, 12 underwent tenodesis (1 had tenotomy); in contrast, of the 10 TOE patients who had biceps treatment, only 2 underwent tenodesis (8 had tenotomy). The difference is explained by the consecutive course of this study and the increasing popularity of tenodesis over tenotomy. The TOE group underwent surgery before the TO group did, at a time when the involved surgeons were routinely performing tenotomy more than tenodesis. We did not include the costs of implants related to biceps treatment in our analysis, as our focus was on the implant cost of RCR. As for operative time, biceps tenodesis would be expected to extend surgery and potentially affect the comparison of operative times between the TO and TOE groups. However, despite the fact that 12 of the 13 TO patients underwent biceps tenodesis, there was no significant difference in overall operative time. Last, regarding the effect of biceps treatment on clinical outcomes, there are no data showing improved outcomes with tenodesis over tenotomy in the setting of RCR.

A final limitation is lack of data from longer term (>12 months) follow-up for all patients. Our analysis included cost and operative time data for all 42 enrolled patients, but our clinical outcome data represent only 74% of the patients enrolled. Eleven of the 42 patients were lost to follow-up at >12 months, and outcome scores could not be obtained, despite multiple attempts at contact (phone, mail, email). The study design and primary outcome variable focused on cost analysis rather than clinical outcomes. Nevertheless, our data support our hypothesis that there is no difference in clinical outcomes between TO and TOE repairs.

 

Conclusion

Arthroscopic TO-RCR provides significant cost savings over arthroscopic TOE-RCR without increasing operative time or compromising outcomes. Arthroscopic TO-RCR may have an important role in the evolving healthcare environment and its changing reimbursement models.

Am J Orthop. 2016;45(7):E415-E420. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

The rate of medical visits for rotator cuff pathology and the US incidence of arthroscopic rotator cuff repair (RCR) have increased over the past 10 years.¹ The increased use of RCR has been justified with improved patient outcomes.^2,3 Advances in surgical techniques and instrumentation have contributed to better outcomes for patients with rotator cuff pathology.^3-5 Several studies have validated RCR with functional outcome measures, cost–benefit analysis, and health-related quality-of-life measurements.^6-9

Healthcare reimbursement models are being changed to include capitated care, pay for performance, and penalties.¹⁰ Given the changing healthcare climate and the increasing incidence of RCR, it is becoming increasingly important for orthopedic surgeons to critically evaluate and modify their practice and procedures to decrease costs without compromising outcomes.¹¹ RCR outcome studies have focused on comparing open/mini-open with arthroscopic techniques, and single-row with double-row techniques, among others.^4,12-18 Furthermore, several studies on the cost-effectiveness of these surgical techniques have been conducted.^19-21Arthroscopic anchorless (transosseous [TO]) RCR, which is increasingly popular,²² combines the minimal invasiveness of arthroscopic procedures with the biomechanical strength of open TO repair. In addition, this technique avoids the potential complications and costs associated with suture anchors, such as anchor pullout and greater tuberosity osteolysis.^22,23 Several studies have documented the effectiveness of this technique.^24-26 Biomechanical and clinical outcome data supporting arthroscopic TO-RCR have been published, but there are no reports of studies that have analyzed the cost savings associated with this technique.

In this study, we compared implant costs associated with arthroscopic TO-RCR and arthroscopic TO-equivalent (TOE) RCR. We also evaluated these techniques’ operative time and outcomes. Our hypothesis was that arthroscopic TO-RCR can be performed at lower cost and without increasing operative time or compromising outcomes.

Materials and Methods

Our Institutional Review Board approved this study. Between February 2013 and January 2014, participating surgeons performed 43 arthroscopic TO-RCRs that met the study’s inclusion criteria. Twenty-one of the 43 patients enrolled and became the study group. The control group of 21 patients, who underwent arthroscopic TOE-RCR the preceding year (between January 2012 and January 2013), was matched to the study group on tear size and concomitant procedures, including biceps treatment, labral treatment, acromioplasty, and distal clavicle excision (Table 1).

Males or nonpregnant females, age 18 years or older, with full-thickness rotator cuff tear treated with arthroscopic RCR at one regional healthcare system were eligible for the study. Exclusion criteria were revision repair, irreparable tear, worker compensation claim, and subscapularis repair.

The primary outcome measure was implant cost (amount paid by institution). Cost was determined and reported by an independent third party using Cerner Surginet as the operating room documentation system and McKessen Pathways Materials Management System for item pricing.

All arthroscopic RCRs were performed by 1 of 3 orthopedic surgeons fellowship-trained in either sports medicine or shoulder and elbow surgery. Using the Cofield classification,²⁷ the treating surgeon recorded the size of the rotator cuff tear: small (<1 cm), medium (1-3 cm), large (3-5 cm), massive (>5 cm). The surgeon also recorded the number of suture anchors used, repair technique, biceps treatment, execution of subacromial decompression, execution of distal clavicle excision, and intraoperative complications. TO repair surgical technique is described in the next section. TOE repair was double-row repair with suture anchors. The number of suture anchors varied by tear size: small (3 anchors), medium (2-5 anchors), large (4-6 anchors), massive (4-5 anchors).

Secondary outcome measures were operative time (time from cut to close) and scores on pain VAS (visual analog scale), SANE (Single Assessment Numeric Evaluation), and SST (Simple Shoulder Test). Demographic information was also obtained: age, sex, body mass index, smoking status (Table 1). All patients were asked to fill out questionnaires before surgery and 3, 6, and >12 months after surgery. Outcome surveys were scored by a single research coordinator, who recorded each patient’s outcome scores at the preoperative and postoperative intervals. Follow-up of >12 months was reached by 17 (81%) of the 21 TO patients and 14 (67%) of the 21 TOE patients. For >12 months, the overall rate of follow-up was 74%.

All patients followed the same postoperative rehabilitation protocol: sling immobilization with pendulums for 6 weeks starting at 2 weeks, passive range of motion starting at 6 weeks, and active range of motion starting at 8 weeks. At 3 months, they were allowed progressive resistant exercises with a 10-pound limit, and at 4.5 months they progressed to a 20-pound limit. At 6 months, they were cleared for discharge.

 

Surgical Technique: Arthroscopic Transosseous Repair

Surgery was performed with the patient in either the beach-chair position or the lateral decubitus position, based on surgeon preference. Our technique is similar to what has been described in the past.^22,28 The glenohumeral joint is accessed through a standard posterior portal, followed by an anterior accessory portal through the rotator interval. Standard diagnostic arthroscopy is performed and intra-articular pathology addressed. Next, the scope is placed in the subacromial space through the posterior portal. A lateral subacromial portal is established and cannulated, and a bursectomy performed. The scope is then placed in a posterolateral portal for better visualization of the rotator cuff tear. The greater tuberosity is débrided with a curette to prepare the bed for repair. An ArthroTunneler (Tornier) is used to pass sutures through the greater tuberosity. For standard 2-tunnel repair, 3 sutures are placed through each tunnel. All 6 sutures are next passed (using a suture passer) through the rotator cuff. The second and fifth suture ends that are passed through the cuff are brought out through the cannula and tied together. They are then brought into the shoulder by pulling on the opposite ends and tied alongside the greater tuberosity to create a box stitch. The box stitch acts as a medial row fixation and as a rip stitch that strengthens the vertical mattress sutures against pullout. The other 4 sutures are tied in vertical mattress configuration.

Statistical Analysis

After obtaining the TO and TOE implant costs, we compared them using a generalized linear model with negative binomial distribution and an identity link function so returned parameters were in additive dollars. This comparison included evaluation of tear size and concomitant procedures. Operative times for TO and TOE were obtained and evaluated, and then compared using time-to-event analysis and the log-rank test. Outcome scores were obtained from patients at baseline and 3, 6, and >12 months after surgery and were compared using a linear mixed model that identified change in outcome scores over time, and difference in outcome scores between the TO and TOE groups.

Results

Table 1 lists patient demographics, including age, sex, body mass index, smoking status, and concomitant procedures. The TO and TOE groups had identical tear-size distributions. In addition, they had similar numbers of concomitant procedures, though our study was underpowered to confirm equivalence. Treatment techniques differed: more biceps tenodesis cases in the TO group (n = 12) than in the TOE group (n = 2) and more biceps tenotomy cases in the TOE group (n = 8) than in the TO group (n = 1).

TO implant cost was significantly lower than TOE implant cost for all tear sizes and independent of concomitant procedures (Figure 1).

Mean (SD) implant cost was $563.10 ($29.65) for the TO group and $1489.00 ($331.05) for the TOE group. With all other factors controlled, mean (SD) implant cost was $946.91 ($100.70) more expensive for the TOE group (P < .0001).

Operative time was not significantly different between the TO and TOE groups. Mean (SD) operative time was 82.38 (24.09) minutes for the TO group and 81.71 (17.27) minutes for the TOE group. With all other factors controlled, mean operative time was 5.96 minutes shorter for the TOE group, but the difference was not significant (P = .549).

There was no significant difference in preoperative pain VAS (P = .93), SANE (P = .35), or SST (P = .36) scores between the TO and TOE groups.

At all postoperative follow-ups (3, 6, and >12 months), there was significant (P < .0001) improvement in outcome scores (VAS, SANE, SST) for both groups (Table 2).

There was no significant difference in pain VAS (P = .688), SANE (P = .882), or SST (P = .272) scores (Figure 2) between the groups across all time points.

Discussion

RCR is one of the most common orthopedic surgical procedures, and its use has increased over the past decade.^9,21 This increase coincides with the emergence of new repair techniques and implants. These advancements come at a cost. Given the increasingly cost-conscious healthcare environment and its changing reimbursement models, now surgeons must evaluate the economics of their surgical procedures in an attempt to decrease costs without compromising outcomes. We hypothesized that arthroscopic TO-RCR can be performed at lower cost relative to arthroscopic TOE-RCR and without increasing operative time or compromising short-term outcomes.

Studies on the cost-effectiveness of different RCR techniques have been conducted.^19-21 Adla and colleagues¹⁹ found that open RCR was more cost-effective than arthroscopic RCR, with most of the difference attributable to disposables and suture anchors. Genuario and colleagues²¹ found that double-row RCR was not as cost-effective as single-row RCR in treating tears of any size. They attributed the difference to 2 more anchors and about 15 more minutes in the operating room.

The increased interest in healthcare costs and the understanding that a substantial part of the cost of arthroscopic RCR is attributable to implants (suture anchors, specifically) led to recent efforts to eliminate the need for anchors. Newly available instrumentation was designed to assist in arthroscopic anchorless repair constructs using the concepts of traditional TO repair.²² Although still considered to be the RCR gold standard, TO fixation has been used less often in recent years, owing to the shift from open to arthroscopic surgery.²⁴ Arthroscopic TO-RCR allows for all the benefits of arthroscopic surgery, plus the biological and mechanical benefits of traditional open or mini-open TO repair. In addition, this technique eliminates the cost of anchors. Kummer and colleagues²⁵ confirmed with biomechanical testing that arthroscopic TO repair and double-row TOE repair are similar in strength, with a trend of less tendon displacement in the TO group.

Our study results support the hypothesis that arthroscopic TO repair provides significant cost savings over tear size–matched arthroscopic TOE repair. Implant cost was substantially higher for TOE repair than for TO repair. Mean (SD) total savings of $946.91 ($100.70) (P < .0001) can be realized performing TO rather than TOE repair. In the United States, where about 250,000 RCRs are performed each year, the use of TO repair would result in an annual savings of almost $250 million.⁶Operative time was analyzed as well. Running an operating room in the United States costs an estimated $62 per minute (range, $22-$133 per minute).²⁹ Much of this cost is indirect, unrelated to the surgery (eg, capital investment, personnel, insurance), and is being paid even when the operating room is not in use. Therefore, for the hospital’s bottom line, operative time savings are less important than direct cost savings (supplies, implants). However, operative time has more of an effect on the surgeon’s bottom line, and longer procedures reduce the number of surgeries that can be performed and billed. We found no significant difference in operative time between TO and TOE repairs. Critical evaluation revealed that operative time was 5.96 minutes shorter for TOE repairs, but this difference was not significant (P = .677).

Our study results showed no significant difference in clinical outcomes between TO and TOE repair patients. Both groups’ outcome scores improved. At all follow-ups, both groups’ VAS, SANE, and SST scores were significantly improved. Overall, this is the first study to validate the proposed cost benefit of arthroscopic TO repair and confirm no compromise in patient outcomes.

This study had limitations. First, it enrolled relatively few patients, particularly those with small tears. In addition, despite the fact that patients were matched on tear size and concomitant procedures, the groups differed in their biceps pathology treatments. Of the 13 TO patients who had biceps treatment, 12 underwent tenodesis (1 had tenotomy); in contrast, of the 10 TOE patients who had biceps treatment, only 2 underwent tenodesis (8 had tenotomy). The difference is explained by the consecutive course of this study and the increasing popularity of tenodesis over tenotomy. The TOE group underwent surgery before the TO group did, at a time when the involved surgeons were routinely performing tenotomy more than tenodesis. We did not include the costs of implants related to biceps treatment in our analysis, as our focus was on the implant cost of RCR. As for operative time, biceps tenodesis would be expected to extend surgery and potentially affect the comparison of operative times between the TO and TOE groups. However, despite the fact that 12 of the 13 TO patients underwent biceps tenodesis, there was no significant difference in overall operative time. Last, regarding the effect of biceps treatment on clinical outcomes, there are no data showing improved outcomes with tenodesis over tenotomy in the setting of RCR.

A final limitation is lack of data from longer term (>12 months) follow-up for all patients. Our analysis included cost and operative time data for all 42 enrolled patients, but our clinical outcome data represent only 74% of the patients enrolled. Eleven of the 42 patients were lost to follow-up at >12 months, and outcome scores could not be obtained, despite multiple attempts at contact (phone, mail, email). The study design and primary outcome variable focused on cost analysis rather than clinical outcomes. Nevertheless, our data support our hypothesis that there is no difference in clinical outcomes between TO and TOE repairs.

 

Conclusion

Arthroscopic TO-RCR provides significant cost savings over arthroscopic TOE-RCR without increasing operative time or compromising outcomes. Arthroscopic TO-RCR may have an important role in the evolving healthcare environment and its changing reimbursement models.

