Before 1990, a considerable number of revisions were performed, largely for implant-associated failures, in the first few years after index primary knee arthroplasties.^1,2 Since then, surgeons, manufacturers, and hospitals have collaborated to improve implant designs, techniques, and care guidelines.^3,4 Despite the substantial improvements in designs, which led to implant longevity of more than 15 years in many cases, these devices still have limited life spans. Large studies have estimated that the risk for revision required after primary knee arthroplasty ranges from as low as 5% at 15 years to up to 9% at 10 years.^4,5

The surgical goals of revision total knee arthroplasty (TKA) are to obtain stable fixation of the prosthesis to host bone, to obtain a stable range of motion compatible with the patient’s activities of daily living, and to achieve these goals while using the smallest amount of prosthetic augments and constraint so that the soft tissues may share in load transfer.⁶ As prosthetic constraint increases, the soft tissues participate less in load sharing, and increasing stresses are put on the implant–bone interface, which further increases the risk for early implant loosening.⁷ Hence, as characteristics of a revision implant become more constrained, there is often a higher rate of aseptic loosening expected.⁸

Controversy remains regarding the ideal implant type for revision TKA. To ensure the success of revision surgery and to reduce the risks for postoperative dissatisfaction, complications, and re-revision, orthopedists must understand the types of revision implant designs available, particularly as each has its own indications and potential complications.

In this article, we review the classification systems used for revision TKA as well as the types of prosthetic designs that can be used: posterior stabilized, nonlinked constrained, rotating hinge, and modular segmental.

1. Classification of bone loss and soft-tissue integrity

To further understand revision TKA, we must consider the complexity level of these cases, particularly by evaluating degree of bone loss and soft-tissue deficiency. The most accepted way to assess bone loss both before and during surgery is to use the AORI (Anderson Orthopaedic Research Institute) classification system.⁹ Bone loss can be classified into 3 types: I, in which metaphyseal bone is intact and small bone defects do not compromise component stability; II, in which metaphyseal bone is damaged and cancellous bone loss requires cement fill, augments, or bone graft; and III, in which metaphyseal bone is deficient, and lost bone comprises a major portion of condyle or plateau and occasionally requires bone grafts or custom implants (Table 1). These patterns of bone loss are occasionally associated with detachment of the collateral ligament or patellar tendon.

In addition to understanding bone loss in revision TKA, surgeons must be aware of soft-tissue deficiencies (eg, collateral ligaments, extensor mechanism), which also influence type and amount of prosthesis constraint. Specifically, constraint choice depends on amount of bone loss and on the condition of stabilizing tissues, such as the collateral ligaments. Under conditions of minimal bone loss and intact peripheral ligaments, a less constrained device, such as a primary posterior stabilized system, can be considered. When ligaments are present but insufficient, a semiconstrained device is recommended. In the presence of medial collateral ligament attenuation or complete medial or lateral collateral ligament dysfunction, a fully constrained prosthesis is required.⁸ Therefore, amount of bone loss or soft-tissue deficiency often dictates which prosthesis to use.

For radiographic classification, the Knee Society roentgenographic evaluation and scoring system¹⁰ has been implemented to allow for uniform reporting of radiographic results and to ensure adequate preoperative planning and postoperative assessment of component alignment. This system incorporates the evaluation of alignment in the coronal, sagittal, and patellofemoral planes and assesses radiolucency using zones dividing the implant–bone interface into segments to allow for easier classification of areas of lucency. More recently, a modified version of the Knee Society system was constructed.¹¹ This modification simplifies zone classifications and accommodates more complex revision knee designs and stem extensions.

2. Posterior stabilized designs

Cruciate-retaining prostheses are seldom applicable in the revision TKA setting because of frequent damage to the posterior cruciate ligament, except in the case of simple polyethylene exchanges or, potentially, revisions of failed unicompartmental TKAs. Thus, posterior stabilized designs are the first-line choice for revision TKA (Figure 1). These prostheses are indicated only when the posterior cruciate ligament is incompetent and in the setting of adequate flexion and extension and medial and lateral collateral ligament balancing.

However, studies have shown that posterior stabilized TKAs have a limited role in revision TKAs, as the amount of ligamentous and bony damage is often underestimated in these patients, and use of a primary implant in a revision setting often requires additional augments, all of which may have contributed to the high failure rate. Thus, this design should be used only when the patient has adequate bone stock (AORI type I) and collateral ligament tension. This situation further emphasizes the importance of performing intraoperative testing for ligamentous balance and bone deficit evaluation in order to determine the most appropriate implant (Table 2).

3. Nonlinked constrained designs

Nonlinked constrained (condylar constrained) designs are the devices most commonly used for revision TKAs (>50% of revision knees). These prostheses provide increased articular constraint, which is required in patients with persistent instability, despite appropriate soft-tissue balancing. Increased articular constraint allows for more knee stability by providing progressive varus-valgus, coronal, and rotational stability with the aid of taller and wider tibial posts.¹² Specifically, these implants incorporate a tibial post that fits closely between the femoral condyles, allowing for less motion compared with a standard posterior stabilized design.¹²

In addition, these designs may be used with augments, stems, and allografts when bone loss is more substantial. In particular, stem extensions allow for load distribution to the diaphyseal regions of the tibia and femur and thereby aid in reducing the increased stress at the bone–implant interface, which is a common concern with these implants. However, these extensions cost more, require intramedullary invasion, and are associated with higher rates of leg and thigh pain.¹²

These prostheses are often implicated in cases involving a high degree of bone loss (eg, AORI type II or III). They are ideally used in cases in which complete revision of both tibial and femoral components is needed and are indicated in cases of incompetent posterior cruciate ligament, partial functional loss of medial or lateral collateral ligaments, or flexion-extension mismatch.¹³ Furthermore, use of a constrained prosthesis is recommended in the setting of varus or valgus instability, or repeated dislocations of a posterior stabilized design (Table 2).

Ten-year survivorship ranges from 85% to 96%, but this is substantially lower than the 95% to 96% for condylar constrained prostheses used in primary TKAs.^14-17 Moreover, the large discrepancy between survivorship of primary TKA and revision TKA with a constrained prosthesis further affirms that the complexity of revision surgery, rather than the prosthesis used, may have more deleterious effects on outcomes. However, surgeons must be aware that increased constraint leads to increased stress on the prosthetic interfaces with associated aseptic loosening and early failure, and this continues to be a legitimate concern.

4. Rotating hinge designs

Many patients who undergo revision TKA can be managed with a posterior stabilizing or nonlinked constrained design. However, in patients who present with severe ligamentous instability and bone loss (AORI type II or III), a rotating hinge prostheses, or highly constrained device, is often recommended (Figure 2).¹⁸ By using a rotating mobile-bearing platform, this prosthesis permits axial rotation through a metal-reinforced polyethylene-post articulation in the tibial tray. In addition, it involves use of modular diaphyseal-engaging stems and diaphyseal sleeves, which allow for the bypass of bony defects and areas of bone loss (Table 2).

However, the rigid biomechanics of hinged prostheses is associated with increased risk for aseptic loosening (aseptic 10-year survival, 60%-80%), imparted by the transfer of stresses across the bone. The higher risk for early loosening, osteolysis, and excessive wear—caused by the highly restricted biomechanics of early generations of fixed hinged designs—has led to the development of new devices with mobile mechanics. Prosthetic designs have been improved with an added rotational axis to reduce torsional stress, a patellar resurfacing option, and better stem fixation and patellofemoral kinematics. Overall, these are aimed to improve rates of instability and aseptic loosening, with promising results demonstrated in the literature.

5. Modular segmental arthroplasty designs

Segmental arthroplasty prostheses, which typically are end-of-the-line revision TKA options, are applicable only in cases of extensive bone loss (more than can be treated with allografts or augments; AORI type 3), complete ligamentous disruption/absence, loss of periprosthetic soft tissue, and multiple previous revision procedures (Figure 3). Despite the limited indications for these prostheses, they yield quick return to function without graft nonunion or resorption, and they augment ingrowth/ongrowth. Furthermore, the next surgical option could be fusion or amputation. When failures were specifically evaluated for aseptic loosening across 4 studies, the survival rate ranged from 83% to 99.5%, with the most frequent complication being infection (up to 33% in one series).^6,19-21

The major roles for segmental arthroplasty prostheses in primary TKAs are in the setting of oncologic conditions that require bony excision, or unreconstuctable fractures about the knee. Used after ancillary metastatic disease, these prostheses demonstrate positive results, according to several reports.^22,23 In the setting of revision TKA, however, these prostheses should be used only when other surgical options are unfeasible, given the high risk for infection and the re-revision rates. Currently, revision TKAs with tumor prostheses have a high failure rate (up to 50%) because of the extensive surgery and the lack of bony and soft-tissue support (Table 2).

Conclusion

Orthopedists performing revision TKAs must consider bone stock and remaining ligament stability. In particular, they should choose implants for least constraint and adequate knee stability, as these are essential in minimizing the stresses on the implant–bone interface. Ultimately, functional outcomes, survivorship, and postoperative satisfaction determine the success of these designs. However, predictors of outcomes of revision surgery are often multifactorial, and surgeons must also consider procedure complexity and patient-specific characteristics.

Before 1990, a considerable number of revisions were performed, largely for implant-associated failures, in the first few years after index primary knee arthroplasties.^1,2 Since then, surgeons, manufacturers, and hospitals have collaborated to improve implant designs, techniques, and care guidelines.^3,4 Despite the substantial improvements in designs, which led to implant longevity of more than 15 years in many cases, these devices still have limited life spans. Large studies have estimated that the risk for revision required after primary knee arthroplasty ranges from as low as 5% at 15 years to up to 9% at 10 years.^4,5

The surgical goals of revision total knee arthroplasty (TKA) are to obtain stable fixation of the prosthesis to host bone, to obtain a stable range of motion compatible with the patient’s activities of daily living, and to achieve these goals while using the smallest amount of prosthetic augments and constraint so that the soft tissues may share in load transfer.⁶ As prosthetic constraint increases, the soft tissues participate less in load sharing, and increasing stresses are put on the implant–bone interface, which further increases the risk for early implant loosening.⁷ Hence, as characteristics of a revision implant become more constrained, there is often a higher rate of aseptic loosening expected.⁸

Controversy remains regarding the ideal implant type for revision TKA. To ensure the success of revision surgery and to reduce the risks for postoperative dissatisfaction, complications, and re-revision, orthopedists must understand the types of revision implant designs available, particularly as each has its own indications and potential complications.

In this article, we review the classification systems used for revision TKA as well as the types of prosthetic designs that can be used: posterior stabilized, nonlinked constrained, rotating hinge, and modular segmental.

1. Classification of bone loss and soft-tissue integrity

To further understand revision TKA, we must consider the complexity level of these cases, particularly by evaluating degree of bone loss and soft-tissue deficiency. The most accepted way to assess bone loss both before and during surgery is to use the AORI (Anderson Orthopaedic Research Institute) classification system.⁹ Bone loss can be classified into 3 types: I, in which metaphyseal bone is intact and small bone defects do not compromise component stability; II, in which metaphyseal bone is damaged and cancellous bone loss requires cement fill, augments, or bone graft; and III, in which metaphyseal bone is deficient, and lost bone comprises a major portion of condyle or plateau and occasionally requires bone grafts or custom implants (Table 1). These patterns of bone loss are occasionally associated with detachment of the collateral ligament or patellar tendon.

In addition to understanding bone loss in revision TKA, surgeons must be aware of soft-tissue deficiencies (eg, collateral ligaments, extensor mechanism), which also influence type and amount of prosthesis constraint. Specifically, constraint choice depends on amount of bone loss and on the condition of stabilizing tissues, such as the collateral ligaments. Under conditions of minimal bone loss and intact peripheral ligaments, a less constrained device, such as a primary posterior stabilized system, can be considered. When ligaments are present but insufficient, a semiconstrained device is recommended. In the presence of medial collateral ligament attenuation or complete medial or lateral collateral ligament dysfunction, a fully constrained prosthesis is required.⁸ Therefore, amount of bone loss or soft-tissue deficiency often dictates which prosthesis to use.

For radiographic classification, the Knee Society roentgenographic evaluation and scoring system¹⁰ has been implemented to allow for uniform reporting of radiographic results and to ensure adequate preoperative planning and postoperative assessment of component alignment. This system incorporates the evaluation of alignment in the coronal, sagittal, and patellofemoral planes and assesses radiolucency using zones dividing the implant–bone interface into segments to allow for easier classification of areas of lucency. More recently, a modified version of the Knee Society system was constructed.¹¹ This modification simplifies zone classifications and accommodates more complex revision knee designs and stem extensions.

2. Posterior stabilized designs

Cruciate-retaining prostheses are seldom applicable in the revision TKA setting because of frequent damage to the posterior cruciate ligament, except in the case of simple polyethylene exchanges or, potentially, revisions of failed unicompartmental TKAs. Thus, posterior stabilized designs are the first-line choice for revision TKA (Figure 1). These prostheses are indicated only when the posterior cruciate ligament is incompetent and in the setting of adequate flexion and extension and medial and lateral collateral ligament balancing.

However, studies have shown that posterior stabilized TKAs have a limited role in revision TKAs, as the amount of ligamentous and bony damage is often underestimated in these patients, and use of a primary implant in a revision setting often requires additional augments, all of which may have contributed to the high failure rate. Thus, this design should be used only when the patient has adequate bone stock (AORI type I) and collateral ligament tension. This situation further emphasizes the importance of performing intraoperative testing for ligamentous balance and bone deficit evaluation in order to determine the most appropriate implant (Table 2).

3. Nonlinked constrained designs

Nonlinked constrained (condylar constrained) designs are the devices most commonly used for revision TKAs (>50% of revision knees). These prostheses provide increased articular constraint, which is required in patients with persistent instability, despite appropriate soft-tissue balancing. Increased articular constraint allows for more knee stability by providing progressive varus-valgus, coronal, and rotational stability with the aid of taller and wider tibial posts.¹² Specifically, these implants incorporate a tibial post that fits closely between the femoral condyles, allowing for less motion compared with a standard posterior stabilized design.¹²

In addition, these designs may be used with augments, stems, and allografts when bone loss is more substantial. In particular, stem extensions allow for load distribution to the diaphyseal regions of the tibia and femur and thereby aid in reducing the increased stress at the bone–implant interface, which is a common concern with these implants. However, these extensions cost more, require intramedullary invasion, and are associated with higher rates of leg and thigh pain.¹²

These prostheses are often implicated in cases involving a high degree of bone loss (eg, AORI type II or III). They are ideally used in cases in which complete revision of both tibial and femoral components is needed and are indicated in cases of incompetent posterior cruciate ligament, partial functional loss of medial or lateral collateral ligaments, or flexion-extension mismatch.¹³ Furthermore, use of a constrained prosthesis is recommended in the setting of varus or valgus instability, or repeated dislocations of a posterior stabilized design (Table 2).

Ten-year survivorship ranges from 85% to 96%, but this is substantially lower than the 95% to 96% for condylar constrained prostheses used in primary TKAs.^14-17 Moreover, the large discrepancy between survivorship of primary TKA and revision TKA with a constrained prosthesis further affirms that the complexity of revision surgery, rather than the prosthesis used, may have more deleterious effects on outcomes. However, surgeons must be aware that increased constraint leads to increased stress on the prosthetic interfaces with associated aseptic loosening and early failure, and this continues to be a legitimate concern.

4. Rotating hinge designs

Many patients who undergo revision TKA can be managed with a posterior stabilizing or nonlinked constrained design. However, in patients who present with severe ligamentous instability and bone loss (AORI type II or III), a rotating hinge prostheses, or highly constrained device, is often recommended (Figure 2).¹⁸ By using a rotating mobile-bearing platform, this prosthesis permits axial rotation through a metal-reinforced polyethylene-post articulation in the tibial tray. In addition, it involves use of modular diaphyseal-engaging stems and diaphyseal sleeves, which allow for the bypass of bony defects and areas of bone loss (Table 2).

However, the rigid biomechanics of hinged prostheses is associated with increased risk for aseptic loosening (aseptic 10-year survival, 60%-80%), imparted by the transfer of stresses across the bone. The higher risk for early loosening, osteolysis, and excessive wear—caused by the highly restricted biomechanics of early generations of fixed hinged designs—has led to the development of new devices with mobile mechanics. Prosthetic designs have been improved with an added rotational axis to reduce torsional stress, a patellar resurfacing option, and better stem fixation and patellofemoral kinematics. Overall, these are aimed to improve rates of instability and aseptic loosening, with promising results demonstrated in the literature.

5. Modular segmental arthroplasty designs

Segmental arthroplasty prostheses, which typically are end-of-the-line revision TKA options, are applicable only in cases of extensive bone loss (more than can be treated with allografts or augments; AORI type 3), complete ligamentous disruption/absence, loss of periprosthetic soft tissue, and multiple previous revision procedures (Figure 3). Despite the limited indications for these prostheses, they yield quick return to function without graft nonunion or resorption, and they augment ingrowth/ongrowth. Furthermore, the next surgical option could be fusion or amputation. When failures were specifically evaluated for aseptic loosening across 4 studies, the survival rate ranged from 83% to 99.5%, with the most frequent complication being infection (up to 33% in one series).^6,19-21

The major roles for segmental arthroplasty prostheses in primary TKAs are in the setting of oncologic conditions that require bony excision, or unreconstuctable fractures about the knee. Used after ancillary metastatic disease, these prostheses demonstrate positive results, according to several reports.^22,23 In the setting of revision TKA, however, these prostheses should be used only when other surgical options are unfeasible, given the high risk for infection and the re-revision rates. Currently, revision TKAs with tumor prostheses have a high failure rate (up to 50%) because of the extensive surgery and the lack of bony and soft-tissue support (Table 2).

Conclusion

Orthopedists performing revision TKAs must consider bone stock and remaining ligament stability. In particular, they should choose implants for least constraint and adequate knee stability, as these are essential in minimizing the stresses on the implant–bone interface. Ultimately, functional outcomes, survivorship, and postoperative satisfaction determine the success of these designs. However, predictors of outcomes of revision surgery are often multifactorial, and surgeons must also consider procedure complexity and patient-specific characteristics.

