Orthopedics

Although total shoulder arthroplasty (TSA) has proved to be a reliable solution in older patients, treatment in younger patients with glenohumeral arthritis remains controversial, and there are still few reliable long-term surgical options.^1-8 These options include abrasion arthroplasty and arthroscopic management,^9,10 biologic glenoid resurfacing,^11,12 and humeral hemiarthroplasty with¹³ or without^14,15 glenoid treatment and anatomical TSA.

In the younger cohort, 20-year TSA survivorship rates up to 84% have been reported, and unsatisfactory subjective outcomes have been unacceptably high.¹⁶ In addition, there is a paucity of literature addressing the impact of TSA on return to sport. Recommendations on returning to an athletic life style are based largely on surveys of expert opinion^17,18 and heterogeneous studies of either older patients (eg, age >50-55 years) who are active^19-21 or younger patients with no defined level of activity.^{5,7,8,16,22-24}

To our knowledge, no one has evaluated the short-term morbidity and clinical outcomes within a young, high-demand patient population, such as the US military. Therefore, we conducted a study to evaluate the clinical success and complications of TSA performed for glenohumeral arthritis in a young, active population. We hypothesized that patients who had undergone TSA would have a low rate of return to duty, an increased rate of component failure, and a higher reoperation rate because of increased upper extremity demands.

Materials and Methods

After obtaining protocol approval from the William Beaumont Army Medical Center Institutional Review Board, we searched the Military Health System (MHS) Management Analysis and Reporting Tool (M2) database to retrospectively review the cases of all tri-service US military service members who had undergone primary anatomical TSA (Current Procedural Terminology code 23472) between January 1, 2007 and June 31, 2014. This was a multisurgeon, multicenter study. Patient exclusion criteria were nonmilitary or retired status at time of surgery; primary surgery consisting of limited glenohumeral resurfacing procedure, hemiarthroplasty, or reverse TSA; surgery for acute proximal humerus fracture; rotator cuff deficiency diagnosed before or during surgery; and insufficient follow-up (eg, <12 months, unless medically separated beforehand).

The M2 database is an established tool that has been used for clinical outcomes research on treatment of a variety of orthopedic conditions.25,26 The Medical Data Repository, which is operated by MHS, is populated by its military healthcare providers. The MHS, which offers worldwide coverage for all beneficiaries either at Department of Defense facilities or purchased using civilian providers, is among the largest known closed healthcare systems.

All active-duty US military service members are uniformly required to adhere to stringent and regularly evaluated physical fitness standards, which typically exceed those of average civilians. Routine physical training is required in the form of aerobic fitness, weight training, tactical field exercises, and core military tasks, such as the ability to march at least 2 miles while carrying heavy fighting loads. In addition to satisfying required height and weight standards, all service members are subject to semiannual service-specific physical fitness evaluations inclusive of timed push-ups, sit-ups, and an aerobic event. Service members may also be required to maintain a level of physical training above these baseline standards, contingent on their branch of service, rank, and military occupational specialty. If a service member is unable to maintain these standards, medical separation may be initiated.

Demographic and occupational data were extracted from the database. These data included age, sex, military rank, and branch of service. Line-by-line analysis of the Armed Forces Health Longitudinal Technology Application (Version 22; 3M) electronic medical record was then performed to confirm the underlying diagnosis, surgical procedure, and surgery date. Further chart review yielded additional patient-based factors (eg, laterality, hand dominance, presence and type of prior shoulder surgeries) and surgical factors (eg, surgery indication, implant design). We evaluated clinical and functional outcomes as well as perioperative complications, including both major and minor systemic and local complications as previously described^27,28; preoperative and postoperative range of motion (ROM) and self-reported pain score (SRPS, scale 1-10) as measured by physical therapist and surgeon at follow-up; secondary surgical interventions; timing of return to duty; and postoperative deployment history. The primary outcome measures were revision reoperation after index procedure, and military discharge for persistent shoulder-related disability. Clinical failure was defined as component failure or reoperation. Medical Evaluation Board (MEB) is a formal separation from the military in which it is deemed that a service member is no longer able to fulfill his or her duty because of a medical condition.

