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New 52-week EASI, pruritus data strengthen case for dupilumab in adult atopic dermatitis
ORLANDO – Treatment with dupilumab was associated with significantly improved measures of disease severity, including in quality of life and pruritus symptoms, at 16 and 52 weeks in adults with moderate to severe atopic dermatitis (AD) in the phase III CHRONOS trial.
In the CHRONOS study of adults with uncontrolled, moderate to severe AD, patients were treated with the investigational biologic dupilumab (Dupixent), an interleukin-4 and interleukin-13 pathway blocker administered in subcutaneous injections, in combination with topical corticosteroids. At 52 weeks, they had achieved significantly improved measures of overall disease severity, compared with those who received corticosteroids alone, according to Andrew Blauvelt, MD, MBA, president of Oregon Medical Research Center, Portland, who presented the new data from the study in a late-breaking clinical session at the annual meeting of the American Academy of Dermatology.
The new 52-week data presented at AAD show that the mean improvement in the EASI score from baseline was 80% in the 300 mg dupilumab every week plus corticosteroid group (group 1) and 78% in the group treated every 2 weeks (group 2), compared with 46% in the placebo plus corticosteroids group (control) (P less than .0001).
The mean improvement in self-reported itch from baseline, as measured by the Pruritus Numerical Rating Scale, was 54% in the first group, 56% in the second group, compared with 27% in controls (P less than .0001).
In the first group, 65% achieved a 4-point or greater improvement in their Patient Oriented Eczema Measure scores, as did 76% of the second group, compared with 26% of controls (P less than .0001).
At least a 4-point improvement over baseline in Dermatology Life Quality Index scores was seen in 63% of group 1, 80% of group 2, and 30% of controls (P less than .0001).
Adverse events across the study were similar, although the treatment groups had higher incidences of injection site reactions: 19% in group 1 and 15% in group 2, compared with 8% in controls. The treatment groups also had higher rates of conjunctivitis: 19% in group 1 and 14% in group 2, compared with 8% in controls.
Dr. Blauvelt said that patients who were “exited from the trial were continued for follow-up” and that rescue therapies such as cyclosporine, and other systemic agents, were also available. The rate of rescue therapy was about 15% in the first two groups, while half of controls needed rescue therapy. “We considered those patients who needed rescue nonresponders,” he noted.
The dropout rate at week 52 was about 15% across the treatment groups, compared with twice that in controls.
“Atopic dermatitis is the new psoriasis. We’re in an exciting area now, and we’ll be seeing more biologic therapies for moderate to severe atopic dermatitis. We have a tremendous need for this,” Dr. Blauvelt commented.
The Food and Drug Administration is expected to make a decision on approval of dupilumab by March 29, 2017. Dupilumab was designated by the FDA as a breakthrough therapy for uncontrolled, moderate to severe AD in 2014.
Dr. Blauvelt disclosed many pharmaceutical industry relationships, including with Regeneron Pharmaceuticals and Sanofi, which are developing dupilumab. (If approved, Regeneron and Sanofi Genzyme, part of Sanofi, will commercialize dupilumab).
CORRECTION 3/10/17: An earlier version of this article misstated the rates of clear or nearly clear skin.
[email protected]
On Twitter @whitneymcknight
ORLANDO – Treatment with dupilumab was associated with significantly improved measures of disease severity, including in quality of life and pruritus symptoms, at 16 and 52 weeks in adults with moderate to severe atopic dermatitis (AD) in the phase III CHRONOS trial.
In the CHRONOS study of adults with uncontrolled, moderate to severe AD, patients were treated with the investigational biologic dupilumab (Dupixent), an interleukin-4 and interleukin-13 pathway blocker administered in subcutaneous injections, in combination with topical corticosteroids. At 52 weeks, they had achieved significantly improved measures of overall disease severity, compared with those who received corticosteroids alone, according to Andrew Blauvelt, MD, MBA, president of Oregon Medical Research Center, Portland, who presented the new data from the study in a late-breaking clinical session at the annual meeting of the American Academy of Dermatology.
The new 52-week data presented at AAD show that the mean improvement in the EASI score from baseline was 80% in the 300 mg dupilumab every week plus corticosteroid group (group 1) and 78% in the group treated every 2 weeks (group 2), compared with 46% in the placebo plus corticosteroids group (control) (P less than .0001).
The mean improvement in self-reported itch from baseline, as measured by the Pruritus Numerical Rating Scale, was 54% in the first group, 56% in the second group, compared with 27% in controls (P less than .0001).
In the first group, 65% achieved a 4-point or greater improvement in their Patient Oriented Eczema Measure scores, as did 76% of the second group, compared with 26% of controls (P less than .0001).
At least a 4-point improvement over baseline in Dermatology Life Quality Index scores was seen in 63% of group 1, 80% of group 2, and 30% of controls (P less than .0001).
Adverse events across the study were similar, although the treatment groups had higher incidences of injection site reactions: 19% in group 1 and 15% in group 2, compared with 8% in controls. The treatment groups also had higher rates of conjunctivitis: 19% in group 1 and 14% in group 2, compared with 8% in controls.
Dr. Blauvelt said that patients who were “exited from the trial were continued for follow-up” and that rescue therapies such as cyclosporine, and other systemic agents, were also available. The rate of rescue therapy was about 15% in the first two groups, while half of controls needed rescue therapy. “We considered those patients who needed rescue nonresponders,” he noted.
The dropout rate at week 52 was about 15% across the treatment groups, compared with twice that in controls.
“Atopic dermatitis is the new psoriasis. We’re in an exciting area now, and we’ll be seeing more biologic therapies for moderate to severe atopic dermatitis. We have a tremendous need for this,” Dr. Blauvelt commented.
The Food and Drug Administration is expected to make a decision on approval of dupilumab by March 29, 2017. Dupilumab was designated by the FDA as a breakthrough therapy for uncontrolled, moderate to severe AD in 2014.
Dr. Blauvelt disclosed many pharmaceutical industry relationships, including with Regeneron Pharmaceuticals and Sanofi, which are developing dupilumab. (If approved, Regeneron and Sanofi Genzyme, part of Sanofi, will commercialize dupilumab).
CORRECTION 3/10/17: An earlier version of this article misstated the rates of clear or nearly clear skin.
[email protected]
On Twitter @whitneymcknight
ORLANDO – Treatment with dupilumab was associated with significantly improved measures of disease severity, including in quality of life and pruritus symptoms, at 16 and 52 weeks in adults with moderate to severe atopic dermatitis (AD) in the phase III CHRONOS trial.
In the CHRONOS study of adults with uncontrolled, moderate to severe AD, patients were treated with the investigational biologic dupilumab (Dupixent), an interleukin-4 and interleukin-13 pathway blocker administered in subcutaneous injections, in combination with topical corticosteroids. At 52 weeks, they had achieved significantly improved measures of overall disease severity, compared with those who received corticosteroids alone, according to Andrew Blauvelt, MD, MBA, president of Oregon Medical Research Center, Portland, who presented the new data from the study in a late-breaking clinical session at the annual meeting of the American Academy of Dermatology.
The new 52-week data presented at AAD show that the mean improvement in the EASI score from baseline was 80% in the 300 mg dupilumab every week plus corticosteroid group (group 1) and 78% in the group treated every 2 weeks (group 2), compared with 46% in the placebo plus corticosteroids group (control) (P less than .0001).
The mean improvement in self-reported itch from baseline, as measured by the Pruritus Numerical Rating Scale, was 54% in the first group, 56% in the second group, compared with 27% in controls (P less than .0001).
In the first group, 65% achieved a 4-point or greater improvement in their Patient Oriented Eczema Measure scores, as did 76% of the second group, compared with 26% of controls (P less than .0001).
At least a 4-point improvement over baseline in Dermatology Life Quality Index scores was seen in 63% of group 1, 80% of group 2, and 30% of controls (P less than .0001).
Adverse events across the study were similar, although the treatment groups had higher incidences of injection site reactions: 19% in group 1 and 15% in group 2, compared with 8% in controls. The treatment groups also had higher rates of conjunctivitis: 19% in group 1 and 14% in group 2, compared with 8% in controls.
Dr. Blauvelt said that patients who were “exited from the trial were continued for follow-up” and that rescue therapies such as cyclosporine, and other systemic agents, were also available. The rate of rescue therapy was about 15% in the first two groups, while half of controls needed rescue therapy. “We considered those patients who needed rescue nonresponders,” he noted.
The dropout rate at week 52 was about 15% across the treatment groups, compared with twice that in controls.
“Atopic dermatitis is the new psoriasis. We’re in an exciting area now, and we’ll be seeing more biologic therapies for moderate to severe atopic dermatitis. We have a tremendous need for this,” Dr. Blauvelt commented.
The Food and Drug Administration is expected to make a decision on approval of dupilumab by March 29, 2017. Dupilumab was designated by the FDA as a breakthrough therapy for uncontrolled, moderate to severe AD in 2014.
Dr. Blauvelt disclosed many pharmaceutical industry relationships, including with Regeneron Pharmaceuticals and Sanofi, which are developing dupilumab. (If approved, Regeneron and Sanofi Genzyme, part of Sanofi, will commercialize dupilumab).
CORRECTION 3/10/17: An earlier version of this article misstated the rates of clear or nearly clear skin.
[email protected]
On Twitter @whitneymcknight
AT AAD 2017
Key clinical point:
Major finding: At 52 weeks, dupilumab 300 mg administered in a subcutaneous injection once a week or every two weeks plus topical corticosteroids resulted in significantly more clearing compared with topical corticosteroids alone (P less than .0001). Self-reported measures of itch and quality-of-life measures were also higher across treatment groups.
Data source: A phase III trial of 740 adults with moderate to severe AD, randomized to treatment with one of the two regimens or corticosteroids alone.
Disclosures: Dr. Blauvelt disclosed many pharmaceutical industry relationships, including with Regeneron Pharmaceuticals and Sanofi, which are developing dupilumab. (If approved, Regeneron and Sanofi Genzyme, part of Sanofi, will commercialize dupilumab).
Cannabis associated with increased risk of heart failure and stroke
Cannabis use was associated with an increased risk of cerebrovascular accidents and heart failure in a retrospective analysis of the Nationwide Inpatient Sample (NIS).
Aditi Kalla, MD, a cardiology fellow at Einstein Medical Center in Philadelphia, and her colleagues analyzed data from nearly 21 million adult patients aged 18-55 years from the NIS 2009-2010 database. Approximately 1.5% (316,397) were diagnosed as cannabis users.
Cannabis users also were more likely to report cardiac risk factors such as hypertension (19.9% vs. 15.7% of nonusers), tobacco use (47.2% vs. 11.4%), alcohol use (28.1% vs 3.8%), and obesity (7% vs. 6.5%). They were older, on average, with a mean age of 33 years, compared with 26 years, and were likely to be male (60%), Dr. Kalla noted during a press briefing held in advance of the annual meeting of the American College of Cardiology.
Using multivariate regression analysis to adjust for these traditional cardiovascular risk factors, the investigators found cannabis remained an independent predictor for heart failure, with an odds ratio of 1.1 (P less than .01) and cerebrovascular accident, with an OR of 1.24 (P less than .001).
“Even when we corrected for known risks, we still found a higher rate of both stroke and heart failure in these patients,” Dr. Kalla said. “That leads us to believe that there is something else going on besides just obesity or diet-related cardiovascular side effects.”
Dr. Kalla noted that an expert analysis published by the ACC in September 2016 linked cannabinoid receptor type 1 with atherogenesis.
Further research is needed on the topic of cannabis and cardiovascular effects, especially as the legalization of medical and recreational cannabis spreads across the country, Dr. Kalla said. “Decriminalization of cannabis has passed in several states, bringing the total count now up to 28 states, plus the District of Columbia. We now need to be more knowledgeable of the risks and benefits of cannabis, as patients in these states may inquire into the use of it, or even ask us for prescriptions for it.”
While the NIS provided a large and strong data set for this analysis, the number of cannabis users likely was underreported because cannabis was legal in just 14 states at the time, Dr. Kalla noted. The study also was limited by a lack of specific information regarding cannabis intake, method of intake (ingestion or smoking), quantity and frequency of use, and whether use was medical or recreational.
The information collected also excluded whether patients used marijuana for medical or recreational purpose and how it was taken, by smoking or ingestion.
[email protected]
On Twitter @EAZTweets
Cannabis use was associated with an increased risk of cerebrovascular accidents and heart failure in a retrospective analysis of the Nationwide Inpatient Sample (NIS).
Aditi Kalla, MD, a cardiology fellow at Einstein Medical Center in Philadelphia, and her colleagues analyzed data from nearly 21 million adult patients aged 18-55 years from the NIS 2009-2010 database. Approximately 1.5% (316,397) were diagnosed as cannabis users.
Cannabis users also were more likely to report cardiac risk factors such as hypertension (19.9% vs. 15.7% of nonusers), tobacco use (47.2% vs. 11.4%), alcohol use (28.1% vs 3.8%), and obesity (7% vs. 6.5%). They were older, on average, with a mean age of 33 years, compared with 26 years, and were likely to be male (60%), Dr. Kalla noted during a press briefing held in advance of the annual meeting of the American College of Cardiology.
Using multivariate regression analysis to adjust for these traditional cardiovascular risk factors, the investigators found cannabis remained an independent predictor for heart failure, with an odds ratio of 1.1 (P less than .01) and cerebrovascular accident, with an OR of 1.24 (P less than .001).
“Even when we corrected for known risks, we still found a higher rate of both stroke and heart failure in these patients,” Dr. Kalla said. “That leads us to believe that there is something else going on besides just obesity or diet-related cardiovascular side effects.”
Dr. Kalla noted that an expert analysis published by the ACC in September 2016 linked cannabinoid receptor type 1 with atherogenesis.
Further research is needed on the topic of cannabis and cardiovascular effects, especially as the legalization of medical and recreational cannabis spreads across the country, Dr. Kalla said. “Decriminalization of cannabis has passed in several states, bringing the total count now up to 28 states, plus the District of Columbia. We now need to be more knowledgeable of the risks and benefits of cannabis, as patients in these states may inquire into the use of it, or even ask us for prescriptions for it.”
While the NIS provided a large and strong data set for this analysis, the number of cannabis users likely was underreported because cannabis was legal in just 14 states at the time, Dr. Kalla noted. The study also was limited by a lack of specific information regarding cannabis intake, method of intake (ingestion or smoking), quantity and frequency of use, and whether use was medical or recreational.
The information collected also excluded whether patients used marijuana for medical or recreational purpose and how it was taken, by smoking or ingestion.
[email protected]
On Twitter @EAZTweets
Cannabis use was associated with an increased risk of cerebrovascular accidents and heart failure in a retrospective analysis of the Nationwide Inpatient Sample (NIS).
Aditi Kalla, MD, a cardiology fellow at Einstein Medical Center in Philadelphia, and her colleagues analyzed data from nearly 21 million adult patients aged 18-55 years from the NIS 2009-2010 database. Approximately 1.5% (316,397) were diagnosed as cannabis users.
Cannabis users also were more likely to report cardiac risk factors such as hypertension (19.9% vs. 15.7% of nonusers), tobacco use (47.2% vs. 11.4%), alcohol use (28.1% vs 3.8%), and obesity (7% vs. 6.5%). They were older, on average, with a mean age of 33 years, compared with 26 years, and were likely to be male (60%), Dr. Kalla noted during a press briefing held in advance of the annual meeting of the American College of Cardiology.
Using multivariate regression analysis to adjust for these traditional cardiovascular risk factors, the investigators found cannabis remained an independent predictor for heart failure, with an odds ratio of 1.1 (P less than .01) and cerebrovascular accident, with an OR of 1.24 (P less than .001).
“Even when we corrected for known risks, we still found a higher rate of both stroke and heart failure in these patients,” Dr. Kalla said. “That leads us to believe that there is something else going on besides just obesity or diet-related cardiovascular side effects.”
Dr. Kalla noted that an expert analysis published by the ACC in September 2016 linked cannabinoid receptor type 1 with atherogenesis.
Further research is needed on the topic of cannabis and cardiovascular effects, especially as the legalization of medical and recreational cannabis spreads across the country, Dr. Kalla said. “Decriminalization of cannabis has passed in several states, bringing the total count now up to 28 states, plus the District of Columbia. We now need to be more knowledgeable of the risks and benefits of cannabis, as patients in these states may inquire into the use of it, or even ask us for prescriptions for it.”
While the NIS provided a large and strong data set for this analysis, the number of cannabis users likely was underreported because cannabis was legal in just 14 states at the time, Dr. Kalla noted. The study also was limited by a lack of specific information regarding cannabis intake, method of intake (ingestion or smoking), quantity and frequency of use, and whether use was medical or recreational.
The information collected also excluded whether patients used marijuana for medical or recreational purpose and how it was taken, by smoking or ingestion.
[email protected]
On Twitter @EAZTweets
FROM ACC 17
Key clinical point:
Major finding: Cannabis users showed 26% increased risk (OR, 1.24) of stroke and 10% increased risk (OR, 1.1) of heart failure.
Data source: Retrospective study of over 20 million patients’ records aged 18-55 years gathered from the Nationwide Inpatient Sample 2009-2010 database.
Disclosures: Researchers reported no relevant conflicts of interest.
VIDEO: Tips, tricks, and pearls for keloid scar steroid injections
ORLANDO – What are the best ways to avoid atrophy when treating keloid scars with steroid injections? When should a keloid be treated with smaller amounts, but with a stronger steroid concentration? What is the most effective way to avoid precipitation in the syringe?
The answers to these questions – along with other tips, tricks, and pearls for treating keloids, both in patients with skin of color and those with white skin – are provided by Temitayo Ogunleye, MD, of the department of dermatology, University of Pennsylvania, Philadelphia, in a video interview at the annual meeting of the American Academy of Dermatology.
Dr. Ogunleye had no relevant disclosures.
[email protected]
On Twitter @whitneymcknight
ORLANDO – What are the best ways to avoid atrophy when treating keloid scars with steroid injections? When should a keloid be treated with smaller amounts, but with a stronger steroid concentration? What is the most effective way to avoid precipitation in the syringe?
The answers to these questions – along with other tips, tricks, and pearls for treating keloids, both in patients with skin of color and those with white skin – are provided by Temitayo Ogunleye, MD, of the department of dermatology, University of Pennsylvania, Philadelphia, in a video interview at the annual meeting of the American Academy of Dermatology.
Dr. Ogunleye had no relevant disclosures.
[email protected]
On Twitter @whitneymcknight
ORLANDO – What are the best ways to avoid atrophy when treating keloid scars with steroid injections? When should a keloid be treated with smaller amounts, but with a stronger steroid concentration? What is the most effective way to avoid precipitation in the syringe?
The answers to these questions – along with other tips, tricks, and pearls for treating keloids, both in patients with skin of color and those with white skin – are provided by Temitayo Ogunleye, MD, of the department of dermatology, University of Pennsylvania, Philadelphia, in a video interview at the annual meeting of the American Academy of Dermatology.
Dr. Ogunleye had no relevant disclosures.
[email protected]
On Twitter @whitneymcknight
AT AAD 17
Norovirus reporting tool yields real-time outbreak data
NoroSTAT, the Centers for Disease Control and Prevention’s new program with which states can report norovirus outbreaks, yields more timely and more complete epidemiologic and laboratory data, which allows a faster and better-informed public health response to such outbreaks, according to a report published in the Morbidity and Mortality Weekly Report.
The CDC launched NoroSTAT (Norovirus Sentinel Testing and Tracking) in 2012 to permit the health departments in selected states to report specific epidemiologic and laboratory data regarding norovirus outbreaks more rapidly than usual – within 7 business days, said Minesh P. Shah, MD, of the Epidemic Intelligence Service and the division of viral diseases, CDC, Atlanta, and his associates.
NoroSTAT significantly reduced the median interval in reporting epidemiologic data concerning norovirus from 22 days to 2 days and significantly reduced the median interval in reporting relevant laboratory data from 21 days to 3 days. The percentage of reports submitted within 7 business days increased from 26% to 95% among the states participating in NoroSTAT, while remaining low – only 12%-13% – in nonparticipating states. The number of complete reports also increased substantially, from 87% to 99.9%, among the participating states.
These improvements likely result from NoroSTAT’s stringent reporting requirements and from the program’s ability “to enhance communication between epidemiologists and laboratorians in both state health departments and at CDC,” Dr. Shah and his associates said (MMWR Morbidity and Mortality Weekly Report. 2017 Feb 24;66:185-9).
NoroSTAT represents a key advancement in norovirus outbreak surveillance and has proved valuable in early identification and better characterization of outbreaks. It was expanded to include nine states in August 2016, the investigators added.
NoroSTAT, the Centers for Disease Control and Prevention’s new program with which states can report norovirus outbreaks, yields more timely and more complete epidemiologic and laboratory data, which allows a faster and better-informed public health response to such outbreaks, according to a report published in the Morbidity and Mortality Weekly Report.
The CDC launched NoroSTAT (Norovirus Sentinel Testing and Tracking) in 2012 to permit the health departments in selected states to report specific epidemiologic and laboratory data regarding norovirus outbreaks more rapidly than usual – within 7 business days, said Minesh P. Shah, MD, of the Epidemic Intelligence Service and the division of viral diseases, CDC, Atlanta, and his associates.