Before 1990, a considerable number of revisions were performed, largely for implant-associated failures, in the first few years after index primary knee arthroplasties.^1,2 Since then, surgeons, manufacturers, and hospitals have collaborated to improve implant designs, techniques, and care guidelines.^3,4 Despite the substantial improvements in designs, which led to implant longevity of more than 15 years in many cases, these devices still have limited life spans. Large studies have estimated that the risk for revision required after primary knee arthroplasty ranges from as low as 5% at 15 years to up to 9% at 10 years.^4,5

The surgical goals of revision total knee arthroplasty (TKA) are to obtain stable fixation of the prosthesis to host bone, to obtain a stable range of motion compatible with the patient’s activities of daily living, and to achieve these goals while using the smallest amount of prosthetic augments and constraint so that the soft tissues may share in load transfer.⁶ As prosthetic constraint increases, the soft tissues participate less in load sharing, and increasing stresses are put on the implant–bone interface, which further increases the risk for early implant loosening.⁷ Hence, as characteristics of a revision implant become more constrained, there is often a higher rate of aseptic loosening expected.⁸

Controversy remains regarding the ideal implant type for revision TKA. To ensure the success of revision surgery and to reduce the risks for postoperative dissatisfaction, complications, and re-revision, orthopedists must understand the types of revision implant designs available, particularly as each has its own indications and potential complications.

In this article, we review the classification systems used for revision TKA as well as the types of prosthetic designs that can be used: posterior stabilized, nonlinked constrained, rotating hinge, and modular segmental.

1. Classification of bone loss and soft-tissue integrity

To further understand revision TKA, we must consider the complexity level of these cases, particularly by evaluating degree of bone loss and soft-tissue deficiency. The most accepted way to assess bone loss both before and during surgery is to use the AORI (Anderson Orthopaedic Research Institute) classification system.⁹ Bone loss can be classified into 3 types: I, in which metaphyseal bone is intact and small bone defects do not compromise component stability; II, in which metaphyseal bone is damaged and cancellous bone loss requires cement fill, augments, or bone graft; and III, in which metaphyseal bone is deficient, and lost bone comprises a major portion of condyle or plateau and occasionally requires bone grafts or custom implants (Table 1). These patterns of bone loss are occasionally associated with detachment of the collateral ligament or patellar tendon.

In addition to understanding bone loss in revision TKA, surgeons must be aware of soft-tissue deficiencies (eg, collateral ligaments, extensor mechanism), which also influence type and amount of prosthesis constraint. Specifically, constraint choice depends on amount of bone loss and on the condition of stabilizing tissues, such as the collateral ligaments. Under conditions of minimal bone loss and intact peripheral ligaments, a less constrained device, such as a primary posterior stabilized system, can be considered. When ligaments are present but insufficient, a semiconstrained device is recommended. In the presence of medial collateral ligament attenuation or complete medial or lateral collateral ligament dysfunction, a fully constrained prosthesis is required.⁸ Therefore, amount of bone loss or soft-tissue deficiency often dictates which prosthesis to use.

For radiographic classification, the Knee Society roentgenographic evaluation and scoring system¹⁰ has been implemented to allow for uniform reporting of radiographic results and to ensure adequate preoperative planning and postoperative assessment of component alignment. This system incorporates the evaluation of alignment in the coronal, sagittal, and patellofemoral planes and assesses radiolucency using zones dividing the implant–bone interface into segments to allow for easier classification of areas of lucency. More recently, a modified version of the Knee Society system was constructed.¹¹ This modification simplifies zone classifications and accommodates more complex revision knee designs and stem extensions.

2. Posterior stabilized designs

Cruciate-retaining prostheses are seldom applicable in the revision TKA setting because of frequent damage to the posterior cruciate ligament, except in the case of simple polyethylene exchanges or, potentially, revisions of failed unicompartmental TKAs. Thus, posterior stabilized designs are the first-line choice for revision TKA (Figure 1). These prostheses are indicated only when the posterior cruciate ligament is incompetent and in the setting of adequate flexion and extension and medial and lateral collateral ligament balancing.

However, studies have shown that posterior stabilized TKAs have a limited role in revision TKAs, as the amount of ligamentous and bony damage is often underestimated in these patients, and use of a primary implant in a revision setting often requires additional augments, all of which may have contributed to the high failure rate. Thus, this design should be used only when the patient has adequate bone stock (AORI type I) and collateral ligament tension. This situation further emphasizes the importance of performing intraoperative testing for ligamentous balance and bone deficit evaluation in order to determine the most appropriate implant (Table 2).

3. Nonlinked constrained designs

Nonlinked constrained (condylar constrained) designs are the devices most commonly used for revision TKAs (>50% of revision knees). These prostheses provide increased articular constraint, which is required in patients with persistent instability, despite appropriate soft-tissue balancing. Increased articular constraint allows for more knee stability by providing progressive varus-valgus, coronal, and rotational stability with the aid of taller and wider tibial posts.¹² Specifically, these implants incorporate a tibial post that fits closely between the femoral condyles, allowing for less motion compared with a standard posterior stabilized design.¹²

In addition, these designs may be used with augments, stems, and allografts when bone loss is more substantial. In particular, stem extensions allow for load distribution to the diaphyseal regions of the tibia and femur and thereby aid in reducing the increased stress at the bone–implant interface, which is a common concern with these implants. However, these extensions cost more, require intramedullary invasion, and are associated with higher rates of leg and thigh pain.¹²

These prostheses are often implicated in cases involving a high degree of bone loss (eg, AORI type II or III). They are ideally used in cases in which complete revision of both tibial and femoral components is needed and are indicated in cases of incompetent posterior cruciate ligament, partial functional loss of medial or lateral collateral ligaments, or flexion-extension mismatch.¹³ Furthermore, use of a constrained prosthesis is recommended in the setting of varus or valgus instability, or repeated dislocations of a posterior stabilized design (Table 2).

Ten-year survivorship ranges from 85% to 96%, but this is substantially lower than the 95% to 96% for condylar constrained prostheses used in primary TKAs.^14-17 Moreover, the large discrepancy between survivorship of primary TKA and revision TKA with a constrained prosthesis further affirms that the complexity of revision surgery, rather than the prosthesis used, may have more deleterious effects on outcomes. However, surgeons must be aware that increased constraint leads to increased stress on the prosthetic interfaces with associated aseptic loosening and early failure, and this continues to be a legitimate concern.

4. Rotating hinge designs

Many patients who undergo revision TKA can be managed with a posterior stabilizing or nonlinked constrained design. However, in patients who present with severe ligamentous instability and bone loss (AORI type II or III), a rotating hinge prostheses, or highly constrained device, is often recommended (Figure 2).¹⁸ By using a rotating mobile-bearing platform, this prosthesis permits axial rotation through a metal-reinforced polyethylene-post articulation in the tibial tray. In addition, it involves use of modular diaphyseal-engaging stems and diaphyseal sleeves, which allow for the bypass of bony defects and areas of bone loss (Table 2).

However, the rigid biomechanics of hinged prostheses is associated with increased risk for aseptic loosening (aseptic 10-year survival, 60%-80%), imparted by the transfer of stresses across the bone. The higher risk for early loosening, osteolysis, and excessive wear—caused by the highly restricted biomechanics of early generations of fixed hinged designs—has led to the development of new devices with mobile mechanics. Prosthetic designs have been improved with an added rotational axis to reduce torsional stress, a patellar resurfacing option, and better stem fixation and patellofemoral kinematics. Overall, these are aimed to improve rates of instability and aseptic loosening, with promising results demonstrated in the literature.

5. Modular segmental arthroplasty designs

Segmental arthroplasty prostheses, which typically are end-of-the-line revision TKA options, are applicable only in cases of extensive bone loss (more than can be treated with allografts or augments; AORI type 3), complete ligamentous disruption/absence, loss of periprosthetic soft tissue, and multiple previous revision procedures (Figure 3). Despite the limited indications for these prostheses, they yield quick return to function without graft nonunion or resorption, and they augment ingrowth/ongrowth. Furthermore, the next surgical option could be fusion or amputation. When failures were specifically evaluated for aseptic loosening across 4 studies, the survival rate ranged from 83% to 99.5%, with the most frequent complication being infection (up to 33% in one series).^6,19-21

The major roles for segmental arthroplasty prostheses in primary TKAs are in the setting of oncologic conditions that require bony excision, or unreconstuctable fractures about the knee. Used after ancillary metastatic disease, these prostheses demonstrate positive results, according to several reports.^22,23 In the setting of revision TKA, however, these prostheses should be used only when other surgical options are unfeasible, given the high risk for infection and the re-revision rates. Currently, revision TKAs with tumor prostheses have a high failure rate (up to 50%) because of the extensive surgery and the lack of bony and soft-tissue support (Table 2).

Conclusion

Orthopedists performing revision TKAs must consider bone stock and remaining ligament stability. In particular, they should choose implants for least constraint and adequate knee stability, as these are essential in minimizing the stresses on the implant–bone interface. Ultimately, functional outcomes, survivorship, and postoperative satisfaction determine the success of these designs. However, predictors of outcomes of revision surgery are often multifactorial, and surgeons must also consider procedure complexity and patient-specific characteristics.

Rotator cuff disease is extremely common, yet indications for surgery are not well established. Unfortunately, data on the natural history of patients with rotator cuff disease are lacking, as are high-level studies evaluating the effectiveness of rotator cuff repair. This deficit is highlighted by the recent American Academy of Orthopaedic Surgeons clinical practice guideline on optimizing the management of rotator cuff problems,¹ in which none of the position statements were based on high-level evidence, and 22 of 25 statements were inconclusive or based on weak evidence or represented the panel’s consensus opinion. Although the traditional teaching is that rotator cuff tears (RCTs) should be surgically repaired, the present article reviews the evidence supporting physical therapy as a treatment for atraumatic full-thickness RCTs.

1. Less than 5% of people with RCTs undergo surgery

Studies on symptomatic and asymptomatic patients have found a high incidence of RCTs in the population at large.^2,3 By conservative estimate, 10% of people older than 65 years have full-thickness RCTs. Therefore, the 2010 US Census⁴ finding of 57 million people over age 65 years translates to 5.7 million with full-thickness RCTs. In the United States, about 275,000 rotator cuff surgeries are performed annually.⁵ That is, less than 5% of people with RCTs undergo surgery each year.

2. Symptoms do not correlate well with RCT severity

Pain is statistically more likely in patients who experience RCT progression than in those who do not.^6-8 However, RCTs may progress without pain, or there may be pain without progression, making pain a poor sign of RCT progression.⁹ The Multicenter Orthopaedic Outcome Network (MOON) Shoulder Group, studying a cohort of patients with atraumatic full-thickness RCTs, found no relationship between RCT severity and pain,¹⁰ symptom duration,¹¹ or activity level,¹² suggesting the relationship between RCTs and symptoms is not robust.

3. The high failure rates of surgical repairs do not affect patient-reported outcomes

Postoperative imaging has demonstrated high failure rates for rotator cuff repairs, yet patient-reported outcome scores do not differ between cases of intact and failed repairs.^13,14 Strength is better, however, in intact repairs.¹⁴

4. Physical therapy is effective in treating atraumatic RCTs

The MOON Shoulder Group conducted a prospective cohort study to determine the predictors of failed physical therapy for atraumatic full-thickness RCTs and to help define the indications for rotator cuff surgery.¹⁵ All enrolled patients started with a well-defined physical therapy program, and they could opt out and have surgery at any time. The physical therapy program, derived from a systematic review of the literature, was found to be effective in more than 80% of patients with follow-up of 2 years or longer.¹⁵ The most important predictor of failed nonoperative treatment was patient expectations: For a patient who thought physical therapy would work, it worked; for a patient who thought it would not work, surgery was the more likely choice. No measure of pain or RCT severity predicted the need for surgery.¹⁶ For 2 randomized trials that compared surgery and physical therapy, the success of nonoperative treatment was similar: 76% (Moosmayer and colleagues¹⁷) and 92% (Kukkonen and colleagues¹⁸).

5. What are the indications for surgery?

These data suggest that physical therapy is reasonable for patients with atraumatic RCTs. Some data suggest that traumatic RCTs should be treated with surgery and that it should be performed early.¹⁹ Other data suggest strength is better after rotator cuff repair.^13,14 What, then, are the indications for surgery? Patients with acute tears probably should have surgery; patients concerned about weakness should consider surgery but should keep in mind that its benefit depends on an intact rotator cuff repair; and patients with low expectations about the effectiveness of physical therapy probably should consider surgery.     

When discussing options with a patient, you might approach informed consent as follows:         

“Mr. Smith, you have a rotator cuff tear. So do at least 6 million other Americans over age 60 years. Only 5% of those undergo surgery. If your problem is weakness or functional loss, you should have surgery, though there is about a 30% chance the repair will fail. I don’t know how to predict the outcome of repair yet, but I worry your atraumatic tear is at risk for repair failure.

“If your problem is pain, you have an 80% chance of improving with physical therapy, and pain relief seems to last at least 2 years. If you go with physical therapy, however, there is a risk your tear could progress and start causing symptoms. I don’t yet know how likely it is your tear will progress or, if it does progress, how likely it is the tear will cause symptoms. I wish we had better information to help you make your decision.”

Rotator cuff disease is extremely common, yet indications for surgery are not well established. Unfortunately, data on the natural history of patients with rotator cuff disease are lacking, as are high-level studies evaluating the effectiveness of rotator cuff repair. This deficit is highlighted by the recent American Academy of Orthopaedic Surgeons clinical practice guideline on optimizing the management of rotator cuff problems,¹ in which none of the position statements were based on high-level evidence, and 22 of 25 statements were inconclusive or based on weak evidence or represented the panel’s consensus opinion. Although the traditional teaching is that rotator cuff tears (RCTs) should be surgically repaired, the present article reviews the evidence supporting physical therapy as a treatment for atraumatic full-thickness RCTs.

1. Less than 5% of people with RCTs undergo surgery

Studies on symptomatic and asymptomatic patients have found a high incidence of RCTs in the population at large.^2,3 By conservative estimate, 10% of people older than 65 years have full-thickness RCTs. Therefore, the 2010 US Census⁴ finding of 57 million people over age 65 years translates to 5.7 million with full-thickness RCTs. In the United States, about 275,000 rotator cuff surgeries are performed annually.⁵ That is, less than 5% of people with RCTs undergo surgery each year.

2. Symptoms do not correlate well with RCT severity

Pain is statistically more likely in patients who experience RCT progression than in those who do not.^6-8 However, RCTs may progress without pain, or there may be pain without progression, making pain a poor sign of RCT progression.⁹ The Multicenter Orthopaedic Outcome Network (MOON) Shoulder Group, studying a cohort of patients with atraumatic full-thickness RCTs, found no relationship between RCT severity and pain,¹⁰ symptom duration,¹¹ or activity level,¹² suggesting the relationship between RCTs and symptoms is not robust.

3. The high failure rates of surgical repairs do not affect patient-reported outcomes

Postoperative imaging has demonstrated high failure rates for rotator cuff repairs, yet patient-reported outcome scores do not differ between cases of intact and failed repairs.^13,14 Strength is better, however, in intact repairs.¹⁴

4. Physical therapy is effective in treating atraumatic RCTs

The MOON Shoulder Group conducted a prospective cohort study to determine the predictors of failed physical therapy for atraumatic full-thickness RCTs and to help define the indications for rotator cuff surgery.¹⁵ All enrolled patients started with a well-defined physical therapy program, and they could opt out and have surgery at any time. The physical therapy program, derived from a systematic review of the literature, was found to be effective in more than 80% of patients with follow-up of 2 years or longer.¹⁵ The most important predictor of failed nonoperative treatment was patient expectations: For a patient who thought physical therapy would work, it worked; for a patient who thought it would not work, surgery was the more likely choice. No measure of pain or RCT severity predicted the need for surgery.¹⁶ For 2 randomized trials that compared surgery and physical therapy, the success of nonoperative treatment was similar: 76% (Moosmayer and colleagues¹⁷) and 92% (Kukkonen and colleagues¹⁸).

5. What are the indications for surgery?

These data suggest that physical therapy is reasonable for patients with atraumatic RCTs. Some data suggest that traumatic RCTs should be treated with surgery and that it should be performed early.¹⁹ Other data suggest strength is better after rotator cuff repair.^13,14 What, then, are the indications for surgery? Patients with acute tears probably should have surgery; patients concerned about weakness should consider surgery but should keep in mind that its benefit depends on an intact rotator cuff repair; and patients with low expectations about the effectiveness of physical therapy probably should consider surgery.     

When discussing options with a patient, you might approach informed consent as follows:         

“Mr. Smith, you have a rotator cuff tear. So do at least 6 million other Americans over age 60 years. Only 5% of those undergo surgery. If your problem is weakness or functional loss, you should have surgery, though there is about a 30% chance the repair will fail. I don’t know how to predict the outcome of repair yet, but I worry your atraumatic tear is at risk for repair failure.

“If your problem is pain, you have an 80% chance of improving with physical therapy, and pain relief seems to last at least 2 years. If you go with physical therapy, however, there is a risk your tear could progress and start causing symptoms. I don’t yet know how likely it is your tear will progress or, if it does progress, how likely it is the tear will cause symptoms. I wish we had better information to help you make your decision.”

Rotator cuff disease is extremely common, yet indications for surgery are not well established. Unfortunately, data on the natural history of patients with rotator cuff disease are lacking, as are high-level studies evaluating the effectiveness of rotator cuff repair. This deficit is highlighted by the recent American Academy of Orthopaedic Surgeons clinical practice guideline on optimizing the management of rotator cuff problems,¹ in which none of the position statements were based on high-level evidence, and 22 of 25 statements were inconclusive or based on weak evidence or represented the panel’s consensus opinion. Although the traditional teaching is that rotator cuff tears (RCTs) should be surgically repaired, the present article reviews the evidence supporting physical therapy as a treatment for atraumatic full-thickness RCTs.

1. Less than 5% of people with RCTs undergo surgery

Studies on symptomatic and asymptomatic patients have found a high incidence of RCTs in the population at large.^2,3 By conservative estimate, 10% of people older than 65 years have full-thickness RCTs. Therefore, the 2010 US Census⁴ finding of 57 million people over age 65 years translates to 5.7 million with full-thickness RCTs. In the United States, about 275,000 rotator cuff surgeries are performed annually.⁵ That is, less than 5% of people with RCTs undergo surgery each year.