Statistical Analysis

Continuous variables were compared using statistical means with 95% confidence intervals (CIs) and/or SDs. Categorical data were reported as frequencies or percentages. Univariate analysis was performed to assess the correlation between possible risk factors and the primary outcome measures. P < .05 was considered statistically significant.

Results

Demographics

We identified 24 service members (26 shoulders) who had undergone anatomical TSA during the study period (Table 1). Mean (SD) age was 45.8 (4.5) years (range, 35-54 years), and the cohort was predominately male (25/26 shoulders; 96.2%). Most cohort members were of senior enlisted rank (14, 58.3%), and the US Army was the predominant branch of military service (13, 54.2%). The right side was the operative extremity in 7 cases (26.9%), and the dominant shoulder was involved in 6 cases (23.1%). Two patients (8.3%) underwent staged bilateral TSA. Most patients (76.9%) underwent TSA on the nondominant extremity.

Surgical Variables

TSA was indicated for post-instability arthropathy in 13 cases (50.0%), posttraumatic osteoarthritis in 7 cases (26.9%), and unspecified glenohumeral arthritis, which includes primary glenohumeral osteoarthritis, in 5 cases (19.2%) (Table 2). One case was attributed to iatrogenically induced chondrolysis secondary to intra-articular lidocaine pump. Twelve patients (46.2%) had at least 1 previous surgery. Of the shoulders with instability, 10 (76.9%) had undergone a total of 14 surgical stabilization procedures—10 anterior labral repairs, 2 posterior labral repairs, and 2 capsular plications. The other shoulders had undergone a total of 18 procedures, which included 4 rotator cuff repairs and 3 cartilage restoration procedures.

Clinical Outcomes

Mean (SD) follow-up was 41.0 (21.3) months (range, 11.6-97.6 months). All but 1 shoulder (96.2%) had follow-up of 12 months or more (the only patient with shorter follow-up was because of MEB), and 76.9% of patients had follow-up of 24 months or more (4 of the 6 patients with follow-up under 24 months were medically separated) (Table 3). In all cases, mean ROM improved with respect to flexion, abduction, and external rotation. At final follow-up, mean (SD) ROM was 138° (36°) forward flexion (range, 60°-180°), 125° (39°) abduction (range, 45°-180°), 48° (19°) external rotation at 0° abduction (range, 20°-90°), and 80° (9.4°) external rotation at 90° abduction (range, 70°-90°). Preoperative flexion, abduction, and external rotation at 0° and 90° abduction were all improved at final follow-up. The most improvement in ROM occurred within 6 months after surgery.

Overall patient satisfaction with surgery was 92.3% (n = 24). Ultimately, 18 (72.0%) of 25 shoulders with follow-up of 1 year or more were able to return to active duty within 1 year after surgery, though only 10 (45.5%) of 22 with follow-up of 2 years or more remained active 2 years after surgery. Furthermore, 5 patients (20.8%) were deployed after surgery, and all were still on active duty at final follow-up. By final follow-up, 9 (37.5%) of 24 service members were unable to return to military function; 7 had been medically discharged from the military for persistent shoulder disability, and 2 were in the process of being medically discharged.

In all cases, SRPS improved from before surgery (5.2 out of 10) to final follow-up (1.4). At final follow-up, 22 patients (88.0%) reported mild pain (0-3), and no one had pain above 6.

Complications

Nine patients had a total of 12 postoperative complications (46.2%): 6 component failures (23.1%), 2 neurologic injuries (7.7%; 1 permanent axillary nerve injury, 1 transient brachial plexus neuritis), 2 cases of adhesive capsulitis (7.7%), and 2 episodes of venous thrombosis (7.7%; 1 superficial, 1 deep) (Table 4). There were no documented infections. Six reoperations (23.1%) were performed for the 6 component failures (2 traumatic dislocations of prosthesis resulting in acute glenoid component failure, 3 cases of atraumatic glenoid loosening, 1 case of humeral stem loosening after periprosthetic fracture). Atraumatic glenoid component loosening occurred a mean (SD) of 40.6 (14.2) months after surgery (range, 20.8-54.2 months).