NoroSTAT significantly reduced the median interval in reporting epidemiologic data concerning norovirus from 22 days to 2 days and significantly reduced the median interval in reporting relevant laboratory data from 21 days to 3 days. The percentage of reports submitted within 7 business days increased from 26% to 95% among the states participating in NoroSTAT, while remaining low – only 12%-13% – in nonparticipating states. The number of complete reports also increased substantially, from 87% to 99.9%, among the participating states.
These improvements likely result from NoroSTAT’s stringent reporting requirements and from the program’s ability “to enhance communication between epidemiologists and laboratorians in both state health departments and at CDC,” Dr. Shah and his associates said (MMWR Morbidity and Mortality Weekly Report. 2017 Feb 24;66:185-9).
NoroSTAT represents a key advancement in norovirus outbreak surveillance and has proved valuable in early identification and better characterization of outbreaks. It was expanded to include nine states in August 2016, the investigators added.
NoroSTAT, the Centers for Disease Control and Prevention’s new program with which states can report norovirus outbreaks, yields more timely and more complete epidemiologic and laboratory data, which allows a faster and better-informed public health response to such outbreaks, according to a report published in the Morbidity and Mortality Weekly Report.
The CDC launched NoroSTAT (Norovirus Sentinel Testing and Tracking) in 2012 to permit the health departments in selected states to report specific epidemiologic and laboratory data regarding norovirus outbreaks more rapidly than usual – within 7 business days, said Minesh P. Shah, MD, of the Epidemic Intelligence Service and the division of viral diseases, CDC, Atlanta, and his associates.
NoroSTAT significantly reduced the median interval in reporting epidemiologic data concerning norovirus from 22 days to 2 days and significantly reduced the median interval in reporting relevant laboratory data from 21 days to 3 days. The percentage of reports submitted within 7 business days increased from 26% to 95% among the states participating in NoroSTAT, while remaining low – only 12%-13% – in nonparticipating states. The number of complete reports also increased substantially, from 87% to 99.9%, among the participating states.
These improvements likely result from NoroSTAT’s stringent reporting requirements and from the program’s ability “to enhance communication between epidemiologists and laboratorians in both state health departments and at CDC,” Dr. Shah and his associates said (MMWR Morbidity and Mortality Weekly Report. 2017 Feb 24;66:185-9).
NoroSTAT represents a key advancement in norovirus outbreak surveillance and has proved valuable in early identification and better characterization of outbreaks. It was expanded to include nine states in August 2016, the investigators added.
Key clinical point: NoroSTAT, the CDC’s new program with which states can report norovirus outbreaks, yields more timely and complete epidemiologic data.
Major finding: NoroSTAT significantly reduced the median interval in reporting epidemiologic data concerning norovirus from 22 days to 2 days and significantly reduced the median interval in reporting relevant laboratory data from 21 days to 3 days.
Data source: A comparison of epidemiologic and laboratory data reported by all 50 states for the 3 years before and the 3 years after NoroSTAT was implemented in 5 states.
Disclosures: This study was sponsored by the Centers for Disease Control and Prevention. No financial disclosures were provided.
Sneak Peek: Journal of Hospital Medicine
Background: Communication among team members within hospitals is typically fragmented. Bedside interdisciplinary rounds (IDR) have the potential to improve communication and outcomes through enhanced structure and patient engagement.
Objective: To decrease length of stay (LOS) and complications through the transformation of daily IDR to a bedside model.
Setting: Two geographic areas of a medical unit using a clinical microsystem structure.
Patients: 2,005 hospitalizations over a 12-month period.
Interventions: A bedside model (mobile interdisciplinary care rounds [MICRO]) was developed. MICRO featured a defined structure, scripting, patient engagement, and a patient safety checklist.
Measurements: The primary outcomes were clinical deterioration (composite of death, transfer to a higher level of care, or development of a hospital-acquired complication) and length of stay (LOS). Patient safety culture and perceptions of bedside interdisciplinary rounding were assessed pre- and post-implementation.
Results: There was no difference in LOS (6.6 vs. 7.0 days, P = .17, for the MICRO and control groups, respectively) or clinical deterioration (7.7% vs. 9.3%, P = .46). LOS was reduced for patients transferred to the study unit (10.4 vs. 14.0 days, P = .02, for the MICRO and control groups, respectively). Nurses and hospitalists gave significantly higher scores for patient safety climate and the efficiency of rounds after implementation of the MICRO model.
Limitations: The trial was performed at a single hospital.
Conclusions: Bedside IDR did not reduce overall LOS or clinical deterioration. Future studies should examine whether comprehensive transformation of medical units, including co-leadership, geographic cohorting of teams, and bedside interdisciplinary rounding, improves clinical outcomes compared to units without these features.
Also in the Journal of Hospital Medicine …
Standardized Attending Rounds to Improve the Patient Experience: A Pragmatic Cluster Randomized Controlled Trial
Authors: Bradley Monash, MD, Nader Najafi, MD, Michelle Mourad, MD, Alvin Rajkomar, MD, Sumant R. Ranji, MD, Margaret C. Fang, MD, MPH, FHM, Marcia Glass, MD, Dimiter Milev, MPH, Yile Ding, MD, Andy Shen, BA, Bradley A. Sharpe, MD, FACP, SFHM, James D Harrison, MPH, PhD
All Together Now: Impact of a Regionalization and Bedside Rounding Initiative on the Efficiency and Inclusiveness of Clinical Rounds
Authors: Kristin T. L. Huang, MD, Jacquelyn Minahan, Patricia Brita-Rossi, RN, MSN, MBA, Patricia Aylward, RN, MSN, Joel T. Katz, MD, SFHM, Christopher Roy, MD, Jeffrey L. Schnipper, MD, MPH, FHM, Robert Boxer, MD, PhD
Family Report Compared to Clinician-Documented Diagnoses for Psychiatric Conditions Among Hospitalized Children
Authors: Stephanie K. Doupnik, MD, Chris Feudtner, MD, PhD, MPH, Steven C. Marcus, PhD
Perceived Safety and Value of Inpatient ‘Very Important Person’ Services
Authors: Joshua Allen-Dicker, MD, MPH, Andrew Auerbach, MD, MPH, SFHM, Shoshana J. Herzig, MD, MPH
A Time and Motion Study of Pharmacists and Pharmacy Technicians Obtaining Admission Medication Histories
Authors: Caroline B. Nguyen, PharmD, BCPS, Rita Shane, PharmD, FASHP, FCSHP, Douglas S. Bell, MD, PhD, Galen Cook-Wiens, MS, Joshua M. Pevnick, MD, MSHS
Background: Communication among team members within hospitals is typically fragmented. Bedside interdisciplinary rounds (IDR) have the potential to improve communication and outcomes through enhanced structure and patient engagement.
Objective: To decrease length of stay (LOS) and complications through the transformation of daily IDR to a bedside model.
Setting: Two geographic areas of a medical unit using a clinical microsystem structure.
Patients: 2,005 hospitalizations over a 12-month period.
Interventions: A bedside model (mobile interdisciplinary care rounds [MICRO]) was developed. MICRO featured a defined structure, scripting, patient engagement, and a patient safety checklist.
Measurements: The primary outcomes were clinical deterioration (composite of death, transfer to a higher level of care, or development of a hospital-acquired complication) and length of stay (LOS). Patient safety culture and perceptions of bedside interdisciplinary rounding were assessed pre- and post-implementation.
Results: There was no difference in LOS (6.6 vs. 7.0 days, P = .17, for the MICRO and control groups, respectively) or clinical deterioration (7.7% vs. 9.3%, P = .46). LOS was reduced for patients transferred to the study unit (10.4 vs. 14.0 days, P = .02, for the MICRO and control groups, respectively). Nurses and hospitalists gave significantly higher scores for patient safety climate and the efficiency of rounds after implementation of the MICRO model.
Limitations: The trial was performed at a single hospital.
Conclusions: Bedside IDR did not reduce overall LOS or clinical deterioration. Future studies should examine whether comprehensive transformation of medical units, including co-leadership, geographic cohorting of teams, and bedside interdisciplinary rounding, improves clinical outcomes compared to units without these features.
Also in the Journal of Hospital Medicine …
Standardized Attending Rounds to Improve the Patient Experience: A Pragmatic Cluster Randomized Controlled Trial
Authors: Bradley Monash, MD, Nader Najafi, MD, Michelle Mourad, MD, Alvin Rajkomar, MD, Sumant R. Ranji, MD, Margaret C. Fang, MD, MPH, FHM, Marcia Glass, MD, Dimiter Milev, MPH, Yile Ding, MD, Andy Shen, BA, Bradley A. Sharpe, MD, FACP, SFHM, James D Harrison, MPH, PhD
All Together Now: Impact of a Regionalization and Bedside Rounding Initiative on the Efficiency and Inclusiveness of Clinical Rounds
Authors: Kristin T. L. Huang, MD, Jacquelyn Minahan, Patricia Brita-Rossi, RN, MSN, MBA, Patricia Aylward, RN, MSN, Joel T. Katz, MD, SFHM, Christopher Roy, MD, Jeffrey L. Schnipper, MD, MPH, FHM, Robert Boxer, MD, PhD
Family Report Compared to Clinician-Documented Diagnoses for Psychiatric Conditions Among Hospitalized Children
Authors: Stephanie K. Doupnik, MD, Chris Feudtner, MD, PhD, MPH, Steven C. Marcus, PhD
Perceived Safety and Value of Inpatient ‘Very Important Person’ Services
Authors: Joshua Allen-Dicker, MD, MPH, Andrew Auerbach, MD, MPH, SFHM, Shoshana J. Herzig, MD, MPH
A Time and Motion Study of Pharmacists and Pharmacy Technicians Obtaining Admission Medication Histories
Authors: Caroline B. Nguyen, PharmD, BCPS, Rita Shane, PharmD, FASHP, FCSHP, Douglas S. Bell, MD, PhD, Galen Cook-Wiens, MS, Joshua M. Pevnick, MD, MSHS
Background: Communication among team members within hospitals is typically fragmented. Bedside interdisciplinary rounds (IDR) have the potential to improve communication and outcomes through enhanced structure and patient engagement.
Objective: To decrease length of stay (LOS) and complications through the transformation of daily IDR to a bedside model.
Setting: Two geographic areas of a medical unit using a clinical microsystem structure.
Patients: 2,005 hospitalizations over a 12-month period.
Interventions: A bedside model (mobile interdisciplinary care rounds [MICRO]) was developed. MICRO featured a defined structure, scripting, patient engagement, and a patient safety checklist.
Measurements: The primary outcomes were clinical deterioration (composite of death, transfer to a higher level of care, or development of a hospital-acquired complication) and length of stay (LOS). Patient safety culture and perceptions of bedside interdisciplinary rounding were assessed pre- and post-implementation.
Results: There was no difference in LOS (6.6 vs. 7.0 days, P = .17, for the MICRO and control groups, respectively) or clinical deterioration (7.7% vs. 9.3%, P = .46). LOS was reduced for patients transferred to the study unit (10.4 vs. 14.0 days, P = .02, for the MICRO and control groups, respectively). Nurses and hospitalists gave significantly higher scores for patient safety climate and the efficiency of rounds after implementation of the MICRO model.
Limitations: The trial was performed at a single hospital.
Conclusions: Bedside IDR did not reduce overall LOS or clinical deterioration. Future studies should examine whether comprehensive transformation of medical units, including co-leadership, geographic cohorting of teams, and bedside interdisciplinary rounding, improves clinical outcomes compared to units without these features.
Also in the Journal of Hospital Medicine …
Standardized Attending Rounds to Improve the Patient Experience: A Pragmatic Cluster Randomized Controlled Trial
Authors: Bradley Monash, MD, Nader Najafi, MD, Michelle Mourad, MD, Alvin Rajkomar, MD, Sumant R. Ranji, MD, Margaret C. Fang, MD, MPH, FHM, Marcia Glass, MD, Dimiter Milev, MPH, Yile Ding, MD, Andy Shen, BA, Bradley A. Sharpe, MD, FACP, SFHM, James D Harrison, MPH, PhD
All Together Now: Impact of a Regionalization and Bedside Rounding Initiative on the Efficiency and Inclusiveness of Clinical Rounds
Authors: Kristin T. L. Huang, MD, Jacquelyn Minahan, Patricia Brita-Rossi, RN, MSN, MBA, Patricia Aylward, RN, MSN, Joel T. Katz, MD, SFHM, Christopher Roy, MD, Jeffrey L. Schnipper, MD, MPH, FHM, Robert Boxer, MD, PhD
Family Report Compared to Clinician-Documented Diagnoses for Psychiatric Conditions Among Hospitalized Children
Authors: Stephanie K. Doupnik, MD, Chris Feudtner, MD, PhD, MPH, Steven C. Marcus, PhD
Perceived Safety and Value of Inpatient ‘Very Important Person’ Services
Authors: Joshua Allen-Dicker, MD, MPH, Andrew Auerbach, MD, MPH, SFHM, Shoshana J. Herzig, MD, MPH
A Time and Motion Study of Pharmacists and Pharmacy Technicians Obtaining Admission Medication Histories
Authors: Caroline B. Nguyen, PharmD, BCPS, Rita Shane, PharmD, FASHP, FCSHP, Douglas S. Bell, MD, PhD, Galen Cook-Wiens, MS, Joshua M. Pevnick, MD, MSHS
Hospitalists trained in family medicine seek critical care training pathway
A nationwide shortage of intensivists has more hospitalists stepping into the critical care arena, but not all with the level of preparation and comfort of David Aymond, MD, a Louisiana-based hospitalist trained in family medicine (HTFM).
Dr. Aymond gained his ICU experience in a fellowship with the University of Alabama, where hospitalists also “were responsible for ICU patients,” he said. Years later, as an employee of both small and large hospitals with busy ICU services, and a faculty member for a family medicine residency with a busy ICU, Dr. Aymond moves seamlessly between roles.
“It was eye-opening to learn how many [HTFM] are not only caring for patients in the ICU, but also are requesting additional training,” said Dr. Aymond, a member of the SHM Family Medicine Committee. “A critical care pathway would provide them with a level of expertise already available to physicians in internal medicine, emergency medicine, and surgery.”
With 71% of HTFM reporting that they round on ICU as the attending physician, the strong endorsement (78%) for critical care certification is not surprising.
“I am currently practicing as a full time intensivist and take consults from other providers, yet I only have a certificate from fellowship, no formal board certification in critical care,” noted a survey respondent.
Other participants stated, “it makes perfect sense to have a pathway to critical care if both family medicine and internal medicine coexist as hospitalists,” that certification is “imperative at rural and underserved hospitals,” and also “helpful for those …who work in larger hospitals and take care of critically ill patients.” More than half of those surveyed want the Family Medicine Committee to work with ABFM to create the pathway.
The majority (87%) of the HTFM survey respondents are certified by the ABFM, and 8% have attained Recognition of Focused Practice in Hospital Medicine. Common pathways for additional credentialing include SHM’s Fellow of Hospital Medicine program (38%), a fellowship in hospital medicine (19%), and certification in hospice and palliative care (15%). More than 38% reported “other qualifications,” such as years of work experience, certification by the American Osteopathic Board of Family Physicians, and prior training in internal medicine.
The survey also found that certification differences in internal medicine and family medicine hospitalists, which may have posed employment obstacles in the past for HTFM, are not as much of an issue.
“The critical care pathway is the bigger concern,” Dr. Aymond said.
SHM’s Family Medicine Committee will be working on a proposal to ABFM to create the training pathway in the coming months. Dr. Aymond wants intensivists to know that this not an attempt to encroach on their professional domain, “but an opportunity to fill the existing professional gap.
Family medicine physicians are already providing critical care services, so a pathway to obtain formal training makes sense,” he adds. “If a family medicine doc completes the fellowship and takes it back to a residency program [the residents] will be more prepared for their potential careers in hospital and ICU medicine and much more comfortable with high-acuity patients.”
Claudia Stahl is SHM’s content manager.
A nationwide shortage of intensivists has more hospitalists stepping into the critical care arena, but not all with the level of preparation and comfort of David Aymond, MD, a Louisiana-based hospitalist trained in family medicine (HTFM).
Dr. Aymond gained his ICU experience in a fellowship with the University of Alabama, where hospitalists also “were responsible for ICU patients,” he said. Years later, as an employee of both small and large hospitals with busy ICU services, and a faculty member for a family medicine residency with a busy ICU, Dr. Aymond moves seamlessly between roles.
“It was eye-opening to learn how many [HTFM] are not only caring for patients in the ICU, but also are requesting additional training,” said Dr. Aymond, a member of the SHM Family Medicine Committee. “A critical care pathway would provide them with a level of expertise already available to physicians in internal medicine, emergency medicine, and surgery.”
With 71% of HTFM reporting that they round on ICU as the attending physician, the strong endorsement (78%) for critical care certification is not surprising.
“I am currently practicing as a full time intensivist and take consults from other providers, yet I only have a certificate from fellowship, no formal board certification in critical care,” noted a survey respondent.
Other participants stated, “it makes perfect sense to have a pathway to critical care if both family medicine and internal medicine coexist as hospitalists,” that certification is “imperative at rural and underserved hospitals,” and also “helpful for those …who work in larger hospitals and take care of critically ill patients.” More than half of those surveyed want the Family Medicine Committee to work with ABFM to create the pathway.
The majority (87%) of the HTFM survey respondents are certified by the ABFM, and 8% have attained Recognition of Focused Practice in Hospital Medicine. Common pathways for additional credentialing include SHM’s Fellow of Hospital Medicine program (38%), a fellowship in hospital medicine (19%), and certification in hospice and palliative care (15%). More than 38% reported “other qualifications,” such as years of work experience, certification by the American Osteopathic Board of Family Physicians, and prior training in internal medicine.
The survey also found that certification differences in internal medicine and family medicine hospitalists, which may have posed employment obstacles in the past for HTFM, are not as much of an issue.
“The critical care pathway is the bigger concern,” Dr. Aymond said.
SHM’s Family Medicine Committee will be working on a proposal to ABFM to create the training pathway in the coming months. Dr. Aymond wants intensivists to know that this not an attempt to encroach on their professional domain, “but an opportunity to fill the existing professional gap.
Family medicine physicians are already providing critical care services, so a pathway to obtain formal training makes sense,” he adds. “If a family medicine doc completes the fellowship and takes it back to a residency program [the residents] will be more prepared for their potential careers in hospital and ICU medicine and much more comfortable with high-acuity patients.”
Claudia Stahl is SHM’s content manager.
A nationwide shortage of intensivists has more hospitalists stepping into the critical care arena, but not all with the level of preparation and comfort of David Aymond, MD, a Louisiana-based hospitalist trained in family medicine (HTFM).
Dr. Aymond gained his ICU experience in a fellowship with the University of Alabama, where hospitalists also “were responsible for ICU patients,” he said. Years later, as an employee of both small and large hospitals with busy ICU services, and a faculty member for a family medicine residency with a busy ICU, Dr. Aymond moves seamlessly between roles.
“It was eye-opening to learn how many [HTFM] are not only caring for patients in the ICU, but also are requesting additional training,” said Dr. Aymond, a member of the SHM Family Medicine Committee. “A critical care pathway would provide them with a level of expertise already available to physicians in internal medicine, emergency medicine, and surgery.”
With 71% of HTFM reporting that they round on ICU as the attending physician, the strong endorsement (78%) for critical care certification is not surprising.
“I am currently practicing as a full time intensivist and take consults from other providers, yet I only have a certificate from fellowship, no formal board certification in critical care,” noted a survey respondent.
Other participants stated, “it makes perfect sense to have a pathway to critical care if both family medicine and internal medicine coexist as hospitalists,” that certification is “imperative at rural and underserved hospitals,” and also “helpful for those …who work in larger hospitals and take care of critically ill patients.” More than half of those surveyed want the Family Medicine Committee to work with ABFM to create the pathway.
The majority (87%) of the HTFM survey respondents are certified by the ABFM, and 8% have attained Recognition of Focused Practice in Hospital Medicine. Common pathways for additional credentialing include SHM’s Fellow of Hospital Medicine program (38%), a fellowship in hospital medicine (19%), and certification in hospice and palliative care (15%). More than 38% reported “other qualifications,” such as years of work experience, certification by the American Osteopathic Board of Family Physicians, and prior training in internal medicine.
The survey also found that certification differences in internal medicine and family medicine hospitalists, which may have posed employment obstacles in the past for HTFM, are not as much of an issue.
“The critical care pathway is the bigger concern,” Dr. Aymond said.
SHM’s Family Medicine Committee will be working on a proposal to ABFM to create the training pathway in the coming months. Dr. Aymond wants intensivists to know that this not an attempt to encroach on their professional domain, “but an opportunity to fill the existing professional gap.
Family medicine physicians are already providing critical care services, so a pathway to obtain formal training makes sense,” he adds. “If a family medicine doc completes the fellowship and takes it back to a residency program [the residents] will be more prepared for their potential careers in hospital and ICU medicine and much more comfortable with high-acuity patients.”
Claudia Stahl is SHM’s content manager.
VIDEO: Working with alopecia patients’ insurers when using novel therapies
ORLANDO – Janus kinase inhibitors are “currently the most promising treatments” for alopecia areata, but they are expensive, are not approved for this indication, and so getting insurance coverage for these treatments can be difficult, Carolyn Goh, MD, said at the annual meeting of the American Academy of Dermatology.