2. Symptoms do not correlate well with RCT severity

Pain is statistically more likely in patients who experience RCT progression than in those who do not.^6-8 However, RCTs may progress without pain, or there may be pain without progression, making pain a poor sign of RCT progression.⁹ The Multicenter Orthopaedic Outcome Network (MOON) Shoulder Group, studying a cohort of patients with atraumatic full-thickness RCTs, found no relationship between RCT severity and pain,¹⁰ symptom duration,¹¹ or activity level,¹² suggesting the relationship between RCTs and symptoms is not robust.

3. The high failure rates of surgical repairs do not affect patient-reported outcomes

Postoperative imaging has demonstrated high failure rates for rotator cuff repairs, yet patient-reported outcome scores do not differ between cases of intact and failed repairs.^13,14 Strength is better, however, in intact repairs.¹⁴

4. Physical therapy is effective in treating atraumatic RCTs

The MOON Shoulder Group conducted a prospective cohort study to determine the predictors of failed physical therapy for atraumatic full-thickness RCTs and to help define the indications for rotator cuff surgery.¹⁵ All enrolled patients started with a well-defined physical therapy program, and they could opt out and have surgery at any time. The physical therapy program, derived from a systematic review of the literature, was found to be effective in more than 80% of patients with follow-up of 2 years or longer.¹⁵ The most important predictor of failed nonoperative treatment was patient expectations: For a patient who thought physical therapy would work, it worked; for a patient who thought it would not work, surgery was the more likely choice. No measure of pain or RCT severity predicted the need for surgery.¹⁶ For 2 randomized trials that compared surgery and physical therapy, the success of nonoperative treatment was similar: 76% (Moosmayer and colleagues¹⁷) and 92% (Kukkonen and colleagues¹⁸).

5. What are the indications for surgery?

These data suggest that physical therapy is reasonable for patients with atraumatic RCTs. Some data suggest that traumatic RCTs should be treated with surgery and that it should be performed early.¹⁹ Other data suggest strength is better after rotator cuff repair.^13,14 What, then, are the indications for surgery? Patients with acute tears probably should have surgery; patients concerned about weakness should consider surgery but should keep in mind that its benefit depends on an intact rotator cuff repair; and patients with low expectations about the effectiveness of physical therapy probably should consider surgery.     

When discussing options with a patient, you might approach informed consent as follows:         

“Mr. Smith, you have a rotator cuff tear. So do at least 6 million other Americans over age 60 years. Only 5% of those undergo surgery. If your problem is weakness or functional loss, you should have surgery, though there is about a 30% chance the repair will fail. I don’t know how to predict the outcome of repair yet, but I worry your atraumatic tear is at risk for repair failure.

“If your problem is pain, you have an 80% chance of improving with physical therapy, and pain relief seems to last at least 2 years. If you go with physical therapy, however, there is a risk your tear could progress and start causing symptoms. I don’t yet know how likely it is your tear will progress or, if it does progress, how likely it is the tear will cause symptoms. I wish we had better information to help you make your decision.”

Sirolimus protects organ-transplant recipients against developing skin cancer, reducing their risk by 40%, according to a retrospective cohort study published in JAMA Dermatology on Jan. 20.

Recipients of solid organs are at three- to fourfold higher risk of developing cancer, compared with the general population, and the most common type they get is nonmelanoma skin cancer. The risk of developing cutaneous squamous cell carcinoma is 65-250 times higher in organ-transplant recipients. Drugs that reduce the growth and proliferation of tumor cells by inhibiting mTOR (mammalian target of rapamycin), including sirolimus, are believed to reduce this cancer risk, said Pritesh S. Karia of the department of dermatology, Brigham and Women’s Hospital and Harvard University, Boston, and his associates (JAMA Dermatol. 2016 Jan 20. doi: 10.1001/jamadermatol.2015.5548).

The investigators reviewed the electronic medical records of 329 patients (mean age, 56 years) who underwent organ transplantation at one of the two medical centers during a 9-year period and who then developed a cancer of any type. The study participants received renal (53.8%), heart (17.6%), lung (16.4%), liver (10.3%), or mixed-organ (1.8%) transplants. The most common index cancers they developed post transplant included cutaneous squamous cell carcinoma (31.9%), basal cell carcinoma (22.5%), and melanoma (2.7%).

Of the 329 patients, 97 (29.5%) then received sirolimus, while 232 (70.5%) did not. During a median follow-up of 38 months, 130 of these patients (39.5%) developed a second posttransplant cancer. The sirolimus-treated group showed a reduction in risk for cancer of any type, compared with the group that did not receive sirolimus (30.9% of 97 vs. 43.1% of 232).

Nearly all (88.5%) of the second posttransplant cancers that developed were skin cancers, and sirolimus reduced the risk of skin cancers by 40%. The 1-year, 3-year, and 5-year rates of skin cancer after an index posttransplant cancer were 9.3%, 20.6%, and 24.7% in the sirolimus group, compared with 17.7%, 31.0%, and 35.8%, respectively, in the untreated group, “thus demonstrating a lower risk for skin cancer with sirolimus treatment,” they said.

“Even for patients who have already had difficulty with skin cancer formation, mTOR inhibition appears to be of benefit. No difference in cancer outcomes was observable between sirolimus-treated and [untreated] groups because poor outcomes were rare,” Mr. Karia and his associates wrote.

These findings suggest that sirolimus chemoprevention should be considered for the subset of organ-transplant recipients who develop post-transplant cancer, they noted. The results also highlight the need for dermatologists and transplant physicians “to be aware of skin cancer history, coordinate regular posttransplant surveillance of skin cancers” in patients with organ transplant recipients, especially those with a history of skin cancer, and to communicate closely “as skin cancers form to consider reduction in immunosuppressive therapy or conversion to an mTOR-based regimen if skin cancer formation is of concern,” they added.

This study was supported by sirolimus manufacturer Novartis Pharmaceuticals. Mr. Karia and his associates reported having no relevant financial disclosures.

Sirolimus protects organ-transplant recipients against developing skin cancer, reducing their risk by 40%, according to a retrospective cohort study published in JAMA Dermatology on Jan. 20.

Recipients of solid organs are at three- to fourfold higher risk of developing cancer, compared with the general population, and the most common type they get is nonmelanoma skin cancer. The risk of developing cutaneous squamous cell carcinoma is 65-250 times higher in organ-transplant recipients. Drugs that reduce the growth and proliferation of tumor cells by inhibiting mTOR (mammalian target of rapamycin), including sirolimus, are believed to reduce this cancer risk, said Pritesh S. Karia of the department of dermatology, Brigham and Women’s Hospital and Harvard University, Boston, and his associates (JAMA Dermatol. 2016 Jan 20. doi: 10.1001/jamadermatol.2015.5548).

The investigators reviewed the electronic medical records of 329 patients (mean age, 56 years) who underwent organ transplantation at one of the two medical centers during a 9-year period and who then developed a cancer of any type. The study participants received renal (53.8%), heart (17.6%), lung (16.4%), liver (10.3%), or mixed-organ (1.8%) transplants. The most common index cancers they developed post transplant included cutaneous squamous cell carcinoma (31.9%), basal cell carcinoma (22.5%), and melanoma (2.7%).

Of the 329 patients, 97 (29.5%) then received sirolimus, while 232 (70.5%) did not. During a median follow-up of 38 months, 130 of these patients (39.5%) developed a second posttransplant cancer. The sirolimus-treated group showed a reduction in risk for cancer of any type, compared with the group that did not receive sirolimus (30.9% of 97 vs. 43.1% of 232).

Nearly all (88.5%) of the second posttransplant cancers that developed were skin cancers, and sirolimus reduced the risk of skin cancers by 40%. The 1-year, 3-year, and 5-year rates of skin cancer after an index posttransplant cancer were 9.3%, 20.6%, and 24.7% in the sirolimus group, compared with 17.7%, 31.0%, and 35.8%, respectively, in the untreated group, “thus demonstrating a lower risk for skin cancer with sirolimus treatment,” they said.

“Even for patients who have already had difficulty with skin cancer formation, mTOR inhibition appears to be of benefit. No difference in cancer outcomes was observable between sirolimus-treated and [untreated] groups because poor outcomes were rare,” Mr. Karia and his associates wrote.

These findings suggest that sirolimus chemoprevention should be considered for the subset of organ-transplant recipients who develop post-transplant cancer, they noted. The results also highlight the need for dermatologists and transplant physicians “to be aware of skin cancer history, coordinate regular posttransplant surveillance of skin cancers” in patients with organ transplant recipients, especially those with a history of skin cancer, and to communicate closely “as skin cancers form to consider reduction in immunosuppressive therapy or conversion to an mTOR-based regimen if skin cancer formation is of concern,” they added.

This study was supported by sirolimus manufacturer Novartis Pharmaceuticals. Mr. Karia and his associates reported having no relevant financial disclosures.

Sirolimus protects organ-transplant recipients against developing skin cancer, reducing their risk by 40%, according to a retrospective cohort study published in JAMA Dermatology on Jan. 20.

Recipients of solid organs are at three- to fourfold higher risk of developing cancer, compared with the general population, and the most common type they get is nonmelanoma skin cancer. The risk of developing cutaneous squamous cell carcinoma is 65-250 times higher in organ-transplant recipients. Drugs that reduce the growth and proliferation of tumor cells by inhibiting mTOR (mammalian target of rapamycin), including sirolimus, are believed to reduce this cancer risk, said Pritesh S. Karia of the department of dermatology, Brigham and Women’s Hospital and Harvard University, Boston, and his associates (JAMA Dermatol. 2016 Jan 20. doi: 10.1001/jamadermatol.2015.5548).

The investigators reviewed the electronic medical records of 329 patients (mean age, 56 years) who underwent organ transplantation at one of the two medical centers during a 9-year period and who then developed a cancer of any type. The study participants received renal (53.8%), heart (17.6%), lung (16.4%), liver (10.3%), or mixed-organ (1.8%) transplants. The most common index cancers they developed post transplant included cutaneous squamous cell carcinoma (31.9%), basal cell carcinoma (22.5%), and melanoma (2.7%).

Of the 329 patients, 97 (29.5%) then received sirolimus, while 232 (70.5%) did not. During a median follow-up of 38 months, 130 of these patients (39.5%) developed a second posttransplant cancer. The sirolimus-treated group showed a reduction in risk for cancer of any type, compared with the group that did not receive sirolimus (30.9% of 97 vs. 43.1% of 232).

Nearly all (88.5%) of the second posttransplant cancers that developed were skin cancers, and sirolimus reduced the risk of skin cancers by 40%. The 1-year, 3-year, and 5-year rates of skin cancer after an index posttransplant cancer were 9.3%, 20.6%, and 24.7% in the sirolimus group, compared with 17.7%, 31.0%, and 35.8%, respectively, in the untreated group, “thus demonstrating a lower risk for skin cancer with sirolimus treatment,” they said.

“Even for patients who have already had difficulty with skin cancer formation, mTOR inhibition appears to be of benefit. No difference in cancer outcomes was observable between sirolimus-treated and [untreated] groups because poor outcomes were rare,” Mr. Karia and his associates wrote.

These findings suggest that sirolimus chemoprevention should be considered for the subset of organ-transplant recipients who develop post-transplant cancer, they noted. The results also highlight the need for dermatologists and transplant physicians “to be aware of skin cancer history, coordinate regular posttransplant surveillance of skin cancers” in patients with organ transplant recipients, especially those with a history of skin cancer, and to communicate closely “as skin cancers form to consider reduction in immunosuppressive therapy or conversion to an mTOR-based regimen if skin cancer formation is of concern,” they added.

This study was supported by sirolimus manufacturer Novartis Pharmaceuticals. Mr. Karia and his associates reported having no relevant financial disclosures.

Compression of the ulnar nerve at the elbow, also referred to as cubital tunnel syndrome (CuTS), is the second most common peripheral nerve compression syndrome in the upper extremity.^1,2 Although the ulnar nerve can be compressed at 5 different sites, including arcade of Struthers, medial intermuscular septum, medial epicondyle, and deep flexor aponeurosis, the cubital tunnel is most commonly affected.³ Patients typically present with paresthesias in the fourth and fifth digits and weakness of hand muscle intrinsics. Activity-related pain or pain at the medial elbow can also occur in more advanced pathology.⁴ It is estimated that conservative therapy fails and surgical intervention is required in up to 30% of patients with CuTS.¹ Surgical approaches range from in situ decompression to transposition techniques, but there is no consensus in the orthopedic community as to which technique offers the best results. In a 2008 meta-analysis, Macadam and colleagues⁵ found no statistical differences in outcomes among the various surgical approaches. Nevertheless, subcutaneous transposition of the ulnar nerve at the elbow is a popular option.⁶

Despite the widespread success of surgical intervention for CuTS, persistent or recurrent pain occurs in 9.9% to 21.0% of cases.^7-10 In addition, several investigators have cited perineural scarring as a major cause of recurrent symptoms after primary surgery.^11-14 Filippi and colleagues¹¹ noted that patients who required reoperation after primary anterior transposition had “serious epineural fibrosis and fibrosis around the transposed ulnar nerve.” At our institution, we have similarly found that scarring of the fascial sling around the ulnar nerve led to recurrence of CuTS within 4 months after initial surgery (Figure 1).

We therefore prefer to use a vascularized adipose flap to secure the anteriorly transposed ulnar nerve. This flap provides a pliable, vascularized adipose environment for the nerve, which helps reduce nerve adherence and may enhance nerve recovery.¹⁵ In the study reported here, we retrospectively reviewed the long-term outcomes of ulnar nerve anterior subcutaneous transposition secured with either an adipose flap or a fascial sling. We hypothesized that patients in the 2 groups (adipose flap, fascial sling) would have equivalent outcomes.

Materials and Methods

After obtaining institutional review board approval, we reviewed the medical and surgical records of 104 patients (107 limbs) who underwent transposition of the ulnar nerve secured with either an adipose flap (27 limbs) or a fascial sling (80 limbs) over a 14-year period. The fascial sling cohort was used as a comparison group, matched to the adipose flap cohort by sex, age at time of surgery, hand dominance, symptom duration, and length of follow-up (Table 1). Patients were indicated for surgery and were included in the study if they had a history and physical examination consistent with primary CuTS, symptom duration longer than 1 year, and failed conservative management, including activity modification, night splinting, elbow pads, occupational therapy, and home exercise regimen. Electrodiagnostic testing was used at the discretion of the attending surgeon when the diagnosis was not clear from the history and physical examination. All fascial sling procedures were performed at our institution by 1 of 3 fellowship-trained hand surgeons, including Dr. Rosenwasser. The adipose flap modification was performed only by Dr. Rosenwasser. Of the 27 patients in the adipose flap group, 23 underwent surgery for primary CuTS and were included in the study; the other 4 (revision cases) were excluded; 1 patient subsequently died of a cause unrelated to the surgical procedure, and 6 were lost to follow-up. Of the 80 patients in the fascial sling group, 30 underwent surgery for primary CuTS; 5 died before follow-up, and 8 declined to participate.

Thirty-three patients (16 adipose flap, 17 fascial sling) met the inclusion criteria. Of the 16 adipose flap patients, 15 underwent the physical examination and completed the questionnaire, and 1 was interviewed by telephone. Similarly, of the 17 fascial sling patients, 15 underwent the physical examination and completed the questionnaire, and 2 were interviewed by telephone. There were no bilateral cases. Conservative management (activity modification, night splinting, elbow pads, occupational therapy, home exercise) failed in all cases.

A trained study team member who was not part of the surgical team performed follow-up evaluations using objective outcome measures and subjective questionnaires. Patients were assessed at a mean follow-up of 5.6 years (range, 1.6-15.9 years). Patients completed the DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire¹⁶ and visual analog scales (VASs) for pain, numbness, tingling, and weakness in the ulnar nerve distribution. They also rated the presence of night symptoms that were interfering with sleep. The Modified Bishop Rating Scale (MBRS) was used to quantify patient self-reported data^17,18 (Figure 2). The MBRS measures overall satisfaction, symptom improvement, presence of residual symptoms, ability to engage in activities, work capability, and subjective changes in strength and sensibility.

In the physical examinations, we tested for Tinel, Wartenberg, and Froment signs; performed an elbow flexion test; and measured elbow range of motion for flexion and extension as well as forearm pronation and supination. We also evaluated lateral pinch strength and grip strength, using a Jamar hydraulic pinch gauge and a Jamar dynamometer (Therapeutic Equipment Corp) and taking the average of 3 assessments. Fifth-digit abduction strength was graded on a standard muscle strength scale. Two-point discrimination was measured at the middle, ring, and small digits of the operated and contralateral hands.¹⁹

Surgical Technique

Standard ulnar nerve decompression with anterior subcutaneous transposition and the following modifications were performed on all patients.²⁰ A posteromedial incision parallel to the intermuscular septum was developed and the ulnar nerve identified. Minimizing stripping of the vascular mesentery, the dissection continued along the course of the nerve, and the medial intermuscular septum was excised to prevent secondary compression after transposition. The ulnar nerve was mobilized and transposed anterior to the medial epicondyle (Figure 3). For patients who received the fascial sling, a fascial sleeve was elevated from the flexor-pronator mass and sutured to the edge of the retinaculum securing the nerve. For patients who received the adipose flap, the flap with its vascular pedicle intact was elevated from the subcutaneous tissue of the anterior skin overlying the transposed nerve. The adipose tissue was sharply dissected in half while sufficient subcutaneous tissue was kept between the skin and the flap. A plane was developed based on an anterior adipose pedicle, which included a cutaneous artery and a vein that would supply the vascularized adipose flap. The flap was elevated and wrapped around the nerve without tension while the ulnar nerve was protected from being kinked by the construct. The flap was sutured to the anterior subcutaneous tissue to create a tunnel of adipose tissue surrounding the nerve along its length (Figure 4). The elbow was then flexed and extended to ensure free nerve gliding before wound closure.

The patient was allowed to move the elbow within the bulky dressings immediately after surgery. After 2 weeks, sutures were removed. Formal occupational therapy is not needed for these patients, except in the presence of significant weakness.

Results

As mentioned, the 2 groups were matched on demographics: age at time of surgery, sex, symptom duration, and length of follow-up (Table 1).