Am J Orthop. 2016;45(7):E415-E420. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

The annual number of total shoulder arthroplasties (TSAs) is rising with the growing elderly population and development of new technologies such as reverse shoulder arthroplasty.¹ In 2008, 47,000 shoulder arthroplasties were performed in the US compared with 19,000 in 1998.¹ As of 2011, there were 53,000 shoulder arthroplasties performed annually.² Pain control after shoulder procedures, particularly TSA, is challenging. ³

Several modalities exist to manage pain after shoulder arthroplasty. The interscalene brachial plexus nerve block is considered the “gold standard” for shoulder analgesia. A new approach is the periarticular injection method, in which the surgeon administers a local anesthetic intraoperatively. Liposomal bupivacaine (Exparel, Pacira Pharmaceuticals, Inc.) is a nonopioid anesthetic that has been shown to improve pain control, shorten hospital stays, and decrease costs for total knee and hip arthroplasty compared with nerve blocks.^4-6 Patients who were treated with liposomal bupivacaine consumed less opioid medication than a placebo group.⁷

Our purpose was to compare intraoperative local liposomal bupivacaine injection with preoperative single-shot interscalene nerve block (ISNB) in terms of pain control, opioid use, and length of hospital stay (LOS) after shoulder arthroplasty. We hypothesized that patients in the liposomal bupivacaine group would have lower pain scores, less opioid use, and shorter LOS compared with patients in the ISNB group.

Methods

A retrospective cohort analysis was conducted with 58 patients who underwent shoulder arthroplasty by 1 surgeon at our academically affiliated community hospital from January 2012 through January 2015. ISNBs were the standard at the beginning of the study period and were used until Exparel became available on the hospital formulary in 2013. We began using Exparel for all shoulder arthroplasties in November 2013. No other changes were made in the perioperative management of our arthroplasty patients during this period. Patients who underwent TSA, reverse TSA, or hemiarthroplasty of the shoulder were included. Patients who underwent revision TSA were excluded. Twenty-one patients received ISNBs and 37 received liposomal bupivacaine injections. This study was approved by our Institutional Review Board.

Baseline data for each patient were age, sex, body mass index, and the American Society of Anesthesiologists (ASA) Physical Status Classification. The primary outcome measure was the numeric rating scale (NRS) pain score at 4 post-operative time intervals. The NRS pain score has a range of 0 to 10, with 10 representing severe pain. Data were gathered from nursing and physical therapy notes in patient charts. The postoperative time intervals were 0 to 1 hour, 8 to 14 hours, 18 to 24 hours, and 27 to 36 hours. Available NRS scores for these time intervals were averaged. Patients were included if they had pain scores for at least 3 of the postoperative time intervals documented in their charts. Secondary outcome measures were LOS and opioid consumption during hospital admission. Intravenous acetaminophen use was also measured in both groups. All data on opioids were converted to oral morphine equivalents using the method described by Schneider and colleagues.⁸

A board-certified, fellowship-trained anesthesiologist, experienced in regional anesthesia, administered the single-shot ISNB before surgery. The block was administered under ultrasound guidance using a 44-mm, 22-gauge needle with the patient in the supine position. No indwelling catheter was used. The medication consisted of 30 mL of 5% ropivacaine (5 mg/mL). The surgeon injected liposomal bupivacaine (266 mg diluted into 40 mL of injectable saline) near the end of the procedure throughout the pericapsular area and multiple layers of the wound, per manufacturer guidelines.⁹ A 60-mL syringe with a 20-gauge needle was used. All operations were performed by 1 board-certified, fellowship-trained surgeon using a standard deltopectoral approach with the same surgical equipment. The same postoperative pain protocol was used for all patients, including intravenous acetaminophen and patient-controlled analgesia. Additional oral pain medication was provided as needed for all patients. Physical therapy protocols were identical between groups.

Statistical Analysis

Mean patient ages in the 2 treatment groups were compared using the Student t test. Sex distribution and the ASA scores were compared using a χ² test and a Fisher exact test, respectively. Arthroplasty types were compared using a Fisher exact test. The medians and interquartile ranges of the NRS scores at each time point measured were tabulated by treatment group, and at each time point the difference between groups was tested using nonparametric rank sum tests.

We tested the longitudinal trajectory of NRS scores over time, accounting for repeated measurements in the same patients using linear mixed model analysis. Treatment group, time period as a categorical variable, and the interaction between treatment and time period were included as fixed effects, and patient identification number was included as the random effect. An initial omnibus test was performed for all treatment and treatment-by-time interaction effects. Subsequently, the treatment-by-time interaction was tested for each of the time periods. The association of day of discharge (as a categorical variable) with treatment was tested using the Fisher exact test. All analyses were conducted using Stata, version 13, software (StataCorp LP). P values <.05 were considered significant.

 

Sample Size Analysis

We calculated the minimum detectable effect size with 80% power at an alpha level of 0.05 for the nonparametric rank sum test in terms of the proportion of every possible pair of patients treated with the 2 treatments, where the patient treated with liposomal bupivacaine has a lower pain score than the patient treated with ISNB. For pain score at 18 to 24 hours, the sample sizes of 33 patients treated with liposomal bupivacaine and 20 treated with ISNB, the minimum detectable effect size is 73%.

Results

Fifty-eight patient charts (21 in the ISNB group and 37 in the liposomal bupivacaine group) were reviewed for the study. Patient sex distribution, mean age, mean body mass index, and mean baseline ASA scores were not statistically different (Table 1).

In the ISNB group, 5 patients had hemiarthroplasty, 12 had TSA, and 4 had reverse TSA. In the liposomal bupivacaine group, 1 patient had hemiarthroplasty, 23 had TSA, and 13 had reverse TSA. Frequency of procedure types was significantly different between groups (P = .039), with the liposomal bupivacaine group undergoing fewer hemiarthroplasties.

The primary outcome measure, NRS pain score, showed no significant differences between groups at 0 to 1 hour after surgery (P = .99) or 8 to 14 hours after surgery (P = .208).

At 18 to 24 hours after surgery, the liposomal bupivacaine group had a lower mean NRS score than the ISNB group (P = .001). This was statistically significant when taking repeated measures of variance into account (Figure 1). Mean NRS score was also lower for the liposomal bupivacaine group at 27 to 36 hours after surgery (P = .029).

This was a significant difference when repeated measures of variance was considered (Table 2).

There was no difference in the amount of intravenous acetaminophen given during the hospital stay between groups. There was no significant difference in opioid consumption on postoperative day 1 in the hospital (P = .59) (Figure 2). However, there were significant differences between groups on postoperative days 2 and 3.

On postoperative day 2, the ISNB group required significantly more opioids (mean, 112 mg morphine equivalents) than the liposomal bupivacaine group (mean, 37 mg morphine equivalents) (P = .001). The ISNB group also required significantly more opioids (mean, 25 mg morphine equivalents) on postoperative day 3 than the liposomal bupivacaine group (mean, 5 mg) (P = .002).

Sixteen of 37 patients in the liposomal bupivacaine group and 2 of 21 in the ISNB group were discharged on the day after surgery (P = .010) (Table 3).

The mean LOS was 46 ± 20 hours for the liposomal bupivacaine group and 57 ± 14 hours for the ISNB group (P = .012).

There were no major cardiac or respiratory events in either group. No long-term paresthesias or neuropathies were noted. There were no readmissions for either group.

Discussion

Postoperative pain control after shoulder arthroplasty can be challenging, and several modalities have been tried in various combinations to minimize pain and decrease adverse effects of opioid medications. The most common method for pain relief after shoulder arthroplasty is the ISNB. Several studies of ISNBs have shown improved pain control after shoulder arthroplasty with associated decreased opioid consumption and related side effects.¹⁰ Patient rehabilitation and satisfaction have improved with the increasing use of peripheral nerve blocks.¹¹

Despite the well-established benefits of ISNBs, several limitations exist. Although the superior portion of the shoulder is well covered by an ISNB, the inferior portion of the brachial plexus can remain uncovered or only partially covered.¹² Complications of ISNBs include hemidiaphragmatic paresis, rebound pain 24 hours after surgery,¹³ chronic neurologic complications,¹⁴ and substantial respiratory and cardiovascular events.¹⁵ Nerve blocks also require additional time and resources in the perioperative period, including an anesthesiologist with specialized training, assistants, and ultrasonography or nerve stimulation equipment contraindicated in patients taking blood thinners.¹⁶

Periarticular injections of local anesthetics have also shown promise in reducing pain after arthroplasty.⁴ Benefits include an enhanced safety profile because local injection avoids the concurrent blockade of the phrenic nerve and recurrent laryngeal nerve and has not been associated with the risk of peripheral neuropathies. Further, local injection is a simple technique that can be performed during surgery without additional personnel or expertise. A limitation of this approach is the relatively short duration of effectiveness of the local anesthetic and uncertainty regarding the best agent and the ideal volume of injection.⁶ Liposomal bupivacaine is a new agent (approved by the US Food and Drug Administration in 2011¹⁷) with a sustained release over 72 to 96 hours.¹⁸ The most common adverse effects of liposomal bupivacaine are nausea, vomiting, constipation, pyrexia, dizziness, and headache.¹⁹ Chondrotoxicity and granulomatous inflammation are more serious, yet rare, complications of liposomal bupivacaine.²⁰

We found that liposomal bupivacaine injections were associated with lower pain scores compared with ISNB at 18 to 24 hours after surgery. This correlated with less opioid consumption in the liposomal bupivacaine group than in the ISNB group on the second postoperative day. These differences in pain values are consistent with the known pharmacokinetics of liposomal bupivacaine.¹⁸ Peak plasma levels normally occur approximately 24 hours after injection, leaving the early postoperative period relatively uncovered by anesthetic agent. This finding of relatively poor pain control early after surgery has also been noted in patients undergoing knee arthroplasty.⁵ On the basis of the findings of this study, we have added standard bupivacaine injections to our separate liposomal bupivacaine injection to cover early postoperative pain. Opioid consumption was significantly lower in the liposomal bupivacaine group than in the ISNB group on postoperative days 2 and 3. We did not measure adverse events related to opioid consumption, so we cannot comment on whether the decreased opioid consumption was associated with the rate of adverse events. However, other studies^21,22 have established this relationship.

We found the liposomal bupivacaine group to have earlier discharges to home. Sixteen of 37 patients in the liposomal bupivacaine group compared with 2 of 21 patients in the ISNB group were discharged on the day after surgery. A mean reduction in LOS of 18 hours for the liposomal bupivacaine group was statistically significant (P = .012). This reduction in LOS has important implications for hospitals and value analysis committees considering whether to keep a new, more expensive local anesthetic on formulary. Savings from reduced LOS and improvements in patient satisfaction may justify the expense (approximately $300 per 266-mg vial) of Exparel.

From a societal cost perspective, liposomal bupivacaine is more economical compared with ISNB, which adds approximately $1500 to the cost of anesthesia per patient.²³ Eliminating the costs associated with ISNB administration in shoulder arthroplasties could result in substantial savings to our healthcare system. More research examining time savings and exact costs of each procedure is needed to determine the true cost effectiveness of each approach.

Limitations of our study include the retrospective design, relatively small numbers of patients in each group, missing data for some patients at various time points, variation in the types of procedures in each group, and lack of long-term outcome measures. It is important to note that we did not confirm the success of the nerve block after administration. However, this study reflects the effectiveness of each of the modalities in actual clinical conditions (as opposed to a controlled experimental setting). The actual effectiveness of a nerve block varies, even when performed by an experienced anesthesiologist with ultrasound guidance. Furthermore, immediate postoperative pain scores in the nerve block group are consistent with those of prior research reporting pain values ranging from 4 to 5 and a mean duration of effect ranging from 9 to 14 hours.^23,24 Additionally, the patients, surgeon, and nursing team were not blinded to the treatment group. Although we did note a significant difference in the types of procedures between groups, this finding is related to the greater number of hemiarthroplasties performed in the ISNB group (N = 5) compared with the liposomal group (N = 1). Because of this variation and the decreased invasiveness of hemiarthroplasties, the bias is against the liposomal group. Finally, our primary outcome variable was pain, which is a subjective, self-reported measure. However, our opioid consumption data and LOS data corroborate the improved pain scores in the liposomal bupivacaine group.

Limiting the study to a single surgeon may limit external validity. Another limitation is the lack of data on adverse events related to opioid medication use. There was no additional experimental group to determine whether less expensive local anesthetics injected locally would perform similarly to liposomal bupivacaine. In total knee arthroplasty, periarticular injections of liposomal bupivacaine were not as effective as less expensive periarticular injections.²⁵ It is unclear which agents (and in what doses or combinations) should be used for periarticular injections. Finally, we acknowledge that our retrospective study design cannot account for all potential factors affecting discharge time.

This is the first comparative study of liposomal bupivacaine and ISNB in TSA. The study design allowed us to control for variables such as surgical technique, postoperative protocols (including use and type of sling), and use of other pain modalities such as patient-controlled analgesia and intravenous acetaminophen that are likely to affect postoperative pain and LOS. This study provides preliminary data that confirm relative equipoise between liposomal bupivacaine and ISNB, which is needed for the ethical conduct of a randomized controlled trial. Such a trial would allow for a more robust comparison, and this retrospective study provides appropriate pilot data on which to base this design and the clinical information needed to counsel patients during enrollment.

Our results suggest that liposomal bupivacaine may provide superior or similar pain relief compared with ISNB after shoulder arthroplasty. Additionally, the use of liposomal bupivacaine was associated with decreased opioid consumption and earlier discharge to home compared with ISNB. These findings have important implications for pain control after TSA because pain represents a major concern for patients and providers after surgery. In addition to clinical improvements, use of liposomal bupivacaine may save time and eliminate costs associated with administering nerve blocks. Local injection may also be used in patients who are contraindicated for ISNB such as those with obesity, pulmonary disease, or peripheral neuropathy. Although we cannot definitively suggest that liposomal bupivacaine is superior to the current gold standard ISNB for pain control after shoulder arthroplasty, our results suggest a relative clinical equipoise between these modalities. Larger analytical studies, including randomized trials, should be performed to explore the potential benefits of liposomal bupivacaine injections for pain control after shoulder arthroplasty.