In a video interview at the meeting, Dr. Goh of the department of dermatology, University of California, Los Angeles, shares the latest treatment algorithms that include these novel therapies, and thoughts on how to work with patients to increase their likelihood of getting insurance coverage for these treatments. Referring to the Janus kinase inhibitors, also known as JAK inhibitors, she said, “I think they would be very helpful for all patients with alopecia areata, but really given their side effect profile and risks involved, they should be reserved for more extensive disease.”
In the interview, Dr. Goh also discusses screening for thyroid disease in this patient population.
She had no disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @whitneymcknight
ORLANDO – Janus kinase inhibitors are “currently the most promising treatments” for alopecia areata, but they are expensive, are not approved for this indication, and so getting insurance coverage for these treatments can be difficult, Carolyn Goh, MD, said at the annual meeting of the American Academy of Dermatology.
In a video interview at the meeting, Dr. Goh of the department of dermatology, University of California, Los Angeles, shares the latest treatment algorithms that include these novel therapies, and thoughts on how to work with patients to increase their likelihood of getting insurance coverage for these treatments. Referring to the Janus kinase inhibitors, also known as JAK inhibitors, she said, “I think they would be very helpful for all patients with alopecia areata, but really given their side effect profile and risks involved, they should be reserved for more extensive disease.”
In the interview, Dr. Goh also discusses screening for thyroid disease in this patient population.
She had no disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @whitneymcknight
ORLANDO – Janus kinase inhibitors are “currently the most promising treatments” for alopecia areata, but they are expensive, are not approved for this indication, and so getting insurance coverage for these treatments can be difficult, Carolyn Goh, MD, said at the annual meeting of the American Academy of Dermatology.
In a video interview at the meeting, Dr. Goh of the department of dermatology, University of California, Los Angeles, shares the latest treatment algorithms that include these novel therapies, and thoughts on how to work with patients to increase their likelihood of getting insurance coverage for these treatments. Referring to the Janus kinase inhibitors, also known as JAK inhibitors, she said, “I think they would be very helpful for all patients with alopecia areata, but really given their side effect profile and risks involved, they should be reserved for more extensive disease.”
In the interview, Dr. Goh also discusses screening for thyroid disease in this patient population.
She had no disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @whitneymcknight
AT AAD 17
No benefit from adjuvant sunitinib or sorafenib for clear cell renal cancer
Adjuvant sunitinib or sorafenib show no significant advantages in disease-free or overall survival over placebo in patients with high-risk clear cell renal cancer, according to secondary analysis of data from the ASSURE trial.
The primary analysis of data from the ASSURE trial, which included patients with all types of renal cell carcinoma, had failed to show a benefit in disease-free survival.
“Given recently published results of a 750-patient randomized trial, S-TRAC, (sunitinib 50 mg daily [4/2 schedule] vs placebo in clear cell predominant pT3-4 or node-positive disease) that show improved [disease-free survival], the appropriate adjuvant strategy for high-risk patients is unclear,” Naomi B. Haas, MD, and coauthors wrote (JAMA Oncol. 2017 Mar 9. doi: 10.1001/jamaoncol.2017.0076).
Therefore, the investigators focused on a subset of patients from the ASSURE trial with high-risk clear cell renal cancer to determine if there might be a benefit in this group.
The secondary analysis involved 1,069 participants with pT3 and higher or node-positive renal cancer with clear cell histology who were randomized to receive 54 weeks of sunitinib (50mg, oral daily for 28 of 42 days per cycle), sorafenib (400 mg, oral twice daily continuously), or placebo.
The 5-year disease-free survival rate was 47.7% for patients in the sunitinib arm, 49.9% for those taking sorafenib, and 50% for placebo, with no statistically significant difference between the three groups. The 5-year overall survival rate was 75.2% for the sunitinib arm, 80.2% in the sorafenib arm, and 76.5% for those on placebo, with no statistically significant differences between the groups, reported Dr. Haas of the Abramson Cancer Center of the University of Pennsylvania, Philadelphia, and colleagues.
“This high-risk population had a better 5-year recurrence-free rate (around 50%) than expected (41.9% for high-risk disease and 36.0% for node-positive disease), possibly a result of better surgical technique, more accurate staging, or unknown biologic factors,” the authors wrote.
When the researchers analyzed disease-free survival according to quartiles of total dose per 6-week cycle, they also found no differences between each quartile of average dose per cycle.
There was, however, a significantly higher rate of grade 3 or higher adverse events in the sunitinib arm (66%) and sorafenib group (72%), compared with placebo (22%).
“Based on this analysis, a rationale for adjuvant therapy in this high-risk population is not elucidated,” Dr. Haas and colleagues said.
The study was coordinated by the ECOG-ACRIN Cancer Research Group and supported by Public Health Service grants, the National Cancer Institute, National Institutes of Health, and the Department of Health & Human Services. The drugs and placebos were provided by Bayer and Pfizer through the National Cancer Institute.
Adjuvant sunitinib or sorafenib show no significant advantages in disease-free or overall survival over placebo in patients with high-risk clear cell renal cancer, according to secondary analysis of data from the ASSURE trial.
The primary analysis of data from the ASSURE trial, which included patients with all types of renal cell carcinoma, had failed to show a benefit in disease-free survival.
“Given recently published results of a 750-patient randomized trial, S-TRAC, (sunitinib 50 mg daily [4/2 schedule] vs placebo in clear cell predominant pT3-4 or node-positive disease) that show improved [disease-free survival], the appropriate adjuvant strategy for high-risk patients is unclear,” Naomi B. Haas, MD, and coauthors wrote (JAMA Oncol. 2017 Mar 9. doi: 10.1001/jamaoncol.2017.0076).
Therefore, the investigators focused on a subset of patients from the ASSURE trial with high-risk clear cell renal cancer to determine if there might be a benefit in this group.
The secondary analysis involved 1,069 participants with pT3 and higher or node-positive renal cancer with clear cell histology who were randomized to receive 54 weeks of sunitinib (50mg, oral daily for 28 of 42 days per cycle), sorafenib (400 mg, oral twice daily continuously), or placebo.
The 5-year disease-free survival rate was 47.7% for patients in the sunitinib arm, 49.9% for those taking sorafenib, and 50% for placebo, with no statistically significant difference between the three groups. The 5-year overall survival rate was 75.2% for the sunitinib arm, 80.2% in the sorafenib arm, and 76.5% for those on placebo, with no statistically significant differences between the groups, reported Dr. Haas of the Abramson Cancer Center of the University of Pennsylvania, Philadelphia, and colleagues.
“This high-risk population had a better 5-year recurrence-free rate (around 50%) than expected (41.9% for high-risk disease and 36.0% for node-positive disease), possibly a result of better surgical technique, more accurate staging, or unknown biologic factors,” the authors wrote.
When the researchers analyzed disease-free survival according to quartiles of total dose per 6-week cycle, they also found no differences between each quartile of average dose per cycle.
There was, however, a significantly higher rate of grade 3 or higher adverse events in the sunitinib arm (66%) and sorafenib group (72%), compared with placebo (22%).
“Based on this analysis, a rationale for adjuvant therapy in this high-risk population is not elucidated,” Dr. Haas and colleagues said.
The study was coordinated by the ECOG-ACRIN Cancer Research Group and supported by Public Health Service grants, the National Cancer Institute, National Institutes of Health, and the Department of Health & Human Services. The drugs and placebos were provided by Bayer and Pfizer through the National Cancer Institute.
Adjuvant sunitinib or sorafenib show no significant advantages in disease-free or overall survival over placebo in patients with high-risk clear cell renal cancer, according to secondary analysis of data from the ASSURE trial.
The primary analysis of data from the ASSURE trial, which included patients with all types of renal cell carcinoma, had failed to show a benefit in disease-free survival.
“Given recently published results of a 750-patient randomized trial, S-TRAC, (sunitinib 50 mg daily [4/2 schedule] vs placebo in clear cell predominant pT3-4 or node-positive disease) that show improved [disease-free survival], the appropriate adjuvant strategy for high-risk patients is unclear,” Naomi B. Haas, MD, and coauthors wrote (JAMA Oncol. 2017 Mar 9. doi: 10.1001/jamaoncol.2017.0076).
Therefore, the investigators focused on a subset of patients from the ASSURE trial with high-risk clear cell renal cancer to determine if there might be a benefit in this group.
The secondary analysis involved 1,069 participants with pT3 and higher or node-positive renal cancer with clear cell histology who were randomized to receive 54 weeks of sunitinib (50mg, oral daily for 28 of 42 days per cycle), sorafenib (400 mg, oral twice daily continuously), or placebo.
The 5-year disease-free survival rate was 47.7% for patients in the sunitinib arm, 49.9% for those taking sorafenib, and 50% for placebo, with no statistically significant difference between the three groups. The 5-year overall survival rate was 75.2% for the sunitinib arm, 80.2% in the sorafenib arm, and 76.5% for those on placebo, with no statistically significant differences between the groups, reported Dr. Haas of the Abramson Cancer Center of the University of Pennsylvania, Philadelphia, and colleagues.
“This high-risk population had a better 5-year recurrence-free rate (around 50%) than expected (41.9% for high-risk disease and 36.0% for node-positive disease), possibly a result of better surgical technique, more accurate staging, or unknown biologic factors,” the authors wrote.
When the researchers analyzed disease-free survival according to quartiles of total dose per 6-week cycle, they also found no differences between each quartile of average dose per cycle.
There was, however, a significantly higher rate of grade 3 or higher adverse events in the sunitinib arm (66%) and sorafenib group (72%), compared with placebo (22%).
“Based on this analysis, a rationale for adjuvant therapy in this high-risk population is not elucidated,” Dr. Haas and colleagues said.
The study was coordinated by the ECOG-ACRIN Cancer Research Group and supported by Public Health Service grants, the National Cancer Institute, National Institutes of Health, and the Department of Health & Human Services. The drugs and placebos were provided by Bayer and Pfizer through the National Cancer Institute.
FROM JAMA ONCOLOGY
Key clinical point: Adjuvant sunitinib or sorafenib show no significant benefit in disease-free or overall survival in patients with high-risk clear cell renal cancer.
Major finding: The 5-year disease-free survival rate was 47.7% for patients treated with sunitinib, 49.9% for those treated with sorafenib, and 50% for those given placebo.
Data source: Secondary analysis of data from the ASSURE trial in 1,943 patients with pT3 and higher or node-positive renal cancer with clear cell histology.
Disclosures: The study was coordinated by the ECOG-ACRIN Cancer Research Group and supported by Public Health Service grants, the National Cancer Institute, National Institutes of Health, and the Department of Health & Human Services. The drugs and placebos were provided by Bayer and Pfizer through the National Cancer Institute.
Guidelines for Treatment of Lateral Patella Dislocations in Skeletally Mature Patients
Take-Home Points
- Lateral patella dislocation is sufficiently treated with modern versions of patellofemoral surgery.
- Comprehensive assessment for underlying osseous pathology is paramount (torsional abnormalities of the femur or tibia, trochlea dysplasia, patella alta, etc).
- In such cases, isolated medial patellofemoral ligament reconstructions will fail. Instead, the underlying osseous abnormalities must be addressed during concomitant procedures (derotational osteotomy, tibial tubercle transfer, trochleoplasty, etc).
The incidence of patellar instability is high, particularly in young females. In principle, cases of patellar instability can be classified as traumatic (dislocation is caused by external, often direct forces) or nontraumatic (anatomy predisposes to instability).1-4
Anatomy Predisposing to Patella Dislocation
Most patients present with specific anatomical factors that predispose to patellar instability (isolated or combined).
Of the osteochondral factors, dysplasia of the femoral trochlea (trochlea groove [TG]) is most important. In healthy patients, the concave trochlea stabilizes the patella in knee flexion angles above 20°. In particular, the lateral facet of the trochlea plays a key role in withstanding the lateralizing quadriceps vector. The dysplastic trochlea, which has a flat or even a convex surface, destabilizes the patella (Figure 1). Moreover, patella alta is a pivotal factor in the development of LPD.
The anteromedial soft tissue of the knee (retinaculum) has 3 layers, the second of which contains the
Diagnostics
Physical Examination
It is recommended that the physician starts the examination by assessing the walking and standing patient while focusing on torsional malalignment of the lower extremities (increased antetorsion of the femur, increased external torsion of the tibia), which is often indicated by squinting patellae.8,27,28
Imaging
Radiographs are the basis for each patient’s imaging analysis. For a patient with valgus or varus clinical appearance, a weight-bearing whole-leg radiograph is used to precisely assess the degree of deformity in the frontal plane. A true lateral radiograph (congruent posterior condyles) provides information about patellar height (patella alta/infera). Most indices that quantify patellar height use the tibia as reference (eg, tuberosity, anterior aspect of articulation surface).
MRI is the gold standard for LPD diagnosis—it can be used to easily identify soft-tissue lesions and establish their patellar or femoral location (eg, MPFL rupture). MRI also provides information on potential pathologies of quadriceps tendon, patella tendon, and infrapatellar fat pad. Compared with radiographs, MRI is more sensitive in detecting osteochondral lesions in LPD.
Treatment
MPFL Reconstruction
Isolated MPFL reconstruction is commonly regarded as a standard, straightforward procedure.
Trochleoplasty
In cases of recurrent LPD or a flat or convex trochlea (Dejour type B, C, or D dysplasia), deepening trochleoplasty should be considered.
Osteotomy
The most popular type of osteotomy in the setting of LPD is the transfer of the TT (TTT).
Derotational osteotomies of the femur (externally rotating) provide good outcomes in patients with LPD and associated torsional deformities,61-63 though the literature is incongruent with respect to whether rotational osteotomies of the femur should be performed at the proximal or distal aspect.64-67 In the majority of our LPD cases, we combine femoral derotation with MPFL reconstruction.
Treatment Algorithms
We suggest using different algorithms for primary LPD (Figure 22, Tables 1-2) and recurrent LPD (Figure 23).
Conclusion
In skeletally mature patients, LPD is sufficiently treated with modern versions of patellofemoral surgery. Comprehensive assessment for underlying pathology is paramount as preparation for developing an appropriate surgical plan for the patient.
Am J Orthop. 2017;46(2):E86-E96. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.
1. Atkin DM, Fithian DC, Marangi KS, Stone ML, Dobson BE, Mendelsohn C. Characteristics of patients with primary acute lateral patellar dislocation and their recovery within the first 6 months of injury. Am J Sports Med. 2000;28(4):472-479.
2. Fithian DC, Paxton EW, Stone ML, et al. Epidemiology and natural history of acute patellar dislocation. Am J Sports Med. 2004;32(5):1114-1121.
3. Hawkins RJ, Bell RH, Anisette G. Acute patellar dislocations. The natural history. Am J Sports Med. 1986;14(2):117-120.
4. Sillanpää P, Mattila VM, Iivonen T, Visuri T, Pihlajamäki H. Incidence and risk factors of acute traumatic primary patellar dislocation. Med Sci Sports Exerc. 2008;40(4):606-611.
5. Ward SR, Terk MR, Powers CM. Patella alta: association with patellofemoral alignment and changes in contact area during weight-bearing. J Bone Joint Surg Am. 2007;89(8):1749-1755.
6. Dejour H, Walch G, Nove-Josserand L, Guier C. Factors of patellar instability: an anatomic radiographic study. Knee Surg Sports Traumatol Arthrosc. 1994;2(1):19-26.
7. Biedert RM. Osteotomies [in German]. Orthopade. 2008;37(9):872, 874-876, 878-880 passim.
8. Bruce WD, Stevens PM. Surgical correction of miserable malalignment syndrome. J Pediatr Orthop. 2004;24(4):392-396.
9. Lee TQ, Anzel SH, Bennett KA, Pang D, Kim WC. The influence of fixed rotational deformities of the femur on the patellofemoral contact pressures in human cadaver knees. Clin Orthop Relat Res. 1994;(302):69-74.
10. Feller JA, Amis AA, Andrish JT, Arendt EA, Erasmus PJ, Powers CM. Surgical biomechanics of the patellofemoral joint. Arthroscopy. 2007;23(5):542-553.
11. Post WR, Teitge R, Amis A. Patellofemoral malalignment: looking beyond the viewbox. Clin Sports Med. 2002;21(3):521-546, x.
12. Elias DA, White LM, Fithian DC. Acute lateral patellar dislocation at MR imaging: injury patterns of medial patellar soft-tissue restraints and osteochondral injuries of the inferomedial patella. Radiology. 2002;225(3):736-743.
13. Warren LA, Marshall JL, Girgis F. The prime static stabilizer of the medical side of the knee. J Bone Joint Surg Am. 1974;56(4):665-674.
14. Amis AA. Current concepts on anatomy and biomechanics of patellar stability. Sports Med Arthrosc. 2007;15(2):48-56.
15. Amis AA, Firer P, Mountney J, Senavongse W, Thomas NP. Anatomy and biomechanics of the medial patellofemoral ligament. Knee. 2003;10(3):215-220.
16. Conlan T, Garth WP Jr, Lemons JE. Evaluation of the medial soft-tissue restraints of the extensor mechanism of the knee. J Bone Joint Surg Am. 1993;75(5):682-693.
17. Tuxøe JI, Teir M, Winge S, Nielsen PL. The medial patellofemoral ligament: a dissection study. Knee Surg Sports Traumatol Arthrosc. 2002;10(3):138-140.
18. Desio SM, Burks RT, Bachus KN. Soft tissue restraints to lateral patellar translation in the human knee. Am J Sports Med. 1998;26(1):59-65.
19. Hautamaa PV, Fithian DC, Kaufman KR, Daniel DM, Pohlmeyer AM. Medial soft tissue restraints in lateral patellar instability and repair. Clin Orthop Relat Res. 1998;(349):174-182.
20. Nomura E, Horiuchi Y, Kihara M. Medial patellofemoral ligament restraint in lateral patellar translation and reconstruction. Knee. 2000;7(2):121-127.
21. Burks RT, Desio SM, Bachus KN, Tyson L, Springer K. Biomechanical evaluation of lateral patellar dislocations. Am J Knee Surg. 1998;11(1):24-31.
22. Muneta T, Sekiya I, Tsuchiya M, Shinomiya K. A technique for reconstruction of the medial patellofemoral ligament. Clin Orthop Relat Res. 1999;(359):151-155.
23. Nomura E, Inoue M, Osada N. Augmented repair of avulsion-tear type medial patellofemoral ligament injury in acute patellar dislocation. Knee Surg Sports Traumatol Arthrosc. 2005;13(5):346-351.
24. Christoforakis J, Bull AM, Strachan RK, Shymkiw R, Senavongse W, Amis AA. Effects of lateral retinacular release on the lateral stability of the patella. Knee Surg Sports Traumatol Arthrosc. 2006;14(3):273-277.
25. Merican AM, Kondo E, Amis AA. The effect on patellofemoral joint stability of selective cutting of lateral retinacular and capsular structures. J Biomech. 2009;42(3):291-296.
26. Ostermeier S, Holst M, Hurschler C, Windhagen H, Stukenborg-Colsman C. Dynamic measurement of patellofemoral kinematics and contact pressure after lateral retinacular release: an in vitro study. Knee Surg Sports Traumatol Arthrosc. 2007;15(5):547-554.
27. Scuderi GR. Surgical treatment for patellar instability. Orthop Clin North Am. 1992;23(4):619-630.
28. James SL, Bates BT, Osternig LR. Injuries to runners. Am J Sports Med. 1978;6(2):40-50.
29. Powers CM, Ward SR, Fredericson M, Guillet M, Shellock FG. Patellofemoral kinematics during weight-bearing and non-weight-bearing knee extension in persons with lateral subluxation of the patella: a preliminary study. J Orthop Sports Phys Ther. 2003;33(11):677-685.
30. Loudon JK, Wiesner D, Goist-Foley HL, Asjes C, Loudon KL. Intrarater reliability of functional performance tests for subjects with patellofemoral pain syndrome. J Athl Train. 2002;37(3):256-261.
31. Kolowich PA, Paulos LE, Rosenberg TD, Farnsworth S. Lateral release of the patella: indications and contraindications. Am J Sports Med. 1990;18(4):359-365.
32. Fairbank HA. Internal derangement of the knee in children and adolescents: (Section of Orthopaedics). Proc R Soc Med. 1937;30(4):427-432.
33. Hughston JC. Subluxation of the patella. J Bone Joint Surg Am. 1968;50(5):1003-1026.
34. Caton JH, Dejour D. Tibial tubercle osteotomy in patello-femoral instability and in patellar height abnormality. Int Orthop. 2010;34(2):305-309.
35. Biedert RM, Albrecht S. The patellotrochlear index: a new index for assessing patellar height. Knee Surg Sports Traumatol Arthrosc. 2006;14(8):707-712.
36. Shah JN, Howard JS, Flanigan DC, Brophy RH, Carey JL, Lattermann C. A systematic review of complications and failures associated with medial patellofemoral ligament reconstruction for recurrent patellar dislocation. Am J Sports Med. 2012;40(8):1916-1923.
37. Hopper GP, Leach WJ, Rooney BP, Walker CR, Blyth MJ. Does degree of trochlear dysplasia and position of femoral tunnel influence outcome after medial patellofemoral ligament reconstruction? Am J Sports Med. 2014;42(3):716-722.