Surgical Failures

Eight service members underwent MEB. Six patients experienced component failure. Factors contributing to both clinical failure and separation from active duty by means of MEB were evaluated with univariate analysis (Table 5). No statistically significant risk factors, including surgical revision and presence of perioperative complications, were identified.

Discussion

We confirmed that our cohort of young service members (mean age, 45.8 years), who had undergone TSA for glenohumeral arthritis, had a relatively higher rate of component failure (23.1%) and a higher reoperation rate (23.1%) with low rates of return to military duty at short-term to midterm follow-up. Our results parallel those of a limited series with a younger cohort (Table 6).^{7,16,19,21,23,24} The high demand and increased life expectancy of the younger patients with glenohumeral arthritis potentiates the risk of complications, component loosening, and ultimate failure.²⁹ To our knowledge, the present article is the first to report clinical and functional outcomes and perioperative risk profiles in a homogenously young, active military cohort after TSA.

The mean age of our study population (46 years) is one of the lowest in the literature. TSA in younger patients (age, <50-55 years) and older, active patients (>55 years) has received increased attention as a result of the expanding indications and growing popularity of TSA in these groups. Other studies have upheld the efficacy of TSA in achieving predictable pain relief and functional improvement in a diverse and predominantly elderly population.^15,30-34 Alternative treatments, including humeral head resurfacing^15,30,35 and soft-tissue interposition,^15,36-40 have also shown inferior short- and long-term results in terms of longevity and degree of clinical or functional improvement.^31-34,41 In addition, the ream-and-run technique has had promising early results by improving glenohumeral kinematics, pain relief, and shoulder function.^13,42,43 However, although implantation of a glenoid component is avoided in young, active people because of reduced longevity and higher rates of component failure, the trade-offs are inadequately treated glenoid disease, suboptimal pain relief, and progression of glenoid arthritis eventually requiring revision. Furthermore, midterm and long-term survivorship of TSA in general is unknown, and there remain few good options for treating end-stage arthritis in young, active patients.

Our cohort had high rates of complications (46.2%) and revisions (23.1%). Two in 5 patients had postoperative complications, most commonly component failure resulting in reoperation. In the literature, complication rates among young patients who underwent TSA are much lower (4.8%-10.9%).^16,23,24 Our cohort’s most common complication was component failure (23.1%), which was most often attributed to atraumatic, aseptic glenoid component loosening and required reoperation. Previously reported revision rates in a young population that underwent TSA (0%-11%)^16,23,24 were also significantly lower than those in the present analysis (23.1%), underscoring the impact of operative indications, postoperative activity levels, and occupational demands on ultimate failure rates. Interestingly, all revisions in our study were for component failure, whereas previous reports have described a higher rate for infection.²² However, the same studies also found glenoid lucency rates as high as 76% at 10-year follow-up.¹⁶ Furthermore, in a review of 136 TSAs with unsatisfactory outcomes, glenoid loosening was the most common reason for presenting to clinic after surgery.⁴⁴ Specifically, our population had a high rate of glenohumeral arthritis secondary to instability (50.0%) and posttraumatic osteoarthritis (26.9%). For many reasons, outcomes were worse in younger patients with a history of glenohumeral instability³³ than in older patients without a high incidence of instability.⁴⁵ This young cohort with higher demands may have had accelerated polyethylene wear patterns caused by repetitive overhead activity, which may have arisen because of a higher functional profile after surgery and greater patient expectations after arthroplasty. In addition, patients with a history of instability may have altered glenohumeral anatomy, especially with previous arthroscopic or open stabilization procedures. Anatomical changes include excessive posterior glenoid wear, internal rotation contracture, patulous capsular tissue, static or dynamic posterior humeral subluxation, and possible overconstraint after prior stabilization procedures. Almost half of our population had a previous surgery; our patients averaged 1.7 previous surgeries each.