Am J Orthop. 2016;45(7):424-430. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

The annual number of total shoulder arthroplasties (TSAs) is rising with the growing elderly population and development of new technologies such as reverse shoulder arthroplasty.¹ In 2008, 47,000 shoulder arthroplasties were performed in the US compared with 19,000 in 1998.¹ As of 2011, there were 53,000 shoulder arthroplasties performed annually.² Pain control after shoulder procedures, particularly TSA, is challenging. ³

Several modalities exist to manage pain after shoulder arthroplasty. The interscalene brachial plexus nerve block is considered the “gold standard” for shoulder analgesia. A new approach is the periarticular injection method, in which the surgeon administers a local anesthetic intraoperatively. Liposomal bupivacaine (Exparel, Pacira Pharmaceuticals, Inc.) is a nonopioid anesthetic that has been shown to improve pain control, shorten hospital stays, and decrease costs for total knee and hip arthroplasty compared with nerve blocks.^4-6 Patients who were treated with liposomal bupivacaine consumed less opioid medication than a placebo group.⁷

Our purpose was to compare intraoperative local liposomal bupivacaine injection with preoperative single-shot interscalene nerve block (ISNB) in terms of pain control, opioid use, and length of hospital stay (LOS) after shoulder arthroplasty. We hypothesized that patients in the liposomal bupivacaine group would have lower pain scores, less opioid use, and shorter LOS compared with patients in the ISNB group.

Methods

A retrospective cohort analysis was conducted with 58 patients who underwent shoulder arthroplasty by 1 surgeon at our academically affiliated community hospital from January 2012 through January 2015. ISNBs were the standard at the beginning of the study period and were used until Exparel became available on the hospital formulary in 2013. We began using Exparel for all shoulder arthroplasties in November 2013. No other changes were made in the perioperative management of our arthroplasty patients during this period. Patients who underwent TSA, reverse TSA, or hemiarthroplasty of the shoulder were included. Patients who underwent revision TSA were excluded. Twenty-one patients received ISNBs and 37 received liposomal bupivacaine injections. This study was approved by our Institutional Review Board.

Baseline data for each patient were age, sex, body mass index, and the American Society of Anesthesiologists (ASA) Physical Status Classification. The primary outcome measure was the numeric rating scale (NRS) pain score at 4 post-operative time intervals. The NRS pain score has a range of 0 to 10, with 10 representing severe pain. Data were gathered from nursing and physical therapy notes in patient charts. The postoperative time intervals were 0 to 1 hour, 8 to 14 hours, 18 to 24 hours, and 27 to 36 hours. Available NRS scores for these time intervals were averaged. Patients were included if they had pain scores for at least 3 of the postoperative time intervals documented in their charts. Secondary outcome measures were LOS and opioid consumption during hospital admission. Intravenous acetaminophen use was also measured in both groups. All data on opioids were converted to oral morphine equivalents using the method described by Schneider and colleagues.⁸

A board-certified, fellowship-trained anesthesiologist, experienced in regional anesthesia, administered the single-shot ISNB before surgery. The block was administered under ultrasound guidance using a 44-mm, 22-gauge needle with the patient in the supine position. No indwelling catheter was used. The medication consisted of 30 mL of 5% ropivacaine (5 mg/mL). The surgeon injected liposomal bupivacaine (266 mg diluted into 40 mL of injectable saline) near the end of the procedure throughout the pericapsular area and multiple layers of the wound, per manufacturer guidelines.⁹ A 60-mL syringe with a 20-gauge needle was used. All operations were performed by 1 board-certified, fellowship-trained surgeon using a standard deltopectoral approach with the same surgical equipment. The same postoperative pain protocol was used for all patients, including intravenous acetaminophen and patient-controlled analgesia. Additional oral pain medication was provided as needed for all patients. Physical therapy protocols were identical between groups.

Statistical Analysis

Mean patient ages in the 2 treatment groups were compared using the Student t test. Sex distribution and the ASA scores were compared using a χ² test and a Fisher exact test, respectively. Arthroplasty types were compared using a Fisher exact test. The medians and interquartile ranges of the NRS scores at each time point measured were tabulated by treatment group, and at each time point the difference between groups was tested using nonparametric rank sum tests.

We tested the longitudinal trajectory of NRS scores over time, accounting for repeated measurements in the same patients using linear mixed model analysis. Treatment group, time period as a categorical variable, and the interaction between treatment and time period were included as fixed effects, and patient identification number was included as the random effect. An initial omnibus test was performed for all treatment and treatment-by-time interaction effects. Subsequently, the treatment-by-time interaction was tested for each of the time periods. The association of day of discharge (as a categorical variable) with treatment was tested using the Fisher exact test. All analyses were conducted using Stata, version 13, software (StataCorp LP). P values <.05 were considered significant.

 

Sample Size Analysis

We calculated the minimum detectable effect size with 80% power at an alpha level of 0.05 for the nonparametric rank sum test in terms of the proportion of every possible pair of patients treated with the 2 treatments, where the patient treated with liposomal bupivacaine has a lower pain score than the patient treated with ISNB. For pain score at 18 to 24 hours, the sample sizes of 33 patients treated with liposomal bupivacaine and 20 treated with ISNB, the minimum detectable effect size is 73%.

Results

Fifty-eight patient charts (21 in the ISNB group and 37 in the liposomal bupivacaine group) were reviewed for the study. Patient sex distribution, mean age, mean body mass index, and mean baseline ASA scores were not statistically different (Table 1).

In the ISNB group, 5 patients had hemiarthroplasty, 12 had TSA, and 4 had reverse TSA. In the liposomal bupivacaine group, 1 patient had hemiarthroplasty, 23 had TSA, and 13 had reverse TSA. Frequency of procedure types was significantly different between groups (P = .039), with the liposomal bupivacaine group undergoing fewer hemiarthroplasties.

The primary outcome measure, NRS pain score, showed no significant differences between groups at 0 to 1 hour after surgery (P = .99) or 8 to 14 hours after surgery (P = .208).

At 18 to 24 hours after surgery, the liposomal bupivacaine group had a lower mean NRS score than the ISNB group (P = .001). This was statistically significant when taking repeated measures of variance into account (Figure 1). Mean NRS score was also lower for the liposomal bupivacaine group at 27 to 36 hours after surgery (P = .029).

This was a significant difference when repeated measures of variance was considered (Table 2).

There was no difference in the amount of intravenous acetaminophen given during the hospital stay between groups. There was no significant difference in opioid consumption on postoperative day 1 in the hospital (P = .59) (Figure 2). However, there were significant differences between groups on postoperative days 2 and 3.

On postoperative day 2, the ISNB group required significantly more opioids (mean, 112 mg morphine equivalents) than the liposomal bupivacaine group (mean, 37 mg morphine equivalents) (P = .001). The ISNB group also required significantly more opioids (mean, 25 mg morphine equivalents) on postoperative day 3 than the liposomal bupivacaine group (mean, 5 mg) (P = .002).

Sixteen of 37 patients in the liposomal bupivacaine group and 2 of 21 in the ISNB group were discharged on the day after surgery (P = .010) (Table 3).

The mean LOS was 46 ± 20 hours for the liposomal bupivacaine group and 57 ± 14 hours for the ISNB group (P = .012).

There were no major cardiac or respiratory events in either group. No long-term paresthesias or neuropathies were noted. There were no readmissions for either group.

Discussion

Postoperative pain control after shoulder arthroplasty can be challenging, and several modalities have been tried in various combinations to minimize pain and decrease adverse effects of opioid medications. The most common method for pain relief after shoulder arthroplasty is the ISNB. Several studies of ISNBs have shown improved pain control after shoulder arthroplasty with associated decreased opioid consumption and related side effects.¹⁰ Patient rehabilitation and satisfaction have improved with the increasing use of peripheral nerve blocks.¹¹

Despite the well-established benefits of ISNBs, several limitations exist. Although the superior portion of the shoulder is well covered by an ISNB, the inferior portion of the brachial plexus can remain uncovered or only partially covered.¹² Complications of ISNBs include hemidiaphragmatic paresis, rebound pain 24 hours after surgery,¹³ chronic neurologic complications,¹⁴ and substantial respiratory and cardiovascular events.¹⁵ Nerve blocks also require additional time and resources in the perioperative period, including an anesthesiologist with specialized training, assistants, and ultrasonography or nerve stimulation equipment contraindicated in patients taking blood thinners.¹⁶

Periarticular injections of local anesthetics have also shown promise in reducing pain after arthroplasty.⁴ Benefits include an enhanced safety profile because local injection avoids the concurrent blockade of the phrenic nerve and recurrent laryngeal nerve and has not been associated with the risk of peripheral neuropathies. Further, local injection is a simple technique that can be performed during surgery without additional personnel or expertise. A limitation of this approach is the relatively short duration of effectiveness of the local anesthetic and uncertainty regarding the best agent and the ideal volume of injection.⁶ Liposomal bupivacaine is a new agent (approved by the US Food and Drug Administration in 2011¹⁷) with a sustained release over 72 to 96 hours.¹⁸ The most common adverse effects of liposomal bupivacaine are nausea, vomiting, constipation, pyrexia, dizziness, and headache.¹⁹ Chondrotoxicity and granulomatous inflammation are more serious, yet rare, complications of liposomal bupivacaine.²⁰

We found that liposomal bupivacaine injections were associated with lower pain scores compared with ISNB at 18 to 24 hours after surgery. This correlated with less opioid consumption in the liposomal bupivacaine group than in the ISNB group on the second postoperative day. These differences in pain values are consistent with the known pharmacokinetics of liposomal bupivacaine.¹⁸ Peak plasma levels normally occur approximately 24 hours after injection, leaving the early postoperative period relatively uncovered by anesthetic agent. This finding of relatively poor pain control early after surgery has also been noted in patients undergoing knee arthroplasty.⁵ On the basis of the findings of this study, we have added standard bupivacaine injections to our separate liposomal bupivacaine injection to cover early postoperative pain. Opioid consumption was significantly lower in the liposomal bupivacaine group than in the ISNB group on postoperative days 2 and 3. We did not measure adverse events related to opioid consumption, so we cannot comment on whether the decreased opioid consumption was associated with the rate of adverse events. However, other studies^21,22 have established this relationship.

We found the liposomal bupivacaine group to have earlier discharges to home. Sixteen of 37 patients in the liposomal bupivacaine group compared with 2 of 21 patients in the ISNB group were discharged on the day after surgery. A mean reduction in LOS of 18 hours for the liposomal bupivacaine group was statistically significant (P = .012). This reduction in LOS has important implications for hospitals and value analysis committees considering whether to keep a new, more expensive local anesthetic on formulary. Savings from reduced LOS and improvements in patient satisfaction may justify the expense (approximately $300 per 266-mg vial) of Exparel.

From a societal cost perspective, liposomal bupivacaine is more economical compared with ISNB, which adds approximately $1500 to the cost of anesthesia per patient.²³ Eliminating the costs associated with ISNB administration in shoulder arthroplasties could result in substantial savings to our healthcare system. More research examining time savings and exact costs of each procedure is needed to determine the true cost effectiveness of each approach.

Limitations of our study include the retrospective design, relatively small numbers of patients in each group, missing data for some patients at various time points, variation in the types of procedures in each group, and lack of long-term outcome measures. It is important to note that we did not confirm the success of the nerve block after administration. However, this study reflects the effectiveness of each of the modalities in actual clinical conditions (as opposed to a controlled experimental setting). The actual effectiveness of a nerve block varies, even when performed by an experienced anesthesiologist with ultrasound guidance. Furthermore, immediate postoperative pain scores in the nerve block group are consistent with those of prior research reporting pain values ranging from 4 to 5 and a mean duration of effect ranging from 9 to 14 hours.^23,24 Additionally, the patients, surgeon, and nursing team were not blinded to the treatment group. Although we did note a significant difference in the types of procedures between groups, this finding is related to the greater number of hemiarthroplasties performed in the ISNB group (N = 5) compared with the liposomal group (N = 1). Because of this variation and the decreased invasiveness of hemiarthroplasties, the bias is against the liposomal group. Finally, our primary outcome variable was pain, which is a subjective, self-reported measure. However, our opioid consumption data and LOS data corroborate the improved pain scores in the liposomal bupivacaine group.

Limiting the study to a single surgeon may limit external validity. Another limitation is the lack of data on adverse events related to opioid medication use. There was no additional experimental group to determine whether less expensive local anesthetics injected locally would perform similarly to liposomal bupivacaine. In total knee arthroplasty, periarticular injections of liposomal bupivacaine were not as effective as less expensive periarticular injections.²⁵ It is unclear which agents (and in what doses or combinations) should be used for periarticular injections. Finally, we acknowledge that our retrospective study design cannot account for all potential factors affecting discharge time.

This is the first comparative study of liposomal bupivacaine and ISNB in TSA. The study design allowed us to control for variables such as surgical technique, postoperative protocols (including use and type of sling), and use of other pain modalities such as patient-controlled analgesia and intravenous acetaminophen that are likely to affect postoperative pain and LOS. This study provides preliminary data that confirm relative equipoise between liposomal bupivacaine and ISNB, which is needed for the ethical conduct of a randomized controlled trial. Such a trial would allow for a more robust comparison, and this retrospective study provides appropriate pilot data on which to base this design and the clinical information needed to counsel patients during enrollment.

Our results suggest that liposomal bupivacaine may provide superior or similar pain relief compared with ISNB after shoulder arthroplasty. Additionally, the use of liposomal bupivacaine was associated with decreased opioid consumption and earlier discharge to home compared with ISNB. These findings have important implications for pain control after TSA because pain represents a major concern for patients and providers after surgery. In addition to clinical improvements, use of liposomal bupivacaine may save time and eliminate costs associated with administering nerve blocks. Local injection may also be used in patients who are contraindicated for ISNB such as those with obesity, pulmonary disease, or peripheral neuropathy. Although we cannot definitively suggest that liposomal bupivacaine is superior to the current gold standard ISNB for pain control after shoulder arthroplasty, our results suggest a relative clinical equipoise between these modalities. Larger analytical studies, including randomized trials, should be performed to explore the potential benefits of liposomal bupivacaine injections for pain control after shoulder arthroplasty.