38. Wagner D, Pfalzer F, Hingelbaum S, Huth J, Mauch F, Bauer G. The influence of risk factors on clinical outcomes following anatomical medial patellofemoral ligament (MPFL) reconstruction using the gracilis tendon. Knee Surg Sports Traumatol Arthrosc. 2013;21(2):318-324.
39. Mackay ND, Smith NA, Parsons N, Spalding T, Thompson P, Sprowson AP. Medial patellofemoral ligament reconstruction for patellar dislocation: a systematic review. Orthop J Sports Med. 2014;2(8):2325967114544021.
40. Stupay KL, Swart E, Shubin Stein BE. Widespread implementation of medial patellofemoral ligament reconstruction for recurrent patellar instability maintains functional outcomes at midterm to long-term follow-up while decreasing complication rates: a systematic review. Arthroscopy. 2015;31(7):1372-1380.
41. Neumann MV, Stalder M, Schuster AJ. Reconstructive surgery for patellofemoral joint incongruency. Knee Surg Sports Traumatol Arthrosc. 2016;24(3):873-878.
42. Banke IJ, Kohn LM, Meidinger G, et al. Combined trochleoplasty and MPFL reconstruction for treatment of chronic patellofemoral instability: a prospective minimum 2-year follow-up study. Knee Surg Sports Traumatol Arthrosc. 2014;22(11):2591-2598.
43. Dejour D, Byn P, Ntagiopoulos PG. The Lyon’s sulcus-deepening trochleoplasty in previous unsuccessful patellofemoral surgery. Int Orthop. 2013;37(3):433-439.
44. Thaunat M, Bessiere C, Pujol N, Boisrenoult P, Beaufils P. Recession wedge trochleoplasty as an additional procedure in the surgical treatment of patellar instability with major trochlear dysplasia: early results. Orthop Traumatol Surg Res. 2011;97(8):833-845.
45. Utting MR, Mulford JS, Eldridge JD. A prospective evaluation of trochleoplasty for the treatment of patellofemoral dislocation and instability. J Bone Joint Surg Br. 2008;90(2):180-185.
46. Blønd L, Haugegaard M. Combined arthroscopic deepening trochleoplasty and reconstruction of the medial patellofemoral ligament for patients with recurrent patella dislocation and trochlear dysplasia. Knee Surg Sports Traumatol Arthrosc. 2014;22(10):2484-2490.
47. Nelitz M, Dreyhaupt J, Lippacher S. Combined trochleoplasty and medial patellofemoral ligament reconstruction for recurrent patellar dislocations in severe trochlear dysplasia: a minimum 2-year follow-up study. Am J Sports Med. 2013;41(5):1005-1012.
48. Ntagiopoulos PG, Byn P, Dejour D. Midterm results of comprehensive surgical reconstruction including sulcus-deepening trochleoplasty in recurrent patellar dislocations with high-grade trochlear dysplasia. Am J Sports Med. 2013;41(5):998-1004.
49. Biedert R. Trochleoplasty—simple or tricky? Knee. 2014;21(6):1297-1298.
50. Ntagiopoulos PG, Dejour D. Current concepts on trochleoplasty procedures for the surgical treatment of trochlear dysplasia. Knee Surg Sports Traumatol Arthrosc. 2014;22(10):2531-2539.
51. Nelitz M, Theile M, Dornacher D, Wölfle J, Reichel H, Lippacher S. Analysis of failed surgery for patellar instability in children with open growth plates. Knee Surg Sports Traumatol Arthrosc. 2012;20(5):822-828.
52. Schöttle PB, Fucentese SF, Pfirrmann C, Bereiter H, Romero J. Trochleaplasty for patellar instability due to trochlear dysplasia: a minimum 2-year clinical and radiological follow-up of 19 knees. Acta Orthop. 2005;76(5):693-698.
53. Longo UG, Rizzello G, Ciuffreda M, et al. Elmslie-Trillat, Maquet, Fulkerson, Roux Goldthwait, and other distal realignment procedures for the management of patellar dislocation: systematic review and quantitative synthesis of the literature. Arthroscopy. 2016;32(5):929-943.
54. Barber FA, McGarry JE. Elmslie-Trillat procedure for the treatment of recurrent patellar instability. Arthroscopy. 2008;24(1):77-81.
55. Karataglis D, Green MA, Learmonth DJ. Functional outcome following modified Elmslie-Trillat procedure. Knee. 2006;13(6):464-468.
56. Kumar A, Jones S, Bickerstaff DR, Smith TW. A functional evaluation of the modified Elmslie-Trillat procedure for patello-femoral dysfunction. Knee. 2001;8(4):287-292.
57. Nakagawa K, Wada Y, Minamide M, Tsuchiya A, Moriya H. Deterioration of long-term clinical results after the Elmslie-Trillat procedure for dislocation of the patella. J Bone Joint Surg Br. 2002;84(6):861-864.
58. Magnussen RA, De Simone V, Lustig S, Neyret P, Flanigan DC. Treatment of patella alta in patients with episodic patellar dislocation: a systematic review. Knee Surg Sports Traumatol Arthrosc. 2014;22(10):2545-2550.
59. Mayer C, Magnussen RA, Servien E, et al. Patellar tendon tenodesis in association with tibial tubercle distalization for the treatment of episodic patellar dislocation with patella alta. Am J Sports Med. 2012;40(2):346-351.
60. Burnham JM, Howard JS, Hayes CB, Lattermann C. Medial patellofemoral ligament reconstruction with concomitant tibial tubercle transfer: a systematic review of outcomes and complications. Arthroscopy. 2016;32(6):1185-1195.
61. Dickschas J, Harrer J, Pfefferkorn R, Strecker W. Operative treatment of patellofemoral maltracking with torsional osteotomy. Arch Orthop Trauma Surg. 2012;132(3):289-298.
62. Nelitz M, Dreyhaupt J, Williams SR, Dornacher D. Combined supracondylar femoral derotation osteotomy and patellofemoral ligament reconstruction for recurrent patellar dislocation and severe femoral anteversion syndrome: surgical technique and clinical outcome. Int Orthop. 2015;39(12):2355-2362.
63. Strecker W, Dickschas J. Torsional osteotomy: operative treatment of patellofemoral maltracking [in German]. Oper Orthop Traumatol. 2015;27(6):505-524.
64. Bruce WD, Stevens PM. Surgical correction of miserable malalignment syndrome. J Pediatr Orthop. 2004;24(4):392-396.
65. Delgado ED, Schoenecker PL, Rich MM, Capelli AM. Treatment of severe torsional malalignment syndrome. J Pediatr Orthop. 1996;16(4):484-488.
66. Dickschas J, Harrer J, Reuter B, Schwitulla J, Strecker W. Torsional osteotomies of the femur. J Orthop Res. 2015;33(3):318-324.
67. Stevens PM, Gililland JM, Anderson LA, Mickelson JB, Nielson J, Klatt JW. Success of torsional correction surgery after failed surgeries for patellofemoral pain and instability. Strategies Trauma Limb Reconstr. 2014;9(1):5-12.
68. Balcarek P, Oberthür S, Hopfensitz S, et al. Which patellae are likely to redislocate? Knee Surg Sports Traumatol Arthrosc. 2014;22(10):2308-2314.
69. Jaquith BP, Parikh SN. Predictors of recurrent patellar instability in children and adolescents after first-time dislocation [published online October 21, 2015]. J Pediatr Orthop. doi:10.1097/BPO.0000000000000674.
Take-Home Points
- Lateral patella dislocation is sufficiently treated with modern versions of patellofemoral surgery.
- Comprehensive assessment for underlying osseous pathology is paramount (torsional abnormalities of the femur or tibia, trochlea dysplasia, patella alta, etc).
- In such cases, isolated medial patellofemoral ligament reconstructions will fail. Instead, the underlying osseous abnormalities must be addressed during concomitant procedures (derotational osteotomy, tibial tubercle transfer, trochleoplasty, etc).
The incidence of patellar instability is high, particularly in young females. In principle, cases of patellar instability can be classified as traumatic (dislocation is caused by external, often direct forces) or nontraumatic (anatomy predisposes to instability).1-4
Anatomy Predisposing to Patella Dislocation
Most patients present with specific anatomical factors that predispose to patellar instability (isolated or combined).
Of the osteochondral factors, dysplasia of the femoral trochlea (trochlea groove [TG]) is most important. In healthy patients, the concave trochlea stabilizes the patella in knee flexion angles above 20°. In particular, the lateral facet of the trochlea plays a key role in withstanding the lateralizing quadriceps vector. The dysplastic trochlea, which has a flat or even a convex surface, destabilizes the patella (Figure 1). Moreover, patella alta is a pivotal factor in the development of LPD.
The anteromedial soft tissue of the knee (retinaculum) has 3 layers, the second of which contains the
Diagnostics
Physical Examination
It is recommended that the physician starts the examination by assessing the walking and standing patient while focusing on torsional malalignment of the lower extremities (increased antetorsion of the femur, increased external torsion of the tibia), which is often indicated by squinting patellae.8,27,28
Imaging
Radiographs are the basis for each patient’s imaging analysis. For a patient with valgus or varus clinical appearance, a weight-bearing whole-leg radiograph is used to precisely assess the degree of deformity in the frontal plane. A true lateral radiograph (congruent posterior condyles) provides information about patellar height (patella alta/infera). Most indices that quantify patellar height use the tibia as reference (eg, tuberosity, anterior aspect of articulation surface).
MRI is the gold standard for LPD diagnosis—it can be used to easily identify soft-tissue lesions and establish their patellar or femoral location (eg, MPFL rupture). MRI also provides information on potential pathologies of quadriceps tendon, patella tendon, and infrapatellar fat pad. Compared with radiographs, MRI is more sensitive in detecting osteochondral lesions in LPD.
Treatment
MPFL Reconstruction
Isolated MPFL reconstruction is commonly regarded as a standard, straightforward procedure.
Trochleoplasty
In cases of recurrent LPD or a flat or convex trochlea (Dejour type B, C, or D dysplasia), deepening trochleoplasty should be considered.
Osteotomy
The most popular type of osteotomy in the setting of LPD is the transfer of the TT (TTT).
Derotational osteotomies of the femur (externally rotating) provide good outcomes in patients with LPD and associated torsional deformities,61-63 though the literature is incongruent with respect to whether rotational osteotomies of the femur should be performed at the proximal or distal aspect.64-67 In the majority of our LPD cases, we combine femoral derotation with MPFL reconstruction.
Treatment Algorithms
We suggest using different algorithms for primary LPD (Figure 22, Tables 1-2) and recurrent LPD (Figure 23).
Conclusion
In skeletally mature patients, LPD is sufficiently treated with modern versions of patellofemoral surgery. Comprehensive assessment for underlying pathology is paramount as preparation for developing an appropriate surgical plan for the patient.
Am J Orthop. 2017;46(2):E86-E96. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.
Take-Home Points
- Lateral patella dislocation is sufficiently treated with modern versions of patellofemoral surgery.
- Comprehensive assessment for underlying osseous pathology is paramount (torsional abnormalities of the femur or tibia, trochlea dysplasia, patella alta, etc).
- In such cases, isolated medial patellofemoral ligament reconstructions will fail. Instead, the underlying osseous abnormalities must be addressed during concomitant procedures (derotational osteotomy, tibial tubercle transfer, trochleoplasty, etc).
The incidence of patellar instability is high, particularly in young females. In principle, cases of patellar instability can be classified as traumatic (dislocation is caused by external, often direct forces) or nontraumatic (anatomy predisposes to instability).1-4
Anatomy Predisposing to Patella Dislocation
Most patients present with specific anatomical factors that predispose to patellar instability (isolated or combined).
Of the osteochondral factors, dysplasia of the femoral trochlea (trochlea groove [TG]) is most important. In healthy patients, the concave trochlea stabilizes the patella in knee flexion angles above 20°. In particular, the lateral facet of the trochlea plays a key role in withstanding the lateralizing quadriceps vector. The dysplastic trochlea, which has a flat or even a convex surface, destabilizes the patella (Figure 1). Moreover, patella alta is a pivotal factor in the development of LPD.
The anteromedial soft tissue of the knee (retinaculum) has 3 layers, the second of which contains the
Diagnostics
Physical Examination
It is recommended that the physician starts the examination by assessing the walking and standing patient while focusing on torsional malalignment of the lower extremities (increased antetorsion of the femur, increased external torsion of the tibia), which is often indicated by squinting patellae.8,27,28
Imaging
Radiographs are the basis for each patient’s imaging analysis. For a patient with valgus or varus clinical appearance, a weight-bearing whole-leg radiograph is used to precisely assess the degree of deformity in the frontal plane. A true lateral radiograph (congruent posterior condyles) provides information about patellar height (patella alta/infera). Most indices that quantify patellar height use the tibia as reference (eg, tuberosity, anterior aspect of articulation surface).
MRI is the gold standard for LPD diagnosis—it can be used to easily identify soft-tissue lesions and establish their patellar or femoral location (eg, MPFL rupture). MRI also provides information on potential pathologies of quadriceps tendon, patella tendon, and infrapatellar fat pad. Compared with radiographs, MRI is more sensitive in detecting osteochondral lesions in LPD.
Treatment
MPFL Reconstruction
Isolated MPFL reconstruction is commonly regarded as a standard, straightforward procedure.
Trochleoplasty
In cases of recurrent LPD or a flat or convex trochlea (Dejour type B, C, or D dysplasia), deepening trochleoplasty should be considered.
Osteotomy
The most popular type of osteotomy in the setting of LPD is the transfer of the TT (TTT).
Derotational osteotomies of the femur (externally rotating) provide good outcomes in patients with LPD and associated torsional deformities,61-63 though the literature is incongruent with respect to whether rotational osteotomies of the femur should be performed at the proximal or distal aspect.64-67 In the majority of our LPD cases, we combine femoral derotation with MPFL reconstruction.
Treatment Algorithms
We suggest using different algorithms for primary LPD (Figure 22, Tables 1-2) and recurrent LPD (Figure 23).
Conclusion
In skeletally mature patients, LPD is sufficiently treated with modern versions of patellofemoral surgery. Comprehensive assessment for underlying pathology is paramount as preparation for developing an appropriate surgical plan for the patient.
Am J Orthop. 2017;46(2):E86-E96. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.
1. Atkin DM, Fithian DC, Marangi KS, Stone ML, Dobson BE, Mendelsohn C. Characteristics of patients with primary acute lateral patellar dislocation and their recovery within the first 6 months of injury. Am J Sports Med. 2000;28(4):472-479.
2. Fithian DC, Paxton EW, Stone ML, et al. Epidemiology and natural history of acute patellar dislocation. Am J Sports Med. 2004;32(5):1114-1121.
3. Hawkins RJ, Bell RH, Anisette G. Acute patellar dislocations. The natural history. Am J Sports Med. 1986;14(2):117-120.
4. Sillanpää P, Mattila VM, Iivonen T, Visuri T, Pihlajamäki H. Incidence and risk factors of acute traumatic primary patellar dislocation. Med Sci Sports Exerc. 2008;40(4):606-611.
5. Ward SR, Terk MR, Powers CM. Patella alta: association with patellofemoral alignment and changes in contact area during weight-bearing. J Bone Joint Surg Am. 2007;89(8):1749-1755.
6. Dejour H, Walch G, Nove-Josserand L, Guier C. Factors of patellar instability: an anatomic radiographic study. Knee Surg Sports Traumatol Arthrosc. 1994;2(1):19-26.
7. Biedert RM. Osteotomies [in German]. Orthopade. 2008;37(9):872, 874-876, 878-880 passim.
8. Bruce WD, Stevens PM. Surgical correction of miserable malalignment syndrome. J Pediatr Orthop. 2004;24(4):392-396.
9. Lee TQ, Anzel SH, Bennett KA, Pang D, Kim WC. The influence of fixed rotational deformities of the femur on the patellofemoral contact pressures in human cadaver knees. Clin Orthop Relat Res. 1994;(302):69-74.
10. Feller JA, Amis AA, Andrish JT, Arendt EA, Erasmus PJ, Powers CM. Surgical biomechanics of the patellofemoral joint. Arthroscopy. 2007;23(5):542-553.
11. Post WR, Teitge R, Amis A. Patellofemoral malalignment: looking beyond the viewbox. Clin Sports Med. 2002;21(3):521-546, x.
12. Elias DA, White LM, Fithian DC. Acute lateral patellar dislocation at MR imaging: injury patterns of medial patellar soft-tissue restraints and osteochondral injuries of the inferomedial patella. Radiology. 2002;225(3):736-743.
13. Warren LA, Marshall JL, Girgis F. The prime static stabilizer of the medical side of the knee. J Bone Joint Surg Am. 1974;56(4):665-674.
14. Amis AA. Current concepts on anatomy and biomechanics of patellar stability. Sports Med Arthrosc. 2007;15(2):48-56.
15. Amis AA, Firer P, Mountney J, Senavongse W, Thomas NP. Anatomy and biomechanics of the medial patellofemoral ligament. Knee. 2003;10(3):215-220.
16. Conlan T, Garth WP Jr, Lemons JE. Evaluation of the medial soft-tissue restraints of the extensor mechanism of the knee. J Bone Joint Surg Am. 1993;75(5):682-693.
17. Tuxøe JI, Teir M, Winge S, Nielsen PL. The medial patellofemoral ligament: a dissection study. Knee Surg Sports Traumatol Arthrosc. 2002;10(3):138-140.
18. Desio SM, Burks RT, Bachus KN. Soft tissue restraints to lateral patellar translation in the human knee. Am J Sports Med. 1998;26(1):59-65.
19. Hautamaa PV, Fithian DC, Kaufman KR, Daniel DM, Pohlmeyer AM. Medial soft tissue restraints in lateral patellar instability and repair. Clin Orthop Relat Res. 1998;(349):174-182.
20. Nomura E, Horiuchi Y, Kihara M. Medial patellofemoral ligament restraint in lateral patellar translation and reconstruction. Knee. 2000;7(2):121-127.
21. Burks RT, Desio SM, Bachus KN, Tyson L, Springer K. Biomechanical evaluation of lateral patellar dislocations. Am J Knee Surg. 1998;11(1):24-31.
22. Muneta T, Sekiya I, Tsuchiya M, Shinomiya K. A technique for reconstruction of the medial patellofemoral ligament. Clin Orthop Relat Res. 1999;(359):151-155.
23. Nomura E, Inoue M, Osada N. Augmented repair of avulsion-tear type medial patellofemoral ligament injury in acute patellar dislocation. Knee Surg Sports Traumatol Arthrosc. 2005;13(5):346-351.
24. Christoforakis J, Bull AM, Strachan RK, Shymkiw R, Senavongse W, Amis AA. Effects of lateral retinacular release on the lateral stability of the patella. Knee Surg Sports Traumatol Arthrosc. 2006;14(3):273-277.
25. Merican AM, Kondo E, Amis AA. The effect on patellofemoral joint stability of selective cutting of lateral retinacular and capsular structures. J Biomech. 2009;42(3):291-296.
26. Ostermeier S, Holst M, Hurschler C, Windhagen H, Stukenborg-Colsman C. Dynamic measurement of patellofemoral kinematics and contact pressure after lateral retinacular release: an in vitro study. Knee Surg Sports Traumatol Arthrosc. 2007;15(5):547-554.
27. Scuderi GR. Surgical treatment for patellar instability. Orthop Clin North Am. 1992;23(4):619-630.
28. James SL, Bates BT, Osternig LR. Injuries to runners. Am J Sports Med. 1978;6(2):40-50.
29. Powers CM, Ward SR, Fredericson M, Guillet M, Shellock FG. Patellofemoral kinematics during weight-bearing and non-weight-bearing knee extension in persons with lateral subluxation of the patella: a preliminary study. J Orthop Sports Phys Ther. 2003;33(11):677-685.
30. Loudon JK, Wiesner D, Goist-Foley HL, Asjes C, Loudon KL. Intrarater reliability of functional performance tests for subjects with patellofemoral pain syndrome. J Athl Train. 2002;37(3):256-261.
31. Kolowich PA, Paulos LE, Rosenberg TD, Farnsworth S. Lateral release of the patella: indications and contraindications. Am J Sports Med. 1990;18(4):359-365.
32. Fairbank HA. Internal derangement of the knee in children and adolescents: (Section of Orthopaedics). Proc R Soc Med. 1937;30(4):427-432.
33. Hughston JC. Subluxation of the patella. J Bone Joint Surg Am. 1968;50(5):1003-1026.
34. Caton JH, Dejour D. Tibial tubercle osteotomy in patello-femoral instability and in patellar height abnormality. Int Orthop. 2010;34(2):305-309.
35. Biedert RM, Albrecht S. The patellotrochlear index: a new index for assessing patellar height. Knee Surg Sports Traumatol Arthrosc. 2006;14(8):707-712.
36. Shah JN, Howard JS, Flanigan DC, Brophy RH, Carey JL, Lattermann C. A systematic review of complications and failures associated with medial patellofemoral ligament reconstruction for recurrent patellar dislocation. Am J Sports Med. 2012;40(8):1916-1923.
37. Hopper GP, Leach WJ, Rooney BP, Walker CR, Blyth MJ. Does degree of trochlear dysplasia and position of femoral tunnel influence outcome after medial patellofemoral ligament reconstruction? Am J Sports Med. 2014;42(3):716-722.