Although estimates of component survivorship at a high-volume civilian tertiary-referral center were as high as 97% at 10 years and 84% at 20 years,^7,16 10-year survivorship in patients with a history of instability was only 61%.3 TSA survivorship in our young, active cohort is already foreseeably dramatically reduced, given the 23.1% revision rate at 28.5-month follow-up. This consideration must be addressed during preoperative counseling with the young patient with glenohumeral arthritis and a history of shoulder instability.

Despite the high rates of complications and revisions in our study, 92.3% of patients were satisfied with surgery, 88.0% experienced minimal persistence of pain (mean 3.8-point decrease on SRPS), and 100% maintained improved ROM at final follow-up. Satisfaction in the young population has varied significantly, from 52% to 95%, generally on the basis of physical activity.^16,22-24 The reasonable rate of postoperative satisfaction in the present analysis is comparable to what has been reported in patients of a similar age (Table 6).^7,16,22 However, despite high satisfaction and pain relief, patients were inconsistently able to return to the upper limits of physical activity required of active-duty military service. In addition, we cannot exclude secondary gain motivations for pursuing medical retirement, similar to that seen in patients receiving worker’s compensation.

Other authors have conversely found more favorable functional outcomes and survivorship rates.^23,24 In a retrospective review of 46 TSAs in patients 55 years or younger, Bartelt and colleagues²⁴ found sustained improvements in pain, ROM, and satisfaction at 7-year follow-up.24 Raiss and colleagues²³ conducted a prospective study of TSA outcomes in 21 patients with a mean age of 55 years and a mean follow-up of 7 years and reported no revisions and only 1 minor complication, a transient brachial plexus palsy.²³ The discrepancy between these studies may reflect different activity levels and underlying pathology between cohorts. The present population is unique in that it represents a particularly difficult confluence of factors for shoulder arthroplasty surgeons. The high activity, significant overhead and lifting occupational demands, and discordant patient expectations of this military cohort place a significant functional burden on the implants, the glenoid component in particular. Furthermore, this patient group has a higher incidence of more complex glenohumeral pathology resulting in instability, posttraumatic, or capsulorrhaphy arthropathy, and multiple prior arthroscopic and open stabilization procedures.

At final follow-up, only 33% of our patients were still on activity duty, 37.5% had completed or were completing medical separation from the military after surgery for persistent shoulder disability, and 37.5% were retired from the military. Five patients (20.8%) deployed after surgery. This young, active cohort of service members who had TSA for glenohumeral arthritis faced a unique set of tremendous physical demands. A retrospective case series investigated return to sport in 100 consecutive patients (mean age, 68.9 years) who were participating in recreational and competitive athletics and underwent unilateral TSA.²¹ The patients were engaged most commonly in swimming (20.4%), golf (16.3%), cycling (16.3%), and fitness training (16.3%). The authors found that, at a mean follow-up of 2.8 years, 49 patients (89%) were able to continue in sports, though 36.7% thought their sport activity was restricted after TSA. In another retrospective case series (61 TSAs), McCarty and colleagues¹⁹ found that 48 patients (71%) were improved in their sports participation, and 50% increased their frequency of participation after surgery.

There are no specific recommendations on returning to military service or high-level sport after surgery. Recommendations on returning to sport after TSA have been based largely on small case series involving specific sports^46,47 and surveys of expert opinion.^17,18 In a survey on postoperative physical activity in young patients after TSA conducted by Healy and colleagues,¹⁷ 35 American Shoulder and Elbow Surgeons members recommended avoiding contact and impact sports while permitting return to nonimpact sports, such as swimming, which may still impart significant stress to the glenohumeral joint. In an international survey of 101 shoulder and elbow surgeons, Magnussen and colleagues¹⁸ also found that most recommended avoiding a return to impact sports that require intensive upper extremity demands and permitting full return to sports at preoperative levels. This likely is a result of the perception that most of these patients having TSA are older and have less rigorous involvement in sports at the outset and a lower propensity for adverse patient outcomes. However, these recommendations may place a younger, more high-demand patient at significantly greater risk. The active-duty cohort engages in daily physical training, including push-ups and frequent overhead lifting, which could account for the high failure rates and low incidence of postoperative deployment. Although TSA seems to demonstrate good initial results in terms of return to high-demand activities, the return-to-duty profile in our study highlights the potential pitfalls of TSA in active individuals attempting to return to high-demand preoperative function.