Am J Orthop. 2016;45(7):424-430. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

The annual number of total shoulder arthroplasties (TSAs) is rising with the growing elderly population and development of new technologies such as reverse shoulder arthroplasty.¹ In 2008, 47,000 shoulder arthroplasties were performed in the US compared with 19,000 in 1998.¹ As of 2011, there were 53,000 shoulder arthroplasties performed annually.² Pain control after shoulder procedures, particularly TSA, is challenging. ³

Several modalities exist to manage pain after shoulder arthroplasty. The interscalene brachial plexus nerve block is considered the “gold standard” for shoulder analgesia. A new approach is the periarticular injection method, in which the surgeon administers a local anesthetic intraoperatively. Liposomal bupivacaine (Exparel, Pacira Pharmaceuticals, Inc.) is a nonopioid anesthetic that has been shown to improve pain control, shorten hospital stays, and decrease costs for total knee and hip arthroplasty compared with nerve blocks.^4-6 Patients who were treated with liposomal bupivacaine consumed less opioid medication than a placebo group.⁷

Our purpose was to compare intraoperative local liposomal bupivacaine injection with preoperative single-shot interscalene nerve block (ISNB) in terms of pain control, opioid use, and length of hospital stay (LOS) after shoulder arthroplasty. We hypothesized that patients in the liposomal bupivacaine group would have lower pain scores, less opioid use, and shorter LOS compared with patients in the ISNB group.

Methods

A retrospective cohort analysis was conducted with 58 patients who underwent shoulder arthroplasty by 1 surgeon at our academically affiliated community hospital from January 2012 through January 2015. ISNBs were the standard at the beginning of the study period and were used until Exparel became available on the hospital formulary in 2013. We began using Exparel for all shoulder arthroplasties in November 2013. No other changes were made in the perioperative management of our arthroplasty patients during this period. Patients who underwent TSA, reverse TSA, or hemiarthroplasty of the shoulder were included. Patients who underwent revision TSA were excluded. Twenty-one patients received ISNBs and 37 received liposomal bupivacaine injections. This study was approved by our Institutional Review Board.

Baseline data for each patient were age, sex, body mass index, and the American Society of Anesthesiologists (ASA) Physical Status Classification. The primary outcome measure was the numeric rating scale (NRS) pain score at 4 post-operative time intervals. The NRS pain score has a range of 0 to 10, with 10 representing severe pain. Data were gathered from nursing and physical therapy notes in patient charts. The postoperative time intervals were 0 to 1 hour, 8 to 14 hours, 18 to 24 hours, and 27 to 36 hours. Available NRS scores for these time intervals were averaged. Patients were included if they had pain scores for at least 3 of the postoperative time intervals documented in their charts. Secondary outcome measures were LOS and opioid consumption during hospital admission. Intravenous acetaminophen use was also measured in both groups. All data on opioids were converted to oral morphine equivalents using the method described by Schneider and colleagues.⁸

A board-certified, fellowship-trained anesthesiologist, experienced in regional anesthesia, administered the single-shot ISNB before surgery. The block was administered under ultrasound guidance using a 44-mm, 22-gauge needle with the patient in the supine position. No indwelling catheter was used. The medication consisted of 30 mL of 5% ropivacaine (5 mg/mL). The surgeon injected liposomal bupivacaine (266 mg diluted into 40 mL of injectable saline) near the end of the procedure throughout the pericapsular area and multiple layers of the wound, per manufacturer guidelines.⁹ A 60-mL syringe with a 20-gauge needle was used. All operations were performed by 1 board-certified, fellowship-trained surgeon using a standard deltopectoral approach with the same surgical equipment. The same postoperative pain protocol was used for all patients, including intravenous acetaminophen and patient-controlled analgesia. Additional oral pain medication was provided as needed for all patients. Physical therapy protocols were identical between groups.

Statistical Analysis

Mean patient ages in the 2 treatment groups were compared using the Student t test. Sex distribution and the ASA scores were compared using a χ² test and a Fisher exact test, respectively. Arthroplasty types were compared using a Fisher exact test. The medians and interquartile ranges of the NRS scores at each time point measured were tabulated by treatment group, and at each time point the difference between groups was tested using nonparametric rank sum tests.

We tested the longitudinal trajectory of NRS scores over time, accounting for repeated measurements in the same patients using linear mixed model analysis. Treatment group, time period as a categorical variable, and the interaction between treatment and time period were included as fixed effects, and patient identification number was included as the random effect. An initial omnibus test was performed for all treatment and treatment-by-time interaction effects. Subsequently, the treatment-by-time interaction was tested for each of the time periods. The association of day of discharge (as a categorical variable) with treatment was tested using the Fisher exact test. All analyses were conducted using Stata, version 13, software (StataCorp LP). P values <.05 were considered significant.

 

Sample Size Analysis

We calculated the minimum detectable effect size with 80% power at an alpha level of 0.05 for the nonparametric rank sum test in terms of the proportion of every possible pair of patients treated with the 2 treatments, where the patient treated with liposomal bupivacaine has a lower pain score than the patient treated with ISNB. For pain score at 18 to 24 hours, the sample sizes of 33 patients treated with liposomal bupivacaine and 20 treated with ISNB, the minimum detectable effect size is 73%.

Results

Fifty-eight patient charts (21 in the ISNB group and 37 in the liposomal bupivacaine group) were reviewed for the study. Patient sex distribution, mean age, mean body mass index, and mean baseline ASA scores were not statistically different (Table 1).

In the ISNB group, 5 patients had hemiarthroplasty, 12 had TSA, and 4 had reverse TSA. In the liposomal bupivacaine group, 1 patient had hemiarthroplasty, 23 had TSA, and 13 had reverse TSA. Frequency of procedure types was significantly different between groups (P = .039), with the liposomal bupivacaine group undergoing fewer hemiarthroplasties.

The primary outcome measure, NRS pain score, showed no significant differences between groups at 0 to 1 hour after surgery (P = .99) or 8 to 14 hours after surgery (P = .208).

At 18 to 24 hours after surgery, the liposomal bupivacaine group had a lower mean NRS score than the ISNB group (P = .001). This was statistically significant when taking repeated measures of variance into account (Figure 1). Mean NRS score was also lower for the liposomal bupivacaine group at 27 to 36 hours after surgery (P = .029).

This was a significant difference when repeated measures of variance was considered (Table 2).

There was no difference in the amount of intravenous acetaminophen given during the hospital stay between groups. There was no significant difference in opioid consumption on postoperative day 1 in the hospital (P = .59) (Figure 2). However, there were significant differences between groups on postoperative days 2 and 3.

On postoperative day 2, the ISNB group required significantly more opioids (mean, 112 mg morphine equivalents) than the liposomal bupivacaine group (mean, 37 mg morphine equivalents) (P = .001). The ISNB group also required significantly more opioids (mean, 25 mg morphine equivalents) on postoperative day 3 than the liposomal bupivacaine group (mean, 5 mg) (P = .002).

Sixteen of 37 patients in the liposomal bupivacaine group and 2 of 21 in the ISNB group were discharged on the day after surgery (P = .010) (Table 3).

The mean LOS was 46 ± 20 hours for the liposomal bupivacaine group and 57 ± 14 hours for the ISNB group (P = .012).

There were no major cardiac or respiratory events in either group. No long-term paresthesias or neuropathies were noted. There were no readmissions for either group.

Discussion

Postoperative pain control after shoulder arthroplasty can be challenging, and several modalities have been tried in various combinations to minimize pain and decrease adverse effects of opioid medications. The most common method for pain relief after shoulder arthroplasty is the ISNB. Several studies of ISNBs have shown improved pain control after shoulder arthroplasty with associated decreased opioid consumption and related side effects.¹⁰ Patient rehabilitation and satisfaction have improved with the increasing use of peripheral nerve blocks.¹¹

Despite the well-established benefits of ISNBs, several limitations exist. Although the superior portion of the shoulder is well covered by an ISNB, the inferior portion of the brachial plexus can remain uncovered or only partially covered.¹² Complications of ISNBs include hemidiaphragmatic paresis, rebound pain 24 hours after surgery,¹³ chronic neurologic complications,¹⁴ and substantial respiratory and cardiovascular events.¹⁵ Nerve blocks also require additional time and resources in the perioperative period, including an anesthesiologist with specialized training, assistants, and ultrasonography or nerve stimulation equipment contraindicated in patients taking blood thinners.¹⁶

Periarticular injections of local anesthetics have also shown promise in reducing pain after arthroplasty.⁴ Benefits include an enhanced safety profile because local injection avoids the concurrent blockade of the phrenic nerve and recurrent laryngeal nerve and has not been associated with the risk of peripheral neuropathies. Further, local injection is a simple technique that can be performed during surgery without additional personnel or expertise. A limitation of this approach is the relatively short duration of effectiveness of the local anesthetic and uncertainty regarding the best agent and the ideal volume of injection.⁶ Liposomal bupivacaine is a new agent (approved by the US Food and Drug Administration in 2011¹⁷) with a sustained release over 72 to 96 hours.¹⁸ The most common adverse effects of liposomal bupivacaine are nausea, vomiting, constipation, pyrexia, dizziness, and headache.¹⁹ Chondrotoxicity and granulomatous inflammation are more serious, yet rare, complications of liposomal bupivacaine.²⁰

We found that liposomal bupivacaine injections were associated with lower pain scores compared with ISNB at 18 to 24 hours after surgery. This correlated with less opioid consumption in the liposomal bupivacaine group than in the ISNB group on the second postoperative day. These differences in pain values are consistent with the known pharmacokinetics of liposomal bupivacaine.¹⁸ Peak plasma levels normally occur approximately 24 hours after injection, leaving the early postoperative period relatively uncovered by anesthetic agent. This finding of relatively poor pain control early after surgery has also been noted in patients undergoing knee arthroplasty.⁵ On the basis of the findings of this study, we have added standard bupivacaine injections to our separate liposomal bupivacaine injection to cover early postoperative pain. Opioid consumption was significantly lower in the liposomal bupivacaine group than in the ISNB group on postoperative days 2 and 3. We did not measure adverse events related to opioid consumption, so we cannot comment on whether the decreased opioid consumption was associated with the rate of adverse events. However, other studies^21,22 have established this relationship.

We found the liposomal bupivacaine group to have earlier discharges to home. Sixteen of 37 patients in the liposomal bupivacaine group compared with 2 of 21 patients in the ISNB group were discharged on the day after surgery. A mean reduction in LOS of 18 hours for the liposomal bupivacaine group was statistically significant (P = .012). This reduction in LOS has important implications for hospitals and value analysis committees considering whether to keep a new, more expensive local anesthetic on formulary. Savings from reduced LOS and improvements in patient satisfaction may justify the expense (approximately $300 per 266-mg vial) of Exparel.

From a societal cost perspective, liposomal bupivacaine is more economical compared with ISNB, which adds approximately $1500 to the cost of anesthesia per patient.²³ Eliminating the costs associated with ISNB administration in shoulder arthroplasties could result in substantial savings to our healthcare system. More research examining time savings and exact costs of each procedure is needed to determine the true cost effectiveness of each approach.

Limitations of our study include the retrospective design, relatively small numbers of patients in each group, missing data for some patients at various time points, variation in the types of procedures in each group, and lack of long-term outcome measures. It is important to note that we did not confirm the success of the nerve block after administration. However, this study reflects the effectiveness of each of the modalities in actual clinical conditions (as opposed to a controlled experimental setting). The actual effectiveness of a nerve block varies, even when performed by an experienced anesthesiologist with ultrasound guidance. Furthermore, immediate postoperative pain scores in the nerve block group are consistent with those of prior research reporting pain values ranging from 4 to 5 and a mean duration of effect ranging from 9 to 14 hours.^23,24 Additionally, the patients, surgeon, and nursing team were not blinded to the treatment group. Although we did note a significant difference in the types of procedures between groups, this finding is related to the greater number of hemiarthroplasties performed in the ISNB group (N = 5) compared with the liposomal group (N = 1). Because of this variation and the decreased invasiveness of hemiarthroplasties, the bias is against the liposomal group. Finally, our primary outcome variable was pain, which is a subjective, self-reported measure. However, our opioid consumption data and LOS data corroborate the improved pain scores in the liposomal bupivacaine group.

Limiting the study to a single surgeon may limit external validity. Another limitation is the lack of data on adverse events related to opioid medication use. There was no additional experimental group to determine whether less expensive local anesthetics injected locally would perform similarly to liposomal bupivacaine. In total knee arthroplasty, periarticular injections of liposomal bupivacaine were not as effective as less expensive periarticular injections.²⁵ It is unclear which agents (and in what doses or combinations) should be used for periarticular injections. Finally, we acknowledge that our retrospective study design cannot account for all potential factors affecting discharge time.

This is the first comparative study of liposomal bupivacaine and ISNB in TSA. The study design allowed us to control for variables such as surgical technique, postoperative protocols (including use and type of sling), and use of other pain modalities such as patient-controlled analgesia and intravenous acetaminophen that are likely to affect postoperative pain and LOS. This study provides preliminary data that confirm relative equipoise between liposomal bupivacaine and ISNB, which is needed for the ethical conduct of a randomized controlled trial. Such a trial would allow for a more robust comparison, and this retrospective study provides appropriate pilot data on which to base this design and the clinical information needed to counsel patients during enrollment.

Our results suggest that liposomal bupivacaine may provide superior or similar pain relief compared with ISNB after shoulder arthroplasty. Additionally, the use of liposomal bupivacaine was associated with decreased opioid consumption and earlier discharge to home compared with ISNB. These findings have important implications for pain control after TSA because pain represents a major concern for patients and providers after surgery. In addition to clinical improvements, use of liposomal bupivacaine may save time and eliminate costs associated with administering nerve blocks. Local injection may also be used in patients who are contraindicated for ISNB such as those with obesity, pulmonary disease, or peripheral neuropathy. Although we cannot definitively suggest that liposomal bupivacaine is superior to the current gold standard ISNB for pain control after shoulder arthroplasty, our results suggest a relative clinical equipoise between these modalities. Larger analytical studies, including randomized trials, should be performed to explore the potential benefits of liposomal bupivacaine injections for pain control after shoulder arthroplasty.

Am J Orthop. 2016;45(7):424-430. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Ultrasound has classically been marketed and used as a diagnostic tool. Radiologists, emergency physicians, and sports physicians used ultrasound units to rapidly and appropriately diagnose numerous injuries and disorders, in a timely and cost effective manner. Part 1¹ and Part 2² of this series showed how to use ultrasound in the shoulder for diagnosis and how to code and get reimbursed for its use.Ultrasound can also be used to help guide procedures and interventions performed to treat patients. Currently, more physicians are beginning to recognize the utility of this modality as an aid to interventional procedures.