38. Wagner D, Pfalzer F, Hingelbaum S, Huth J, Mauch F, Bauer G. The influence of risk factors on clinical outcomes following anatomical medial patellofemoral ligament (MPFL) reconstruction using the gracilis tendon. Knee Surg Sports Traumatol Arthrosc. 2013;21(2):318-324.
39. Mackay ND, Smith NA, Parsons N, Spalding T, Thompson P, Sprowson AP. Medial patellofemoral ligament reconstruction for patellar dislocation: a systematic review. Orthop J Sports Med. 2014;2(8):2325967114544021.
40. Stupay KL, Swart E, Shubin Stein BE. Widespread implementation of medial patellofemoral ligament reconstruction for recurrent patellar instability maintains functional outcomes at midterm to long-term follow-up while decreasing complication rates: a systematic review. Arthroscopy. 2015;31(7):1372-1380.
41. Neumann MV, Stalder M, Schuster AJ. Reconstructive surgery for patellofemoral joint incongruency. Knee Surg Sports Traumatol Arthrosc. 2016;24(3):873-878.
42. Banke IJ, Kohn LM, Meidinger G, et al. Combined trochleoplasty and MPFL reconstruction for treatment of chronic patellofemoral instability: a prospective minimum 2-year follow-up study. Knee Surg Sports Traumatol Arthrosc. 2014;22(11):2591-2598.
43. Dejour D, Byn P, Ntagiopoulos PG. The Lyon’s sulcus-deepening trochleoplasty in previous unsuccessful patellofemoral surgery. Int Orthop. 2013;37(3):433-439.
44. Thaunat M, Bessiere C, Pujol N, Boisrenoult P, Beaufils P. Recession wedge trochleoplasty as an additional procedure in the surgical treatment of patellar instability with major trochlear dysplasia: early results. Orthop Traumatol Surg Res. 2011;97(8):833-845.
45. Utting MR, Mulford JS, Eldridge JD. A prospective evaluation of trochleoplasty for the treatment of patellofemoral dislocation and instability. J Bone Joint Surg Br. 2008;90(2):180-185.
46. Blønd L, Haugegaard M. Combined arthroscopic deepening trochleoplasty and reconstruction of the medial patellofemoral ligament for patients with recurrent patella dislocation and trochlear dysplasia. Knee Surg Sports Traumatol Arthrosc. 2014;22(10):2484-2490.
47. Nelitz M, Dreyhaupt J, Lippacher S. Combined trochleoplasty and medial patellofemoral ligament reconstruction for recurrent patellar dislocations in severe trochlear dysplasia: a minimum 2-year follow-up study. Am J Sports Med. 2013;41(5):1005-1012.
48. Ntagiopoulos PG, Byn P, Dejour D. Midterm results of comprehensive surgical reconstruction including sulcus-deepening trochleoplasty in recurrent patellar dislocations with high-grade trochlear dysplasia. Am J Sports Med. 2013;41(5):998-1004.
49. Biedert R. Trochleoplasty—simple or tricky? Knee. 2014;21(6):1297-1298.
50. Ntagiopoulos PG, Dejour D. Current concepts on trochleoplasty procedures for the surgical treatment of trochlear dysplasia. Knee Surg Sports Traumatol Arthrosc. 2014;22(10):2531-2539.
51. Nelitz M, Theile M, Dornacher D, Wölfle J, Reichel H, Lippacher S. Analysis of failed surgery for patellar instability in children with open growth plates. Knee Surg Sports Traumatol Arthrosc. 2012;20(5):822-828.
52. Schöttle PB, Fucentese SF, Pfirrmann C, Bereiter H, Romero J. Trochleaplasty for patellar instability due to trochlear dysplasia: a minimum 2-year clinical and radiological follow-up of 19 knees. Acta Orthop. 2005;76(5):693-698.
53. Longo UG, Rizzello G, Ciuffreda M, et al. Elmslie-Trillat, Maquet, Fulkerson, Roux Goldthwait, and other distal realignment procedures for the management of patellar dislocation: systematic review and quantitative synthesis of the literature. Arthroscopy. 2016;32(5):929-943.
54. Barber FA, McGarry JE. Elmslie-Trillat procedure for the treatment of recurrent patellar instability. Arthroscopy. 2008;24(1):77-81.
55. Karataglis D, Green MA, Learmonth DJ. Functional outcome following modified Elmslie-Trillat procedure. Knee. 2006;13(6):464-468.
56. Kumar A, Jones S, Bickerstaff DR, Smith TW. A functional evaluation of the modified Elmslie-Trillat procedure for patello-femoral dysfunction. Knee. 2001;8(4):287-292.
57. Nakagawa K, Wada Y, Minamide M, Tsuchiya A, Moriya H. Deterioration of long-term clinical results after the Elmslie-Trillat procedure for dislocation of the patella. J Bone Joint Surg Br. 2002;84(6):861-864.
58. Magnussen RA, De Simone V, Lustig S, Neyret P, Flanigan DC. Treatment of patella alta in patients with episodic patellar dislocation: a systematic review. Knee Surg Sports Traumatol Arthrosc. 2014;22(10):2545-2550.
59. Mayer C, Magnussen RA, Servien E, et al. Patellar tendon tenodesis in association with tibial tubercle distalization for the treatment of episodic patellar dislocation with patella alta. Am J Sports Med. 2012;40(2):346-351.
60. Burnham JM, Howard JS, Hayes CB, Lattermann C. Medial patellofemoral ligament reconstruction with concomitant tibial tubercle transfer: a systematic review of outcomes and complications. Arthroscopy. 2016;32(6):1185-1195.
61. Dickschas J, Harrer J, Pfefferkorn R, Strecker W. Operative treatment of patellofemoral maltracking with torsional osteotomy. Arch Orthop Trauma Surg. 2012;132(3):289-298.
62. Nelitz M, Dreyhaupt J, Williams SR, Dornacher D. Combined supracondylar femoral derotation osteotomy and patellofemoral ligament reconstruction for recurrent patellar dislocation and severe femoral anteversion syndrome: surgical technique and clinical outcome. Int Orthop. 2015;39(12):2355-2362.
63. Strecker W, Dickschas J. Torsional osteotomy: operative treatment of patellofemoral maltracking [in German]. Oper Orthop Traumatol. 2015;27(6):505-524.
64. Bruce WD, Stevens PM. Surgical correction of miserable malalignment syndrome. J Pediatr Orthop. 2004;24(4):392-396.
65. Delgado ED, Schoenecker PL, Rich MM, Capelli AM. Treatment of severe torsional malalignment syndrome. J Pediatr Orthop. 1996;16(4):484-488.
66. Dickschas J, Harrer J, Reuter B, Schwitulla J, Strecker W. Torsional osteotomies of the femur. J Orthop Res. 2015;33(3):318-324.
67. Stevens PM, Gililland JM, Anderson LA, Mickelson JB, Nielson J, Klatt JW. Success of torsional correction surgery after failed surgeries for patellofemoral pain and instability. Strategies Trauma Limb Reconstr. 2014;9(1):5-12.
68. Balcarek P, Oberthür S, Hopfensitz S, et al. Which patellae are likely to redislocate? Knee Surg Sports Traumatol Arthrosc. 2014;22(10):2308-2314.
69. Jaquith BP, Parikh SN. Predictors of recurrent patellar instability in children and adolescents after first-time dislocation [published online October 21, 2015]. J Pediatr Orthop. doi:10.1097/BPO.0000000000000674.
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23. Nomura E, Inoue M, Osada N. Augmented repair of avulsion-tear type medial patellofemoral ligament injury in acute patellar dislocation. Knee Surg Sports Traumatol Arthrosc. 2005;13(5):346-351.
24. Christoforakis J, Bull AM, Strachan RK, Shymkiw R, Senavongse W, Amis AA. Effects of lateral retinacular release on the lateral stability of the patella. Knee Surg Sports Traumatol Arthrosc. 2006;14(3):273-277.
25. Merican AM, Kondo E, Amis AA. The effect on patellofemoral joint stability of selective cutting of lateral retinacular and capsular structures. J Biomech. 2009;42(3):291-296.
26. Ostermeier S, Holst M, Hurschler C, Windhagen H, Stukenborg-Colsman C. Dynamic measurement of patellofemoral kinematics and contact pressure after lateral retinacular release: an in vitro study. Knee Surg Sports Traumatol Arthrosc. 2007;15(5):547-554.
27. Scuderi GR. Surgical treatment for patellar instability. Orthop Clin North Am. 1992;23(4):619-630.
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29. Powers CM, Ward SR, Fredericson M, Guillet M, Shellock FG. Patellofemoral kinematics during weight-bearing and non-weight-bearing knee extension in persons with lateral subluxation of the patella: a preliminary study. J Orthop Sports Phys Ther. 2003;33(11):677-685.
30. Loudon JK, Wiesner D, Goist-Foley HL, Asjes C, Loudon KL. Intrarater reliability of functional performance tests for subjects with patellofemoral pain syndrome. J Athl Train. 2002;37(3):256-261.
31. Kolowich PA, Paulos LE, Rosenberg TD, Farnsworth S. Lateral release of the patella: indications and contraindications. Am J Sports Med. 1990;18(4):359-365.
32. Fairbank HA. Internal derangement of the knee in children and adolescents: (Section of Orthopaedics). Proc R Soc Med. 1937;30(4):427-432.
33. Hughston JC. Subluxation of the patella. J Bone Joint Surg Am. 1968;50(5):1003-1026.
34. Caton JH, Dejour D. Tibial tubercle osteotomy in patello-femoral instability and in patellar height abnormality. Int Orthop. 2010;34(2):305-309.
35. Biedert RM, Albrecht S. The patellotrochlear index: a new index for assessing patellar height. Knee Surg Sports Traumatol Arthrosc. 2006;14(8):707-712.
36. Shah JN, Howard JS, Flanigan DC, Brophy RH, Carey JL, Lattermann C. A systematic review of complications and failures associated with medial patellofemoral ligament reconstruction for recurrent patellar dislocation. Am J Sports Med. 2012;40(8):1916-1923.
37. Hopper GP, Leach WJ, Rooney BP, Walker CR, Blyth MJ. Does degree of trochlear dysplasia and position of femoral tunnel influence outcome after medial patellofemoral ligament reconstruction? Am J Sports Med. 2014;42(3):716-722.
38. Wagner D, Pfalzer F, Hingelbaum S, Huth J, Mauch F, Bauer G. The influence of risk factors on clinical outcomes following anatomical medial patellofemoral ligament (MPFL) reconstruction using the gracilis tendon. Knee Surg Sports Traumatol Arthrosc. 2013;21(2):318-324.
39. Mackay ND, Smith NA, Parsons N, Spalding T, Thompson P, Sprowson AP. Medial patellofemoral ligament reconstruction for patellar dislocation: a systematic review. Orthop J Sports Med. 2014;2(8):2325967114544021.
40. Stupay KL, Swart E, Shubin Stein BE. Widespread implementation of medial patellofemoral ligament reconstruction for recurrent patellar instability maintains functional outcomes at midterm to long-term follow-up while decreasing complication rates: a systematic review. Arthroscopy. 2015;31(7):1372-1380.
41. Neumann MV, Stalder M, Schuster AJ. Reconstructive surgery for patellofemoral joint incongruency. Knee Surg Sports Traumatol Arthrosc. 2016;24(3):873-878.
42. Banke IJ, Kohn LM, Meidinger G, et al. Combined trochleoplasty and MPFL reconstruction for treatment of chronic patellofemoral instability: a prospective minimum 2-year follow-up study. Knee Surg Sports Traumatol Arthrosc. 2014;22(11):2591-2598.
43. Dejour D, Byn P, Ntagiopoulos PG. The Lyon’s sulcus-deepening trochleoplasty in previous unsuccessful patellofemoral surgery. Int Orthop. 2013;37(3):433-439.
44. Thaunat M, Bessiere C, Pujol N, Boisrenoult P, Beaufils P. Recession wedge trochleoplasty as an additional procedure in the surgical treatment of patellar instability with major trochlear dysplasia: early results. Orthop Traumatol Surg Res. 2011;97(8):833-845.
45. Utting MR, Mulford JS, Eldridge JD. A prospective evaluation of trochleoplasty for the treatment of patellofemoral dislocation and instability. J Bone Joint Surg Br. 2008;90(2):180-185.
46. Blønd L, Haugegaard M. Combined arthroscopic deepening trochleoplasty and reconstruction of the medial patellofemoral ligament for patients with recurrent patella dislocation and trochlear dysplasia. Knee Surg Sports Traumatol Arthrosc. 2014;22(10):2484-2490.
47. Nelitz M, Dreyhaupt J, Lippacher S. Combined trochleoplasty and medial patellofemoral ligament reconstruction for recurrent patellar dislocations in severe trochlear dysplasia: a minimum 2-year follow-up study. Am J Sports Med. 2013;41(5):1005-1012.
48. Ntagiopoulos PG, Byn P, Dejour D. Midterm results of comprehensive surgical reconstruction including sulcus-deepening trochleoplasty in recurrent patellar dislocations with high-grade trochlear dysplasia. Am J Sports Med. 2013;41(5):998-1004.
49. Biedert R. Trochleoplasty—simple or tricky? Knee. 2014;21(6):1297-1298.
50. Ntagiopoulos PG, Dejour D. Current concepts on trochleoplasty procedures for the surgical treatment of trochlear dysplasia. Knee Surg Sports Traumatol Arthrosc. 2014;22(10):2531-2539.
51. Nelitz M, Theile M, Dornacher D, Wölfle J, Reichel H, Lippacher S. Analysis of failed surgery for patellar instability in children with open growth plates. Knee Surg Sports Traumatol Arthrosc. 2012;20(5):822-828.
52. Schöttle PB, Fucentese SF, Pfirrmann C, Bereiter H, Romero J. Trochleaplasty for patellar instability due to trochlear dysplasia: a minimum 2-year clinical and radiological follow-up of 19 knees. Acta Orthop. 2005;76(5):693-698.
53. Longo UG, Rizzello G, Ciuffreda M, et al. Elmslie-Trillat, Maquet, Fulkerson, Roux Goldthwait, and other distal realignment procedures for the management of patellar dislocation: systematic review and quantitative synthesis of the literature. Arthroscopy. 2016;32(5):929-943.
54. Barber FA, McGarry JE. Elmslie-Trillat procedure for the treatment of recurrent patellar instability. Arthroscopy. 2008;24(1):77-81.
55. Karataglis D, Green MA, Learmonth DJ. Functional outcome following modified Elmslie-Trillat procedure. Knee. 2006;13(6):464-468.
56. Kumar A, Jones S, Bickerstaff DR, Smith TW. A functional evaluation of the modified Elmslie-Trillat procedure for patello-femoral dysfunction. Knee. 2001;8(4):287-292.
57. Nakagawa K, Wada Y, Minamide M, Tsuchiya A, Moriya H. Deterioration of long-term clinical results after the Elmslie-Trillat procedure for dislocation of the patella. J Bone Joint Surg Br. 2002;84(6):861-864.
58. Magnussen RA, De Simone V, Lustig S, Neyret P, Flanigan DC. Treatment of patella alta in patients with episodic patellar dislocation: a systematic review. Knee Surg Sports Traumatol Arthrosc. 2014;22(10):2545-2550.
59. Mayer C, Magnussen RA, Servien E, et al. Patellar tendon tenodesis in association with tibial tubercle distalization for the treatment of episodic patellar dislocation with patella alta. Am J Sports Med. 2012;40(2):346-351.
60. Burnham JM, Howard JS, Hayes CB, Lattermann C. Medial patellofemoral ligament reconstruction with concomitant tibial tubercle transfer: a systematic review of outcomes and complications. Arthroscopy. 2016;32(6):1185-1195.
61. Dickschas J, Harrer J, Pfefferkorn R, Strecker W. Operative treatment of patellofemoral maltracking with torsional osteotomy. Arch Orthop Trauma Surg. 2012;132(3):289-298.
62. Nelitz M, Dreyhaupt J, Williams SR, Dornacher D. Combined supracondylar femoral derotation osteotomy and patellofemoral ligament reconstruction for recurrent patellar dislocation and severe femoral anteversion syndrome: surgical technique and clinical outcome. Int Orthop. 2015;39(12):2355-2362.
63. Strecker W, Dickschas J. Torsional osteotomy: operative treatment of patellofemoral maltracking [in German]. Oper Orthop Traumatol. 2015;27(6):505-524.
64. Bruce WD, Stevens PM. Surgical correction of miserable malalignment syndrome. J Pediatr Orthop. 2004;24(4):392-396.
65. Delgado ED, Schoenecker PL, Rich MM, Capelli AM. Treatment of severe torsional malalignment syndrome. J Pediatr Orthop. 1996;16(4):484-488.
66. Dickschas J, Harrer J, Reuter B, Schwitulla J, Strecker W. Torsional osteotomies of the femur. J Orthop Res. 2015;33(3):318-324.
67. Stevens PM, Gililland JM, Anderson LA, Mickelson JB, Nielson J, Klatt JW. Success of torsional correction surgery after failed surgeries for patellofemoral pain and instability. Strategies Trauma Limb Reconstr. 2014;9(1):5-12.
68. Balcarek P, Oberthür S, Hopfensitz S, et al. Which patellae are likely to redislocate? Knee Surg Sports Traumatol Arthrosc. 2014;22(10):2308-2314.
69. Jaquith BP, Parikh SN. Predictors of recurrent patellar instability in children and adolescents after first-time dislocation [published online October 21, 2015]. J Pediatr Orthop. doi:10.1097/BPO.0000000000000674.
Combined Anterior-Posterior Decompression and Fusion for Cervical Spondylotic Myelopathy
Take-Home Points
- Surgical intervention for cervical spondylosis and radiculopathy classically involves either an anterior or posterior approach for adequate decompression of the spinal cord and associated nerve roots.
- Combined anterior-posterior surgery for cervical spondylotic myelopathy is a relatively new technique that has previously been used for disorders of the thoracolumbar spine.
- Combined anterior-posterior cervical decompression and fusion for the treatment of cervical spondylotic myelopathy is associated with minor complications and excellent neurologic outcomes.
- Combined surgery can either be performed in a single day or in a staged manner, with current literature showing that same-day surgery is superior with respect to estimated blood loss and length of stay.
Cervical spondylotic myelopathy (CSM) is a degenerative disease characterized by progressive compression of the spinal cord. CSM has been found to be the most common cause of spinal impairment as well as the most frequently acquired cause of spinal dysfunction in people over 55 years of age.1,2 If left untreated, this condition can reduce manual dexterity and cause gait disturbances, dysesthesias, and weakness in the extremities. When conservative treatments fail, surgical intervention often becomes the preferred course of action for CSM and/or myeloradiculopathy.
The surgical approach for CSM and other advanced cervical spine (CS) deformities varies and is often a source of debate. Being a relatively safe and effective procedure, anterior decompression with fusion is optimal in treating discogenic lesions causing myelopathy but is less effective in multilevel disease.3,4 When pseudarthrosis, adjacent segment degeneration (ASD), and hardware failure are of concern, posterior decompressive laminectomy with instrumentation is a promising option.5 However, this method is less effective in restoring lordosis and can increase the risk for later clinical deterioration.6 There is a select subset of patients for whom a combined anterior-posterior approach is ideal.7-9In cases in which a combined anterior-posterior approach is identified as the best treatment option, whether to perform the operation in a sequential or staged manner must be decided, and this question is another source of debate. Single-day surgery is sometimes anecdotally criticized as posing a greater risk to the patient. On the other hand, some comparative studies have shown no statistically significant difference in major complication rates between the 2 options.10,11 More descriptive studies of combined anterior-posterior decompression and fusion (CAPDF) are needed to explore the efficacy of the procedure. In this article, we describe a study we conducted to characterize the operative data, perioperative complications, and short-term outcomes associated with CAPDF for the treatment of CSM in a select group of patients.
Methods
After receiving Institutional Review Board approval for this study (formal consent was not required), we retrospectively reviewed the charts of 21 patients who underwent CAPDF for CSM at our institution. All patients underwent surgery between February 2010 and March 2015. Criteria for inclusion in the study included same-day CAPDF for CSM. Staged procedures were excluded, as were combined procedures for the treatment of other diseases (eg, malignancies). All patients were operated on by the same primary surgeon (Dr. Davis) and co-surgeon (Dr. Labiak). The 1 patient who was lost to follow-up was excluded from the postoperative outcome analysis.
We reviewed the patients’ medical records for surgical consultations, operative reports, intraoperative reports, progress notes, and postoperative office visit reports. Demographic information included age, sex, body mass index, and preoperative risk factors, such as diabetes and tobacco use. All patients had been diagnosed with myelopathy. Clinical data included previous history of CS surgery, levels fused (and number of levels fused) anteriorly and posteriorly, operative time, estimated blood loss (EBL), length of stay (LOS), and perioperative complications. Short-term (3-month follow-up) neurologic improvement was determined both objectively, with the Nurick grading system,12 and subjectively, with determination of patient quality of life before and after surgery and with neurologic examination.