For the 16 adipose flap patients (Table 2), mean DASH score was 19.9 (range, 0-71.7). Seven of these patients reported upper extremity pain with a mean VAS score of 1.7 (range, 0-8); 4 patients reported pain in the wrist and fourth and fifth digits; only 1 patient reported pain that occasionally woke the patient from sleep. Constant numbness was present in 6 patients. Four patients reported constant mild tingling in the hand, and 11 reported intermittent tingling. Eleven patients (68.7%) reported operated-arm weakness with a mean VAS score of 3.4 (range, 0-8). In patients who had a physical examination, mean elbow flexion–extension arc of motion was 134° (range, 95°-150°), representing 99% of the motion of the contralateral arm. Mean pronation–supination arc was 174° (range, 150°-180°), accounting for 104% of the contralateral arm. Mean lateral pinch strength was 73% of the contralateral arm, and mean grip strength was 114% of the contralateral arm. The Tinel sign was present in 2 patients, the Froment sign was present in 3 patients, and the elbow flexion test was positive in 2 patients. No patient had a positive Wartenberg sign. On the MBRS, 10 patients had an excellent score, and 6 had a good score.

For the 17 fascial sling patients (Table 2), mean DASH score was 22.7 (range, 0-63.3). Three patients reported upper extremity pain with a mean VAS score of 1.4 (range, 0-7); 3 patients reported pain that occasionally woke them from sleep. Seven patients had constant numbness in the distribution of the ulnar nerve. Two patients had constant paresthesias, and 7 had intermittent paresthesias. Nine patients (52.9%) reported arm weakness with a mean VAS score of 2.5 (range, 0-8). Mean elbow flexion–extension arc of motion was 136° (range, 100°-150°), representing 100% of the contralateral arm. Mean pronation–supination arc was 187° (range, 155°-225°), accounting for 102% of the contralateral arm. Mean lateral pinch strength was 93% of the contralateral arm, and mean grip strength was 80% of the contralateral arm. The Tinel sign was present in 6 patients, the Froment sign in 3 patients, and the Wartenberg sign in 2 patients. The elbow flexion test was positive in 4 patients. On the MBRS, 10 patients had an excellent score, and 7 had a good score.

There was no recurrence of CuTS in either group. One adipose flap patient developed a wound infection that required reoperation.

Discussion

Ulnar neuropathy was described by Magee and Phalen²¹ in 1949 and termed cubital tunnel syndrome by Feindel and Stratford²² in 1958. Since then, numerous procedures, including in situ decompression, medial epicondylectomy, and endoscopic decompression,^23,24 have been advocated for the treatment of this condition. In addition, anterior transposition, which involves securing the ulnar nerve in a submuscular, intramuscular, or subcutaneous sleeve,⁶ remains a popular option. Despite more than half a century of surgical treatment for this condition, there is no consensus about which procedure offers the best outcomes. Bartels and colleagues⁸ retrospectively reviewed surgical treatments for CuTS, examining 3148 arms over a 27-year period. They found simple decompression and anterior intramuscular transposition had the best results, followed by medial epicondylectomy and anterior subcutaneous transposition, with anterior submuscular transposition yielding the poorest outcomes. Despite these findings, the operative groups’ recurrence rates remained significant. These results were challenged in a 2008 meta-analysis⁵ that found no significant difference among simple decompression, subcutaneous transposition, and submuscular transposition and instead demonstrated trends toward better outcomes with anterior transposition. Osterman and Davis⁷ reported a 5% to 15% rate of unsatisfactory outcomes with anterior subcutaneous transposition, a popular technique used by surgeons at our institution.

The causes for failure or recurrence of ulnar neuropathy after surgical intervention are multifactorial and include preexisting medical conditions and improper operative technique. It is well established that failure to excise all 5 anatomical points of entrapment, or creation of new points of tension during surgery, leads to poor outcomes.¹² Nevertheless, the contribution of perineural scarring to postoperative recurrent ulnar neuropathy is currently being recognized: Gabel and Amadio¹³ described postoperative fibrosis in one-third of their patients with surgically treated recurrent CuTS, Rogers and colleagues¹⁴ noted dense perineural fibrosis after intramuscular and subcutaneous transposition procedures, Filippi and colleagues¹¹ cited serious epineural fibrosis and fibrosis around the ulnar nerve as the main findings in their study of 22 patients with recurrent ulnar neuropathy, and Vogel and colleagues¹² found that 88% of their patients with persistent CuTS after surgery exhibited perineural scarring.

We think that use of a scar tissue barrier during ulnar nerve transposition reduces the incidence of cicatrix and produces better outcomes—a position largely echoed by the orthopedic community, as fascial, fasciocutaneous, free, and venous flaps have all been used for such purposes.^25,26 Vein wrapping has demonstrated good recovery of a nerve after perineural scarring.²⁷ Advocates of intramuscular transposition argue that their technique provides the nerve with a vascularized tunnel, as segmental vascular stripping is an inevitability in transposition. However, this technique increases the incidence of scarring and potential muscle damage.^28,29 We think the pedicled adipofascial flap benefits the peripheral nerve by providing a scar tissue barrier and an optimal milieu for vascular regeneration. Kilic and colleagues¹⁵ demonstrated the regenerative effects of adipose tissue flaps on peripheral nerves after crush injuries in a rat model, and Strickland and colleagues³⁰ retrospectively examined the effects of hypothenar fat flaps on recalcitrant carpal tunnel syndrome, showing excellent results for this procedure. It is hypothesized that adipose tissue provides not only adipose-derived stem cells but also a rich vascular bed on which nerves will regenerate.

For all patients in the present study, symptoms improved, though the adipose flap and fascial sling groups were not significantly different in their outcomes. We used the MBRS to quantify and compare the groups’ patient-rated outcomes. No statistically significant difference was found between the adipose flap and fascial sling groups. On the MBRS, excellent and good outcomes were reported by 62.5% and 37.5% of the adipose flap patients, respectively, and 59% and 41% of the fascial sling patients (Table 3). Likewise, objective measurements did not show a significant difference between the 2 interventions—indicating that, compared with the current standard of care, adipose flaps are more efficacious in securing the anteriorly transposed nerve.

Complications of the adipose flap technique are consistent with those reported for other techniques for anterior transposition of the ulnar nerve. The most common complication is hematoma, which can be avoided with meticulous hemostasis. Damage of the medial antebrachial cutaneous nerve or motor branches to the flexor carpi ulnaris has been reported for the fascial technique (we have not had such outcomes at our institution). Contraindications to the adipofascial technique include insufficient subcutaneous adipose tissue for covering the ulnar nerve.

This study was limited by its retrospective setup, which reduced access to preoperative objective and subjective data. The small sample size also limited our ability to demonstrate the advantageous effects of an adipofascial flap in preventing postoperative perineural scarring.

The adipose flap technique is a viable option for securing the anteriorly transposed ulnar nerve. Outcomes in this study demonstrated an efficacy comparable to that of the fascial sling technique. Symptoms resolve or improve, and the majority of patients are satisfied with long-term surgical outcomes. The adipofascial flap may have additional advantages, as it provides a pliable, vascular fat envelope mimicking the natural fatty environment of peripheral nerves.

Compression of the ulnar nerve at the elbow, also referred to as cubital tunnel syndrome (CuTS), is the second most common peripheral nerve compression syndrome in the upper extremity.^1,2 Although the ulnar nerve can be compressed at 5 different sites, including arcade of Struthers, medial intermuscular septum, medial epicondyle, and deep flexor aponeurosis, the cubital tunnel is most commonly affected.³ Patients typically present with paresthesias in the fourth and fifth digits and weakness of hand muscle intrinsics. Activity-related pain or pain at the medial elbow can also occur in more advanced pathology.⁴ It is estimated that conservative therapy fails and surgical intervention is required in up to 30% of patients with CuTS.¹ Surgical approaches range from in situ decompression to transposition techniques, but there is no consensus in the orthopedic community as to which technique offers the best results. In a 2008 meta-analysis, Macadam and colleagues⁵ found no statistical differences in outcomes among the various surgical approaches. Nevertheless, subcutaneous transposition of the ulnar nerve at the elbow is a popular option.⁶

Despite the widespread success of surgical intervention for CuTS, persistent or recurrent pain occurs in 9.9% to 21.0% of cases.^7-10 In addition, several investigators have cited perineural scarring as a major cause of recurrent symptoms after primary surgery.^11-14 Filippi and colleagues¹¹ noted that patients who required reoperation after primary anterior transposition had “serious epineural fibrosis and fibrosis around the transposed ulnar nerve.” At our institution, we have similarly found that scarring of the fascial sling around the ulnar nerve led to recurrence of CuTS within 4 months after initial surgery (Figure 1).

We therefore prefer to use a vascularized adipose flap to secure the anteriorly transposed ulnar nerve. This flap provides a pliable, vascularized adipose environment for the nerve, which helps reduce nerve adherence and may enhance nerve recovery.¹⁵ In the study reported here, we retrospectively reviewed the long-term outcomes of ulnar nerve anterior subcutaneous transposition secured with either an adipose flap or a fascial sling. We hypothesized that patients in the 2 groups (adipose flap, fascial sling) would have equivalent outcomes.

Materials and Methods

After obtaining institutional review board approval, we reviewed the medical and surgical records of 104 patients (107 limbs) who underwent transposition of the ulnar nerve secured with either an adipose flap (27 limbs) or a fascial sling (80 limbs) over a 14-year period. The fascial sling cohort was used as a comparison group, matched to the adipose flap cohort by sex, age at time of surgery, hand dominance, symptom duration, and length of follow-up (Table 1). Patients were indicated for surgery and were included in the study if they had a history and physical examination consistent with primary CuTS, symptom duration longer than 1 year, and failed conservative management, including activity modification, night splinting, elbow pads, occupational therapy, and home exercise regimen. Electrodiagnostic testing was used at the discretion of the attending surgeon when the diagnosis was not clear from the history and physical examination. All fascial sling procedures were performed at our institution by 1 of 3 fellowship-trained hand surgeons, including Dr. Rosenwasser. The adipose flap modification was performed only by Dr. Rosenwasser. Of the 27 patients in the adipose flap group, 23 underwent surgery for primary CuTS and were included in the study; the other 4 (revision cases) were excluded; 1 patient subsequently died of a cause unrelated to the surgical procedure, and 6 were lost to follow-up. Of the 80 patients in the fascial sling group, 30 underwent surgery for primary CuTS; 5 died before follow-up, and 8 declined to participate.

Thirty-three patients (16 adipose flap, 17 fascial sling) met the inclusion criteria. Of the 16 adipose flap patients, 15 underwent the physical examination and completed the questionnaire, and 1 was interviewed by telephone. Similarly, of the 17 fascial sling patients, 15 underwent the physical examination and completed the questionnaire, and 2 were interviewed by telephone. There were no bilateral cases. Conservative management (activity modification, night splinting, elbow pads, occupational therapy, home exercise) failed in all cases.

A trained study team member who was not part of the surgical team performed follow-up evaluations using objective outcome measures and subjective questionnaires. Patients were assessed at a mean follow-up of 5.6 years (range, 1.6-15.9 years). Patients completed the DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire¹⁶ and visual analog scales (VASs) for pain, numbness, tingling, and weakness in the ulnar nerve distribution. They also rated the presence of night symptoms that were interfering with sleep. The Modified Bishop Rating Scale (MBRS) was used to quantify patient self-reported data^17,18 (Figure 2). The MBRS measures overall satisfaction, symptom improvement, presence of residual symptoms, ability to engage in activities, work capability, and subjective changes in strength and sensibility.

In the physical examinations, we tested for Tinel, Wartenberg, and Froment signs; performed an elbow flexion test; and measured elbow range of motion for flexion and extension as well as forearm pronation and supination. We also evaluated lateral pinch strength and grip strength, using a Jamar hydraulic pinch gauge and a Jamar dynamometer (Therapeutic Equipment Corp) and taking the average of 3 assessments. Fifth-digit abduction strength was graded on a standard muscle strength scale. Two-point discrimination was measured at the middle, ring, and small digits of the operated and contralateral hands.¹⁹

Surgical Technique

Standard ulnar nerve decompression with anterior subcutaneous transposition and the following modifications were performed on all patients.²⁰ A posteromedial incision parallel to the intermuscular septum was developed and the ulnar nerve identified. Minimizing stripping of the vascular mesentery, the dissection continued along the course of the nerve, and the medial intermuscular septum was excised to prevent secondary compression after transposition. The ulnar nerve was mobilized and transposed anterior to the medial epicondyle (Figure 3). For patients who received the fascial sling, a fascial sleeve was elevated from the flexor-pronator mass and sutured to the edge of the retinaculum securing the nerve. For patients who received the adipose flap, the flap with its vascular pedicle intact was elevated from the subcutaneous tissue of the anterior skin overlying the transposed nerve. The adipose tissue was sharply dissected in half while sufficient subcutaneous tissue was kept between the skin and the flap. A plane was developed based on an anterior adipose pedicle, which included a cutaneous artery and a vein that would supply the vascularized adipose flap. The flap was elevated and wrapped around the nerve without tension while the ulnar nerve was protected from being kinked by the construct. The flap was sutured to the anterior subcutaneous tissue to create a tunnel of adipose tissue surrounding the nerve along its length (Figure 4). The elbow was then flexed and extended to ensure free nerve gliding before wound closure.

The patient was allowed to move the elbow within the bulky dressings immediately after surgery. After 2 weeks, sutures were removed. Formal occupational therapy is not needed for these patients, except in the presence of significant weakness.

Results

As mentioned, the 2 groups were matched on demographics: age at time of surgery, sex, symptom duration, and length of follow-up (Table 1).

For the 16 adipose flap patients (Table 2), mean DASH score was 19.9 (range, 0-71.7). Seven of these patients reported upper extremity pain with a mean VAS score of 1.7 (range, 0-8); 4 patients reported pain in the wrist and fourth and fifth digits; only 1 patient reported pain that occasionally woke the patient from sleep. Constant numbness was present in 6 patients. Four patients reported constant mild tingling in the hand, and 11 reported intermittent tingling. Eleven patients (68.7%) reported operated-arm weakness with a mean VAS score of 3.4 (range, 0-8). In patients who had a physical examination, mean elbow flexion–extension arc of motion was 134° (range, 95°-150°), representing 99% of the motion of the contralateral arm. Mean pronation–supination arc was 174° (range, 150°-180°), accounting for 104% of the contralateral arm. Mean lateral pinch strength was 73% of the contralateral arm, and mean grip strength was 114% of the contralateral arm. The Tinel sign was present in 2 patients, the Froment sign was present in 3 patients, and the elbow flexion test was positive in 2 patients. No patient had a positive Wartenberg sign. On the MBRS, 10 patients had an excellent score, and 6 had a good score.

For the 17 fascial sling patients (Table 2), mean DASH score was 22.7 (range, 0-63.3). Three patients reported upper extremity pain with a mean VAS score of 1.4 (range, 0-7); 3 patients reported pain that occasionally woke them from sleep. Seven patients had constant numbness in the distribution of the ulnar nerve. Two patients had constant paresthesias, and 7 had intermittent paresthesias. Nine patients (52.9%) reported arm weakness with a mean VAS score of 2.5 (range, 0-8). Mean elbow flexion–extension arc of motion was 136° (range, 100°-150°), representing 100% of the contralateral arm. Mean pronation–supination arc was 187° (range, 155°-225°), accounting for 102% of the contralateral arm. Mean lateral pinch strength was 93% of the contralateral arm, and mean grip strength was 80% of the contralateral arm. The Tinel sign was present in 6 patients, the Froment sign in 3 patients, and the Wartenberg sign in 2 patients. The elbow flexion test was positive in 4 patients. On the MBRS, 10 patients had an excellent score, and 7 had a good score.

There was no recurrence of CuTS in either group. One adipose flap patient developed a wound infection that required reoperation.

Discussion

Ulnar neuropathy was described by Magee and Phalen²¹ in 1949 and termed cubital tunnel syndrome by Feindel and Stratford²² in 1958. Since then, numerous procedures, including in situ decompression, medial epicondylectomy, and endoscopic decompression,^23,24 have been advocated for the treatment of this condition. In addition, anterior transposition, which involves securing the ulnar nerve in a submuscular, intramuscular, or subcutaneous sleeve,⁶ remains a popular option. Despite more than half a century of surgical treatment for this condition, there is no consensus about which procedure offers the best outcomes. Bartels and colleagues⁸ retrospectively reviewed surgical treatments for CuTS, examining 3148 arms over a 27-year period. They found simple decompression and anterior intramuscular transposition had the best results, followed by medial epicondylectomy and anterior subcutaneous transposition, with anterior submuscular transposition yielding the poorest outcomes. Despite these findings, the operative groups’ recurrence rates remained significant. These results were challenged in a 2008 meta-analysis⁵ that found no significant difference among simple decompression, subcutaneous transposition, and submuscular transposition and instead demonstrated trends toward better outcomes with anterior transposition. Osterman and Davis⁷ reported a 5% to 15% rate of unsatisfactory outcomes with anterior subcutaneous transposition, a popular technique used by surgeons at our institution.

The causes for failure or recurrence of ulnar neuropathy after surgical intervention are multifactorial and include preexisting medical conditions and improper operative technique. It is well established that failure to excise all 5 anatomical points of entrapment, or creation of new points of tension during surgery, leads to poor outcomes.¹² Nevertheless, the contribution of perineural scarring to postoperative recurrent ulnar neuropathy is currently being recognized: Gabel and Amadio¹³ described postoperative fibrosis in one-third of their patients with surgically treated recurrent CuTS, Rogers and colleagues¹⁴ noted dense perineural fibrosis after intramuscular and subcutaneous transposition procedures, Filippi and colleagues¹¹ cited serious epineural fibrosis and fibrosis around the ulnar nerve as the main findings in their study of 22 patients with recurrent ulnar neuropathy, and Vogel and colleagues¹² found that 88% of their patients with persistent CuTS after surgery exhibited perineural scarring.