First-generation procedures use ultrasound to improve accuracy of joint, bursal, tendon, and muscular injections.³ Recent studies have shown a significant improvement in accuracy, outcomes, and patient satisfaction using ultrasound guidance for injections.^3-12 Within the limitation of using a needle, second-generation procedures—hydrodissection of peripherally entrapped nerves, capsular distention, mechanical disruption of neovascularization, and needle fenestration or barbotage in chronic tendinopathy—try to simulate surgical objectives while minimizing tissue burden and other complications of surgery.³ More advanced procedures include needle fenestration/release of the carpal ligament in carpal tunnel syndrome and A1 pulley needle release in the setting of trigger finger.³ Innovative third-generation procedures involve the use of surgical tools such as hook blades under ultrasound guidance to perform surgical procedures. Surgeons are now improving already established percutaneous, arthroscopic, and open surgical procedures with ultrasound assistance.³ Aside from better guidance, reducing cost and improving surgeon comfort may be additional benefits of ultrasound assisted surgery.

Image-Guided Treatment Options

Prior to image guidance, palpation of surface anatomy helped physicians determine the anatomic placement of injections, incisions, or portals. Joints and bursas that do not have any inflammation or fluid can sometimes be difficult to identify or locate by palpation alone. Palpation-guided joint injections often miss their target and cause significant pain when the therapeutic agent is injected into a muscle, tendon, ligament, fat, or other tissue. Ultrasound-guided injections have proven to be more accurate and have better patient satisfaction when compared to blind injections.^3-12

X-ray fluoroscopy has been the primary option for surgeons to assist in surgery. This is a natural modality for orthopedic surgeons; their primary use is for bone to help with fracture reduction and fixation as the bone, instrumentation, and fixation methods are usually radio-opaque. With the advancement in technology, many orthopedic surgeons are regularly using radiolucent fixation devices and working with soft tissue as opposed to bone. Fixation of tendons, ligaments, and muscles would be done using a large incision, palpation of the anatomy, then fixation or repair. Many surgeons began looking for ways to minimize the incisions. Turning to fluoroscopy, a traditional and well-used modality, was a natural progression. Guides and methods were developed to isolate insertions and drill placements. However, fluoroscopy is limited by its difficulty in changing planes and the large equipment required. Also, it is limited in its ability to image soft tissue.

Computed tomography (CT) scans and magnetic resonance imaging (MRI) are far better at imaging soft tissue but cannot be taken for use into the office or surgical suite. These modalities are also far more expensive and take up significant space.

CT scans have significant radiation exposure, and MRIs prohibit the use of metal objects around them. Overall, ultrasound has far more advantages over the other modalities as an adjunct for procedures (Table).

Ultrasound Procedural Basics

Appropriate use of ultrasound still remains highly technician-dependent. Unlike other imaging modalities, ultrasound requires a higher skill level by the physician to implement the use of ultrasound and identification of pathology to treat these disease processes. However, this is no different from the use of arthroscopy or fluoroscopy to treat patients. Training is required, as well as an understanding of the ultrasound machine, anatomy, and sono-anatomy—identification of anatomy and pathology as shown by the ultrasound machine.²

In ultrasound, the long axis refers to looking at a structure along its length, as in longitudinal. The short axis refers to evaluating a structure in cross-section, transverse, or along its shortest length. “In plane” refers to performing a procedure where the needle or object being used enters the ultrasound field along the plane of the transducer, allowing visualization of the majority of the needle as it crosses tissue planes. “Out of plane” has the needle entering perpendicular to the plane of the transducer, showing the needle on the monitor as a bright, hyperechoic dot. Some studies have suggested that novice ultrasonographers should start in a long axis view and use the in plane technique when injecting, as doing so may decrease time to identify the target and improve mean imaging quality during needle advancement.¹³

Anisotropy is the property of being directionally dependent. The ultrasound beam needs to be perpendicular to the structure being imaged to give the optimal image. When the beam hits a longitudinal structure like a needle at an angle <90°, the linear structure might reflect most of the beam away from the transducer. So when using a needle to localize or inject a specific area, maintaining the probe as close to perpendicular as possible with the needle will give a better image. New technology exists to better visualize needles even at high acuity angles by using a multi-beam processing algorithm, which can significantly aid the physician without the need for specialized needles.

Despite better technology, advance planning is key to a successful procedure. Positioning the patient and ultrasound machine in a manner that is comfortable and makes the desired target accessible while being able to visualize the ultrasound monitor comes first. Identifying the target, mapping the needle trajectory using depth markings, and scanning for nerves, vessels, and other structures that may be damaged along the needle path comes next. Using the in plane ultrasound technique with color Doppler and the nerve contrast setting can ensure that the physician has placed the therapeutic agent to the proper location while avoiding any nerves, arteries, or veins. Marking the borders of the ultrasound probe and needle entry site can be helpful to return to the same area after sterile preparation is done. As in any procedure, sterile technique is paramount. Sterile technique considerations may include using sterile gloves and a probe cover with sterile gel, cleaning the area thoroughly, planning the needle entry point 3 cm to 5 cm away from the probe, and maintaining a dry and gel-free needle entry.^14-15 The probe should be sterilized between patients to avoid cross-contamination; note that certain solutions like alcohol or ethyl chloride can damage the transducer.^14-15 However, simple injections do not require such stringent standards when simple sterile technique is observed by cleaning and then never touching the cleaned area again except with the needle to avoid contamination. Also, ethyl chloride has been found to not contaminate a sterile site and can be used safely to anesthetize the skin.

 

Ultrasound-Guided Procedures

Many injectable therapeutic options exist as interventions. Cortisone, hyaluronic acid, platelet-rich plasma (PRP), stem cells/bone marrow concentrate (BMC), amniotic fluid, prolotherapy, and saline are now commonly used.^16-17 A meta-analysis of the literature assessing the accuracy of ultrasound-guided shoulder girdle injections vs a landmark-guided injection was done in 2015.¹⁸ It showed that for the acromioclavicular joint, accuracy was 93.6% vs 68.2% (P < .0001), based on single studies. The accuracy of ultrasound vs a landmark-guided injection was 65% vs 70% for the subacromial space (P > .05); 86.7% vs 26.7% for the biceps tendon sheath (P < .05); and 92.5% vs 72.5% for the glenohumeral joint (P = .025).¹⁸ 

With cortisone, injecting into muscle, ligament, or tendons could potentially harm the tissue or cause worsening of the disease process.^19-20 With the advent of orthobiologics, injecting into these structures is now desirable, instead of a potential complication.^19-20 Ultrasound has become even more important to the accurate delivery of these therapies to the disease locations. Multiple studies using leukocyte-poor PRP for osteoarthritis show significant differences in pain scores.^21-23 Peerbooms and colleagues^24,25 also showed that PRP reduced pain and increased function compared to cortisone injections for lateral epicondylitis in 1- and 2-year double-blind randomized controlled trials. Centeno and colleagues²⁶ performed a prospective, multi-site registry study on 102 patients with symptomatic osteoarthritis and/or rotator cuff tears that were injected with bone marrow concentrate. There was a statistically significant improvement in Disabilities of the Arm, Shoulder and Hand (DASH) scores from 36.1 to 17.1 (P < .001) and numeric pain scores improved from 4.3 to 2.4 (P < .001).

By being able to see the pathology, like a hypoechoic region in a tendon, ligament, or muscle, the physician can reliably place the therapeutic agent into the precise location. Also, adjacent para-tendon or para-ligament injections allow for in-season athletes to get some relief from symptoms while allowing to return to play quickly; injections into muscle, ligament, or tendon can damage the structure and require days or weeks of rest, while para-tendon and para-ligament injections are far less painful.

Second-generation techniques have provided patients with great options that can help avoid surgery. Calcific tendonitis appears brightly hyperechoic on ultrasound and is easily identified. The physician can attempt to break up the calcium by fenestration or barbotage of the calcium. The same can be accomplished by injecting the density with PRP or stem cells. If the calcium is soft or “toothpaste-like,” the negative pressure will make it easy to aspirate it into the syringe. A 2-year, longitudinal prospective study of 121 patients demonstrated that visual analog score (VAS) pain scores and size of calcium significantly decreased with ultrasound-guided percutaneous needle lavage; 89% of patients were pain-free at 1-year follow-up.²⁷ Moreover, a randomized controlled trial of 48 patients comparing needle lavage vs subacromial steroid injection showed statistically significant radiographic and clinically better outcomes with the needle lavage group at the 1-year mark.²⁸

The Tenex procedure is a novel technique that uses ultrasonic energy to fenestrate diseased tendon tissue. It also can be used to break up calcific deposits. After the Tenex probe is guided to the diseased tendon/calcium, the TX-1 tip oscillates at the speed of sound, fenestrating/cutting through the tendon or calcium while lavaging the tendon with saline. Multiple prospective, noncontrolled studies done in common extensor, patellar, and rotator cuff tendinopathy have demonstrated good to excellent improvements in pain scores with the Tenex procedure.^29-31

Ultrasound is extremely useful in the treatment of adhesive capsulitis.³² The posterior glenohumeral capsule can be distended using a large volume (60 cc) of saline to loosen adhesions in preparation for manipulation. Because the manipulation can be an extremely painful procedure, ultrasound can be used to perform an inter-scalene block for regional anesthesia prior to the procedure. In 2014, Park and colleagues³³ performed a randomized prospective trial that showed that capsular distension followed by manipulation was more effective than cortisone injection alone for the treatment of adhesive capsulitis.Ultrasound guidance was found to be just as efficacious as fluoroscopy in a randomized controlled trial in 2014; the authors noted that ultrasound does not expose the patient or clinician to radiation and can be done in office.³⁴

Currently, techniques to perform ultrasound-guided percutaneous tenotomies of the long head of the biceps tendon using hook blades are being studied.³⁵

Ultrasound-Assisted Surgery

Ultrasound has been a boon to surgeons who perform minimally invasive procedures. It is far less cumbersome than classic fluoroscopy. Fluoroscopy requires the use of heavy lead aprons by the surgeons. Combining this with the impervious gowns and hot lights, the surgeons’ comfort level is severely sacrificed. When having to do many long surgeries in a row, this situation can take a toll on the surgeons’ endurance and strength. Improving the comfort of the surgeon is not the primary goal of surgery, but can significantly help our ability to do a better job.

 

Ultrasound allows the surgeon to localize any superficial foreign objects, especially with radiolucent objects like fragments of glass. Small glass fragments or pieces of wood have always been extremely difficult to remove. X-rays cannot localize these objects, so getting a proper orientation is difficult. MRI and CT scans easily identify these types of foreign objects, but cannot be used intraoperatively (Figure 1A). Often, these objects cannot be felt and therefore require a large dissection. The objects may encapsulate and be easily confused with other soft tissues.

These objects often take large incisions and wide dissections to find and remove. With ultrasound, the objects can be localized in real time while in surgery (Figure 1B). Using a sterile probe cover, the surgeon can take advantage of the multi-planar nature of ultrasound. Since the probe can be manipulated in any direction and angle, the only limitations to finding objects are the user, the object density, the location depth, and if the object is behind a hard structure, such as bone. The foreign body can then be removed under ultrasound guidance (Figure 1C).Being able to identify specific structures in surgery allows the surgeon to be more accurate when performing certain procedures. Arthroscopic biceps tenodesis is a common shoulder procedure that can be done many different ways. When using the “below the groove/supra-pec” position, the incisions become more variable and difficult to place. If the surgeon is too high/low or medial/lateral, the localization of the drill position will be very difficult, which will result in having to angle the drill to compensate for poorly placed portals, and finding the biceps becomes very challenging.

By using the ultrasound intraoperatively, the surgeon can identify the exact position of the biceps tendon (medial/lateral) and where it lies just below the groove and above the pectoralis major (superior/inferior) (Figure 2A).

This allows the surgeon to mark the appropriate placement of the portals by the position of the transducer (Figure 2B). When entering with the arthroscope to perform the procedure, the surgeon will “fall” right onto the biceps tendon at the exact level needed to perform the tenodesis. This is not just more accurate, but safer, as it will not endanger any nerves or vessels.

Reconstruction of ligaments is another ideal use of ultrasound. Surface anatomy cannot always tell the exact location of a ligament or tendon insertion. The best example of this is the anterolateral ligament (ALL). Identification of the lateral epicondyle of the femur and anatomic insertion of the ALL can be difficult in some patients. Ultrasound can be used to identify the origin and insertion of the ALL during surgery under sterile conditions (see page 418). A spinal needle can be placed under direct vision with an in-plane ultrasound guidance over the bony insertion (Figure 3A). A percutaneous incision is made.

The spinal needle is replaced with a guide wire and drilled into place (Figure 3B). A cannulated drill of appropriate size is used to create the socket or tunnel. In the case of the ALL, a 5.0-mm diameter reamer is used to a depth of 22 mm at both the origin and insertion. A 4.5-mm semitendinosus graft is prepared with a collagen-coated FiberTape (Arthrex) attached to a 5.5 BioComposite Vented SwiveLock (Arthrex). It is attached proximally, buried under the iliotibial band (ITB) and then attached distally with the knee in 40° of flexion with a second 5.5 BioComposite Vented SwiveLock. The FiberTape is used as an internal brace to allow for early motion and weight-bearing.

This technique is also used by the senior author (AMH) to repair, reconstruct, or internally brace the medial collateral ligament, medial patellofemoral ligament, and lateral collateral ligament. This technique is ideally suited to superficial ligament and tendon reattachment, reconstruction, or internal bracing. The knee, ankle, and elbow superficial ligaments are especially amenable to this easy, percutaneous technique.

Conclusion

Ultrasound is quickly becoming a popular imaging modality due to its simplicity, portability, and cost efficiency. Its use as a diagnostic tool is widely known. As an adjunct for procedures and interventions, its advantages over larger, more expensive modalities such as fluoroscopy, CT, or MRI make it stand out. Ultrasound is not the perfect solution to all problems, but it is clearly a technology that is gaining traction. Ultrasound is another imaging modality and tool that physicians and surgeons can use to improve their patients’ treatment.