Operative Technique: Anterior Approach
All operations were performed with continuous somatosensory evoked potential monitoring of both upper and lower extremities. Each patient, positioned supine with the head in a neutral position, underwent standard endotracheal intubation. Intubation was followed by a transverse incision and dissection down to the deep cervical fascia with maintenance of the carotid sheath laterally and tracheoesophageal complex medially. Interspaces were identified and later were confirmed with lateral radiographs. Discectomy, osteophytectomy, and removal of hypertrophied or calcified ligament were then performed until decompression was satisfactory. Corpectomies were not performed. Polyetheretherketone interbody spacers (Stryker) were used with autograft harvested from vertebral body resection. Low-profile screw-plate systems were placed. After completion of the anterior procedure, the patient was placed prone, with the head fixed in a Mayfield clamping device in neutral position and with all pressure points carefully padded.
Operative Technique: Posterior Approach
A midline incision was made through the skin and subcutaneous tissue to the level of the deep cervical fascia. Then, dissection was performed to the tips of the lateral masses. Instrumentation and fusion preceded spinal decompression. This order, chosen to preserve bony landmarks for guidance during instrumentation, did not interfere with subsequent decompression. Segmental spinal instrumentation was placed using lateral mass screw-rod fixation. After the laminae and ligamenta flava were bilaterally mobilized, the entire bony ligamentous complex spanning the area of fusion was removed en masse (most commonly C3–C7) in order to decrease the number of instrument passes near the spinal cord. Next, a modest foraminotomy was performed to extend the opening laterally and ensure adequate decompression of the nerve roots. Autograft harvested from the spinous processes and laminae was used. The posterior portion of the operation contributed significantly to blood loss and postoperative pain during the perioperative period. We recommend performing a very meticulous dissection to minimize these consequences. No patient in this study required a halo orthosis.
Results
Twenty-one patients with CSM were treated with CAPDF between February 2010 and March 2015 (Table 1).
Table 2 summarizes the operative data. Mean number of levels fused was 2 (range, 1-3) anteriorly and 3 (range, 1-4) posteriorly.
Of the 21 patients, 9 (42.3%) had at least 1 complication during the perioperative period. Table 3 summarizes all encountered complications. Neither neurologic instability nor mortality was observed after surgery.
Patient 7 was lost to follow-up. For the other 20 patients, mean time to “3-month follow-up” was 96 days (range, 51-149 days). The most commonly noted improvements in quality of life included resolution of numbness, improvement in gait, and return to previous activities, such as walking and even exercising.
Representative Case
Patient 15, a 53-year-old man, presented with complaints of dysesthesias of the hands. Focused neurologic evaluation at the time revealed limited CS range of motion on extension. The patient (Figures 2A-2D) was diffusely hyperreflexic and had pathologic spread in the upper extremities.
Discussion
Cervical myelopathy is a common yet frequently underdiagnosed disease, owing to the fact that many patients remain asymptomatic even after experiencing degenerative changes in the spinal column.14-16 The additive effects of spondylosis, osteophyte formation, ligamentous hypertrophy, and listhesis lead to progressive canal and intervertebral foraminal compromise, ultimately producing the clinical syndromes of myelopathy and radiculopathy.17 The characteristic symptoms of CSM are known to have an insidious onset. In the early stages, patients note a subtle gait disturbance and later experience manual dexterity reductions and upper extremity dysesthesias.18 As the condition progresses and conservative management fails, surgical intervention is sought.
Nevertheless, the pursuit of surgical treatment for CSM remains somewhat controversial. Some authors have found no statistically significant difference between conservative and surgical management of mild to moderate CSM,19 whereas others have found that surgically treated patients had much better outcomes than their medically treated counterparts.20 In 2010, Scardino and colleagues21 reported that CSM patients who were bedridden and/or wheelchair-bound with seemingly irreversible myelopathy were capable of neurologic improvement after surgical intervention. At the very least, what remains clear is that untreated CSM is known to follow an unpredictable course, with the condition deteriorating faster for some patients than others.22Traditional anterior or posterior approaches, which can be used in the majority of cases of cervical spondylosis and/or radiculopathy, have been compared extensively.23,24 The inverse relationship concerning the integrity of an anterior construct and the number of levels fused is a well-established clinical finding.3,4,8,25-28 Laminectomy with fusion is not without its disadvantages: Cervical instability secondary to mechanical loss of posterior cervical support, and subsequent post-laminectomy kyphosis, is a common complication.23 In cases in which more stability is required, the combined anterior-posterior approach is more promising than either approach alone. This technique has its roots in the treatment of several thoracolumbar spine disorders, including infections, scoliosis, trauma, and tumors.29-31 More recently, the technique has been applied to CS disorders.
In 2008, Gok and colleagues32 retrospectively compared the results of anterior-only fusion and CAPDF for CSM. Forty-six patients underwent anterior surgery only, and 21 underwent CAPDF. The groups’ complication rates were similar: 28.6% (anterior only) and 24% (CAPDF); the incidence of ASD was lower in the combined group. Song and colleagues33 conducted a similar study in 2010. They compared anterior fusion alone and CAPDF in treating degenerative cervical kyphosis. Results were strongly in favor of the combined technique, as it led to “greater correction of sagittal alignment, a better maintenance of correction angle, a higher rate of fusion, a lower rate of subsidence and lower complications.” Both studies established that, in a select group of patients, the benefits of CAPDF outweighed the risks. These findings, combined with our study’s findings of no major complications and the transience of minor complications, suggest CAPDF should not be considered too invasive or risky.
The results of our study also mirror those of 3 other studies on the use of CAPDF for CS disorders. In 1995, McAfee and colleagues34 reported on a group of 100 patients with follow-up of 2 years or more. In most cases, the surgical indication was trauma, but neoplasm, infection, rheumatoid arthritis, and CSM were found as well. Outcomes were very favorable: improvement in a previous neurologic deficit (57/75 patients), ability to walk again (21/35 patients), no new neurologic deficits, and no hardware failures. In 2000, Schultz and colleagues35 retrospectively reviewed the cases of 72 patients who underwent CAPDF for a variety of complex CS disorders. Two of the 72 experienced transient neurologic deficits, and, though the immediate complication rate was relatively high (32%), the long-term complication rate was down to 5%. In 2009, Konya and colleagues36 retrospectively reviewed the cases of 40 patients who underwent CAPDF, primarily for CSM. Within 1 week after surgery, neurologic deficits were reduced in 36 patients; by 1 year after surgery, neurologic deficits were reduced in all 40 patients, and fusion was achieved in 39. These 3 studies34-36 helped establish CAPDF of the CS as a viable and effective procedure that can be performed within a single day.
Although many physicians have achieved favorable results with single-day surgery, the decision to operate in a sequential or staged manner remains controversial. Some anecdotally claim CAPDF poses a greater operative risk to the patient. In 1991, the continuous procedure was found to involve less blood loss and shorter LOS while providing for better correction of severe spinal deformity in patients with scoliosis and rigid kyphosis.37 Three more recent comparative studies examining the same issue in the treatment of CS diseases found staging did not reduce the complication rate and may in fact have been associated with higher complication rates, more blood loss, and longer total operative time and LOS.10,11,38 Our study’s lower blood loss, shorter LOS, and lower major complication rate relative to the combined groups in all 3 of those studies are most likely attributable to our operating on a lower mean number of spinal levels and our restricting the surgical indication to CSM. The positive short-term outcomes and low rate of long-term complications in our study, combined with the data from these 3 comparative studies, suggest that same-day surgery is superior to staged surgery. A staged operation should be considered only if the patient cannot tolerate long periods under general anesthesia.
Many have advocated extending fusion down to T1 to prevent ASD at the C7–T1 disk space.35,39,40 We decided against this approach for 2 reasons. First, at C7, lateral mass screws were always chosen over pedicle screws. When possible, shorter lateral mass screws were used at this level, making C7 much less rigid. Second, the C7–T1 facet capsule was maintained to preserve joint integrity. We suggest extending fusion down to T1 only if there is prior evidence of spinal disease and/or listhesis at C7–T1. Although long-term (many-year) follow-up is often desired, we specifically assessed short-term (3-month) outcomes. We have anecdotally found that degree of improvement often follows a predictable course after 3-month follow-up. If myelopathy resolves even to a small extent during the first 3 postoperative months, later improvement will likely follow an upward course. Conversely, if myelopathy does not improve during the first 3 months, further improvement is much less likely.
This trend in neurologic improvement likely is directly related to degree of myelopathy before surgery. Patients with CSM generally experience symptoms over an extended period and try conservative management before any surgical consultation. Although spinal ischemia is often resolved by decompression, permanent ischemic damage to the cord is not uncommon. In this setting, postoperative neurologic improvement is minimal or even nonexistent, and decompression is preventive rather than curative. In our study, 1 patient had no subjective improvement after surgery. At 3-month follow-up, magnetic resonance imaging showed notable myelomalacia without residual spinal cord compression. We attribute the failure of the ischemic changes to resolve to long-standing preoperative damage to the cord. Nevertheless, surgery stabilized the myelopathy and prevented further ischemic damage and clinical deterioration.
As is the case with any operation, patients must be carefully selected for CAPDF. Indications for CAPDF, as described by Kim and Alexander,7 include acute spinal trauma, post-laminectomy kyphosis, kyphotic deformity with intact posterior tension band, multilevel spondylosis and OPLL, and preexisting risk factors for pseudarthrosis. Clearly, the severity of each varies, and the pathologies are not mutually exclusive. We emphasize that these indications provide only a guideline for performing CAPDF, and patients must be selected on a case-by-case basis. All the patients in our study were symptomatic and exhibited significant compression of the spinal cord anteriorly and posteriorly at multiple levels. Several presented with concomitant pathologies, such as cervical kyphotic deformity, congenital spinal stenosis, and OPLL. In each case, the indication for surgical intervention was undoubted. We sought both to improve the patient’s baseline symptoms and to prevent further damage to the spinal cord.
This study had its limitations. First, its retrospective design predisposed it to a higher degree of bias. Second, because CAPDF is not commonly performed, the sample size was relatively small. Third, although it provided a descriptive analysis of CAPDF for CSM, the study did not use a direct comparison group to establish whether treatment within a single day or staged treatment was more beneficial for our cohort in particular. On the basis of prior experience and observation, we think performing the operation within a single day is much more beneficial for the patient. Our discussion of studies that have compared same-day and staged surgery supports this observation. Therefore, staged treatment was not recommended to our patients.
Conclusion
Few descriptive studies have explored CAPDF for CSM. Our study’s results showed the procedure was associated with minor complications and provided symptomatic relief for a majority of patients as early as 3 months after surgery. In addition, CAPDF can be successfully performed sequentially within a single day. As such, it represents an excellent option for treating multilevel symptomatic CSM cases that require more extensive spinal decompression and more stability.
Am J Orthop. 2017;46(2):E97-E104. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.
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4. Zdeblick TA, Hughes SS, Riew KD, Bohlman HH. Failed anterior cervical discectomy and arthrodesis. Analysis and treatment of thirty-five patients. J Bone Joint Surg Am. 1997;79(4):523-532.
5. Zhu B, Xu Y, Liu X, Liu Z, Dang G. Anterior approach versus posterior approach for the treatment of multilevel cervical spondylotic myelopathy: a systemic review and meta-analysis. Eur Spine J. 2013;22(7):1583-1593.
6. Cabraja M, Abbushi A, Koeppen D, Kroppenstedt S, Woiciechowsky C. Comparison between anterior and posterior decompression with instrumentation for cervical spondylotic myelopathy: sagittal alignment and clinical outcome. Neurosurg Focus. 2010;28(3):E15.
7. Kim PK, Alexander JT. Indications for circumferential surgery for cervical spondylotic myelopathy. Spine J. 2006;6(6 suppl):299S-307S.
8. König SA, Ranguis S, Spetzger U. Management of complex cervical instability. J Neurol Surg A Cent Eur Neurosurg. 2015;76(2):119-125.
9. König SA, Spetzger U. Surgical management of cervical spondylotic myelopathy—indications for anterior, posterior or combined procedures for decompression and stabilisation. Acta Neurochir. 2014;156(2):253-258.
10. Harel R, Hwang R, Fakhar M, et al. Circumferential cervical surgery: to stage or not to stage? J Spinal Disord Tech. 2013;26(4):183-188.
11. Siemionow K, Tyrakowski M, Patel K, Neckrysh S. Comparison of perioperative complications following staged versus one-day anterior and posterior cervical decompression and fusion crossing the cervico-thoracic junction. Neurol Neurochir Pol. 2014;48(6):403-409.
12. Nurick S. The pathogenesis of the spinal cord disorder associated with cervical spondylosis. Brain. 1972;95(1):87-100.
13. Chen CJ, Saulle D, Fu KM, Smith JS, Shaffrey CI. Dysphagia following combined anterior-posterior cervical spine surgeries. J Neurosurg Spine. 2013;19(3):279-287.
14. Boden SD, McCowin PR, Davis DO, Dina TS, Mark AS, Wiesel S. Abnormal magnetic-resonance scans of the cervical spine in asymptomatic subjects. A prospective investigation. J Bone Joint Surg Am. 1990;72(8):1178-1184.
15. Gore DR, Sepic SB, Gardner GM. Roentgenographic findings of the cervical spine in asymptomatic people. Spine. 1986;11(6):521-524.
16. Law MD Jr, Bernhardt M, White AA 3rd. Cervical spondylotic myelopathy: a review of surgical indications and decision making. Yale J Biol Med. 1993;66(3):165-177.
17. Kelly JC, Groarke PJ, Butler JS, Poynton AR, O’Byrne JM. The natural history and clinical syndromes of degenerative cervical spondylosis. Adv Orthop. 2012;(2012):393642.
18. Baron EM, Young WF. Cervical spondylotic myelopathy: a brief review of its pathophysiology, clinical course, and diagnosis. Neurosurgery. 2007;60(1 suppl 1):S35-S41.
19. Kadanka Z, Mares M, Bednarik J, et al. Approaches to spondylotic cervical myelopathy: conservative versus surgical results in a 3-year follow-up study. Spine. 2002;27(20):2205-2210.
20. Sampath P, Bendebba M, Davis JD, Ducker TB. Outcome of patients treated for cervical myelopathy. A prospective, multicenter study with independent clinical review. Spine. 2000;25(6):670-676.
21. Scardino FB, Rocha LP, Barcelos AC, Rotta JM, Botelho RV. Is there a benefit to operating on patients (bedridden or in wheelchairs) with advanced stage cervical spondylotic myelopathy? Eur Spine J. 2010;19(5):699-705.
22. Edwards CC 2nd, Riew KD, Anderson PA, Hilibrand AS, Vaccaro AF. Cervical myelopathy. Current diagnostic and treatment strategies. Spine J. 2003;3(1):68-81.
23. Herkowitz HN. A comparison of anterior cervical fusion, cervical laminectomy, and cervical laminoplasty for the surgical management of multiple level spondylotic radiculopathy. Spine. 1988;13(7):774-780.
24. Hukuda S, Mochizuki T, Ogata M, Shichikawa K, Shimomura Y. Operations for cervical spondylotic myelopathy. A comparison of the results of anterior and posterior procedures. J Bone Joint Surg Br. 1985;67(4):609-615.
25. Fernyhough JC, White JI, LaRocca H. Fusion rates in multilevel cervical spondylosis comparing allograft fibula with autograft fibula in 126 patients. Spine. 1991;16(10 suppl):S561-S564.
26. Macdonald RL, Fehlings MG, Tator CH, et al. Multilevel anterior cervical corpectomy and fibular allograft fusion for cervical myelopathy. J Neurosurg. 1997;86(6):990-997.
27. Mayr MT, Subach BR, Comey CH, Rodts GE, Haid RW Jr. Cervical spinal stenosis: outcome after anterior corpectomy, allograft reconstruction, and instrumentation. J Neurosurg. 2002;96(1 suppl):10-16.
28. Swank ML, Lowery GL, Bhat AL, McDonough RF. Anterior cervical allograft arthrodesis and instrumentation: multilevel interbody grafting or strut graft reconstruction. Eur Spine J. 1997;6(2):138-143.
29. Böhm H, Harms J, Donk R, Zielke K. Correction and stabilization of angular kyphosis. Clin Orthop Relat Res. 1990;(258):56-61.
30. Spencer DL, DeWald RL. Simultaneous anterior and posterior surgical approach to the thoracic and lumbar spine. Spine. 1979;4(1):29-36.
31. Whitesides TE Jr, Shah SGA. On the management of unstable fractures of the thoracolumbar spine: rationale for use of anterior decompression and fusion and posterior stabilization. Spine. 1976;1(2):99-107.
32. Gok B, Sciubba DM, McLoughlin GS, et al. Surgical treatment of cervical spondylotic myelopathy with anterior compression: a review of 67 cases. J Neurosurg Spine. 2008;9(2):152-157.
33. Song KJ, Johnson JS, Choi BR, Wang JC, Lee KB. Anterior fusion alone compared with combined anterior and posterior fusion for the treatment of degenerative cervical kyphosis. J Bone Joint Surg Br. 2010;92(11):1548-1552.
34. McAfee PC, Bohlman HH, Ducker TB, Zeidman SM, Goldstein JA. One-stage anterior cervical decompression and posterior stabilization. A study of one hundred patients with a minimum of two years of follow-up. J Bone Joint Surg Am. 1995;77(12):1791-1800.
35. Schultz KD Jr, McLaughlin MR, Haid RW Jr, Comey CH, Rodts GE Jr, Alexander J. Single-stage anterior-posterior decompression and stabilization for complex cervical spine disorders. J Neurosurg. 2000;93(2 suppl):214-221.
36. Konya D, Ozgen S, Gercek A, Pamir MN. Outcomes for combined anterior and posterior surgical approaches for patients with multisegmental cervical spondylotic myelopathy. J Clin Neurosci. 2009;16(3):404-409.
37. Shufflebarger HL, Grimm JO, Bui V, Thomson JD. Anterior and posterior spinal fusion. Staged versus same-day surgery. Spine. 1991;16(8):930-933.
38. Ozturk C, Aydinli U, Vural R, Sehirlioglu A, Mutlu M. Simultaneous versus sequential one-stage combined anterior and posterior spinal surgery for spinal infections (outcomes and complications). Int Orthop. 2007;31(3):363-366.
39. Aryan HE, Sanchez-Mejia RO, Ben-Haim S, Ames CP. Successful treatment of cervical myelopathy with minimal morbidity by circumferential decompression and fusion. Eur Spine J. 2007;16(9):1401-1409.
40. Steinmetz MP, Miller J, Warbel A, Krishnaney AA, Bingaman W, Benzel EC. Regional instability following cervicothoracic junction surgery. J Neurosurg Spine. 2006;4(4):278-284.
Take-Home Points
- Surgical intervention for cervical spondylosis and radiculopathy classically involves either an anterior or posterior approach for adequate decompression of the spinal cord and associated nerve roots.
- Combined anterior-posterior surgery for cervical spondylotic myelopathy is a relatively new technique that has previously been used for disorders of the thoracolumbar spine.
- Combined anterior-posterior cervical decompression and fusion for the treatment of cervical spondylotic myelopathy is associated with minor complications and excellent neurologic outcomes.
- Combined surgery can either be performed in a single day or in a staged manner, with current literature showing that same-day surgery is superior with respect to estimated blood loss and length of stay.
Cervical spondylotic myelopathy (CSM) is a degenerative disease characterized by progressive compression of the spinal cord. CSM has been found to be the most common cause of spinal impairment as well as the most frequently acquired cause of spinal dysfunction in people over 55 years of age.1,2 If left untreated, this condition can reduce manual dexterity and cause gait disturbances, dysesthesias, and weakness in the extremities. When conservative treatments fail, surgical intervention often becomes the preferred course of action for CSM and/or myeloradiculopathy.
The surgical approach for CSM and other advanced cervical spine (CS) deformities varies and is often a source of debate. Being a relatively safe and effective procedure, anterior decompression with fusion is optimal in treating discogenic lesions causing myelopathy but is less effective in multilevel disease.3,4 When pseudarthrosis, adjacent segment degeneration (ASD), and hardware failure are of concern, posterior decompressive laminectomy with instrumentation is a promising option.5 However, this method is less effective in restoring lordosis and can increase the risk for later clinical deterioration.6 There is a select subset of patients for whom a combined anterior-posterior approach is ideal.7-9In cases in which a combined anterior-posterior approach is identified as the best treatment option, whether to perform the operation in a sequential or staged manner must be decided, and this question is another source of debate. Single-day surgery is sometimes anecdotally criticized as posing a greater risk to the patient. On the other hand, some comparative studies have shown no statistically significant difference in major complication rates between the 2 options.10,11 More descriptive studies of combined anterior-posterior decompression and fusion (CAPDF) are needed to explore the efficacy of the procedure. In this article, we describe a study we conducted to characterize the operative data, perioperative complications, and short-term outcomes associated with CAPDF for the treatment of CSM in a select group of patients.
Methods
After receiving Institutional Review Board approval for this study (formal consent was not required), we retrospectively reviewed the charts of 21 patients who underwent CAPDF for CSM at our institution. All patients underwent surgery between February 2010 and March 2015. Criteria for inclusion in the study included same-day CAPDF for CSM. Staged procedures were excluded, as were combined procedures for the treatment of other diseases (eg, malignancies). All patients were operated on by the same primary surgeon (Dr. Davis) and co-surgeon (Dr. Labiak). The 1 patient who was lost to follow-up was excluded from the postoperative outcome analysis.