We think that use of a scar tissue barrier during ulnar nerve transposition reduces the incidence of cicatrix and produces better outcomes—a position largely echoed by the orthopedic community, as fascial, fasciocutaneous, free, and venous flaps have all been used for such purposes.^25,26 Vein wrapping has demonstrated good recovery of a nerve after perineural scarring.²⁷ Advocates of intramuscular transposition argue that their technique provides the nerve with a vascularized tunnel, as segmental vascular stripping is an inevitability in transposition. However, this technique increases the incidence of scarring and potential muscle damage.^28,29 We think the pedicled adipofascial flap benefits the peripheral nerve by providing a scar tissue barrier and an optimal milieu for vascular regeneration. Kilic and colleagues¹⁵ demonstrated the regenerative effects of adipose tissue flaps on peripheral nerves after crush injuries in a rat model, and Strickland and colleagues³⁰ retrospectively examined the effects of hypothenar fat flaps on recalcitrant carpal tunnel syndrome, showing excellent results for this procedure. It is hypothesized that adipose tissue provides not only adipose-derived stem cells but also a rich vascular bed on which nerves will regenerate.

For all patients in the present study, symptoms improved, though the adipose flap and fascial sling groups were not significantly different in their outcomes. We used the MBRS to quantify and compare the groups’ patient-rated outcomes. No statistically significant difference was found between the adipose flap and fascial sling groups. On the MBRS, excellent and good outcomes were reported by 62.5% and 37.5% of the adipose flap patients, respectively, and 59% and 41% of the fascial sling patients (Table 3). Likewise, objective measurements did not show a significant difference between the 2 interventions—indicating that, compared with the current standard of care, adipose flaps are more efficacious in securing the anteriorly transposed nerve.

Complications of the adipose flap technique are consistent with those reported for other techniques for anterior transposition of the ulnar nerve. The most common complication is hematoma, which can be avoided with meticulous hemostasis. Damage of the medial antebrachial cutaneous nerve or motor branches to the flexor carpi ulnaris has been reported for the fascial technique (we have not had such outcomes at our institution). Contraindications to the adipofascial technique include insufficient subcutaneous adipose tissue for covering the ulnar nerve.

This study was limited by its retrospective setup, which reduced access to preoperative objective and subjective data. The small sample size also limited our ability to demonstrate the advantageous effects of an adipofascial flap in preventing postoperative perineural scarring.

The adipose flap technique is a viable option for securing the anteriorly transposed ulnar nerve. Outcomes in this study demonstrated an efficacy comparable to that of the fascial sling technique. Symptoms resolve or improve, and the majority of patients are satisfied with long-term surgical outcomes. The adipofascial flap may have additional advantages, as it provides a pliable, vascular fat envelope mimicking the natural fatty environment of peripheral nerves.

Compression of the ulnar nerve at the elbow, also referred to as cubital tunnel syndrome (CuTS), is the second most common peripheral nerve compression syndrome in the upper extremity.^1,2 Although the ulnar nerve can be compressed at 5 different sites, including arcade of Struthers, medial intermuscular septum, medial epicondyle, and deep flexor aponeurosis, the cubital tunnel is most commonly affected.³ Patients typically present with paresthesias in the fourth and fifth digits and weakness of hand muscle intrinsics. Activity-related pain or pain at the medial elbow can also occur in more advanced pathology.⁴ It is estimated that conservative therapy fails and surgical intervention is required in up to 30% of patients with CuTS.¹ Surgical approaches range from in situ decompression to transposition techniques, but there is no consensus in the orthopedic community as to which technique offers the best results. In a 2008 meta-analysis, Macadam and colleagues⁵ found no statistical differences in outcomes among the various surgical approaches. Nevertheless, subcutaneous transposition of the ulnar nerve at the elbow is a popular option.⁶

Despite the widespread success of surgical intervention for CuTS, persistent or recurrent pain occurs in 9.9% to 21.0% of cases.^7-10 In addition, several investigators have cited perineural scarring as a major cause of recurrent symptoms after primary surgery.^11-14 Filippi and colleagues¹¹ noted that patients who required reoperation after primary anterior transposition had “serious epineural fibrosis and fibrosis around the transposed ulnar nerve.” At our institution, we have similarly found that scarring of the fascial sling around the ulnar nerve led to recurrence of CuTS within 4 months after initial surgery (Figure 1).

We therefore prefer to use a vascularized adipose flap to secure the anteriorly transposed ulnar nerve. This flap provides a pliable, vascularized adipose environment for the nerve, which helps reduce nerve adherence and may enhance nerve recovery.¹⁵ In the study reported here, we retrospectively reviewed the long-term outcomes of ulnar nerve anterior subcutaneous transposition secured with either an adipose flap or a fascial sling. We hypothesized that patients in the 2 groups (adipose flap, fascial sling) would have equivalent outcomes.

Materials and Methods

After obtaining institutional review board approval, we reviewed the medical and surgical records of 104 patients (107 limbs) who underwent transposition of the ulnar nerve secured with either an adipose flap (27 limbs) or a fascial sling (80 limbs) over a 14-year period. The fascial sling cohort was used as a comparison group, matched to the adipose flap cohort by sex, age at time of surgery, hand dominance, symptom duration, and length of follow-up (Table 1). Patients were indicated for surgery and were included in the study if they had a history and physical examination consistent with primary CuTS, symptom duration longer than 1 year, and failed conservative management, including activity modification, night splinting, elbow pads, occupational therapy, and home exercise regimen. Electrodiagnostic testing was used at the discretion of the attending surgeon when the diagnosis was not clear from the history and physical examination. All fascial sling procedures were performed at our institution by 1 of 3 fellowship-trained hand surgeons, including Dr. Rosenwasser. The adipose flap modification was performed only by Dr. Rosenwasser. Of the 27 patients in the adipose flap group, 23 underwent surgery for primary CuTS and were included in the study; the other 4 (revision cases) were excluded; 1 patient subsequently died of a cause unrelated to the surgical procedure, and 6 were lost to follow-up. Of the 80 patients in the fascial sling group, 30 underwent surgery for primary CuTS; 5 died before follow-up, and 8 declined to participate.

Thirty-three patients (16 adipose flap, 17 fascial sling) met the inclusion criteria. Of the 16 adipose flap patients, 15 underwent the physical examination and completed the questionnaire, and 1 was interviewed by telephone. Similarly, of the 17 fascial sling patients, 15 underwent the physical examination and completed the questionnaire, and 2 were interviewed by telephone. There were no bilateral cases. Conservative management (activity modification, night splinting, elbow pads, occupational therapy, home exercise) failed in all cases.

A trained study team member who was not part of the surgical team performed follow-up evaluations using objective outcome measures and subjective questionnaires. Patients were assessed at a mean follow-up of 5.6 years (range, 1.6-15.9 years). Patients completed the DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire¹⁶ and visual analog scales (VASs) for pain, numbness, tingling, and weakness in the ulnar nerve distribution. They also rated the presence of night symptoms that were interfering with sleep. The Modified Bishop Rating Scale (MBRS) was used to quantify patient self-reported data^17,18 (Figure 2). The MBRS measures overall satisfaction, symptom improvement, presence of residual symptoms, ability to engage in activities, work capability, and subjective changes in strength and sensibility.

In the physical examinations, we tested for Tinel, Wartenberg, and Froment signs; performed an elbow flexion test; and measured elbow range of motion for flexion and extension as well as forearm pronation and supination. We also evaluated lateral pinch strength and grip strength, using a Jamar hydraulic pinch gauge and a Jamar dynamometer (Therapeutic Equipment Corp) and taking the average of 3 assessments. Fifth-digit abduction strength was graded on a standard muscle strength scale. Two-point discrimination was measured at the middle, ring, and small digits of the operated and contralateral hands.¹⁹

Surgical Technique

Standard ulnar nerve decompression with anterior subcutaneous transposition and the following modifications were performed on all patients.²⁰ A posteromedial incision parallel to the intermuscular septum was developed and the ulnar nerve identified. Minimizing stripping of the vascular mesentery, the dissection continued along the course of the nerve, and the medial intermuscular septum was excised to prevent secondary compression after transposition. The ulnar nerve was mobilized and transposed anterior to the medial epicondyle (Figure 3). For patients who received the fascial sling, a fascial sleeve was elevated from the flexor-pronator mass and sutured to the edge of the retinaculum securing the nerve. For patients who received the adipose flap, the flap with its vascular pedicle intact was elevated from the subcutaneous tissue of the anterior skin overlying the transposed nerve. The adipose tissue was sharply dissected in half while sufficient subcutaneous tissue was kept between the skin and the flap. A plane was developed based on an anterior adipose pedicle, which included a cutaneous artery and a vein that would supply the vascularized adipose flap. The flap was elevated and wrapped around the nerve without tension while the ulnar nerve was protected from being kinked by the construct. The flap was sutured to the anterior subcutaneous tissue to create a tunnel of adipose tissue surrounding the nerve along its length (Figure 4). The elbow was then flexed and extended to ensure free nerve gliding before wound closure.

The patient was allowed to move the elbow within the bulky dressings immediately after surgery. After 2 weeks, sutures were removed. Formal occupational therapy is not needed for these patients, except in the presence of significant weakness.

Results

As mentioned, the 2 groups were matched on demographics: age at time of surgery, sex, symptom duration, and length of follow-up (Table 1).

For the 16 adipose flap patients (Table 2), mean DASH score was 19.9 (range, 0-71.7). Seven of these patients reported upper extremity pain with a mean VAS score of 1.7 (range, 0-8); 4 patients reported pain in the wrist and fourth and fifth digits; only 1 patient reported pain that occasionally woke the patient from sleep. Constant numbness was present in 6 patients. Four patients reported constant mild tingling in the hand, and 11 reported intermittent tingling. Eleven patients (68.7%) reported operated-arm weakness with a mean VAS score of 3.4 (range, 0-8). In patients who had a physical examination, mean elbow flexion–extension arc of motion was 134° (range, 95°-150°), representing 99% of the motion of the contralateral arm. Mean pronation–supination arc was 174° (range, 150°-180°), accounting for 104% of the contralateral arm. Mean lateral pinch strength was 73% of the contralateral arm, and mean grip strength was 114% of the contralateral arm. The Tinel sign was present in 2 patients, the Froment sign was present in 3 patients, and the elbow flexion test was positive in 2 patients. No patient had a positive Wartenberg sign. On the MBRS, 10 patients had an excellent score, and 6 had a good score.

For the 17 fascial sling patients (Table 2), mean DASH score was 22.7 (range, 0-63.3). Three patients reported upper extremity pain with a mean VAS score of 1.4 (range, 0-7); 3 patients reported pain that occasionally woke them from sleep. Seven patients had constant numbness in the distribution of the ulnar nerve. Two patients had constant paresthesias, and 7 had intermittent paresthesias. Nine patients (52.9%) reported arm weakness with a mean VAS score of 2.5 (range, 0-8). Mean elbow flexion–extension arc of motion was 136° (range, 100°-150°), representing 100% of the contralateral arm. Mean pronation–supination arc was 187° (range, 155°-225°), accounting for 102% of the contralateral arm. Mean lateral pinch strength was 93% of the contralateral arm, and mean grip strength was 80% of the contralateral arm. The Tinel sign was present in 6 patients, the Froment sign in 3 patients, and the Wartenberg sign in 2 patients. The elbow flexion test was positive in 4 patients. On the MBRS, 10 patients had an excellent score, and 7 had a good score.

There was no recurrence of CuTS in either group. One adipose flap patient developed a wound infection that required reoperation.

Discussion

Ulnar neuropathy was described by Magee and Phalen²¹ in 1949 and termed cubital tunnel syndrome by Feindel and Stratford²² in 1958. Since then, numerous procedures, including in situ decompression, medial epicondylectomy, and endoscopic decompression,^23,24 have been advocated for the treatment of this condition. In addition, anterior transposition, which involves securing the ulnar nerve in a submuscular, intramuscular, or subcutaneous sleeve,⁶ remains a popular option. Despite more than half a century of surgical treatment for this condition, there is no consensus about which procedure offers the best outcomes. Bartels and colleagues⁸ retrospectively reviewed surgical treatments for CuTS, examining 3148 arms over a 27-year period. They found simple decompression and anterior intramuscular transposition had the best results, followed by medial epicondylectomy and anterior subcutaneous transposition, with anterior submuscular transposition yielding the poorest outcomes. Despite these findings, the operative groups’ recurrence rates remained significant. These results were challenged in a 2008 meta-analysis⁵ that found no significant difference among simple decompression, subcutaneous transposition, and submuscular transposition and instead demonstrated trends toward better outcomes with anterior transposition. Osterman and Davis⁷ reported a 5% to 15% rate of unsatisfactory outcomes with anterior subcutaneous transposition, a popular technique used by surgeons at our institution.

The causes for failure or recurrence of ulnar neuropathy after surgical intervention are multifactorial and include preexisting medical conditions and improper operative technique. It is well established that failure to excise all 5 anatomical points of entrapment, or creation of new points of tension during surgery, leads to poor outcomes.¹² Nevertheless, the contribution of perineural scarring to postoperative recurrent ulnar neuropathy is currently being recognized: Gabel and Amadio¹³ described postoperative fibrosis in one-third of their patients with surgically treated recurrent CuTS, Rogers and colleagues¹⁴ noted dense perineural fibrosis after intramuscular and subcutaneous transposition procedures, Filippi and colleagues¹¹ cited serious epineural fibrosis and fibrosis around the ulnar nerve as the main findings in their study of 22 patients with recurrent ulnar neuropathy, and Vogel and colleagues¹² found that 88% of their patients with persistent CuTS after surgery exhibited perineural scarring.

We think that use of a scar tissue barrier during ulnar nerve transposition reduces the incidence of cicatrix and produces better outcomes—a position largely echoed by the orthopedic community, as fascial, fasciocutaneous, free, and venous flaps have all been used for such purposes.^25,26 Vein wrapping has demonstrated good recovery of a nerve after perineural scarring.²⁷ Advocates of intramuscular transposition argue that their technique provides the nerve with a vascularized tunnel, as segmental vascular stripping is an inevitability in transposition. However, this technique increases the incidence of scarring and potential muscle damage.^28,29 We think the pedicled adipofascial flap benefits the peripheral nerve by providing a scar tissue barrier and an optimal milieu for vascular regeneration. Kilic and colleagues¹⁵ demonstrated the regenerative effects of adipose tissue flaps on peripheral nerves after crush injuries in a rat model, and Strickland and colleagues³⁰ retrospectively examined the effects of hypothenar fat flaps on recalcitrant carpal tunnel syndrome, showing excellent results for this procedure. It is hypothesized that adipose tissue provides not only adipose-derived stem cells but also a rich vascular bed on which nerves will regenerate.

For all patients in the present study, symptoms improved, though the adipose flap and fascial sling groups were not significantly different in their outcomes. We used the MBRS to quantify and compare the groups’ patient-rated outcomes. No statistically significant difference was found between the adipose flap and fascial sling groups. On the MBRS, excellent and good outcomes were reported by 62.5% and 37.5% of the adipose flap patients, respectively, and 59% and 41% of the fascial sling patients (Table 3). Likewise, objective measurements did not show a significant difference between the 2 interventions—indicating that, compared with the current standard of care, adipose flaps are more efficacious in securing the anteriorly transposed nerve.

Complications of the adipose flap technique are consistent with those reported for other techniques for anterior transposition of the ulnar nerve. The most common complication is hematoma, which can be avoided with meticulous hemostasis. Damage of the medial antebrachial cutaneous nerve or motor branches to the flexor carpi ulnaris has been reported for the fascial technique (we have not had such outcomes at our institution). Contraindications to the adipofascial technique include insufficient subcutaneous adipose tissue for covering the ulnar nerve.

This study was limited by its retrospective setup, which reduced access to preoperative objective and subjective data. The small sample size also limited our ability to demonstrate the advantageous effects of an adipofascial flap in preventing postoperative perineural scarring.

The adipose flap technique is a viable option for securing the anteriorly transposed ulnar nerve. Outcomes in this study demonstrated an efficacy comparable to that of the fascial sling technique. Symptoms resolve or improve, and the majority of patients are satisfied with long-term surgical outcomes. The adipofascial flap may have additional advantages, as it provides a pliable, vascular fat envelope mimicking the natural fatty environment of peripheral nerves.

Ulnar nerve injury leads to clawing of the ulnar digits and loss of digital abduction and adduction because of paralysis of the ulnar innervated extrinsic and intrinsic muscles. Isolated motor paralysis without sensory deficit can occur from compression within the Guyon canal.¹ Cubital tunnel at the elbow is the most common site for ulnar nerve compression.² Compression at both levels can be encountered in sports-related activities. Nerve compression in the Guyon canal can occur with bicycling and is known as cyclist’s palsy,^3-6 but it can also develop from canoeing.⁷ Cubital tunnel syndrome is the most common neuropathy of the elbow among throwing athletes, especially in baseball pitchers and can result from nerve traction and compression within the fibro-osseous tunnel or subluxation out of the tunnel.² Both compression syndromes can develop from repetitive stress and/or pressure to the nerve in the retrocondylar groove.

Ulnar nerve palsy may be associated with forearm fractures, which is usually caused by simultaneous ulna and radius fractures, especially in children.^8-12 To our knowledge, there are no reports in the literature of an ulnar nerve palsy associated with an isolated ulnar shaft fracture in an adult. We report a case of delayed ulnar nerve palsy after an ulnar shaft fracture in a baseball player. The patient provided written informed consent for print and electronic publication of this case report.

Case Report

A 19-year-old, right hand–dominant college baseball player was batting right-handed in an intrasquad scrimmage when a high and inside pitched ball from a right-handed pitcher struck the volar-ulnar aspect of his right forearm. Examination in the training room and emergency department revealed moderate swelling and ecchymosis over the distal third of the ulna. He had a normal neurovascular examination, including normal sensation to light touch and normal finger abduction/adduction and wrist flexion/extension. He was otherwise healthy. Radiographs of the right forearm showed a minimally displaced transverse fracture of the distal third of the ulna (Figures 1A, 1B).