Ultrasound has classically been marketed and used as a diagnostic tool. Radiologists, emergency physicians, and sports physicians used ultrasound units to rapidly and appropriately diagnose numerous injuries and disorders, in a timely and cost effective manner. Part 1¹ and Part 2² of this series showed how to use ultrasound in the shoulder for diagnosis and how to code and get reimbursed for its use.Ultrasound can also be used to help guide procedures and interventions performed to treat patients. Currently, more physicians are beginning to recognize the utility of this modality as an aid to interventional procedures.

First-generation procedures use ultrasound to improve accuracy of joint, bursal, tendon, and muscular injections.³ Recent studies have shown a significant improvement in accuracy, outcomes, and patient satisfaction using ultrasound guidance for injections.^3-12 Within the limitation of using a needle, second-generation procedures—hydrodissection of peripherally entrapped nerves, capsular distention, mechanical disruption of neovascularization, and needle fenestration or barbotage in chronic tendinopathy—try to simulate surgical objectives while minimizing tissue burden and other complications of surgery.³ More advanced procedures include needle fenestration/release of the carpal ligament in carpal tunnel syndrome and A1 pulley needle release in the setting of trigger finger.³ Innovative third-generation procedures involve the use of surgical tools such as hook blades under ultrasound guidance to perform surgical procedures. Surgeons are now improving already established percutaneous, arthroscopic, and open surgical procedures with ultrasound assistance.³ Aside from better guidance, reducing cost and improving surgeon comfort may be additional benefits of ultrasound assisted surgery.

Image-Guided Treatment Options

Prior to image guidance, palpation of surface anatomy helped physicians determine the anatomic placement of injections, incisions, or portals. Joints and bursas that do not have any inflammation or fluid can sometimes be difficult to identify or locate by palpation alone. Palpation-guided joint injections often miss their target and cause significant pain when the therapeutic agent is injected into a muscle, tendon, ligament, fat, or other tissue. Ultrasound-guided injections have proven to be more accurate and have better patient satisfaction when compared to blind injections.^3-12

X-ray fluoroscopy has been the primary option for surgeons to assist in surgery. This is a natural modality for orthopedic surgeons; their primary use is for bone to help with fracture reduction and fixation as the bone, instrumentation, and fixation methods are usually radio-opaque. With the advancement in technology, many orthopedic surgeons are regularly using radiolucent fixation devices and working with soft tissue as opposed to bone. Fixation of tendons, ligaments, and muscles would be done using a large incision, palpation of the anatomy, then fixation or repair. Many surgeons began looking for ways to minimize the incisions. Turning to fluoroscopy, a traditional and well-used modality, was a natural progression. Guides and methods were developed to isolate insertions and drill placements. However, fluoroscopy is limited by its difficulty in changing planes and the large equipment required. Also, it is limited in its ability to image soft tissue.

Computed tomography (CT) scans and magnetic resonance imaging (MRI) are far better at imaging soft tissue but cannot be taken for use into the office or surgical suite. These modalities are also far more expensive and take up significant space.

CT scans have significant radiation exposure, and MRIs prohibit the use of metal objects around them. Overall, ultrasound has far more advantages over the other modalities as an adjunct for procedures (Table).

Ultrasound Procedural Basics

Appropriate use of ultrasound still remains highly technician-dependent. Unlike other imaging modalities, ultrasound requires a higher skill level by the physician to implement the use of ultrasound and identification of pathology to treat these disease processes. However, this is no different from the use of arthroscopy or fluoroscopy to treat patients. Training is required, as well as an understanding of the ultrasound machine, anatomy, and sono-anatomy—identification of anatomy and pathology as shown by the ultrasound machine.²

In ultrasound, the long axis refers to looking at a structure along its length, as in longitudinal. The short axis refers to evaluating a structure in cross-section, transverse, or along its shortest length. “In plane” refers to performing a procedure where the needle or object being used enters the ultrasound field along the plane of the transducer, allowing visualization of the majority of the needle as it crosses tissue planes. “Out of plane” has the needle entering perpendicular to the plane of the transducer, showing the needle on the monitor as a bright, hyperechoic dot. Some studies have suggested that novice ultrasonographers should start in a long axis view and use the in plane technique when injecting, as doing so may decrease time to identify the target and improve mean imaging quality during needle advancement.¹³

Anisotropy is the property of being directionally dependent. The ultrasound beam needs to be perpendicular to the structure being imaged to give the optimal image. When the beam hits a longitudinal structure like a needle at an angle <90°, the linear structure might reflect most of the beam away from the transducer. So when using a needle to localize or inject a specific area, maintaining the probe as close to perpendicular as possible with the needle will give a better image. New technology exists to better visualize needles even at high acuity angles by using a multi-beam processing algorithm, which can significantly aid the physician without the need for specialized needles.

Despite better technology, advance planning is key to a successful procedure. Positioning the patient and ultrasound machine in a manner that is comfortable and makes the desired target accessible while being able to visualize the ultrasound monitor comes first. Identifying the target, mapping the needle trajectory using depth markings, and scanning for nerves, vessels, and other structures that may be damaged along the needle path comes next. Using the in plane ultrasound technique with color Doppler and the nerve contrast setting can ensure that the physician has placed the therapeutic agent to the proper location while avoiding any nerves, arteries, or veins. Marking the borders of the ultrasound probe and needle entry site can be helpful to return to the same area after sterile preparation is done. As in any procedure, sterile technique is paramount. Sterile technique considerations may include using sterile gloves and a probe cover with sterile gel, cleaning the area thoroughly, planning the needle entry point 3 cm to 5 cm away from the probe, and maintaining a dry and gel-free needle entry.^14-15 The probe should be sterilized between patients to avoid cross-contamination; note that certain solutions like alcohol or ethyl chloride can damage the transducer.^14-15 However, simple injections do not require such stringent standards when simple sterile technique is observed by cleaning and then never touching the cleaned area again except with the needle to avoid contamination. Also, ethyl chloride has been found to not contaminate a sterile site and can be used safely to anesthetize the skin.

 

Ultrasound-Guided Procedures

Many injectable therapeutic options exist as interventions. Cortisone, hyaluronic acid, platelet-rich plasma (PRP), stem cells/bone marrow concentrate (BMC), amniotic fluid, prolotherapy, and saline are now commonly used.^16-17 A meta-analysis of the literature assessing the accuracy of ultrasound-guided shoulder girdle injections vs a landmark-guided injection was done in 2015.¹⁸ It showed that for the acromioclavicular joint, accuracy was 93.6% vs 68.2% (P < .0001), based on single studies. The accuracy of ultrasound vs a landmark-guided injection was 65% vs 70% for the subacromial space (P > .05); 86.7% vs 26.7% for the biceps tendon sheath (P < .05); and 92.5% vs 72.5% for the glenohumeral joint (P = .025).¹⁸ 

With cortisone, injecting into muscle, ligament, or tendons could potentially harm the tissue or cause worsening of the disease process.^19-20 With the advent of orthobiologics, injecting into these structures is now desirable, instead of a potential complication.^19-20 Ultrasound has become even more important to the accurate delivery of these therapies to the disease locations. Multiple studies using leukocyte-poor PRP for osteoarthritis show significant differences in pain scores.^21-23 Peerbooms and colleagues^24,25 also showed that PRP reduced pain and increased function compared to cortisone injections for lateral epicondylitis in 1- and 2-year double-blind randomized controlled trials. Centeno and colleagues²⁶ performed a prospective, multi-site registry study on 102 patients with symptomatic osteoarthritis and/or rotator cuff tears that were injected with bone marrow concentrate. There was a statistically significant improvement in Disabilities of the Arm, Shoulder and Hand (DASH) scores from 36.1 to 17.1 (P < .001) and numeric pain scores improved from 4.3 to 2.4 (P < .001).

By being able to see the pathology, like a hypoechoic region in a tendon, ligament, or muscle, the physician can reliably place the therapeutic agent into the precise location. Also, adjacent para-tendon or para-ligament injections allow for in-season athletes to get some relief from symptoms while allowing to return to play quickly; injections into muscle, ligament, or tendon can damage the structure and require days or weeks of rest, while para-tendon and para-ligament injections are far less painful.

Second-generation techniques have provided patients with great options that can help avoid surgery. Calcific tendonitis appears brightly hyperechoic on ultrasound and is easily identified. The physician can attempt to break up the calcium by fenestration or barbotage of the calcium. The same can be accomplished by injecting the density with PRP or stem cells. If the calcium is soft or “toothpaste-like,” the negative pressure will make it easy to aspirate it into the syringe. A 2-year, longitudinal prospective study of 121 patients demonstrated that visual analog score (VAS) pain scores and size of calcium significantly decreased with ultrasound-guided percutaneous needle lavage; 89% of patients were pain-free at 1-year follow-up.²⁷ Moreover, a randomized controlled trial of 48 patients comparing needle lavage vs subacromial steroid injection showed statistically significant radiographic and clinically better outcomes with the needle lavage group at the 1-year mark.²⁸

The Tenex procedure is a novel technique that uses ultrasonic energy to fenestrate diseased tendon tissue. It also can be used to break up calcific deposits. After the Tenex probe is guided to the diseased tendon/calcium, the TX-1 tip oscillates at the speed of sound, fenestrating/cutting through the tendon or calcium while lavaging the tendon with saline. Multiple prospective, noncontrolled studies done in common extensor, patellar, and rotator cuff tendinopathy have demonstrated good to excellent improvements in pain scores with the Tenex procedure.^29-31

Ultrasound is extremely useful in the treatment of adhesive capsulitis.³² The posterior glenohumeral capsule can be distended using a large volume (60 cc) of saline to loosen adhesions in preparation for manipulation. Because the manipulation can be an extremely painful procedure, ultrasound can be used to perform an inter-scalene block for regional anesthesia prior to the procedure. In 2014, Park and colleagues³³ performed a randomized prospective trial that showed that capsular distension followed by manipulation was more effective than cortisone injection alone for the treatment of adhesive capsulitis.Ultrasound guidance was found to be just as efficacious as fluoroscopy in a randomized controlled trial in 2014; the authors noted that ultrasound does not expose the patient or clinician to radiation and can be done in office.³⁴

Currently, techniques to perform ultrasound-guided percutaneous tenotomies of the long head of the biceps tendon using hook blades are being studied.³⁵

Ultrasound-Assisted Surgery

Ultrasound has been a boon to surgeons who perform minimally invasive procedures. It is far less cumbersome than classic fluoroscopy. Fluoroscopy requires the use of heavy lead aprons by the surgeons. Combining this with the impervious gowns and hot lights, the surgeons’ comfort level is severely sacrificed. When having to do many long surgeries in a row, this situation can take a toll on the surgeons’ endurance and strength. Improving the comfort of the surgeon is not the primary goal of surgery, but can significantly help our ability to do a better job.

 

Ultrasound allows the surgeon to localize any superficial foreign objects, especially with radiolucent objects like fragments of glass. Small glass fragments or pieces of wood have always been extremely difficult to remove. X-rays cannot localize these objects, so getting a proper orientation is difficult. MRI and CT scans easily identify these types of foreign objects, but cannot be used intraoperatively (Figure 1A). Often, these objects cannot be felt and therefore require a large dissection. The objects may encapsulate and be easily confused with other soft tissues.

These objects often take large incisions and wide dissections to find and remove. With ultrasound, the objects can be localized in real time while in surgery (Figure 1B). Using a sterile probe cover, the surgeon can take advantage of the multi-planar nature of ultrasound. Since the probe can be manipulated in any direction and angle, the only limitations to finding objects are the user, the object density, the location depth, and if the object is behind a hard structure, such as bone. The foreign body can then be removed under ultrasound guidance (Figure 1C).Being able to identify specific structures in surgery allows the surgeon to be more accurate when performing certain procedures. Arthroscopic biceps tenodesis is a common shoulder procedure that can be done many different ways. When using the “below the groove/supra-pec” position, the incisions become more variable and difficult to place. If the surgeon is too high/low or medial/lateral, the localization of the drill position will be very difficult, which will result in having to angle the drill to compensate for poorly placed portals, and finding the biceps becomes very challenging.

By using the ultrasound intraoperatively, the surgeon can identify the exact position of the biceps tendon (medial/lateral) and where it lies just below the groove and above the pectoralis major (superior/inferior) (Figure 2A).

This allows the surgeon to mark the appropriate placement of the portals by the position of the transducer (Figure 2B). When entering with the arthroscope to perform the procedure, the surgeon will “fall” right onto the biceps tendon at the exact level needed to perform the tenodesis. This is not just more accurate, but safer, as it will not endanger any nerves or vessels.

Reconstruction of ligaments is another ideal use of ultrasound. Surface anatomy cannot always tell the exact location of a ligament or tendon insertion. The best example of this is the anterolateral ligament (ALL). Identification of the lateral epicondyle of the femur and anatomic insertion of the ALL can be difficult in some patients. Ultrasound can be used to identify the origin and insertion of the ALL during surgery under sterile conditions (see page 418). A spinal needle can be placed under direct vision with an in-plane ultrasound guidance over the bony insertion (Figure 3A). A percutaneous incision is made.

The spinal needle is replaced with a guide wire and drilled into place (Figure 3B). A cannulated drill of appropriate size is used to create the socket or tunnel. In the case of the ALL, a 5.0-mm diameter reamer is used to a depth of 22 mm at both the origin and insertion. A 4.5-mm semitendinosus graft is prepared with a collagen-coated FiberTape (Arthrex) attached to a 5.5 BioComposite Vented SwiveLock (Arthrex). It is attached proximally, buried under the iliotibial band (ITB) and then attached distally with the knee in 40° of flexion with a second 5.5 BioComposite Vented SwiveLock. The FiberTape is used as an internal brace to allow for early motion and weight-bearing.

This technique is also used by the senior author (AMH) to repair, reconstruct, or internally brace the medial collateral ligament, medial patellofemoral ligament, and lateral collateral ligament. This technique is ideally suited to superficial ligament and tendon reattachment, reconstruction, or internal bracing. The knee, ankle, and elbow superficial ligaments are especially amenable to this easy, percutaneous technique.

Conclusion

Ultrasound is quickly becoming a popular imaging modality due to its simplicity, portability, and cost efficiency. Its use as a diagnostic tool is widely known. As an adjunct for procedures and interventions, its advantages over larger, more expensive modalities such as fluoroscopy, CT, or MRI make it stand out. Ultrasound is not the perfect solution to all problems, but it is clearly a technology that is gaining traction. Ultrasound is another imaging modality and tool that physicians and surgeons can use to improve their patients’ treatment.