We reviewed the patients’ medical records for surgical consultations, operative reports, intraoperative reports, progress notes, and postoperative office visit reports. Demographic information included age, sex, body mass index, and preoperative risk factors, such as diabetes and tobacco use. All patients had been diagnosed with myelopathy. Clinical data included previous history of CS surgery, levels fused (and number of levels fused) anteriorly and posteriorly, operative time, estimated blood loss (EBL), length of stay (LOS), and perioperative complications. Short-term (3-month follow-up) neurologic improvement was determined both objectively, with the Nurick grading system,12 and subjectively, with determination of patient quality of life before and after surgery and with neurologic examination.
Operative Technique: Anterior Approach
All operations were performed with continuous somatosensory evoked potential monitoring of both upper and lower extremities. Each patient, positioned supine with the head in a neutral position, underwent standard endotracheal intubation. Intubation was followed by a transverse incision and dissection down to the deep cervical fascia with maintenance of the carotid sheath laterally and tracheoesophageal complex medially. Interspaces were identified and later were confirmed with lateral radiographs. Discectomy, osteophytectomy, and removal of hypertrophied or calcified ligament were then performed until decompression was satisfactory. Corpectomies were not performed. Polyetheretherketone interbody spacers (Stryker) were used with autograft harvested from vertebral body resection. Low-profile screw-plate systems were placed. After completion of the anterior procedure, the patient was placed prone, with the head fixed in a Mayfield clamping device in neutral position and with all pressure points carefully padded.
Operative Technique: Posterior Approach
A midline incision was made through the skin and subcutaneous tissue to the level of the deep cervical fascia. Then, dissection was performed to the tips of the lateral masses. Instrumentation and fusion preceded spinal decompression. This order, chosen to preserve bony landmarks for guidance during instrumentation, did not interfere with subsequent decompression. Segmental spinal instrumentation was placed using lateral mass screw-rod fixation. After the laminae and ligamenta flava were bilaterally mobilized, the entire bony ligamentous complex spanning the area of fusion was removed en masse (most commonly C3–C7) in order to decrease the number of instrument passes near the spinal cord. Next, a modest foraminotomy was performed to extend the opening laterally and ensure adequate decompression of the nerve roots. Autograft harvested from the spinous processes and laminae was used. The posterior portion of the operation contributed significantly to blood loss and postoperative pain during the perioperative period. We recommend performing a very meticulous dissection to minimize these consequences. No patient in this study required a halo orthosis.
Results
Twenty-one patients with CSM were treated with CAPDF between February 2010 and March 2015 (Table 1).
Table 2 summarizes the operative data. Mean number of levels fused was 2 (range, 1-3) anteriorly and 3 (range, 1-4) posteriorly.
Of the 21 patients, 9 (42.3%) had at least 1 complication during the perioperative period. Table 3 summarizes all encountered complications. Neither neurologic instability nor mortality was observed after surgery.
Patient 7 was lost to follow-up. For the other 20 patients, mean time to “3-month follow-up” was 96 days (range, 51-149 days). The most commonly noted improvements in quality of life included resolution of numbness, improvement in gait, and return to previous activities, such as walking and even exercising.
Representative Case
Patient 15, a 53-year-old man, presented with complaints of dysesthesias of the hands. Focused neurologic evaluation at the time revealed limited CS range of motion on extension. The patient (Figures 2A-2D) was diffusely hyperreflexic and had pathologic spread in the upper extremities.
Discussion
Cervical myelopathy is a common yet frequently underdiagnosed disease, owing to the fact that many patients remain asymptomatic even after experiencing degenerative changes in the spinal column.14-16 The additive effects of spondylosis, osteophyte formation, ligamentous hypertrophy, and listhesis lead to progressive canal and intervertebral foraminal compromise, ultimately producing the clinical syndromes of myelopathy and radiculopathy.17 The characteristic symptoms of CSM are known to have an insidious onset. In the early stages, patients note a subtle gait disturbance and later experience manual dexterity reductions and upper extremity dysesthesias.18 As the condition progresses and conservative management fails, surgical intervention is sought.
Nevertheless, the pursuit of surgical treatment for CSM remains somewhat controversial. Some authors have found no statistically significant difference between conservative and surgical management of mild to moderate CSM,19 whereas others have found that surgically treated patients had much better outcomes than their medically treated counterparts.20 In 2010, Scardino and colleagues21 reported that CSM patients who were bedridden and/or wheelchair-bound with seemingly irreversible myelopathy were capable of neurologic improvement after surgical intervention. At the very least, what remains clear is that untreated CSM is known to follow an unpredictable course, with the condition deteriorating faster for some patients than others.22Traditional anterior or posterior approaches, which can be used in the majority of cases of cervical spondylosis and/or radiculopathy, have been compared extensively.23,24 The inverse relationship concerning the integrity of an anterior construct and the number of levels fused is a well-established clinical finding.3,4,8,25-28 Laminectomy with fusion is not without its disadvantages: Cervical instability secondary to mechanical loss of posterior cervical support, and subsequent post-laminectomy kyphosis, is a common complication.23 In cases in which more stability is required, the combined anterior-posterior approach is more promising than either approach alone. This technique has its roots in the treatment of several thoracolumbar spine disorders, including infections, scoliosis, trauma, and tumors.29-31 More recently, the technique has been applied to CS disorders.
In 2008, Gok and colleagues32 retrospectively compared the results of anterior-only fusion and CAPDF for CSM. Forty-six patients underwent anterior surgery only, and 21 underwent CAPDF. The groups’ complication rates were similar: 28.6% (anterior only) and 24% (CAPDF); the incidence of ASD was lower in the combined group. Song and colleagues33 conducted a similar study in 2010. They compared anterior fusion alone and CAPDF in treating degenerative cervical kyphosis. Results were strongly in favor of the combined technique, as it led to “greater correction of sagittal alignment, a better maintenance of correction angle, a higher rate of fusion, a lower rate of subsidence and lower complications.” Both studies established that, in a select group of patients, the benefits of CAPDF outweighed the risks. These findings, combined with our study’s findings of no major complications and the transience of minor complications, suggest CAPDF should not be considered too invasive or risky.
The results of our study also mirror those of 3 other studies on the use of CAPDF for CS disorders. In 1995, McAfee and colleagues34 reported on a group of 100 patients with follow-up of 2 years or more. In most cases, the surgical indication was trauma, but neoplasm, infection, rheumatoid arthritis, and CSM were found as well. Outcomes were very favorable: improvement in a previous neurologic deficit (57/75 patients), ability to walk again (21/35 patients), no new neurologic deficits, and no hardware failures. In 2000, Schultz and colleagues35 retrospectively reviewed the cases of 72 patients who underwent CAPDF for a variety of complex CS disorders. Two of the 72 experienced transient neurologic deficits, and, though the immediate complication rate was relatively high (32%), the long-term complication rate was down to 5%. In 2009, Konya and colleagues36 retrospectively reviewed the cases of 40 patients who underwent CAPDF, primarily for CSM. Within 1 week after surgery, neurologic deficits were reduced in 36 patients; by 1 year after surgery, neurologic deficits were reduced in all 40 patients, and fusion was achieved in 39. These 3 studies34-36 helped establish CAPDF of the CS as a viable and effective procedure that can be performed within a single day.
Although many physicians have achieved favorable results with single-day surgery, the decision to operate in a sequential or staged manner remains controversial. Some anecdotally claim CAPDF poses a greater operative risk to the patient. In 1991, the continuous procedure was found to involve less blood loss and shorter LOS while providing for better correction of severe spinal deformity in patients with scoliosis and rigid kyphosis.37 Three more recent comparative studies examining the same issue in the treatment of CS diseases found staging did not reduce the complication rate and may in fact have been associated with higher complication rates, more blood loss, and longer total operative time and LOS.10,11,38 Our study’s lower blood loss, shorter LOS, and lower major complication rate relative to the combined groups in all 3 of those studies are most likely attributable to our operating on a lower mean number of spinal levels and our restricting the surgical indication to CSM. The positive short-term outcomes and low rate of long-term complications in our study, combined with the data from these 3 comparative studies, suggest that same-day surgery is superior to staged surgery. A staged operation should be considered only if the patient cannot tolerate long periods under general anesthesia.
Many have advocated extending fusion down to T1 to prevent ASD at the C7–T1 disk space.35,39,40 We decided against this approach for 2 reasons. First, at C7, lateral mass screws were always chosen over pedicle screws. When possible, shorter lateral mass screws were used at this level, making C7 much less rigid. Second, the C7–T1 facet capsule was maintained to preserve joint integrity. We suggest extending fusion down to T1 only if there is prior evidence of spinal disease and/or listhesis at C7–T1. Although long-term (many-year) follow-up is often desired, we specifically assessed short-term (3-month) outcomes. We have anecdotally found that degree of improvement often follows a predictable course after 3-month follow-up. If myelopathy resolves even to a small extent during the first 3 postoperative months, later improvement will likely follow an upward course. Conversely, if myelopathy does not improve during the first 3 months, further improvement is much less likely.
This trend in neurologic improvement likely is directly related to degree of myelopathy before surgery. Patients with CSM generally experience symptoms over an extended period and try conservative management before any surgical consultation. Although spinal ischemia is often resolved by decompression, permanent ischemic damage to the cord is not uncommon. In this setting, postoperative neurologic improvement is minimal or even nonexistent, and decompression is preventive rather than curative. In our study, 1 patient had no subjective improvement after surgery. At 3-month follow-up, magnetic resonance imaging showed notable myelomalacia without residual spinal cord compression. We attribute the failure of the ischemic changes to resolve to long-standing preoperative damage to the cord. Nevertheless, surgery stabilized the myelopathy and prevented further ischemic damage and clinical deterioration.
As is the case with any operation, patients must be carefully selected for CAPDF. Indications for CAPDF, as described by Kim and Alexander,7 include acute spinal trauma, post-laminectomy kyphosis, kyphotic deformity with intact posterior tension band, multilevel spondylosis and OPLL, and preexisting risk factors for pseudarthrosis. Clearly, the severity of each varies, and the pathologies are not mutually exclusive. We emphasize that these indications provide only a guideline for performing CAPDF, and patients must be selected on a case-by-case basis. All the patients in our study were symptomatic and exhibited significant compression of the spinal cord anteriorly and posteriorly at multiple levels. Several presented with concomitant pathologies, such as cervical kyphotic deformity, congenital spinal stenosis, and OPLL. In each case, the indication for surgical intervention was undoubted. We sought both to improve the patient’s baseline symptoms and to prevent further damage to the spinal cord.
This study had its limitations. First, its retrospective design predisposed it to a higher degree of bias. Second, because CAPDF is not commonly performed, the sample size was relatively small. Third, although it provided a descriptive analysis of CAPDF for CSM, the study did not use a direct comparison group to establish whether treatment within a single day or staged treatment was more beneficial for our cohort in particular. On the basis of prior experience and observation, we think performing the operation within a single day is much more beneficial for the patient. Our discussion of studies that have compared same-day and staged surgery supports this observation. Therefore, staged treatment was not recommended to our patients.
Conclusion
Few descriptive studies have explored CAPDF for CSM. Our study’s results showed the procedure was associated with minor complications and provided symptomatic relief for a majority of patients as early as 3 months after surgery. In addition, CAPDF can be successfully performed sequentially within a single day. As such, it represents an excellent option for treating multilevel symptomatic CSM cases that require more extensive spinal decompression and more stability.
Am J Orthop. 2017;46(2):E97-E104. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.
Take-Home Points
- Surgical intervention for cervical spondylosis and radiculopathy classically involves either an anterior or posterior approach for adequate decompression of the spinal cord and associated nerve roots.
- Combined anterior-posterior surgery for cervical spondylotic myelopathy is a relatively new technique that has previously been used for disorders of the thoracolumbar spine.
- Combined anterior-posterior cervical decompression and fusion for the treatment of cervical spondylotic myelopathy is associated with minor complications and excellent neurologic outcomes.
- Combined surgery can either be performed in a single day or in a staged manner, with current literature showing that same-day surgery is superior with respect to estimated blood loss and length of stay.
Cervical spondylotic myelopathy (CSM) is a degenerative disease characterized by progressive compression of the spinal cord. CSM has been found to be the most common cause of spinal impairment as well as the most frequently acquired cause of spinal dysfunction in people over 55 years of age.1,2 If left untreated, this condition can reduce manual dexterity and cause gait disturbances, dysesthesias, and weakness in the extremities. When conservative treatments fail, surgical intervention often becomes the preferred course of action for CSM and/or myeloradiculopathy.
The surgical approach for CSM and other advanced cervical spine (CS) deformities varies and is often a source of debate. Being a relatively safe and effective procedure, anterior decompression with fusion is optimal in treating discogenic lesions causing myelopathy but is less effective in multilevel disease.3,4 When pseudarthrosis, adjacent segment degeneration (ASD), and hardware failure are of concern, posterior decompressive laminectomy with instrumentation is a promising option.5 However, this method is less effective in restoring lordosis and can increase the risk for later clinical deterioration.6 There is a select subset of patients for whom a combined anterior-posterior approach is ideal.7-9In cases in which a combined anterior-posterior approach is identified as the best treatment option, whether to perform the operation in a sequential or staged manner must be decided, and this question is another source of debate. Single-day surgery is sometimes anecdotally criticized as posing a greater risk to the patient. On the other hand, some comparative studies have shown no statistically significant difference in major complication rates between the 2 options.10,11 More descriptive studies of combined anterior-posterior decompression and fusion (CAPDF) are needed to explore the efficacy of the procedure. In this article, we describe a study we conducted to characterize the operative data, perioperative complications, and short-term outcomes associated with CAPDF for the treatment of CSM in a select group of patients.
Methods
After receiving Institutional Review Board approval for this study (formal consent was not required), we retrospectively reviewed the charts of 21 patients who underwent CAPDF for CSM at our institution. All patients underwent surgery between February 2010 and March 2015. Criteria for inclusion in the study included same-day CAPDF for CSM. Staged procedures were excluded, as were combined procedures for the treatment of other diseases (eg, malignancies). All patients were operated on by the same primary surgeon (Dr. Davis) and co-surgeon (Dr. Labiak). The 1 patient who was lost to follow-up was excluded from the postoperative outcome analysis.
We reviewed the patients’ medical records for surgical consultations, operative reports, intraoperative reports, progress notes, and postoperative office visit reports. Demographic information included age, sex, body mass index, and preoperative risk factors, such as diabetes and tobacco use. All patients had been diagnosed with myelopathy. Clinical data included previous history of CS surgery, levels fused (and number of levels fused) anteriorly and posteriorly, operative time, estimated blood loss (EBL), length of stay (LOS), and perioperative complications. Short-term (3-month follow-up) neurologic improvement was determined both objectively, with the Nurick grading system,12 and subjectively, with determination of patient quality of life before and after surgery and with neurologic examination.
Operative Technique: Anterior Approach
All operations were performed with continuous somatosensory evoked potential monitoring of both upper and lower extremities. Each patient, positioned supine with the head in a neutral position, underwent standard endotracheal intubation. Intubation was followed by a transverse incision and dissection down to the deep cervical fascia with maintenance of the carotid sheath laterally and tracheoesophageal complex medially. Interspaces were identified and later were confirmed with lateral radiographs. Discectomy, osteophytectomy, and removal of hypertrophied or calcified ligament were then performed until decompression was satisfactory. Corpectomies were not performed. Polyetheretherketone interbody spacers (Stryker) were used with autograft harvested from vertebral body resection. Low-profile screw-plate systems were placed. After completion of the anterior procedure, the patient was placed prone, with the head fixed in a Mayfield clamping device in neutral position and with all pressure points carefully padded.
Operative Technique: Posterior Approach
A midline incision was made through the skin and subcutaneous tissue to the level of the deep cervical fascia. Then, dissection was performed to the tips of the lateral masses. Instrumentation and fusion preceded spinal decompression. This order, chosen to preserve bony landmarks for guidance during instrumentation, did not interfere with subsequent decompression. Segmental spinal instrumentation was placed using lateral mass screw-rod fixation. After the laminae and ligamenta flava were bilaterally mobilized, the entire bony ligamentous complex spanning the area of fusion was removed en masse (most commonly C3–C7) in order to decrease the number of instrument passes near the spinal cord. Next, a modest foraminotomy was performed to extend the opening laterally and ensure adequate decompression of the nerve roots. Autograft harvested from the spinous processes and laminae was used. The posterior portion of the operation contributed significantly to blood loss and postoperative pain during the perioperative period. We recommend performing a very meticulous dissection to minimize these consequences. No patient in this study required a halo orthosis.
Results
Twenty-one patients with CSM were treated with CAPDF between February 2010 and March 2015 (Table 1).
Table 2 summarizes the operative data. Mean number of levels fused was 2 (range, 1-3) anteriorly and 3 (range, 1-4) posteriorly.
Of the 21 patients, 9 (42.3%) had at least 1 complication during the perioperative period. Table 3 summarizes all encountered complications. Neither neurologic instability nor mortality was observed after surgery.
Patient 7 was lost to follow-up. For the other 20 patients, mean time to “3-month follow-up” was 96 days (range, 51-149 days). The most commonly noted improvements in quality of life included resolution of numbness, improvement in gait, and return to previous activities, such as walking and even exercising.
Representative Case
Patient 15, a 53-year-old man, presented with complaints of dysesthesias of the hands. Focused neurologic evaluation at the time revealed limited CS range of motion on extension. The patient (Figures 2A-2D) was diffusely hyperreflexic and had pathologic spread in the upper extremities.
Discussion
Cervical myelopathy is a common yet frequently underdiagnosed disease, owing to the fact that many patients remain asymptomatic even after experiencing degenerative changes in the spinal column.14-16 The additive effects of spondylosis, osteophyte formation, ligamentous hypertrophy, and listhesis lead to progressive canal and intervertebral foraminal compromise, ultimately producing the clinical syndromes of myelopathy and radiculopathy.17 The characteristic symptoms of CSM are known to have an insidious onset. In the early stages, patients note a subtle gait disturbance and later experience manual dexterity reductions and upper extremity dysesthesias.18 As the condition progresses and conservative management fails, surgical intervention is sought.
Nevertheless, the pursuit of surgical treatment for CSM remains somewhat controversial. Some authors have found no statistically significant difference between conservative and surgical management of mild to moderate CSM,19 whereas others have found that surgically treated patients had much better outcomes than their medically treated counterparts.20 In 2010, Scardino and colleagues21 reported that CSM patients who were bedridden and/or wheelchair-bound with seemingly irreversible myelopathy were capable of neurologic improvement after surgical intervention. At the very least, what remains clear is that untreated CSM is known to follow an unpredictable course, with the condition deteriorating faster for some patients than others.22Traditional anterior or posterior approaches, which can be used in the majority of cases of cervical spondylosis and/or radiculopathy, have been compared extensively.23,24 The inverse relationship concerning the integrity of an anterior construct and the number of levels fused is a well-established clinical finding.3,4,8,25-28 Laminectomy with fusion is not without its disadvantages: Cervical instability secondary to mechanical loss of posterior cervical support, and subsequent post-laminectomy kyphosis, is a common complication.23 In cases in which more stability is required, the combined anterior-posterior approach is more promising than either approach alone. This technique has its roots in the treatment of several thoracolumbar spine disorders, including infections, scoliosis, trauma, and tumors.29-31 More recently, the technique has been applied to CS disorders.
In 2008, Gok and colleagues32 retrospectively compared the results of anterior-only fusion and CAPDF for CSM. Forty-six patients underwent anterior surgery only, and 21 underwent CAPDF. The groups’ complication rates were similar: 28.6% (anterior only) and 24% (CAPDF); the incidence of ASD was lower in the combined group. Song and colleagues33 conducted a similar study in 2010. They compared anterior fusion alone and CAPDF in treating degenerative cervical kyphosis. Results were strongly in favor of the combined technique, as it led to “greater correction of sagittal alignment, a better maintenance of correction angle, a higher rate of fusion, a lower rate of subsidence and lower complications.” Both studies established that, in a select group of patients, the benefits of CAPDF outweighed the risks. These findings, combined with our study’s findings of no major complications and the transience of minor complications, suggest CAPDF should not be considered too invasive or risky.
The results of our study also mirror those of 3 other studies on the use of CAPDF for CS disorders. In 1995, McAfee and colleagues34 reported on a group of 100 patients with follow-up of 2 years or more. In most cases, the surgical indication was trauma, but neoplasm, infection, rheumatoid arthritis, and CSM were found as well. Outcomes were very favorable: improvement in a previous neurologic deficit (57/75 patients), ability to walk again (21/35 patients), no new neurologic deficits, and no hardware failures. In 2000, Schultz and colleagues35 retrospectively reviewed the cases of 72 patients who underwent CAPDF for a variety of complex CS disorders. Two of the 72 experienced transient neurologic deficits, and, though the immediate complication rate was relatively high (32%), the long-term complication rate was down to 5%. In 2009, Konya and colleagues36 retrospectively reviewed the cases of 40 patients who underwent CAPDF, primarily for CSM. Within 1 week after surgery, neurologic deficits were reduced in 36 patients; by 1 year after surgery, neurologic deficits were reduced in all 40 patients, and fusion was achieved in 39. These 3 studies34-36 helped establish CAPDF of the CS as a viable and effective procedure that can be performed within a single day.