The patient was initially treated with a well-padded, removable, long-arm posterior splint for 2 weeks with serial examinations each day in the training room. At 2-week follow-up, he reported less pain and swelling but stated that his hand had “felt funny” the past several days. Examination revealed clawing of the ulnar digits with paresthesias in the ulnar nerve distribution (Figures 2A, 2B). His extrinsic muscle function was normal. Radiographs showed stable fracture alignment. Ulnar neuropathy was diagnosed, and treatment was observation with a plan for electromyography (EMG) at 6 weeks after injury if there were no signs of nerve recovery. Physical therapy was instituted and focused on improving intrinsic muscle and proprioceptive functions with the goal of an expeditious, but safe, return to playing baseball. Three weeks after his injury, the patient had decreased tenderness at his fracture site and was given a forearm pad and sleeve for light, noncontact baseball activity (Figure 3). A long velcro wrist splint was used during conditioning and when not playing baseball. Forearm supination and pronation were limited initially because of patient discomfort and to prevent torsional fracture displacement or delayed healing. Six weeks after his injury, the patient returned to hitting and was showing early signs of improved sensation and intrinsic hand strength. He had progressed to a light throwing program and reported difficult hand coordination, poor ball control, and overall difficulty in accurately throwing over the next 3 to 4 months. Because of his difficulty with ball control, the patient began a progressive return to full-game activity over 6 weeks, which initially included a return to batting only, then playing in the outfield, and, eventually, a return to his normal position in the infield. Serial radiographs continued to show good fracture alignment with appropriate new bone formation (Figures 4A, 4B). Normal motor strength was noted at 3 months after injury and normal sensation at 4 months after injury.

By the end of his summer league, 6 months after his injury, the patient was named Most Valuable Player and had a batting average over .400. He reported near-normal hand function. One year after injury, his examination revealed normal hand function (Figure 5), including normal sensation to light touch, 5/5 intrinsic hand function, and symmetric grip strength. Radiographs showed a healed fracture (Figures 6A, 6B). The patient has gone on to play more than 9 years of professional baseball.

Discussion

The ulnar nerve has a course that runs down the volar compartment of the distal forearm. The flexor carpi ulnaris provides coverage to the nerve in this area. Proximal to the wrist, the nerve emerges from under the flexor carpi ulnaris tendon and passes deep to the flexor retinaculum, which is the distal extension of the antebrachial fascia and blends distally into the palmar carpal ligament.¹³ In our patient, the most likely cause of this presentation of ulnar neuropathy was the direct blow to the nerve from the high-intensity impact of a thrown baseball to this superficial and exposed area of the forearm. Since the patient presented with delayed paresthesias and ulnar clawing 2 weeks after injury, possible contributing causes could be evolving pressure or nerve damage from a perineural hematoma and/or intraneural hematoma or increased local pressure from intramuscular hemorrhage.¹⁴ There are both acute and chronic cases of ulnar nerve entrapment by bone or scar tissue that resolved by surgical decompression.^8-12 Surgical exploration was not deemed necessary in our case because the fracture was minimally displaced, and the patient regained sensation and motor function over the course of 3 to 4 months.

Nerve injuries can be classified as neurapraxia, axonotmesis, or neurotmesis. Neurapraxia is the mildest form of nerve injury and neurotmesis the most severe. Neurapraxia may be associated with a temporary block to conduction or nerve demyelination without axonal disruption. Spontaneous recovery takes 2 weeks to 2 months. Axonotmesis involves an actual loss of axonal continuity; however, connective tissue supporting structures remain intact and allow axonal regeneration. Finally, neurotmesis is transection of the peripheral nerve, and spontaneous regeneration is not possible. The mechanism of injury in our patient suggests that the pathology was neurapraxia.^1,15

Management of these injuries should proceed according to basic extremity injury–care practices. Initial care should include thorough neurovascular and radiographic evaluations. If nerve deficits are present with a closed injury and minimal fracture displacement, treatment can include observation and serial examinations with a baseline EMG, or waiting until 4 to 6 weeks after injury to obtain an EMG if there are no signs of nerve recovery. Early EMG testing and surgical exploration may be warranted if there is a concern for nerve disruption or entrapment, such as marked fracture displacement or an open injury. Additional early-care measures should include swelling control modalities and immobilization based on the type of fracture. Ultrasound was not readily available at the time of our patient’s injury, but it may be a helpful adjunct in guiding decision-making regarding whether to perform early surgical exploration for hematoma evacuation or nerve injury.^16-18 Our case report was intended to provide an awareness of the unusual association between an isolated ulnar shaft fracture and a delayed ulnar nerve palsy in an athlete. Nerve injuries may be unrecognized in some patients in a trauma situation, since the focus is usually on the fracture and the typical patient does not have to return to high-demand, coordinated athletic activity, such as throwing a ball. Because of the possible delayed presentation of these nerve injuries, close observation of nerve function after ulna fractures from blunt trauma is warranted.

Ulnar nerve injury leads to clawing of the ulnar digits and loss of digital abduction and adduction because of paralysis of the ulnar innervated extrinsic and intrinsic muscles. Isolated motor paralysis without sensory deficit can occur from compression within the Guyon canal.¹ Cubital tunnel at the elbow is the most common site for ulnar nerve compression.² Compression at both levels can be encountered in sports-related activities. Nerve compression in the Guyon canal can occur with bicycling and is known as cyclist’s palsy,^3-6 but it can also develop from canoeing.⁷ Cubital tunnel syndrome is the most common neuropathy of the elbow among throwing athletes, especially in baseball pitchers and can result from nerve traction and compression within the fibro-osseous tunnel or subluxation out of the tunnel.² Both compression syndromes can develop from repetitive stress and/or pressure to the nerve in the retrocondylar groove.

Ulnar nerve palsy may be associated with forearm fractures, which is usually caused by simultaneous ulna and radius fractures, especially in children.^8-12 To our knowledge, there are no reports in the literature of an ulnar nerve palsy associated with an isolated ulnar shaft fracture in an adult. We report a case of delayed ulnar nerve palsy after an ulnar shaft fracture in a baseball player. The patient provided written informed consent for print and electronic publication of this case report.

Case Report

A 19-year-old, right hand–dominant college baseball player was batting right-handed in an intrasquad scrimmage when a high and inside pitched ball from a right-handed pitcher struck the volar-ulnar aspect of his right forearm. Examination in the training room and emergency department revealed moderate swelling and ecchymosis over the distal third of the ulna. He had a normal neurovascular examination, including normal sensation to light touch and normal finger abduction/adduction and wrist flexion/extension. He was otherwise healthy. Radiographs of the right forearm showed a minimally displaced transverse fracture of the distal third of the ulna (Figures 1A, 1B).

The patient was initially treated with a well-padded, removable, long-arm posterior splint for 2 weeks with serial examinations each day in the training room. At 2-week follow-up, he reported less pain and swelling but stated that his hand had “felt funny” the past several days. Examination revealed clawing of the ulnar digits with paresthesias in the ulnar nerve distribution (Figures 2A, 2B). His extrinsic muscle function was normal. Radiographs showed stable fracture alignment. Ulnar neuropathy was diagnosed, and treatment was observation with a plan for electromyography (EMG) at 6 weeks after injury if there were no signs of nerve recovery. Physical therapy was instituted and focused on improving intrinsic muscle and proprioceptive functions with the goal of an expeditious, but safe, return to playing baseball. Three weeks after his injury, the patient had decreased tenderness at his fracture site and was given a forearm pad and sleeve for light, noncontact baseball activity (Figure 3). A long velcro wrist splint was used during conditioning and when not playing baseball. Forearm supination and pronation were limited initially because of patient discomfort and to prevent torsional fracture displacement or delayed healing. Six weeks after his injury, the patient returned to hitting and was showing early signs of improved sensation and intrinsic hand strength. He had progressed to a light throwing program and reported difficult hand coordination, poor ball control, and overall difficulty in accurately throwing over the next 3 to 4 months. Because of his difficulty with ball control, the patient began a progressive return to full-game activity over 6 weeks, which initially included a return to batting only, then playing in the outfield, and, eventually, a return to his normal position in the infield. Serial radiographs continued to show good fracture alignment with appropriate new bone formation (Figures 4A, 4B). Normal motor strength was noted at 3 months after injury and normal sensation at 4 months after injury.

By the end of his summer league, 6 months after his injury, the patient was named Most Valuable Player and had a batting average over .400. He reported near-normal hand function. One year after injury, his examination revealed normal hand function (Figure 5), including normal sensation to light touch, 5/5 intrinsic hand function, and symmetric grip strength. Radiographs showed a healed fracture (Figures 6A, 6B). The patient has gone on to play more than 9 years of professional baseball.

Discussion

The ulnar nerve has a course that runs down the volar compartment of the distal forearm. The flexor carpi ulnaris provides coverage to the nerve in this area. Proximal to the wrist, the nerve emerges from under the flexor carpi ulnaris tendon and passes deep to the flexor retinaculum, which is the distal extension of the antebrachial fascia and blends distally into the palmar carpal ligament.¹³ In our patient, the most likely cause of this presentation of ulnar neuropathy was the direct blow to the nerve from the high-intensity impact of a thrown baseball to this superficial and exposed area of the forearm. Since the patient presented with delayed paresthesias and ulnar clawing 2 weeks after injury, possible contributing causes could be evolving pressure or nerve damage from a perineural hematoma and/or intraneural hematoma or increased local pressure from intramuscular hemorrhage.¹⁴ There are both acute and chronic cases of ulnar nerve entrapment by bone or scar tissue that resolved by surgical decompression.^8-12 Surgical exploration was not deemed necessary in our case because the fracture was minimally displaced, and the patient regained sensation and motor function over the course of 3 to 4 months.

Nerve injuries can be classified as neurapraxia, axonotmesis, or neurotmesis. Neurapraxia is the mildest form of nerve injury and neurotmesis the most severe. Neurapraxia may be associated with a temporary block to conduction or nerve demyelination without axonal disruption. Spontaneous recovery takes 2 weeks to 2 months. Axonotmesis involves an actual loss of axonal continuity; however, connective tissue supporting structures remain intact and allow axonal regeneration. Finally, neurotmesis is transection of the peripheral nerve, and spontaneous regeneration is not possible. The mechanism of injury in our patient suggests that the pathology was neurapraxia.^1,15

Management of these injuries should proceed according to basic extremity injury–care practices. Initial care should include thorough neurovascular and radiographic evaluations. If nerve deficits are present with a closed injury and minimal fracture displacement, treatment can include observation and serial examinations with a baseline EMG, or waiting until 4 to 6 weeks after injury to obtain an EMG if there are no signs of nerve recovery. Early EMG testing and surgical exploration may be warranted if there is a concern for nerve disruption or entrapment, such as marked fracture displacement or an open injury. Additional early-care measures should include swelling control modalities and immobilization based on the type of fracture. Ultrasound was not readily available at the time of our patient’s injury, but it may be a helpful adjunct in guiding decision-making regarding whether to perform early surgical exploration for hematoma evacuation or nerve injury.^16-18 Our case report was intended to provide an awareness of the unusual association between an isolated ulnar shaft fracture and a delayed ulnar nerve palsy in an athlete. Nerve injuries may be unrecognized in some patients in a trauma situation, since the focus is usually on the fracture and the typical patient does not have to return to high-demand, coordinated athletic activity, such as throwing a ball. Because of the possible delayed presentation of these nerve injuries, close observation of nerve function after ulna fractures from blunt trauma is warranted.

Ulnar nerve injury leads to clawing of the ulnar digits and loss of digital abduction and adduction because of paralysis of the ulnar innervated extrinsic and intrinsic muscles. Isolated motor paralysis without sensory deficit can occur from compression within the Guyon canal.¹ Cubital tunnel at the elbow is the most common site for ulnar nerve compression.² Compression at both levels can be encountered in sports-related activities. Nerve compression in the Guyon canal can occur with bicycling and is known as cyclist’s palsy,^3-6 but it can also develop from canoeing.⁷ Cubital tunnel syndrome is the most common neuropathy of the elbow among throwing athletes, especially in baseball pitchers and can result from nerve traction and compression within the fibro-osseous tunnel or subluxation out of the tunnel.² Both compression syndromes can develop from repetitive stress and/or pressure to the nerve in the retrocondylar groove.

Ulnar nerve palsy may be associated with forearm fractures, which is usually caused by simultaneous ulna and radius fractures, especially in children.^8-12 To our knowledge, there are no reports in the literature of an ulnar nerve palsy associated with an isolated ulnar shaft fracture in an adult. We report a case of delayed ulnar nerve palsy after an ulnar shaft fracture in a baseball player. The patient provided written informed consent for print and electronic publication of this case report.

Case Report

A 19-year-old, right hand–dominant college baseball player was batting right-handed in an intrasquad scrimmage when a high and inside pitched ball from a right-handed pitcher struck the volar-ulnar aspect of his right forearm. Examination in the training room and emergency department revealed moderate swelling and ecchymosis over the distal third of the ulna. He had a normal neurovascular examination, including normal sensation to light touch and normal finger abduction/adduction and wrist flexion/extension. He was otherwise healthy. Radiographs of the right forearm showed a minimally displaced transverse fracture of the distal third of the ulna (Figures 1A, 1B).

The patient was initially treated with a well-padded, removable, long-arm posterior splint for 2 weeks with serial examinations each day in the training room. At 2-week follow-up, he reported less pain and swelling but stated that his hand had “felt funny” the past several days. Examination revealed clawing of the ulnar digits with paresthesias in the ulnar nerve distribution (Figures 2A, 2B). His extrinsic muscle function was normal. Radiographs showed stable fracture alignment. Ulnar neuropathy was diagnosed, and treatment was observation with a plan for electromyography (EMG) at 6 weeks after injury if there were no signs of nerve recovery. Physical therapy was instituted and focused on improving intrinsic muscle and proprioceptive functions with the goal of an expeditious, but safe, return to playing baseball. Three weeks after his injury, the patient had decreased tenderness at his fracture site and was given a forearm pad and sleeve for light, noncontact baseball activity (Figure 3). A long velcro wrist splint was used during conditioning and when not playing baseball. Forearm supination and pronation were limited initially because of patient discomfort and to prevent torsional fracture displacement or delayed healing. Six weeks after his injury, the patient returned to hitting and was showing early signs of improved sensation and intrinsic hand strength. He had progressed to a light throwing program and reported difficult hand coordination, poor ball control, and overall difficulty in accurately throwing over the next 3 to 4 months. Because of his difficulty with ball control, the patient began a progressive return to full-game activity over 6 weeks, which initially included a return to batting only, then playing in the outfield, and, eventually, a return to his normal position in the infield. Serial radiographs continued to show good fracture alignment with appropriate new bone formation (Figures 4A, 4B). Normal motor strength was noted at 3 months after injury and normal sensation at 4 months after injury.

By the end of his summer league, 6 months after his injury, the patient was named Most Valuable Player and had a batting average over .400. He reported near-normal hand function. One year after injury, his examination revealed normal hand function (Figure 5), including normal sensation to light touch, 5/5 intrinsic hand function, and symmetric grip strength. Radiographs showed a healed fracture (Figures 6A, 6B). The patient has gone on to play more than 9 years of professional baseball.

Discussion

The ulnar nerve has a course that runs down the volar compartment of the distal forearm. The flexor carpi ulnaris provides coverage to the nerve in this area. Proximal to the wrist, the nerve emerges from under the flexor carpi ulnaris tendon and passes deep to the flexor retinaculum, which is the distal extension of the antebrachial fascia and blends distally into the palmar carpal ligament.¹³ In our patient, the most likely cause of this presentation of ulnar neuropathy was the direct blow to the nerve from the high-intensity impact of a thrown baseball to this superficial and exposed area of the forearm. Since the patient presented with delayed paresthesias and ulnar clawing 2 weeks after injury, possible contributing causes could be evolving pressure or nerve damage from a perineural hematoma and/or intraneural hematoma or increased local pressure from intramuscular hemorrhage.¹⁴ There are both acute and chronic cases of ulnar nerve entrapment by bone or scar tissue that resolved by surgical decompression.^8-12 Surgical exploration was not deemed necessary in our case because the fracture was minimally displaced, and the patient regained sensation and motor function over the course of 3 to 4 months.

Nerve injuries can be classified as neurapraxia, axonotmesis, or neurotmesis. Neurapraxia is the mildest form of nerve injury and neurotmesis the most severe. Neurapraxia may be associated with a temporary block to conduction or nerve demyelination without axonal disruption. Spontaneous recovery takes 2 weeks to 2 months. Axonotmesis involves an actual loss of axonal continuity; however, connective tissue supporting structures remain intact and allow axonal regeneration. Finally, neurotmesis is transection of the peripheral nerve, and spontaneous regeneration is not possible. The mechanism of injury in our patient suggests that the pathology was neurapraxia.^1,15

Management of these injuries should proceed according to basic extremity injury–care practices. Initial care should include thorough neurovascular and radiographic evaluations. If nerve deficits are present with a closed injury and minimal fracture displacement, treatment can include observation and serial examinations with a baseline EMG, or waiting until 4 to 6 weeks after injury to obtain an EMG if there are no signs of nerve recovery. Early EMG testing and surgical exploration may be warranted if there is a concern for nerve disruption or entrapment, such as marked fracture displacement or an open injury. Additional early-care measures should include swelling control modalities and immobilization based on the type of fracture. Ultrasound was not readily available at the time of our patient’s injury, but it may be a helpful adjunct in guiding decision-making regarding whether to perform early surgical exploration for hematoma evacuation or nerve injury.^16-18 Our case report was intended to provide an awareness of the unusual association between an isolated ulnar shaft fracture and a delayed ulnar nerve palsy in an athlete. Nerve injuries may be unrecognized in some patients in a trauma situation, since the focus is usually on the fracture and the typical patient does not have to return to high-demand, coordinated athletic activity, such as throwing a ball. Because of the possible delayed presentation of these nerve injuries, close observation of nerve function after ulna fractures from blunt trauma is warranted.

Take a look at the HM16 program, and you get a snapshot of the most pressing topics in hospital medicine. Specifically, four new educational tracks are being rolled out at this year’s annual meeting, including a new track on the patient-doctor relationship, which is so crucial with today’s growing emphasis on patient satisfaction, and a track focused on perioperative medicine, an important area with a fast-moving frontier. Another new track covers post-acute care, a setting in which more and more hospitalists find themselves practicing. Then there’s the big daddy: health information technology (IT) for hospitalists.

Course Director Melissa Mattison, MD, SFHM, also points to a new twist in the way the conference will attempt to tackle the tough topic of work-life balance.

Read the full interview with Melissa Mattison, MD, SFHM. 

Here’s a look at what’s new for HM16 attendees.