Our analysis was limited by the fact that we used a small patient cohort, contributing to underpowered analysis of the potential risk factors predictive of reoperation and medical discharge. Although our minimum follow-up was 12 months, with the exception of 1 patient who was medically separated at 11.6 months because of shoulder disability, we captured 5 patients (19.2%) who underwent medical separation but who would otherwise be excluded. Therefore, this limitation is not major in that, with a longer minimum follow-up, we would be excluding a significant number of patients with such persistent disability after TSA that they would not be able to return to duty at anywhere near their previous level. In this retrospective study, we were additionally limited to analysis of the data in the medical records and could not control for variables such as surgeon technique, implant choice, and experience. Complete radiographic images were not available, limiting analysis of radiographic outcomes. Given the lack of a standardized preoperative imaging protocol, we could not evaluate glenoid version on axial imaging. It is possible that some patients with early aseptic glenoid loosening had posterior subluxation or a Walch B2 glenoid, which has a higher failure rate.⁴⁸ The strengths of this study include its unique analysis of a homogeneous young, active, high-risk patient cohort within a closed healthcare system. In the military, these patients are subject to intense daily physical and occupational demands. In addition, the clinical and functional outcomes we studied are patient-centered and therefore relevant during preoperative counseling. Further investigations might focus on validated outcome measures and on midterm to long-term TSA outcomes in an active military population vis-à-vis other alternatives for clinical management.

Conclusion

By a mean follow-up of 3.5 years, only a third of the service members had returned to active duty, roughly a third had retired, and more than a third had been medically discharged because of persistent disability attributable to the shoulder. Despite initial improvements in ROM and pain, midterm outcomes were poor. The short-term complication rate (46.2%) and the rate of reoperation for component failure (23.1%) should be emphasized during preoperative counseling.

Although total shoulder arthroplasty (TSA) has proved to be a reliable solution in older patients, treatment in younger patients with glenohumeral arthritis remains controversial, and there are still few reliable long-term surgical options.^1-8 These options include abrasion arthroplasty and arthroscopic management,^9,10 biologic glenoid resurfacing,^11,12 and humeral hemiarthroplasty with¹³ or without^14,15 glenoid treatment and anatomical TSA.

In the younger cohort, 20-year TSA survivorship rates up to 84% have been reported, and unsatisfactory subjective outcomes have been unacceptably high.¹⁶ In addition, there is a paucity of literature addressing the impact of TSA on return to sport. Recommendations on returning to an athletic life style are based largely on surveys of expert opinion^17,18 and heterogeneous studies of either older patients (eg, age >50-55 years) who are active^19-21 or younger patients with no defined level of activity.^{5,7,8,16,22-24}

To our knowledge, no one has evaluated the short-term morbidity and clinical outcomes within a young, high-demand patient population, such as the US military. Therefore, we conducted a study to evaluate the clinical success and complications of TSA performed for glenohumeral arthritis in a young, active population. We hypothesized that patients who had undergone TSA would have a low rate of return to duty, an increased rate of component failure, and a higher reoperation rate because of increased upper extremity demands.

Materials and Methods

After obtaining protocol approval from the William Beaumont Army Medical Center Institutional Review Board, we searched the Military Health System (MHS) Management Analysis and Reporting Tool (M2) database to retrospectively review the cases of all tri-service US military service members who had undergone primary anatomical TSA (Current Procedural Terminology code 23472) between January 1, 2007 and June 31, 2014. This was a multisurgeon, multicenter study. Patient exclusion criteria were nonmilitary or retired status at time of surgery; primary surgery consisting of limited glenohumeral resurfacing procedure, hemiarthroplasty, or reverse TSA; surgery for acute proximal humerus fracture; rotator cuff deficiency diagnosed before or during surgery; and insufficient follow-up (eg, <12 months, unless medically separated beforehand).