Ultrasound has classically been marketed and used as a diagnostic tool. Radiologists, emergency physicians, and sports physicians used ultrasound units to rapidly and appropriately diagnose numerous injuries and disorders, in a timely and cost effective manner. Part 1¹ and Part 2² of this series showed how to use ultrasound in the shoulder for diagnosis and how to code and get reimbursed for its use.Ultrasound can also be used to help guide procedures and interventions performed to treat patients. Currently, more physicians are beginning to recognize the utility of this modality as an aid to interventional procedures.

First-generation procedures use ultrasound to improve accuracy of joint, bursal, tendon, and muscular injections.³ Recent studies have shown a significant improvement in accuracy, outcomes, and patient satisfaction using ultrasound guidance for injections.^3-12 Within the limitation of using a needle, second-generation procedures—hydrodissection of peripherally entrapped nerves, capsular distention, mechanical disruption of neovascularization, and needle fenestration or barbotage in chronic tendinopathy—try to simulate surgical objectives while minimizing tissue burden and other complications of surgery.³ More advanced procedures include needle fenestration/release of the carpal ligament in carpal tunnel syndrome and A1 pulley needle release in the setting of trigger finger.³ Innovative third-generation procedures involve the use of surgical tools such as hook blades under ultrasound guidance to perform surgical procedures. Surgeons are now improving already established percutaneous, arthroscopic, and open surgical procedures with ultrasound assistance.³ Aside from better guidance, reducing cost and improving surgeon comfort may be additional benefits of ultrasound assisted surgery.

Image-Guided Treatment Options

Prior to image guidance, palpation of surface anatomy helped physicians determine the anatomic placement of injections, incisions, or portals. Joints and bursas that do not have any inflammation or fluid can sometimes be difficult to identify or locate by palpation alone. Palpation-guided joint injections often miss their target and cause significant pain when the therapeutic agent is injected into a muscle, tendon, ligament, fat, or other tissue. Ultrasound-guided injections have proven to be more accurate and have better patient satisfaction when compared to blind injections.^3-12

X-ray fluoroscopy has been the primary option for surgeons to assist in surgery. This is a natural modality for orthopedic surgeons; their primary use is for bone to help with fracture reduction and fixation as the bone, instrumentation, and fixation methods are usually radio-opaque. With the advancement in technology, many orthopedic surgeons are regularly using radiolucent fixation devices and working with soft tissue as opposed to bone. Fixation of tendons, ligaments, and muscles would be done using a large incision, palpation of the anatomy, then fixation or repair. Many surgeons began looking for ways to minimize the incisions. Turning to fluoroscopy, a traditional and well-used modality, was a natural progression. Guides and methods were developed to isolate insertions and drill placements. However, fluoroscopy is limited by its difficulty in changing planes and the large equipment required. Also, it is limited in its ability to image soft tissue.

Computed tomography (CT) scans and magnetic resonance imaging (MRI) are far better at imaging soft tissue but cannot be taken for use into the office or surgical suite. These modalities are also far more expensive and take up significant space.

CT scans have significant radiation exposure, and MRIs prohibit the use of metal objects around them. Overall, ultrasound has far more advantages over the other modalities as an adjunct for procedures (Table).

Ultrasound Procedural Basics

Appropriate use of ultrasound still remains highly technician-dependent. Unlike other imaging modalities, ultrasound requires a higher skill level by the physician to implement the use of ultrasound and identification of pathology to treat these disease processes. However, this is no different from the use of arthroscopy or fluoroscopy to treat patients. Training is required, as well as an understanding of the ultrasound machine, anatomy, and sono-anatomy—identification of anatomy and pathology as shown by the ultrasound machine.²

In ultrasound, the long axis refers to looking at a structure along its length, as in longitudinal. The short axis refers to evaluating a structure in cross-section, transverse, or along its shortest length. “In plane” refers to performing a procedure where the needle or object being used enters the ultrasound field along the plane of the transducer, allowing visualization of the majority of the needle as it crosses tissue planes. “Out of plane” has the needle entering perpendicular to the plane of the transducer, showing the needle on the monitor as a bright, hyperechoic dot. Some studies have suggested that novice ultrasonographers should start in a long axis view and use the in plane technique when injecting, as doing so may decrease time to identify the target and improve mean imaging quality during needle advancement.¹³

Anisotropy is the property of being directionally dependent. The ultrasound beam needs to be perpendicular to the structure being imaged to give the optimal image. When the beam hits a longitudinal structure like a needle at an angle <90°, the linear structure might reflect most of the beam away from the transducer. So when using a needle to localize or inject a specific area, maintaining the probe as close to perpendicular as possible with the needle will give a better image. New technology exists to better visualize needles even at high acuity angles by using a multi-beam processing algorithm, which can significantly aid the physician without the need for specialized needles.

Despite better technology, advance planning is key to a successful procedure. Positioning the patient and ultrasound machine in a manner that is comfortable and makes the desired target accessible while being able to visualize the ultrasound monitor comes first. Identifying the target, mapping the needle trajectory using depth markings, and scanning for nerves, vessels, and other structures that may be damaged along the needle path comes next. Using the in plane ultrasound technique with color Doppler and the nerve contrast setting can ensure that the physician has placed the therapeutic agent to the proper location while avoiding any nerves, arteries, or veins. Marking the borders of the ultrasound probe and needle entry site can be helpful to return to the same area after sterile preparation is done. As in any procedure, sterile technique is paramount. Sterile technique considerations may include using sterile gloves and a probe cover with sterile gel, cleaning the area thoroughly, planning the needle entry point 3 cm to 5 cm away from the probe, and maintaining a dry and gel-free needle entry.^14-15 The probe should be sterilized between patients to avoid cross-contamination; note that certain solutions like alcohol or ethyl chloride can damage the transducer.^14-15 However, simple injections do not require such stringent standards when simple sterile technique is observed by cleaning and then never touching the cleaned area again except with the needle to avoid contamination. Also, ethyl chloride has been found to not contaminate a sterile site and can be used safely to anesthetize the skin.

 

Ultrasound-Guided Procedures

Many injectable therapeutic options exist as interventions. Cortisone, hyaluronic acid, platelet-rich plasma (PRP), stem cells/bone marrow concentrate (BMC), amniotic fluid, prolotherapy, and saline are now commonly used.^16-17 A meta-analysis of the literature assessing the accuracy of ultrasound-guided shoulder girdle injections vs a landmark-guided injection was done in 2015.¹⁸ It showed that for the acromioclavicular joint, accuracy was 93.6% vs 68.2% (P < .0001), based on single studies. The accuracy of ultrasound vs a landmark-guided injection was 65% vs 70% for the subacromial space (P > .05); 86.7% vs 26.7% for the biceps tendon sheath (P < .05); and 92.5% vs 72.5% for the glenohumeral joint (P = .025).¹⁸ 

With cortisone, injecting into muscle, ligament, or tendons could potentially harm the tissue or cause worsening of the disease process.^19-20 With the advent of orthobiologics, injecting into these structures is now desirable, instead of a potential complication.^19-20 Ultrasound has become even more important to the accurate delivery of these therapies to the disease locations. Multiple studies using leukocyte-poor PRP for osteoarthritis show significant differences in pain scores.^21-23 Peerbooms and colleagues^24,25 also showed that PRP reduced pain and increased function compared to cortisone injections for lateral epicondylitis in 1- and 2-year double-blind randomized controlled trials. Centeno and colleagues²⁶ performed a prospective, multi-site registry study on 102 patients with symptomatic osteoarthritis and/or rotator cuff tears that were injected with bone marrow concentrate. There was a statistically significant improvement in Disabilities of the Arm, Shoulder and Hand (DASH) scores from 36.1 to 17.1 (P < .001) and numeric pain scores improved from 4.3 to 2.4 (P < .001).

By being able to see the pathology, like a hypoechoic region in a tendon, ligament, or muscle, the physician can reliably place the therapeutic agent into the precise location. Also, adjacent para-tendon or para-ligament injections allow for in-season athletes to get some relief from symptoms while allowing to return to play quickly; injections into muscle, ligament, or tendon can damage the structure and require days or weeks of rest, while para-tendon and para-ligament injections are far less painful.

Second-generation techniques have provided patients with great options that can help avoid surgery. Calcific tendonitis appears brightly hyperechoic on ultrasound and is easily identified. The physician can attempt to break up the calcium by fenestration or barbotage of the calcium. The same can be accomplished by injecting the density with PRP or stem cells. If the calcium is soft or “toothpaste-like,” the negative pressure will make it easy to aspirate it into the syringe. A 2-year, longitudinal prospective study of 121 patients demonstrated that visual analog score (VAS) pain scores and size of calcium significantly decreased with ultrasound-guided percutaneous needle lavage; 89% of patients were pain-free at 1-year follow-up.²⁷ Moreover, a randomized controlled trial of 48 patients comparing needle lavage vs subacromial steroid injection showed statistically significant radiographic and clinically better outcomes with the needle lavage group at the 1-year mark.²⁸

The Tenex procedure is a novel technique that uses ultrasonic energy to fenestrate diseased tendon tissue. It also can be used to break up calcific deposits. After the Tenex probe is guided to the diseased tendon/calcium, the TX-1 tip oscillates at the speed of sound, fenestrating/cutting through the tendon or calcium while lavaging the tendon with saline. Multiple prospective, noncontrolled studies done in common extensor, patellar, and rotator cuff tendinopathy have demonstrated good to excellent improvements in pain scores with the Tenex procedure.^29-31

Ultrasound is extremely useful in the treatment of adhesive capsulitis.³² The posterior glenohumeral capsule can be distended using a large volume (60 cc) of saline to loosen adhesions in preparation for manipulation. Because the manipulation can be an extremely painful procedure, ultrasound can be used to perform an inter-scalene block for regional anesthesia prior to the procedure. In 2014, Park and colleagues³³ performed a randomized prospective trial that showed that capsular distension followed by manipulation was more effective than cortisone injection alone for the treatment of adhesive capsulitis.Ultrasound guidance was found to be just as efficacious as fluoroscopy in a randomized controlled trial in 2014; the authors noted that ultrasound does not expose the patient or clinician to radiation and can be done in office.³⁴

Currently, techniques to perform ultrasound-guided percutaneous tenotomies of the long head of the biceps tendon using hook blades are being studied.³⁵

Ultrasound-Assisted Surgery

Ultrasound has been a boon to surgeons who perform minimally invasive procedures. It is far less cumbersome than classic fluoroscopy. Fluoroscopy requires the use of heavy lead aprons by the surgeons. Combining this with the impervious gowns and hot lights, the surgeons’ comfort level is severely sacrificed. When having to do many long surgeries in a row, this situation can take a toll on the surgeons’ endurance and strength. Improving the comfort of the surgeon is not the primary goal of surgery, but can significantly help our ability to do a better job.

 

Ultrasound allows the surgeon to localize any superficial foreign objects, especially with radiolucent objects like fragments of glass. Small glass fragments or pieces of wood have always been extremely difficult to remove. X-rays cannot localize these objects, so getting a proper orientation is difficult. MRI and CT scans easily identify these types of foreign objects, but cannot be used intraoperatively (Figure 1A). Often, these objects cannot be felt and therefore require a large dissection. The objects may encapsulate and be easily confused with other soft tissues.

These objects often take large incisions and wide dissections to find and remove. With ultrasound, the objects can be localized in real time while in surgery (Figure 1B). Using a sterile probe cover, the surgeon can take advantage of the multi-planar nature of ultrasound. Since the probe can be manipulated in any direction and angle, the only limitations to finding objects are the user, the object density, the location depth, and if the object is behind a hard structure, such as bone. The foreign body can then be removed under ultrasound guidance (Figure 1C).Being able to identify specific structures in surgery allows the surgeon to be more accurate when performing certain procedures. Arthroscopic biceps tenodesis is a common shoulder procedure that can be done many different ways. When using the “below the groove/supra-pec” position, the incisions become more variable and difficult to place. If the surgeon is too high/low or medial/lateral, the localization of the drill position will be very difficult, which will result in having to angle the drill to compensate for poorly placed portals, and finding the biceps becomes very challenging.

By using the ultrasound intraoperatively, the surgeon can identify the exact position of the biceps tendon (medial/lateral) and where it lies just below the groove and above the pectoralis major (superior/inferior) (Figure 2A).

This allows the surgeon to mark the appropriate placement of the portals by the position of the transducer (Figure 2B). When entering with the arthroscope to perform the procedure, the surgeon will “fall” right onto the biceps tendon at the exact level needed to perform the tenodesis. This is not just more accurate, but safer, as it will not endanger any nerves or vessels.

Reconstruction of ligaments is another ideal use of ultrasound. Surface anatomy cannot always tell the exact location of a ligament or tendon insertion. The best example of this is the anterolateral ligament (ALL). Identification of the lateral epicondyle of the femur and anatomic insertion of the ALL can be difficult in some patients. Ultrasound can be used to identify the origin and insertion of the ALL during surgery under sterile conditions (see page 418). A spinal needle can be placed under direct vision with an in-plane ultrasound guidance over the bony insertion (Figure 3A). A percutaneous incision is made.

The spinal needle is replaced with a guide wire and drilled into place (Figure 3B). A cannulated drill of appropriate size is used to create the socket or tunnel. In the case of the ALL, a 5.0-mm diameter reamer is used to a depth of 22 mm at both the origin and insertion. A 4.5-mm semitendinosus graft is prepared with a collagen-coated FiberTape (Arthrex) attached to a 5.5 BioComposite Vented SwiveLock (Arthrex). It is attached proximally, buried under the iliotibial band (ITB) and then attached distally with the knee in 40° of flexion with a second 5.5 BioComposite Vented SwiveLock. The FiberTape is used as an internal brace to allow for early motion and weight-bearing.

This technique is also used by the senior author (AMH) to repair, reconstruct, or internally brace the medial collateral ligament, medial patellofemoral ligament, and lateral collateral ligament. This technique is ideally suited to superficial ligament and tendon reattachment, reconstruction, or internal bracing. The knee, ankle, and elbow superficial ligaments are especially amenable to this easy, percutaneous technique.