Although many physicians have achieved favorable results with single-day surgery, the decision to operate in a sequential or staged manner remains controversial. Some anecdotally claim CAPDF poses a greater operative risk to the patient. In 1991, the continuous procedure was found to involve less blood loss and shorter LOS while providing for better correction of severe spinal deformity in patients with scoliosis and rigid kyphosis.37 Three more recent comparative studies examining the same issue in the treatment of CS diseases found staging did not reduce the complication rate and may in fact have been associated with higher complication rates, more blood loss, and longer total operative time and LOS.10,11,38 Our study’s lower blood loss, shorter LOS, and lower major complication rate relative to the combined groups in all 3 of those studies are most likely attributable to our operating on a lower mean number of spinal levels and our restricting the surgical indication to CSM. The positive short-term outcomes and low rate of long-term complications in our study, combined with the data from these 3 comparative studies, suggest that same-day surgery is superior to staged surgery. A staged operation should be considered only if the patient cannot tolerate long periods under general anesthesia.
Many have advocated extending fusion down to T1 to prevent ASD at the C7–T1 disk space.35,39,40 We decided against this approach for 2 reasons. First, at C7, lateral mass screws were always chosen over pedicle screws. When possible, shorter lateral mass screws were used at this level, making C7 much less rigid. Second, the C7–T1 facet capsule was maintained to preserve joint integrity. We suggest extending fusion down to T1 only if there is prior evidence of spinal disease and/or listhesis at C7–T1. Although long-term (many-year) follow-up is often desired, we specifically assessed short-term (3-month) outcomes. We have anecdotally found that degree of improvement often follows a predictable course after 3-month follow-up. If myelopathy resolves even to a small extent during the first 3 postoperative months, later improvement will likely follow an upward course. Conversely, if myelopathy does not improve during the first 3 months, further improvement is much less likely.
This trend in neurologic improvement likely is directly related to degree of myelopathy before surgery. Patients with CSM generally experience symptoms over an extended period and try conservative management before any surgical consultation. Although spinal ischemia is often resolved by decompression, permanent ischemic damage to the cord is not uncommon. In this setting, postoperative neurologic improvement is minimal or even nonexistent, and decompression is preventive rather than curative. In our study, 1 patient had no subjective improvement after surgery. At 3-month follow-up, magnetic resonance imaging showed notable myelomalacia without residual spinal cord compression. We attribute the failure of the ischemic changes to resolve to long-standing preoperative damage to the cord. Nevertheless, surgery stabilized the myelopathy and prevented further ischemic damage and clinical deterioration.
As is the case with any operation, patients must be carefully selected for CAPDF. Indications for CAPDF, as described by Kim and Alexander,7 include acute spinal trauma, post-laminectomy kyphosis, kyphotic deformity with intact posterior tension band, multilevel spondylosis and OPLL, and preexisting risk factors for pseudarthrosis. Clearly, the severity of each varies, and the pathologies are not mutually exclusive. We emphasize that these indications provide only a guideline for performing CAPDF, and patients must be selected on a case-by-case basis. All the patients in our study were symptomatic and exhibited significant compression of the spinal cord anteriorly and posteriorly at multiple levels. Several presented with concomitant pathologies, such as cervical kyphotic deformity, congenital spinal stenosis, and OPLL. In each case, the indication for surgical intervention was undoubted. We sought both to improve the patient’s baseline symptoms and to prevent further damage to the spinal cord.
This study had its limitations. First, its retrospective design predisposed it to a higher degree of bias. Second, because CAPDF is not commonly performed, the sample size was relatively small. Third, although it provided a descriptive analysis of CAPDF for CSM, the study did not use a direct comparison group to establish whether treatment within a single day or staged treatment was more beneficial for our cohort in particular. On the basis of prior experience and observation, we think performing the operation within a single day is much more beneficial for the patient. Our discussion of studies that have compared same-day and staged surgery supports this observation. Therefore, staged treatment was not recommended to our patients.
Conclusion
Few descriptive studies have explored CAPDF for CSM. Our study’s results showed the procedure was associated with minor complications and provided symptomatic relief for a majority of patients as early as 3 months after surgery. In addition, CAPDF can be successfully performed sequentially within a single day. As such, it represents an excellent option for treating multilevel symptomatic CSM cases that require more extensive spinal decompression and more stability.
Am J Orthop. 2017;46(2):E97-E104. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.
1. Baptiste DC, Fehlings MG. Pathophysiology of cervical myelopathy. Spine J. 2006;6(6 suppl):190S-197S.
2. Kalsi-Ryan S, Karadimas SK, Fehlings MG. Cervical spondylotic myelopathy: the clinical phenomenon and the current pathobiology of an increasingly prevalent and devastating disorder. Neuroscientist. 2013;19(4):409-421.
3. Sasso RC, Ruggiero RA Jr, Reilly TM, Hall PV. Early reconstruction failures after multilevel cervical corpectomy. Spine. 2003;28(2):140-142.
4. Zdeblick TA, Hughes SS, Riew KD, Bohlman HH. Failed anterior cervical discectomy and arthrodesis. Analysis and treatment of thirty-five patients. J Bone Joint Surg Am. 1997;79(4):523-532.
5. Zhu B, Xu Y, Liu X, Liu Z, Dang G. Anterior approach versus posterior approach for the treatment of multilevel cervical spondylotic myelopathy: a systemic review and meta-analysis. Eur Spine J. 2013;22(7):1583-1593.
6. Cabraja M, Abbushi A, Koeppen D, Kroppenstedt S, Woiciechowsky C. Comparison between anterior and posterior decompression with instrumentation for cervical spondylotic myelopathy: sagittal alignment and clinical outcome. Neurosurg Focus. 2010;28(3):E15.
7. Kim PK, Alexander JT. Indications for circumferential surgery for cervical spondylotic myelopathy. Spine J. 2006;6(6 suppl):299S-307S.
8. König SA, Ranguis S, Spetzger U. Management of complex cervical instability. J Neurol Surg A Cent Eur Neurosurg. 2015;76(2):119-125.
9. König SA, Spetzger U. Surgical management of cervical spondylotic myelopathy—indications for anterior, posterior or combined procedures for decompression and stabilisation. Acta Neurochir. 2014;156(2):253-258.
10. Harel R, Hwang R, Fakhar M, et al. Circumferential cervical surgery: to stage or not to stage? J Spinal Disord Tech. 2013;26(4):183-188.
11. Siemionow K, Tyrakowski M, Patel K, Neckrysh S. Comparison of perioperative complications following staged versus one-day anterior and posterior cervical decompression and fusion crossing the cervico-thoracic junction. Neurol Neurochir Pol. 2014;48(6):403-409.
12. Nurick S. The pathogenesis of the spinal cord disorder associated with cervical spondylosis. Brain. 1972;95(1):87-100.
13. Chen CJ, Saulle D, Fu KM, Smith JS, Shaffrey CI. Dysphagia following combined anterior-posterior cervical spine surgeries. J Neurosurg Spine. 2013;19(3):279-287.
14. Boden SD, McCowin PR, Davis DO, Dina TS, Mark AS, Wiesel S. Abnormal magnetic-resonance scans of the cervical spine in asymptomatic subjects. A prospective investigation. J Bone Joint Surg Am. 1990;72(8):1178-1184.
15. Gore DR, Sepic SB, Gardner GM. Roentgenographic findings of the cervical spine in asymptomatic people. Spine. 1986;11(6):521-524.
16. Law MD Jr, Bernhardt M, White AA 3rd. Cervical spondylotic myelopathy: a review of surgical indications and decision making. Yale J Biol Med. 1993;66(3):165-177.
17. Kelly JC, Groarke PJ, Butler JS, Poynton AR, O’Byrne JM. The natural history and clinical syndromes of degenerative cervical spondylosis. Adv Orthop. 2012;(2012):393642.
18. Baron EM, Young WF. Cervical spondylotic myelopathy: a brief review of its pathophysiology, clinical course, and diagnosis. Neurosurgery. 2007;60(1 suppl 1):S35-S41.
19. Kadanka Z, Mares M, Bednarik J, et al. Approaches to spondylotic cervical myelopathy: conservative versus surgical results in a 3-year follow-up study. Spine. 2002;27(20):2205-2210.
20. Sampath P, Bendebba M, Davis JD, Ducker TB. Outcome of patients treated for cervical myelopathy. A prospective, multicenter study with independent clinical review. Spine. 2000;25(6):670-676.
21. Scardino FB, Rocha LP, Barcelos AC, Rotta JM, Botelho RV. Is there a benefit to operating on patients (bedridden or in wheelchairs) with advanced stage cervical spondylotic myelopathy? Eur Spine J. 2010;19(5):699-705.
22. Edwards CC 2nd, Riew KD, Anderson PA, Hilibrand AS, Vaccaro AF. Cervical myelopathy. Current diagnostic and treatment strategies. Spine J. 2003;3(1):68-81.
23. Herkowitz HN. A comparison of anterior cervical fusion, cervical laminectomy, and cervical laminoplasty for the surgical management of multiple level spondylotic radiculopathy. Spine. 1988;13(7):774-780.
24. Hukuda S, Mochizuki T, Ogata M, Shichikawa K, Shimomura Y. Operations for cervical spondylotic myelopathy. A comparison of the results of anterior and posterior procedures. J Bone Joint Surg Br. 1985;67(4):609-615.
25. Fernyhough JC, White JI, LaRocca H. Fusion rates in multilevel cervical spondylosis comparing allograft fibula with autograft fibula in 126 patients. Spine. 1991;16(10 suppl):S561-S564.
26. Macdonald RL, Fehlings MG, Tator CH, et al. Multilevel anterior cervical corpectomy and fibular allograft fusion for cervical myelopathy. J Neurosurg. 1997;86(6):990-997.
27. Mayr MT, Subach BR, Comey CH, Rodts GE, Haid RW Jr. Cervical spinal stenosis: outcome after anterior corpectomy, allograft reconstruction, and instrumentation. J Neurosurg. 2002;96(1 suppl):10-16.
28. Swank ML, Lowery GL, Bhat AL, McDonough RF. Anterior cervical allograft arthrodesis and instrumentation: multilevel interbody grafting or strut graft reconstruction. Eur Spine J. 1997;6(2):138-143.
29. Böhm H, Harms J, Donk R, Zielke K. Correction and stabilization of angular kyphosis. Clin Orthop Relat Res. 1990;(258):56-61.
30. Spencer DL, DeWald RL. Simultaneous anterior and posterior surgical approach to the thoracic and lumbar spine. Spine. 1979;4(1):29-36.
31. Whitesides TE Jr, Shah SGA. On the management of unstable fractures of the thoracolumbar spine: rationale for use of anterior decompression and fusion and posterior stabilization. Spine. 1976;1(2):99-107.
32. Gok B, Sciubba DM, McLoughlin GS, et al. Surgical treatment of cervical spondylotic myelopathy with anterior compression: a review of 67 cases. J Neurosurg Spine. 2008;9(2):152-157.
33. Song KJ, Johnson JS, Choi BR, Wang JC, Lee KB. Anterior fusion alone compared with combined anterior and posterior fusion for the treatment of degenerative cervical kyphosis. J Bone Joint Surg Br. 2010;92(11):1548-1552.
34. McAfee PC, Bohlman HH, Ducker TB, Zeidman SM, Goldstein JA. One-stage anterior cervical decompression and posterior stabilization. A study of one hundred patients with a minimum of two years of follow-up. J Bone Joint Surg Am. 1995;77(12):1791-1800.
35. Schultz KD Jr, McLaughlin MR, Haid RW Jr, Comey CH, Rodts GE Jr, Alexander J. Single-stage anterior-posterior decompression and stabilization for complex cervical spine disorders. J Neurosurg. 2000;93(2 suppl):214-221.
36. Konya D, Ozgen S, Gercek A, Pamir MN. Outcomes for combined anterior and posterior surgical approaches for patients with multisegmental cervical spondylotic myelopathy. J Clin Neurosci. 2009;16(3):404-409.
37. Shufflebarger HL, Grimm JO, Bui V, Thomson JD. Anterior and posterior spinal fusion. Staged versus same-day surgery. Spine. 1991;16(8):930-933.
38. Ozturk C, Aydinli U, Vural R, Sehirlioglu A, Mutlu M. Simultaneous versus sequential one-stage combined anterior and posterior spinal surgery for spinal infections (outcomes and complications). Int Orthop. 2007;31(3):363-366.
39. Aryan HE, Sanchez-Mejia RO, Ben-Haim S, Ames CP. Successful treatment of cervical myelopathy with minimal morbidity by circumferential decompression and fusion. Eur Spine J. 2007;16(9):1401-1409.
40. Steinmetz MP, Miller J, Warbel A, Krishnaney AA, Bingaman W, Benzel EC. Regional instability following cervicothoracic junction surgery. J Neurosurg Spine. 2006;4(4):278-284.
1. Baptiste DC, Fehlings MG. Pathophysiology of cervical myelopathy. Spine J. 2006;6(6 suppl):190S-197S.
2. Kalsi-Ryan S, Karadimas SK, Fehlings MG. Cervical spondylotic myelopathy: the clinical phenomenon and the current pathobiology of an increasingly prevalent and devastating disorder. Neuroscientist. 2013;19(4):409-421.
3. Sasso RC, Ruggiero RA Jr, Reilly TM, Hall PV. Early reconstruction failures after multilevel cervical corpectomy. Spine. 2003;28(2):140-142.
4. Zdeblick TA, Hughes SS, Riew KD, Bohlman HH. Failed anterior cervical discectomy and arthrodesis. Analysis and treatment of thirty-five patients. J Bone Joint Surg Am. 1997;79(4):523-532.
5. Zhu B, Xu Y, Liu X, Liu Z, Dang G. Anterior approach versus posterior approach for the treatment of multilevel cervical spondylotic myelopathy: a systemic review and meta-analysis. Eur Spine J. 2013;22(7):1583-1593.
6. Cabraja M, Abbushi A, Koeppen D, Kroppenstedt S, Woiciechowsky C. Comparison between anterior and posterior decompression with instrumentation for cervical spondylotic myelopathy: sagittal alignment and clinical outcome. Neurosurg Focus. 2010;28(3):E15.
7. Kim PK, Alexander JT. Indications for circumferential surgery for cervical spondylotic myelopathy. Spine J. 2006;6(6 suppl):299S-307S.
8. König SA, Ranguis S, Spetzger U. Management of complex cervical instability. J Neurol Surg A Cent Eur Neurosurg. 2015;76(2):119-125.
9. König SA, Spetzger U. Surgical management of cervical spondylotic myelopathy—indications for anterior, posterior or combined procedures for decompression and stabilisation. Acta Neurochir. 2014;156(2):253-258.
10. Harel R, Hwang R, Fakhar M, et al. Circumferential cervical surgery: to stage or not to stage? J Spinal Disord Tech. 2013;26(4):183-188.
11. Siemionow K, Tyrakowski M, Patel K, Neckrysh S. Comparison of perioperative complications following staged versus one-day anterior and posterior cervical decompression and fusion crossing the cervico-thoracic junction. Neurol Neurochir Pol. 2014;48(6):403-409.
12. Nurick S. The pathogenesis of the spinal cord disorder associated with cervical spondylosis. Brain. 1972;95(1):87-100.
13. Chen CJ, Saulle D, Fu KM, Smith JS, Shaffrey CI. Dysphagia following combined anterior-posterior cervical spine surgeries. J Neurosurg Spine. 2013;19(3):279-287.
14. Boden SD, McCowin PR, Davis DO, Dina TS, Mark AS, Wiesel S. Abnormal magnetic-resonance scans of the cervical spine in asymptomatic subjects. A prospective investigation. J Bone Joint Surg Am. 1990;72(8):1178-1184.
15. Gore DR, Sepic SB, Gardner GM. Roentgenographic findings of the cervical spine in asymptomatic people. Spine. 1986;11(6):521-524.
16. Law MD Jr, Bernhardt M, White AA 3rd. Cervical spondylotic myelopathy: a review of surgical indications and decision making. Yale J Biol Med. 1993;66(3):165-177.
17. Kelly JC, Groarke PJ, Butler JS, Poynton AR, O’Byrne JM. The natural history and clinical syndromes of degenerative cervical spondylosis. Adv Orthop. 2012;(2012):393642.
18. Baron EM, Young WF. Cervical spondylotic myelopathy: a brief review of its pathophysiology, clinical course, and diagnosis. Neurosurgery. 2007;60(1 suppl 1):S35-S41.
19. Kadanka Z, Mares M, Bednarik J, et al. Approaches to spondylotic cervical myelopathy: conservative versus surgical results in a 3-year follow-up study. Spine. 2002;27(20):2205-2210.
20. Sampath P, Bendebba M, Davis JD, Ducker TB. Outcome of patients treated for cervical myelopathy. A prospective, multicenter study with independent clinical review. Spine. 2000;25(6):670-676.
21. Scardino FB, Rocha LP, Barcelos AC, Rotta JM, Botelho RV. Is there a benefit to operating on patients (bedridden or in wheelchairs) with advanced stage cervical spondylotic myelopathy? Eur Spine J. 2010;19(5):699-705.
22. Edwards CC 2nd, Riew KD, Anderson PA, Hilibrand AS, Vaccaro AF. Cervical myelopathy. Current diagnostic and treatment strategies. Spine J. 2003;3(1):68-81.
23. Herkowitz HN. A comparison of anterior cervical fusion, cervical laminectomy, and cervical laminoplasty for the surgical management of multiple level spondylotic radiculopathy. Spine. 1988;13(7):774-780.
24. Hukuda S, Mochizuki T, Ogata M, Shichikawa K, Shimomura Y. Operations for cervical spondylotic myelopathy. A comparison of the results of anterior and posterior procedures. J Bone Joint Surg Br. 1985;67(4):609-615.
25. Fernyhough JC, White JI, LaRocca H. Fusion rates in multilevel cervical spondylosis comparing allograft fibula with autograft fibula in 126 patients. Spine. 1991;16(10 suppl):S561-S564.
26. Macdonald RL, Fehlings MG, Tator CH, et al. Multilevel anterior cervical corpectomy and fibular allograft fusion for cervical myelopathy. J Neurosurg. 1997;86(6):990-997.
27. Mayr MT, Subach BR, Comey CH, Rodts GE, Haid RW Jr. Cervical spinal stenosis: outcome after anterior corpectomy, allograft reconstruction, and instrumentation. J Neurosurg. 2002;96(1 suppl):10-16.
28. Swank ML, Lowery GL, Bhat AL, McDonough RF. Anterior cervical allograft arthrodesis and instrumentation: multilevel interbody grafting or strut graft reconstruction. Eur Spine J. 1997;6(2):138-143.
29. Böhm H, Harms J, Donk R, Zielke K. Correction and stabilization of angular kyphosis. Clin Orthop Relat Res. 1990;(258):56-61.
30. Spencer DL, DeWald RL. Simultaneous anterior and posterior surgical approach to the thoracic and lumbar spine. Spine. 1979;4(1):29-36.
31. Whitesides TE Jr, Shah SGA. On the management of unstable fractures of the thoracolumbar spine: rationale for use of anterior decompression and fusion and posterior stabilization. Spine. 1976;1(2):99-107.
32. Gok B, Sciubba DM, McLoughlin GS, et al. Surgical treatment of cervical spondylotic myelopathy with anterior compression: a review of 67 cases. J Neurosurg Spine. 2008;9(2):152-157.
33. Song KJ, Johnson JS, Choi BR, Wang JC, Lee KB. Anterior fusion alone compared with combined anterior and posterior fusion for the treatment of degenerative cervical kyphosis. J Bone Joint Surg Br. 2010;92(11):1548-1552.
34. McAfee PC, Bohlman HH, Ducker TB, Zeidman SM, Goldstein JA. One-stage anterior cervical decompression and posterior stabilization. A study of one hundred patients with a minimum of two years of follow-up. J Bone Joint Surg Am. 1995;77(12):1791-1800.
35. Schultz KD Jr, McLaughlin MR, Haid RW Jr, Comey CH, Rodts GE Jr, Alexander J. Single-stage anterior-posterior decompression and stabilization for complex cervical spine disorders. J Neurosurg. 2000;93(2 suppl):214-221.
36. Konya D, Ozgen S, Gercek A, Pamir MN. Outcomes for combined anterior and posterior surgical approaches for patients with multisegmental cervical spondylotic myelopathy. J Clin Neurosci. 2009;16(3):404-409.
37. Shufflebarger HL, Grimm JO, Bui V, Thomson JD. Anterior and posterior spinal fusion. Staged versus same-day surgery. Spine. 1991;16(8):930-933.
38. Ozturk C, Aydinli U, Vural R, Sehirlioglu A, Mutlu M. Simultaneous versus sequential one-stage combined anterior and posterior spinal surgery for spinal infections (outcomes and complications). Int Orthop. 2007;31(3):363-366.
39. Aryan HE, Sanchez-Mejia RO, Ben-Haim S, Ames CP. Successful treatment of cervical myelopathy with minimal morbidity by circumferential decompression and fusion. Eur Spine J. 2007;16(9):1401-1409.
40. Steinmetz MP, Miller J, Warbel A, Krishnaney AA, Bingaman W, Benzel EC. Regional instability following cervicothoracic junction surgery. J Neurosurg Spine. 2006;4(4):278-284.


