The M2 database is an established tool that has been used for clinical outcomes research on treatment of a variety of orthopedic conditions.25,26 The Medical Data Repository, which is operated by MHS, is populated by its military healthcare providers. The MHS, which offers worldwide coverage for all beneficiaries either at Department of Defense facilities or purchased using civilian providers, is among the largest known closed healthcare systems.

All active-duty US military service members are uniformly required to adhere to stringent and regularly evaluated physical fitness standards, which typically exceed those of average civilians. Routine physical training is required in the form of aerobic fitness, weight training, tactical field exercises, and core military tasks, such as the ability to march at least 2 miles while carrying heavy fighting loads. In addition to satisfying required height and weight standards, all service members are subject to semiannual service-specific physical fitness evaluations inclusive of timed push-ups, sit-ups, and an aerobic event. Service members may also be required to maintain a level of physical training above these baseline standards, contingent on their branch of service, rank, and military occupational specialty. If a service member is unable to maintain these standards, medical separation may be initiated.

Demographic and occupational data were extracted from the database. These data included age, sex, military rank, and branch of service. Line-by-line analysis of the Armed Forces Health Longitudinal Technology Application (Version 22; 3M) electronic medical record was then performed to confirm the underlying diagnosis, surgical procedure, and surgery date. Further chart review yielded additional patient-based factors (eg, laterality, hand dominance, presence and type of prior shoulder surgeries) and surgical factors (eg, surgery indication, implant design). We evaluated clinical and functional outcomes as well as perioperative complications, including both major and minor systemic and local complications as previously described^27,28; preoperative and postoperative range of motion (ROM) and self-reported pain score (SRPS, scale 1-10) as measured by physical therapist and surgeon at follow-up; secondary surgical interventions; timing of return to duty; and postoperative deployment history. The primary outcome measures were revision reoperation after index procedure, and military discharge for persistent shoulder-related disability. Clinical failure was defined as component failure or reoperation. Medical Evaluation Board (MEB) is a formal separation from the military in which it is deemed that a service member is no longer able to fulfill his or her duty because of a medical condition.

Statistical Analysis

Continuous variables were compared using statistical means with 95% confidence intervals (CIs) and/or SDs. Categorical data were reported as frequencies or percentages. Univariate analysis was performed to assess the correlation between possible risk factors and the primary outcome measures. P < .05 was considered statistically significant.

Results

Demographics

We identified 24 service members (26 shoulders) who had undergone anatomical TSA during the study period (Table 1). Mean (SD) age was 45.8 (4.5) years (range, 35-54 years), and the cohort was predominately male (25/26 shoulders; 96.2%). Most cohort members were of senior enlisted rank (14, 58.3%), and the US Army was the predominant branch of military service (13, 54.2%). The right side was the operative extremity in 7 cases (26.9%), and the dominant shoulder was involved in 6 cases (23.1%). Two patients (8.3%) underwent staged bilateral TSA. Most patients (76.9%) underwent TSA on the nondominant extremity.

Surgical Variables

TSA was indicated for post-instability arthropathy in 13 cases (50.0%), posttraumatic osteoarthritis in 7 cases (26.9%), and unspecified glenohumeral arthritis, which includes primary glenohumeral osteoarthritis, in 5 cases (19.2%) (Table 2). One case was attributed to iatrogenically induced chondrolysis secondary to intra-articular lidocaine pump. Twelve patients (46.2%) had at least 1 previous surgery. Of the shoulders with instability, 10 (76.9%) had undergone a total of 14 surgical stabilization procedures—10 anterior labral repairs, 2 posterior labral repairs, and 2 capsular plications. The other shoulders had undergone a total of 18 procedures, which included 4 rotator cuff repairs and 3 cartilage restoration procedures.