Health IT for Hospitalists

“There’s not a hospitalist in the country who’s not affected by IT and updates to their [electronic medical records (EMR)], new adoption of EMR technology, different vendors,” Dr. Mattison says. “We’re always searching for something to make our lives better and make the care that we provide more high quality.”

There will be sessions of a general nature, such as “There’s an App for That,” a review of mobile apps helpful to hospitalists. And there will be those for the more passionate technophiles, such as a session on clinical informatics and “Using IT to Help Drive the Shift from Volume to Value.”

“We’ve spent a lot of time trying to make sure there’s something for everyone,” says Kendall Rogers, MD, SFHM, chair of SHM’s IT Committee. “And even within each individual talk, we’ve tried to make sure that there is material that can be applicable from the frontline hospitalist to the CMIO of a hospital.”

Dr. Rogers says the committee has “really been pushing” to have its own track at the annual meeting.

Listen to more of our interview with Dr. Rogers.

“Health IT continues to be an area of great frustration and great promise,” he says. “I think most of the frustration that hospitalists have is because they realize the potential of health IT, and they see how far it is from the reality of what they’re working with every day.

“Hospitalists are well-suited for actively being involved in clinical informatics, but many of us would be far more effective in our roles with more formal education and training.”

Post-Acute Care

It’s estimated that as many as 35% of hospitalists work in the post-acute setting. The number very much surprised Dr. Mattison. When she heard of the figure, “[the committee] lobbied very hard to get a track for post-acute care.”

One session, “Building and Managing a PAC Practice,” will review setting up a staff, relevant regulations, billing, and collecting, and it should be of interest to both managers and physicians, says Sean Muldoon, MD, senior vice president and chief medical officer of the hospitalist division at Louisville, Ken.–based Kindred Healthcare and chair of SHM’s Post-Acute Care Task Force.

Another session, “Lost in Transitions,” will review information gaps and propose solutions “to the well-known voltage drop of information that can happen in transfer from the hospital to post-acute care.”

At Kindred, Dr. Muldoon says he has seen the benefits of hospitalist involvement in post-acute care.

“In many markets, we seek out and often are able to become a practice site for a large hospitalist medical group,” he says. “That’s really good for us, the patients, and, we think, the hospitalists because it allows the hospitalists to be exposed to the practice and benefits of post-acute care without having to make a full commitment to be a skilled-nursing physician or a long-term acute-care physician.”

It also makes transitions of care smoother and less disruptive, he says, “because a patient is simply transferred from one hospitalist in a group to another or often maintaining that same hospitalist in the post-acute-care setting.”

Dr. Muldoon says the new track is of value to any hospitalist, whether they actually work in post-acute care or not.

“A hospitalist would be hard-pressed to provide knowledgeable input into where a patient should receive post-acute care without a working knowledge of which patients should be directed to which post-acute-care setting,” he says.

Doctor-Patient Relationship

This topic was a pre-course last year, and organizers decided to make this a full track on the final day of the meeting schedule.

“It’s really about communication style,” Dr. Mattison says. “There’s one session called ‘The Language of Empathy and Engagement: Communication Essentials for Patient-Centered Care.’ There’s one on unconscious biases and our underlying assumptions and how it affects how we care for patients. [Another is focused] on improving the patient experience in the hospital.”

Co-Management/ Perioperative Medicine

“There are a lot of challenges around anticoagulation management, optimizing patients’ physical heath prior to the surgery, what things should we be doing, what medications should we be giving, what ones shouldn’t we be giving,” Dr. Mattison says. “It’s an evolving field that has, every year, new information.”

Hidden Gems

Dr. Mattison draws special attention to “Work-Life Balance: Is It Possible?” (Tuesday, March 8, 4:20–5:40 p.m.). This year, this problem—all too familiar to hospitalists—will be addressed in a panel discussion, which is a change from previous years.

“There’s been, year after year after year, a lot of discussion around, how can I make my job manageable if my boss isn’t listening to me or is not attuned to work-life balance? How can I navigate this process?” she says. “I’m hopeful that the panel discussion will provide people with some real examples and strategies for success.”

She also draws attention to the session “Perioperative Pitfalls: Overcoming Common Challenges in Managing Medical Problems in Surgical Patients” (Monday, March 7, 3:05–4:20 p.m.).

“There are some true leaders in perioperative management, and they’re going to come together and have a panel discussion,” she says. “It’ll be an opportunity to see some of the great minds think, if you will.” TH

Thomas R. Collins is a freelance writer in South Florida.

Take a look at the HM16 program, and you get a snapshot of the most pressing topics in hospital medicine. Specifically, four new educational tracks are being rolled out at this year’s annual meeting, including a new track on the patient-doctor relationship, which is so crucial with today’s growing emphasis on patient satisfaction, and a track focused on perioperative medicine, an important area with a fast-moving frontier. Another new track covers post-acute care, a setting in which more and more hospitalists find themselves practicing. Then there’s the big daddy: health information technology (IT) for hospitalists.

Course Director Melissa Mattison, MD, SFHM, also points to a new twist in the way the conference will attempt to tackle the tough topic of work-life balance.

Read the full interview with Melissa Mattison, MD, SFHM. 

Here’s a look at what’s new for HM16 attendees.

Health IT for Hospitalists

“There’s not a hospitalist in the country who’s not affected by IT and updates to their [electronic medical records (EMR)], new adoption of EMR technology, different vendors,” Dr. Mattison says. “We’re always searching for something to make our lives better and make the care that we provide more high quality.”

There will be sessions of a general nature, such as “There’s an App for That,” a review of mobile apps helpful to hospitalists. And there will be those for the more passionate technophiles, such as a session on clinical informatics and “Using IT to Help Drive the Shift from Volume to Value.”

“We’ve spent a lot of time trying to make sure there’s something for everyone,” says Kendall Rogers, MD, SFHM, chair of SHM’s IT Committee. “And even within each individual talk, we’ve tried to make sure that there is material that can be applicable from the frontline hospitalist to the CMIO of a hospital.”

Dr. Rogers says the committee has “really been pushing” to have its own track at the annual meeting.

Listen to more of our interview with Dr. Rogers.

“Health IT continues to be an area of great frustration and great promise,” he says. “I think most of the frustration that hospitalists have is because they realize the potential of health IT, and they see how far it is from the reality of what they’re working with every day.

“Hospitalists are well-suited for actively being involved in clinical informatics, but many of us would be far more effective in our roles with more formal education and training.”

Post-Acute Care

It’s estimated that as many as 35% of hospitalists work in the post-acute setting. The number very much surprised Dr. Mattison. When she heard of the figure, “[the committee] lobbied very hard to get a track for post-acute care.”

One session, “Building and Managing a PAC Practice,” will review setting up a staff, relevant regulations, billing, and collecting, and it should be of interest to both managers and physicians, says Sean Muldoon, MD, senior vice president and chief medical officer of the hospitalist division at Louisville, Ken.–based Kindred Healthcare and chair of SHM’s Post-Acute Care Task Force.

Another session, “Lost in Transitions,” will review information gaps and propose solutions “to the well-known voltage drop of information that can happen in transfer from the hospital to post-acute care.”

At Kindred, Dr. Muldoon says he has seen the benefits of hospitalist involvement in post-acute care.

“In many markets, we seek out and often are able to become a practice site for a large hospitalist medical group,” he says. “That’s really good for us, the patients, and, we think, the hospitalists because it allows the hospitalists to be exposed to the practice and benefits of post-acute care without having to make a full commitment to be a skilled-nursing physician or a long-term acute-care physician.”

It also makes transitions of care smoother and less disruptive, he says, “because a patient is simply transferred from one hospitalist in a group to another or often maintaining that same hospitalist in the post-acute-care setting.”

Dr. Muldoon says the new track is of value to any hospitalist, whether they actually work in post-acute care or not.

“A hospitalist would be hard-pressed to provide knowledgeable input into where a patient should receive post-acute care without a working knowledge of which patients should be directed to which post-acute-care setting,” he says.

Doctor-Patient Relationship

This topic was a pre-course last year, and organizers decided to make this a full track on the final day of the meeting schedule.

“It’s really about communication style,” Dr. Mattison says. “There’s one session called ‘The Language of Empathy and Engagement: Communication Essentials for Patient-Centered Care.’ There’s one on unconscious biases and our underlying assumptions and how it affects how we care for patients. [Another is focused] on improving the patient experience in the hospital.”

Co-Management/ Perioperative Medicine

“There are a lot of challenges around anticoagulation management, optimizing patients’ physical heath prior to the surgery, what things should we be doing, what medications should we be giving, what ones shouldn’t we be giving,” Dr. Mattison says. “It’s an evolving field that has, every year, new information.”

Hidden Gems

Dr. Mattison draws special attention to “Work-Life Balance: Is It Possible?” (Tuesday, March 8, 4:20–5:40 p.m.). This year, this problem—all too familiar to hospitalists—will be addressed in a panel discussion, which is a change from previous years.

“There’s been, year after year after year, a lot of discussion around, how can I make my job manageable if my boss isn’t listening to me or is not attuned to work-life balance? How can I navigate this process?” she says. “I’m hopeful that the panel discussion will provide people with some real examples and strategies for success.”

She also draws attention to the session “Perioperative Pitfalls: Overcoming Common Challenges in Managing Medical Problems in Surgical Patients” (Monday, March 7, 3:05–4:20 p.m.).

“There are some true leaders in perioperative management, and they’re going to come together and have a panel discussion,” she says. “It’ll be an opportunity to see some of the great minds think, if you will.” TH

Thomas R. Collins is a freelance writer in South Florida.

Take a look at the HM16 program, and you get a snapshot of the most pressing topics in hospital medicine. Specifically, four new educational tracks are being rolled out at this year’s annual meeting, including a new track on the patient-doctor relationship, which is so crucial with today’s growing emphasis on patient satisfaction, and a track focused on perioperative medicine, an important area with a fast-moving frontier. Another new track covers post-acute care, a setting in which more and more hospitalists find themselves practicing. Then there’s the big daddy: health information technology (IT) for hospitalists.

Course Director Melissa Mattison, MD, SFHM, also points to a new twist in the way the conference will attempt to tackle the tough topic of work-life balance.

Read the full interview with Melissa Mattison, MD, SFHM. 

Here’s a look at what’s new for HM16 attendees.

Health IT for Hospitalists

“There’s not a hospitalist in the country who’s not affected by IT and updates to their [electronic medical records (EMR)], new adoption of EMR technology, different vendors,” Dr. Mattison says. “We’re always searching for something to make our lives better and make the care that we provide more high quality.”

There will be sessions of a general nature, such as “There’s an App for That,” a review of mobile apps helpful to hospitalists. And there will be those for the more passionate technophiles, such as a session on clinical informatics and “Using IT to Help Drive the Shift from Volume to Value.”

“We’ve spent a lot of time trying to make sure there’s something for everyone,” says Kendall Rogers, MD, SFHM, chair of SHM’s IT Committee. “And even within each individual talk, we’ve tried to make sure that there is material that can be applicable from the frontline hospitalist to the CMIO of a hospital.”

Dr. Rogers says the committee has “really been pushing” to have its own track at the annual meeting.

Listen to more of our interview with Dr. Rogers.

“Health IT continues to be an area of great frustration and great promise,” he says. “I think most of the frustration that hospitalists have is because they realize the potential of health IT, and they see how far it is from the reality of what they’re working with every day.

“Hospitalists are well-suited for actively being involved in clinical informatics, but many of us would be far more effective in our roles with more formal education and training.”

Post-Acute Care

It’s estimated that as many as 35% of hospitalists work in the post-acute setting. The number very much surprised Dr. Mattison. When she heard of the figure, “[the committee] lobbied very hard to get a track for post-acute care.”

One session, “Building and Managing a PAC Practice,” will review setting up a staff, relevant regulations, billing, and collecting, and it should be of interest to both managers and physicians, says Sean Muldoon, MD, senior vice president and chief medical officer of the hospitalist division at Louisville, Ken.–based Kindred Healthcare and chair of SHM’s Post-Acute Care Task Force.

Another session, “Lost in Transitions,” will review information gaps and propose solutions “to the well-known voltage drop of information that can happen in transfer from the hospital to post-acute care.”

At Kindred, Dr. Muldoon says he has seen the benefits of hospitalist involvement in post-acute care.

“In many markets, we seek out and often are able to become a practice site for a large hospitalist medical group,” he says. “That’s really good for us, the patients, and, we think, the hospitalists because it allows the hospitalists to be exposed to the practice and benefits of post-acute care without having to make a full commitment to be a skilled-nursing physician or a long-term acute-care physician.”

It also makes transitions of care smoother and less disruptive, he says, “because a patient is simply transferred from one hospitalist in a group to another or often maintaining that same hospitalist in the post-acute-care setting.”

Dr. Muldoon says the new track is of value to any hospitalist, whether they actually work in post-acute care or not.

“A hospitalist would be hard-pressed to provide knowledgeable input into where a patient should receive post-acute care without a working knowledge of which patients should be directed to which post-acute-care setting,” he says.

Doctor-Patient Relationship

This topic was a pre-course last year, and organizers decided to make this a full track on the final day of the meeting schedule.

“It’s really about communication style,” Dr. Mattison says. “There’s one session called ‘The Language of Empathy and Engagement: Communication Essentials for Patient-Centered Care.’ There’s one on unconscious biases and our underlying assumptions and how it affects how we care for patients. [Another is focused] on improving the patient experience in the hospital.”

Co-Management/ Perioperative Medicine

“There are a lot of challenges around anticoagulation management, optimizing patients’ physical heath prior to the surgery, what things should we be doing, what medications should we be giving, what ones shouldn’t we be giving,” Dr. Mattison says. “It’s an evolving field that has, every year, new information.”

Hidden Gems

Dr. Mattison draws special attention to “Work-Life Balance: Is It Possible?” (Tuesday, March 8, 4:20–5:40 p.m.). This year, this problem—all too familiar to hospitalists—will be addressed in a panel discussion, which is a change from previous years.

“There’s been, year after year after year, a lot of discussion around, how can I make my job manageable if my boss isn’t listening to me or is not attuned to work-life balance? How can I navigate this process?” she says. “I’m hopeful that the panel discussion will provide people with some real examples and strategies for success.”

She also draws attention to the session “Perioperative Pitfalls: Overcoming Common Challenges in Managing Medical Problems in Surgical Patients” (Monday, March 7, 3:05–4:20 p.m.).

“There are some true leaders in perioperative management, and they’re going to come together and have a panel discussion,” she says. “It’ll be an opportunity to see some of the great minds think, if you will.” TH

Thomas R. Collins is a freelance writer in South Florida.

Ofatumumab (Arzerra)

Photo courtesy of GSK

The US Food and Drug Administration (FDA) has approved the use of ofatumumab (Arzerra) as maintenance therapy for patients with chronic lymphocytic leukemia (CLL).

The drug can now be given for an extended period to patients who are in complete or partial response after receiving at least 2 lines of therapy for recurrent or progressive CLL.

Ofatumumab is also FDA-approved as a single agent to treat CLL that is refractory to fludarabine and alemtuzumab.

And the drug is approved for use in combination with chlorambucil to treat previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate.

The FDA granted the new approval for ofatumumab based on an interim analysis of the PROLONG study. The results suggested that ofatumumab maintenance can improve progression-free survival (PFS) in CLL patients when compared to observation.

Ofatumumab is marketed as Arzerra under a collaboration agreement between Genmab and Novartis. For more details on ofatumumab, see the full prescribing information.

PROLONG trial

The PROLONG trial was designed to compare ofatumumab maintenance to no further treatment in patients with a complete or partial response after second- or third-line treatment for CLL. Interim results of the study were presented at ASH 2014.

These results—in 474 patients—suggested that ofatumumab can significantly improve PFS. The median PFS was about 29 months in patients who received ofatumumab and about 15 months for patients who did not receive maintenance therapy (P<0.0001).

There was no significant difference in the median overall survival, which was not reached in either treatment arm.

The researchers said there were no unexpected safety findings. The most common adverse events (≥10%) were infusion reactions, neutropenia, and upper respiratory tract infection.

Ofatumumab (Arzerra)

Photo courtesy of GSK

The US Food and Drug Administration (FDA) has approved the use of ofatumumab (Arzerra) as maintenance therapy for patients with chronic lymphocytic leukemia (CLL).

The drug can now be given for an extended period to patients who are in complete or partial response after receiving at least 2 lines of therapy for recurrent or progressive CLL.

Ofatumumab is also FDA-approved as a single agent to treat CLL that is refractory to fludarabine and alemtuzumab.

And the drug is approved for use in combination with chlorambucil to treat previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate.

The FDA granted the new approval for ofatumumab based on an interim analysis of the PROLONG study. The results suggested that ofatumumab maintenance can improve progression-free survival (PFS) in CLL patients when compared to observation.

Ofatumumab is marketed as Arzerra under a collaboration agreement between Genmab and Novartis. For more details on ofatumumab, see the full prescribing information.

PROLONG trial

The PROLONG trial was designed to compare ofatumumab maintenance to no further treatment in patients with a complete or partial response after second- or third-line treatment for CLL. Interim results of the study were presented at ASH 2014.

These results—in 474 patients—suggested that ofatumumab can significantly improve PFS. The median PFS was about 29 months in patients who received ofatumumab and about 15 months for patients who did not receive maintenance therapy (P<0.0001).

There was no significant difference in the median overall survival, which was not reached in either treatment arm.

The researchers said there were no unexpected safety findings. The most common adverse events (≥10%) were infusion reactions, neutropenia, and upper respiratory tract infection.

Ofatumumab (Arzerra)

Photo courtesy of GSK

The US Food and Drug Administration (FDA) has approved the use of ofatumumab (Arzerra) as maintenance therapy for patients with chronic lymphocytic leukemia (CLL).

The drug can now be given for an extended period to patients who are in complete or partial response after receiving at least 2 lines of therapy for recurrent or progressive CLL.

Ofatumumab is also FDA-approved as a single agent to treat CLL that is refractory to fludarabine and alemtuzumab.

And the drug is approved for use in combination with chlorambucil to treat previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate.

The FDA granted the new approval for ofatumumab based on an interim analysis of the PROLONG study. The results suggested that ofatumumab maintenance can improve progression-free survival (PFS) in CLL patients when compared to observation.

Ofatumumab is marketed as Arzerra under a collaboration agreement between Genmab and Novartis. For more details on ofatumumab, see the full prescribing information.