Conclusion

Ultrasound is quickly becoming a popular imaging modality due to its simplicity, portability, and cost efficiency. Its use as a diagnostic tool is widely known. As an adjunct for procedures and interventions, its advantages over larger, more expensive modalities such as fluoroscopy, CT, or MRI make it stand out. Ultrasound is not the perfect solution to all problems, but it is clearly a technology that is gaining traction. Ultrasound is another imaging modality and tool that physicians and surgeons can use to improve their patients’ treatment.

Hospital readmissions are undesirable and expensive.¹ The Centers for Medicare & Medicaid Services (CMS) use hospital readmission rates as one measure of healthcare quality and hospital performance.² In addition, the Patient Protection and Affordable Care Act of 2010 established a provision that decreases payments to hospitals with above-average readmission rates.³ Total knee arthroplasties (TKAs) and total hip arthroplasties (THAs) are among the most common surgical procedures leading to readmission and cost almost $20 billion dollars annually in the Medicare population alone.¹ Identifying factors that lead to readmissions after certain popular procedures may be a way to improve healthcare quality and outcomes while decreasing costs.

One such operation is shoulder arthroplasty (SA), which has surged in popularity over the past decade and is projected to increase faster than TKAs and THAs.^4-6 SA is used to treat a variety of shoulder conditions, including osteoarthritis, inflammatory arthritis, severe proximal humeral fracture, avascular necrosis, and rotator cuff tear arthropathy.^7-12 Much as with knee and hip arthroplasty, good outcomes have been reported with SA: decreased pain, improved range of motion, and high patient satisfaction.^10,13 However, there have been few studies of rates of readmission after SA and the associated risk factors.^3,14,15 The reported rates of early readmission after SA have ranged from 5.6% to 7.3%.^3,14,15 These rates are comparable to rates of readmission after TKA (4.0%-6.6%) and THA (3.5%-8.4%).^15-17Recently, CMS introduced legislation to void payments for hospital-acquired conditions (HACs), preventable medical conditions that patients develop during or as a result of their hospital care and that were not present on admission.¹⁸ Although many factors contribute to readmission, a recent study regarding all-cause readmission during the first 30 days after discharge found that almost 50% of 30-day readmissions after knee and hip replacements were potentially preventable.¹⁹ HACs resulting in readmission after SAs make up 9.3% to 34.5% of all readmissions, after anatomical total shoulder arthroplasties (ATSAs) and reverse total shoulder arthroplasties (RTSAs).^3,14 The most common HACs include retained foreign body after surgery, air embolism, falls and trauma, catheter-associated urinary tract infection (CAUTI), surgical-site infection, deep vein thrombosis (DVT), and pulmonary embolism (PE).¹⁸ Raines and colleagues¹⁶ found that HACs accounted for 41.7% of all complications in knee or hip arthroplasty and that HACs were the greatest predictors of early readmission after both procedures.

We conducted a study to evaluate rates of readmission within 30 days after ATSA and RTSA and to describe the independent risk factors for readmission. We hypothesized that the rate of readmission after SA would be similar to the rate after knee and hip arthroplasty and that readmission risk factors would be similar. Elucidating these rates and associated risk factors may ultimately help to minimize the burden of disability on patients and the burden of financial costs on healthcare institutions.

Materials and Methods

Institutional Review Board approval was not required for this study, and all data used were de-identified to Health Insurance Portability and Accountability Act (HIPAA) standards. We used the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database for this study. The NSQIP was developed in the 1990s to improve surgical quality in the Veterans Health Administration and was later adapted by the ACS.²⁰ NSQIP follows patients for 30 days after operations and provides clinical data and outcome measures that are closely regulated and internally audited.²¹ The program has continued to expand and now includes more than 400 institutions. The NSQIP database has been validated as a reliable source of surgical outcomes data, including outcomes data for orthopedic procedures, and has been used in other studies of readmissions.^17,22

In the present study, the ACS-NSQIP files for the period 2011-2013 were queried for all total shoulder arthroplasties (TSAs) (Current Procedural Terminology [CPT] code 23472, which includes ATSA and RTSA). Descriptive analysis was performed to determine the overall readmission rate as well as the percentages of readmissions for medical and surgical complications. Reasons for readmission were collected from 2012 and 2013 (information from 2011 was absent).

The various patient parameters compiled within the database were examined in a review of ATSAs and RTSAs. Demographics, comorbidities, operative characteristics, and predischarge complications were amassed from these data. Demographics included age, sex, race, body mass index, smoking status, preoperative functional health status, and American Society of Anesthesiologists (ASA) score. Comorbidities included diabetes mellitus, hypertension, chronic corticosteroid use, coagulation disorder, peripheral vascular disease, chronic obstructive pulmonary disease (COPD), cardiac comorbidity (including congestive heart failure, history of myocardial infarction, previous coronary intervention or cardiac surgery, and angina), renal comorbidity (including acute renal failure and preoperative dialysis), neurologic comorbidity (including impaired sensorium, hemiplegia, history of transient ischemic attack, and history of cerebrovascular accident with or without residual deficit), and preoperative blood transfusion. Operative characteristics included resident involvement, operative time more than 1 SD from the mean (>164.4 minutes), intraoperative blood transfusion, and revision surgery. Predischarge complications included pneumonia, CAUTI, DVT, PE, postoperative bleeding that required transfusion, cerebrovascular accident, myocardial infarction, and sepsis. Surgical-site infection, CAUTI, DVT, and PE were selected for analysis because these HACs are common in our cohort.

After the data on these characteristics were collected, univariate analysis was performed to determine association with any readmission. Factors with P < .20 were then entered into multivariate analysis to determine independent risk factors for readmission. This P value was selected to make the model inclusive of any potentially important predictor. Univariate analysis was performed using the Fisher exact test. Multivariate analysis was performed using backward conditional binary logistic regression. Statistical significance was set at P < .05. All analysis was performed with SPSS Version 22.0 (SPSS).

 

Results

This study included a combined total of 3501 ATSAs and RTSAs performed between 2011 and 2013. The overall readmission rate was 2.7%. The associated diagnosis for readmission was available for 54% of the readmitted patients. Of the known readmission diagnoses, 33% were secondary to HACs.

Three independent risk factors for readmission were identified: revision surgery (odds ratio [OR], 2.59), 3 or more comorbidities (OR, 2.02), and extended length of stay (LOS, >4.3 days) during index admission (OR, 2.48). These factors, plus P values and ORs, are listed in Table 1.

Of the 51 readmissions, 34 (67%) were for medical complications, and 17 (33%) were for surgical complications. Pneumonia was the most common medical complication (11.8%), followed by UTI (7.8%), DVT (5.9%), PE (5.9%), and renal insufficiency (3.9%). Surgical-site infection was the most common surgical complication (13.7%), followed by prosthetic joint dislocation (9.8%) and hematoma (3.9%).

Of the HACs, 41.2% were surgical-site infections, 23.5% were CAUTIs, 17.6% were DVTs, and 17.6% were PEs (Table 2).

Other risk factors significantly (P < .05) associated with readmission were age over 75 years, dependent functional status, ASA score of 4 or higher, cardiac comorbidity, 2 or more comorbidities, postoperative CAUTI, extended LOS, and revision surgery (Table 3).

The most common comorbidities were hypertension (67.8%), diabetes (16.6%), and COPD (6.3%). Readmitted patients were more likely to be female (56.3%) than male (43.6%). The majority of patients were white (86.1%), and 48.1% were obese (body mass index, >30). In addition, 16.9% of readmissions had resident involvement in the operation, and 13.2% of readmissions had an operative time >164.4 minutes. Of readmitted patients, 3.8% required a postoperative blood transfusion (Table 4).

Discussion

Hospital readmissions are important because they represent quality of care and play a role in patient outcomes. Arthroplasty research has focused mainly on readmissions after primary knee and hip replacements.^23-25

Given the increasing popularity of SAs, we initiated the present study to quantify short-term rates of readmission after ATSAs and RTSAs and to determine independent risk factors for readmission based on data from a national database. The results identified a 30-day readmission rate of 2.7%. Risk factors for readmission included revision surgery, 3 or more comorbidities, and extended LOS during the index admission.

Historical rates of early readmission after SA¹⁴ are comparable to those found in our study. Previously identified risk factors have included increasing age, Medicaid insurance status, low-volume surgical centers, and SA type.³ Mahoney and colleagues¹⁴ reported a 90-day readmission rate of 5.9%, but, when they removed hemiarthroplasty replacement from the analysis and shortened the readmission timeline to 30 days, the readmission rate was identical to the 2.7% rate in the present study. In their series from a single high-volume institution, the highest 90-day readmission rate was found for hemiarthroplasty (8.8%), followed by RTSA (6.6%) and ATSA (4.5%). In a study by Schairer and colleagues,³ the readmission rate was also influenced by replacement type, but their results differed from those of Mahoney and colleagues.¹⁴ Schairer and colleagues³ analyzed data from 7 state inpatient databases and found that the highest readmission rate was associated with RTSA (11.2%), followed by hemiarthroplasty (8.2%) and ATSA (6.0%). In both series, RTSA readmission rates were higher than ATSA readmission rates—consistent with the complication profiles of these procedures, with RTSA often provided as a surgery of last resort, after failure of other procedures, including ATSA.²⁶ The lower 30-day readmission rate in the present study may be attributable to the fact that some surgical and medical complications may not have developed within this short time. Nonetheless, the majority of readmissions typically present within the first 30 days after SA.^14,15 Other factors, including hospital volume, surgeon volume, race, and hospital type, may also influence readmission rates but could not be compared between studies.^27,28

The present study found that revision surgery, 3 or more comorbidities, and extended LOS (>4.3 days) more than doubled the risk of readmission. Published SA revision rates range from 5% to 42%, with most revisions performed for instability, dislocation, infection, and component loosening.^6,29 Complication rates are higher for revision SA than for primary SA, which may explain why revisions predispose patients to readmission.³⁰ Compared with primary SAs, revision SAs are also more likely to be RTSAs, and these salvage procedures have been found to have high complication rates.³¹ In the present study, the most common comorbidities were hypertension, diabetes, and COPD; the literature supports these as some of the most common comorbid medical conditions in patients who undergo ATSA or RTSA.^5,26,32 Furthermore, all 3 of these comorbidities have been shown to be independent predictors of increased postoperative complications in patients who undergo SA, which ultimately would increase the risk of readmission.^3,26,33,34 Last, extended LOS has also been shown to increase the risk of unplanned readmissions after orthopedic procedures.³⁵ Risk factors associated with increased LOS after ATSA or RTSA include female sex, advanced age, multiple comorbidities, and postoperative complications.³²Several other factors must be noted with respect to individual risk for readmission. In the present study, age over 75 years, dependent functional status, ASA score of 4 or higher, and cardiac comorbidity were found to have a significant association with readmission. Increased age is a risk factor for increased postoperative complications, more medical comorbidities, and increased LOS.^34,36 Older people are at higher risk of developing osteoarthritis and rotator cuff tear arthropathy and are more likely to undergo SA.^5,6 Older people also are more likely to be dependent, which itself is a risk factor for readmission.¹⁹ An ASA score of 3 or 4 has been found to be associated with increased LOS and complications after SA, and cardiac comorbidities predispose patients to a variety of complications.^34,36,37In studies that have combined surgical and medical factors, rates of complications early after ATSA and RTSA have ranged from 3.6% to 17.8%.^26,38,39 After SAs, medical complications (80%) are more common than surgical complications (20%).³⁹ In the present cohort, many more readmissions were for medical complications (67%) than for surgical complications (33%). In addition, Schairer and colleagues³ found medical complications associated with more than 80% of readmissions after SA.³ Infection was the most common medical reason (pneumonia) and surgical reason (surgical-site infection) for readmission—consistent with findings of other studies.^3,35,40 Infection has accounted for 9.4% to 41.4% of readmissions after ATSA and RTSA.^3,14In joint arthroplasty, infection occurs more often in patients with coexisting medical comorbidities, leading to higher mortality and increased LOS.⁴¹ Prosthetic joint dislocation was common as well—similar to findings in other studies.^3,10In the present study, 33% of known readmission diagnoses were secondary to HACs. Surgical-site infection was the most common, followed by CAUTI, DVT, and PE. In another study, of knee and hip arthroplasties, HACs accounted for more than 40% of all complications and were the strongest predictor of early readmission.¹⁶ In SA studies, HACs were responsible for 9.3% to 34.5% of readmissions after ATSA and RTSA.^3,14 Our finding (33%) is more in line with Mahoney and colleagues¹⁴ (34.5%) than Schairer and colleagues³ (9.3%). One explanation for the large discrepancy with Schairer and colleagues³ is that UTI was not among the medical reasons for readmission in their study, but it was in ours. Another difference is that we used a database that included data from multiple institutions. Last, Schairer and colleagues³ excluded revision SAs from their analysis (complication rates are higher for revision SAs than for primary SAs³⁰). They also excluded cases of SA used for fracture (shown to increase the risk for PE⁴²). The US Department of Health and Human Services estimated that patients experienced 1.3 million fewer HACs during the period 2010-2013, corresponding to a 17% decline over the 3 years.⁴³ This translates to an estimated 50,000 fewer mortalities, and $12 billion saved in healthcare costs, over the same period.⁴³ Preventing HACs helps reduce readmission rates while improving patient outcomes and decreasing healthcare costs.

This study had several limitations. We could not differentiate between ATSA and RTSA readmission rates because, for the study period, these procedures are collectively organized under a common CPT code in the NSQIP database. Readmission and complication rates are higher for RTSAs than for ATSAs.^3,14 In addition, our data were limited to hospitals that were participating in NSQIP, which could lead to selection bias. We studied rates of only those readmissions and complications that occurred within 30 days, but many complications develop after 30 days, and these increase the readmission rate. Last, reasons for readmission were not recorded for 2011, so this information was available only for the final 2 years of the study. Despite these limitations, NSQIP still allows for a powerful study, as it includes multiple institutions and a very large cohort.

 

Conclusion

With medical costs increasing, focus has shifted to quality care and good outcomes with the goal of reducing readmissions and complications after various procedures. SA has recently become more popular because of its multiple indications, and this trend will continue. In the present study, the rate of readmission within 30 days after ATSA or RTSA was 2.7%. Revision surgery, 3 or more comorbidities, and extended LOS were independent risk factors that more than doubled the risk of readmission. Understanding the risk factors for short-term readmission will allow for better patient care and decreased costs, and will benefit the healthcare system as a whole.

Am J Orthop. 2016;45(6):E386-E392. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.