Clinical Outcomes

Mean (SD) follow-up was 41.0 (21.3) months (range, 11.6-97.6 months). All but 1 shoulder (96.2%) had follow-up of 12 months or more (the only patient with shorter follow-up was because of MEB), and 76.9% of patients had follow-up of 24 months or more (4 of the 6 patients with follow-up under 24 months were medically separated) (Table 3). In all cases, mean ROM improved with respect to flexion, abduction, and external rotation. At final follow-up, mean (SD) ROM was 138° (36°) forward flexion (range, 60°-180°), 125° (39°) abduction (range, 45°-180°), 48° (19°) external rotation at 0° abduction (range, 20°-90°), and 80° (9.4°) external rotation at 90° abduction (range, 70°-90°). Preoperative flexion, abduction, and external rotation at 0° and 90° abduction were all improved at final follow-up. The most improvement in ROM occurred within 6 months after surgery.

Overall patient satisfaction with surgery was 92.3% (n = 24). Ultimately, 18 (72.0%) of 25 shoulders with follow-up of 1 year or more were able to return to active duty within 1 year after surgery, though only 10 (45.5%) of 22 with follow-up of 2 years or more remained active 2 years after surgery. Furthermore, 5 patients (20.8%) were deployed after surgery, and all were still on active duty at final follow-up. By final follow-up, 9 (37.5%) of 24 service members were unable to return to military function; 7 had been medically discharged from the military for persistent shoulder disability, and 2 were in the process of being medically discharged.

In all cases, SRPS improved from before surgery (5.2 out of 10) to final follow-up (1.4). At final follow-up, 22 patients (88.0%) reported mild pain (0-3), and no one had pain above 6.

Complications

Nine patients had a total of 12 postoperative complications (46.2%): 6 component failures (23.1%), 2 neurologic injuries (7.7%; 1 permanent axillary nerve injury, 1 transient brachial plexus neuritis), 2 cases of adhesive capsulitis (7.7%), and 2 episodes of venous thrombosis (7.7%; 1 superficial, 1 deep) (Table 4). There were no documented infections. Six reoperations (23.1%) were performed for the 6 component failures (2 traumatic dislocations of prosthesis resulting in acute glenoid component failure, 3 cases of atraumatic glenoid loosening, 1 case of humeral stem loosening after periprosthetic fracture). Atraumatic glenoid component loosening occurred a mean (SD) of 40.6 (14.2) months after surgery (range, 20.8-54.2 months).

Surgical Failures

Eight service members underwent MEB. Six patients experienced component failure. Factors contributing to both clinical failure and separation from active duty by means of MEB were evaluated with univariate analysis (Table 5). No statistically significant risk factors, including surgical revision and presence of perioperative complications, were identified.

Discussion

We confirmed that our cohort of young service members (mean age, 45.8 years), who had undergone TSA for glenohumeral arthritis, had a relatively higher rate of component failure (23.1%) and a higher reoperation rate (23.1%) with low rates of return to military duty at short-term to midterm follow-up. Our results parallel those of a limited series with a younger cohort (Table 6).^{7,16,19,21,23,24} The high demand and increased life expectancy of the younger patients with glenohumeral arthritis potentiates the risk of complications, component loosening, and ultimate failure.²⁹ To our knowledge, the present article is the first to report clinical and functional outcomes and perioperative risk profiles in a homogenously young, active military cohort after TSA.

The mean age of our study population (46 years) is one of the lowest in the literature. TSA in younger patients (age, <50-55 years) and older, active patients (>55 years) has received increased attention as a result of the expanding indications and growing popularity of TSA in these groups. Other studies have upheld the efficacy of TSA in achieving predictable pain relief and functional improvement in a diverse and predominantly elderly population.^15,30-34 Alternative treatments, including humeral head resurfacing^15,30,35 and soft-tissue interposition,^15,36-40 have also shown inferior short- and long-term results in terms of longevity and degree of clinical or functional improvement.^31-34,41 In addition, the ream-and-run technique has had promising early results by improving glenohumeral kinematics, pain relief, and shoulder function.^13,42,43 However, although implantation of a glenoid component is avoided in young, active people because of reduced longevity and higher rates of component failure, the trade-offs are inadequately treated glenoid disease, suboptimal pain relief, and progression of glenoid arthritis eventually requiring revision. Furthermore, midterm and long-term survivorship of TSA in general is unknown, and there remain few good options for treating end-stage arthritis in young, active patients.