PROLONG trial

The PROLONG trial was designed to compare ofatumumab maintenance to no further treatment in patients with a complete or partial response after second- or third-line treatment for CLL. Interim results of the study were presented at ASH 2014.

These results—in 474 patients—suggested that ofatumumab can significantly improve PFS. The median PFS was about 29 months in patients who received ofatumumab and about 15 months for patients who did not receive maintenance therapy (P<0.0001).

There was no significant difference in the median overall survival, which was not reached in either treatment arm.

The researchers said there were no unexpected safety findings. The most common adverse events (≥10%) were infusion reactions, neutropenia, and upper respiratory tract infection.

Drug vials and a syringe

The US Food and Drug Administration (FDA) has approved a generic version of tranexamic acid for short-term control of bleeding in patients with hemophilia.

The drug, tranexamic acid injection (100 mg/mL) 1000 mg/10 mL single-dose vial, is a product of Aurobindo Pharma Limited.

The drug has been deemed bioequivalent and therapeutically equivalent to Cyklokapron® injection, 100 mg/mL, a product of Pharmacia and Upjohn Company.

Aurobindo Pharma Limited said the generic drug should be launched in the US by the end of March.

Drug vials and a syringe

The US Food and Drug Administration (FDA) has approved a generic version of tranexamic acid for short-term control of bleeding in patients with hemophilia.

The drug, tranexamic acid injection (100 mg/mL) 1000 mg/10 mL single-dose vial, is a product of Aurobindo Pharma Limited.

The drug has been deemed bioequivalent and therapeutically equivalent to Cyklokapron® injection, 100 mg/mL, a product of Pharmacia and Upjohn Company.

Aurobindo Pharma Limited said the generic drug should be launched in the US by the end of March.

Drug vials and a syringe

The US Food and Drug Administration (FDA) has approved a generic version of tranexamic acid for short-term control of bleeding in patients with hemophilia.

The drug, tranexamic acid injection (100 mg/mL) 1000 mg/10 mL single-dose vial, is a product of Aurobindo Pharma Limited.

The drug has been deemed bioequivalent and therapeutically equivalent to Cyklokapron® injection, 100 mg/mL, a product of Pharmacia and Upjohn Company.

Aurobindo Pharma Limited said the generic drug should be launched in the US by the end of March.

Red blood cells

Scientists say they have determined how red blood cells (RBCs) move, showing that RBCs can be moved by external forces and actively “wriggle” on their own.

Linking physical principles and biological reality, the team found that fast molecules in the vicinity of RBCs make the cell membranes wriggle, but the cells themselves also become active when they have enough reaction time.

The group recounted these findings in Nature Physics.

Previously, scientists had only shown that RBCs’ constant wriggling was caused by external forces. But biological considerations suggested that internal forces might also be responsible for the RBCs’ membranes changing shape.

“So we started with the following question, ‘As blood cells are living cells, why shouldn’t internal forces inside the cell also have an impact on the membrane?’” said study author Timo Betz, PhD, of Münster University in Münster, Germany.

“For biologists, this is all clear, but these forces were just never a part of any physical equation.”

Dr Betz and his colleagues wanted to find out more about the mechanics of blood cells and gain a detailed understanding of the forces that move and shape cells.

The team said it is important to learn about RBCs’ properties and their internal forces because they are unusually soft and elastic and must change their shape to pass through blood vessels. It is precisely because RBCs are normally so soft that, in previous studies, physicists measured large thermal fluctuations at the outer membrane of the cells.

These natural movements of molecules are defined by the ambient temperature. In other words, the cell membrane moves because molecules in the vicinity jog it. Under the microscope, this makes the RBCs appear to be wriggling.

Although this explains why RBCs move, it does not address the question of possible internal forces being a contributing factor.

So Dr Betz and his colleagues used optical tweezers to take a close look at the fluctuations of RBCs. The team stretched RBCs in a petri dish and analyzed the behavior of the cells.

The result was that, if the RBCs had enough reaction time, they became active themselves and were able to counteract the force of the optical tweezers. If they did not have this time, they were at the mercy of their environment, and only temperature-related forces were measured.

“By comparing both sets of measurements, we can exactly define how fast the cells become active themselves and what force they generate in order to change shape,” Dr Betz explained.

He and his colleagues have a theory as to which forces inside RBCs cause the cell membrane to change shape.

“Transport proteins could generate such forces in the membrane by moving ions from one side of the membrane to the other,” said study author Gerhard Gompper, PhD, of the Jülich Institute of Complex Systems in Jülich, Germany.

“Now, it’s up to the biologists, because we physicists only have a rough idea about which proteins might be the drivers for this movement,” Dr Betz added. “On the other hand, we can predict exactly how fast and how strong they are.”

Red blood cells

Scientists say they have determined how red blood cells (RBCs) move, showing that RBCs can be moved by external forces and actively “wriggle” on their own.

Linking physical principles and biological reality, the team found that fast molecules in the vicinity of RBCs make the cell membranes wriggle, but the cells themselves also become active when they have enough reaction time.

The group recounted these findings in Nature Physics.

Previously, scientists had only shown that RBCs’ constant wriggling was caused by external forces. But biological considerations suggested that internal forces might also be responsible for the RBCs’ membranes changing shape.

“So we started with the following question, ‘As blood cells are living cells, why shouldn’t internal forces inside the cell also have an impact on the membrane?’” said study author Timo Betz, PhD, of Münster University in Münster, Germany.

“For biologists, this is all clear, but these forces were just never a part of any physical equation.”

Dr Betz and his colleagues wanted to find out more about the mechanics of blood cells and gain a detailed understanding of the forces that move and shape cells.

The team said it is important to learn about RBCs’ properties and their internal forces because they are unusually soft and elastic and must change their shape to pass through blood vessels. It is precisely because RBCs are normally so soft that, in previous studies, physicists measured large thermal fluctuations at the outer membrane of the cells.

These natural movements of molecules are defined by the ambient temperature. In other words, the cell membrane moves because molecules in the vicinity jog it. Under the microscope, this makes the RBCs appear to be wriggling.

Although this explains why RBCs move, it does not address the question of possible internal forces being a contributing factor.

So Dr Betz and his colleagues used optical tweezers to take a close look at the fluctuations of RBCs. The team stretched RBCs in a petri dish and analyzed the behavior of the cells.

The result was that, if the RBCs had enough reaction time, they became active themselves and were able to counteract the force of the optical tweezers. If they did not have this time, they were at the mercy of their environment, and only temperature-related forces were measured.

“By comparing both sets of measurements, we can exactly define how fast the cells become active themselves and what force they generate in order to change shape,” Dr Betz explained.

He and his colleagues have a theory as to which forces inside RBCs cause the cell membrane to change shape.

“Transport proteins could generate such forces in the membrane by moving ions from one side of the membrane to the other,” said study author Gerhard Gompper, PhD, of the Jülich Institute of Complex Systems in Jülich, Germany.

“Now, it’s up to the biologists, because we physicists only have a rough idea about which proteins might be the drivers for this movement,” Dr Betz added. “On the other hand, we can predict exactly how fast and how strong they are.”

Red blood cells

Scientists say they have determined how red blood cells (RBCs) move, showing that RBCs can be moved by external forces and actively “wriggle” on their own.

Linking physical principles and biological reality, the team found that fast molecules in the vicinity of RBCs make the cell membranes wriggle, but the cells themselves also become active when they have enough reaction time.

The group recounted these findings in Nature Physics.

Previously, scientists had only shown that RBCs’ constant wriggling was caused by external forces. But biological considerations suggested that internal forces might also be responsible for the RBCs’ membranes changing shape.

“So we started with the following question, ‘As blood cells are living cells, why shouldn’t internal forces inside the cell also have an impact on the membrane?’” said study author Timo Betz, PhD, of Münster University in Münster, Germany.

“For biologists, this is all clear, but these forces were just never a part of any physical equation.”

Dr Betz and his colleagues wanted to find out more about the mechanics of blood cells and gain a detailed understanding of the forces that move and shape cells.

The team said it is important to learn about RBCs’ properties and their internal forces because they are unusually soft and elastic and must change their shape to pass through blood vessels. It is precisely because RBCs are normally so soft that, in previous studies, physicists measured large thermal fluctuations at the outer membrane of the cells.

These natural movements of molecules are defined by the ambient temperature. In other words, the cell membrane moves because molecules in the vicinity jog it. Under the microscope, this makes the RBCs appear to be wriggling.

Although this explains why RBCs move, it does not address the question of possible internal forces being a contributing factor.

So Dr Betz and his colleagues used optical tweezers to take a close look at the fluctuations of RBCs. The team stretched RBCs in a petri dish and analyzed the behavior of the cells.

The result was that, if the RBCs had enough reaction time, they became active themselves and were able to counteract the force of the optical tweezers. If they did not have this time, they were at the mercy of their environment, and only temperature-related forces were measured.

“By comparing both sets of measurements, we can exactly define how fast the cells become active themselves and what force they generate in order to change shape,” Dr Betz explained.

He and his colleagues have a theory as to which forces inside RBCs cause the cell membrane to change shape.

“Transport proteins could generate such forces in the membrane by moving ions from one side of the membrane to the other,” said study author Gerhard Gompper, PhD, of the Jülich Institute of Complex Systems in Jülich, Germany.

“Now, it’s up to the biologists, because we physicists only have a rough idea about which proteins might be the drivers for this movement,” Dr Betz added. “On the other hand, we can predict exactly how fast and how strong they are.”

Micrograph showing ALL

The European Commission has granted marketing authorization for pegaspargase (Oncaspar) to be used as part of combination antineoplastic therapy for pediatric and adult patients with acute lymphoblastic leukemia (ALL).

The approval means the drug can be marketed for this indication in the 28 member countries of the European Union (EU), as well as Iceland, Liechtenstein, and Norway.

Pegaspargase was already approved for use in Argentina, Belarus, Germany, Kazakhstan, Poland, Russia, Ukraine, and the US.

“Oncaspar has been used as an integral component of the treatment regimen for pediatric and adult patients with ALL for many years, in Europe and worldwide,” said Martin Schrappe, of Schleswig-Holstein University Hospital in Kiel, Germany.

“Today’s marketing authorization will ensure that more patients across the EU will benefit from access to Oncaspar as part of a standard of care regimen.”

The drug is being developed by Baxalta Incorporated.

First-line ALL

Researchers have evaluated the safety and effectiveness of pegaspargase in a study of 118 pediatric patients (ages 1 to 9) with newly diagnosed ALL. The patients were randomized 1:1 to pegaspargase or native E coli L-asparaginase, both as part of combination therapy.

Asparagine depletion (magnitude and duration) was similar between the 2 treatment arms. Event-free survival rates were also similar (about 80% in both arms), but the study was not designed to evaluate differences in event-free survival.

Grade 3/4 adverse events occurring in the pegaspargase and native E coli L-asparaginase arms, respectively, were abnormal liver tests (5% and 8%), elevated transaminases (3% and 7%), hyperbilirubinemia (2% and 2%), hyperglycemia (5% and 3%), central nervous system thrombosis (3% and 3%), coagulopathy (2% and 5%), pancreatitis (2% and 2%), and clinical allergic reactions to asparaginase (2% and 0%).

Previously treated ALL

Researchers have evaluated the effectiveness of pegaspargase in 4 open-label studies of patients with a history of prior clinical allergic reaction to asparaginase. The studies enrolled a total of 42 patients with multiply relapsed acute leukemia (39 with ALL).

Patients received pegaspargase as a single agent or as part of multi-agent chemotherapy. The re-induction response rate was 50%—36% complete responses and 14% partial responses. Three responses occurred in patients who received single-agent pegaspargase.

Adverse event information on pegaspargase in relapsed ALL has been compiled from 5 clinical trials. The studies enrolled a total of 174 patients with relapsed ALL who received pegaspargase as a single agent or as part of combination therapy.

Sixty-two of the patients had prior hypersensitivity reactions to asparaginase, and 112 did not. Allergic reactions to pegaspargase occurred in 32% of previously hypersensitive patients and 10% of non-hypersensitive patients.

The most common adverse events observed in patients who received pegaspargase were clinical allergic reactions, elevated transaminases, hyperbilirubinemia, and coagulopathies.

The most common serious adverse events due to pegaspargase were thrombosis (4%), hyperglycemia requiring insulin therapy (3%), and pancreatitis (1%).

For more details on these trials and pegaspargase in general, see the product information.

Micrograph showing ALL

The European Commission has granted marketing authorization for pegaspargase (Oncaspar) to be used as part of combination antineoplastic therapy for pediatric and adult patients with acute lymphoblastic leukemia (ALL).

The approval means the drug can be marketed for this indication in the 28 member countries of the European Union (EU), as well as Iceland, Liechtenstein, and Norway.

Pegaspargase was already approved for use in Argentina, Belarus, Germany, Kazakhstan, Poland, Russia, Ukraine, and the US.

“Oncaspar has been used as an integral component of the treatment regimen for pediatric and adult patients with ALL for many years, in Europe and worldwide,” said Martin Schrappe, of Schleswig-Holstein University Hospital in Kiel, Germany.

“Today’s marketing authorization will ensure that more patients across the EU will benefit from access to Oncaspar as part of a standard of care regimen.”

The drug is being developed by Baxalta Incorporated.

First-line ALL

Researchers have evaluated the safety and effectiveness of pegaspargase in a study of 118 pediatric patients (ages 1 to 9) with newly diagnosed ALL. The patients were randomized 1:1 to pegaspargase or native E coli L-asparaginase, both as part of combination therapy.

Asparagine depletion (magnitude and duration) was similar between the 2 treatment arms. Event-free survival rates were also similar (about 80% in both arms), but the study was not designed to evaluate differences in event-free survival.

Grade 3/4 adverse events occurring in the pegaspargase and native E coli L-asparaginase arms, respectively, were abnormal liver tests (5% and 8%), elevated transaminases (3% and 7%), hyperbilirubinemia (2% and 2%), hyperglycemia (5% and 3%), central nervous system thrombosis (3% and 3%), coagulopathy (2% and 5%), pancreatitis (2% and 2%), and clinical allergic reactions to asparaginase (2% and 0%).

Previously treated ALL

Researchers have evaluated the effectiveness of pegaspargase in 4 open-label studies of patients with a history of prior clinical allergic reaction to asparaginase. The studies enrolled a total of 42 patients with multiply relapsed acute leukemia (39 with ALL).

Patients received pegaspargase as a single agent or as part of multi-agent chemotherapy. The re-induction response rate was 50%—36% complete responses and 14% partial responses. Three responses occurred in patients who received single-agent pegaspargase.

Adverse event information on pegaspargase in relapsed ALL has been compiled from 5 clinical trials. The studies enrolled a total of 174 patients with relapsed ALL who received pegaspargase as a single agent or as part of combination therapy.

Sixty-two of the patients had prior hypersensitivity reactions to asparaginase, and 112 did not. Allergic reactions to pegaspargase occurred in 32% of previously hypersensitive patients and 10% of non-hypersensitive patients.

The most common adverse events observed in patients who received pegaspargase were clinical allergic reactions, elevated transaminases, hyperbilirubinemia, and coagulopathies.

The most common serious adverse events due to pegaspargase were thrombosis (4%), hyperglycemia requiring insulin therapy (3%), and pancreatitis (1%).

For more details on these trials and pegaspargase in general, see the product information.

Micrograph showing ALL

The European Commission has granted marketing authorization for pegaspargase (Oncaspar) to be used as part of combination antineoplastic therapy for pediatric and adult patients with acute lymphoblastic leukemia (ALL).

The approval means the drug can be marketed for this indication in the 28 member countries of the European Union (EU), as well as Iceland, Liechtenstein, and Norway.

Pegaspargase was already approved for use in Argentina, Belarus, Germany, Kazakhstan, Poland, Russia, Ukraine, and the US.

“Oncaspar has been used as an integral component of the treatment regimen for pediatric and adult patients with ALL for many years, in Europe and worldwide,” said Martin Schrappe, of Schleswig-Holstein University Hospital in Kiel, Germany.

“Today’s marketing authorization will ensure that more patients across the EU will benefit from access to Oncaspar as part of a standard of care regimen.”

The drug is being developed by Baxalta Incorporated.

First-line ALL

Researchers have evaluated the safety and effectiveness of pegaspargase in a study of 118 pediatric patients (ages 1 to 9) with newly diagnosed ALL. The patients were randomized 1:1 to pegaspargase or native E coli L-asparaginase, both as part of combination therapy.

Asparagine depletion (magnitude and duration) was similar between the 2 treatment arms. Event-free survival rates were also similar (about 80% in both arms), but the study was not designed to evaluate differences in event-free survival.

Grade 3/4 adverse events occurring in the pegaspargase and native E coli L-asparaginase arms, respectively, were abnormal liver tests (5% and 8%), elevated transaminases (3% and 7%), hyperbilirubinemia (2% and 2%), hyperglycemia (5% and 3%), central nervous system thrombosis (3% and 3%), coagulopathy (2% and 5%), pancreatitis (2% and 2%), and clinical allergic reactions to asparaginase (2% and 0%).

Previously treated ALL

Researchers have evaluated the effectiveness of pegaspargase in 4 open-label studies of patients with a history of prior clinical allergic reaction to asparaginase. The studies enrolled a total of 42 patients with multiply relapsed acute leukemia (39 with ALL).

Patients received pegaspargase as a single agent or as part of multi-agent chemotherapy. The re-induction response rate was 50%—36% complete responses and 14% partial responses. Three responses occurred in patients who received single-agent pegaspargase.

Adverse event information on pegaspargase in relapsed ALL has been compiled from 5 clinical trials. The studies enrolled a total of 174 patients with relapsed ALL who received pegaspargase as a single agent or as part of combination therapy.

Sixty-two of the patients had prior hypersensitivity reactions to asparaginase, and 112 did not. Allergic reactions to pegaspargase occurred in 32% of previously hypersensitive patients and 10% of non-hypersensitive patients.

The most common adverse events observed in patients who received pegaspargase were clinical allergic reactions, elevated transaminases, hyperbilirubinemia, and coagulopathies.

The most common serious adverse events due to pegaspargase were thrombosis (4%), hyperglycemia requiring insulin therapy (3%), and pancreatitis (1%).

For more details on these trials and pegaspargase in general, see the product information.