Our cohort had high rates of complications (46.2%) and revisions (23.1%). Two in 5 patients had postoperative complications, most commonly component failure resulting in reoperation. In the literature, complication rates among young patients who underwent TSA are much lower (4.8%-10.9%).^16,23,24 Our cohort’s most common complication was component failure (23.1%), which was most often attributed to atraumatic, aseptic glenoid component loosening and required reoperation. Previously reported revision rates in a young population that underwent TSA (0%-11%)^16,23,24 were also significantly lower than those in the present analysis (23.1%), underscoring the impact of operative indications, postoperative activity levels, and occupational demands on ultimate failure rates. Interestingly, all revisions in our study were for component failure, whereas previous reports have described a higher rate for infection.²² However, the same studies also found glenoid lucency rates as high as 76% at 10-year follow-up.¹⁶ Furthermore, in a review of 136 TSAs with unsatisfactory outcomes, glenoid loosening was the most common reason for presenting to clinic after surgery.⁴⁴ Specifically, our population had a high rate of glenohumeral arthritis secondary to instability (50.0%) and posttraumatic osteoarthritis (26.9%). For many reasons, outcomes were worse in younger patients with a history of glenohumeral instability³³ than in older patients without a high incidence of instability.⁴⁵ This young cohort with higher demands may have had accelerated polyethylene wear patterns caused by repetitive overhead activity, which may have arisen because of a higher functional profile after surgery and greater patient expectations after arthroplasty. In addition, patients with a history of instability may have altered glenohumeral anatomy, especially with previous arthroscopic or open stabilization procedures. Anatomical changes include excessive posterior glenoid wear, internal rotation contracture, patulous capsular tissue, static or dynamic posterior humeral subluxation, and possible overconstraint after prior stabilization procedures. Almost half of our population had a previous surgery; our patients averaged 1.7 previous surgeries each.

Although estimates of component survivorship at a high-volume civilian tertiary-referral center were as high as 97% at 10 years and 84% at 20 years,^7,16 10-year survivorship in patients with a history of instability was only 61%.3 TSA survivorship in our young, active cohort is already foreseeably dramatically reduced, given the 23.1% revision rate at 28.5-month follow-up. This consideration must be addressed during preoperative counseling with the young patient with glenohumeral arthritis and a history of shoulder instability.

Despite the high rates of complications and revisions in our study, 92.3% of patients were satisfied with surgery, 88.0% experienced minimal persistence of pain (mean 3.8-point decrease on SRPS), and 100% maintained improved ROM at final follow-up. Satisfaction in the young population has varied significantly, from 52% to 95%, generally on the basis of physical activity.^16,22-24 The reasonable rate of postoperative satisfaction in the present analysis is comparable to what has been reported in patients of a similar age (Table 6).^7,16,22 However, despite high satisfaction and pain relief, patients were inconsistently able to return to the upper limits of physical activity required of active-duty military service. In addition, we cannot exclude secondary gain motivations for pursuing medical retirement, similar to that seen in patients receiving worker’s compensation.

Other authors have conversely found more favorable functional outcomes and survivorship rates.^23,24 In a retrospective review of 46 TSAs in patients 55 years or younger, Bartelt and colleagues²⁴ found sustained improvements in pain, ROM, and satisfaction at 7-year follow-up.24 Raiss and colleagues²³ conducted a prospective study of TSA outcomes in 21 patients with a mean age of 55 years and a mean follow-up of 7 years and reported no revisions and only 1 minor complication, a transient brachial plexus palsy.²³ The discrepancy between these studies may reflect different activity levels and underlying pathology between cohorts. The present population is unique in that it represents a particularly difficult confluence of factors for shoulder arthroplasty surgeons. The high activity, significant overhead and lifting occupational demands, and discordant patient expectations of this military cohort place a significant functional burden on the implants, the glenoid component in particular. Furthermore, this patient group has a higher incidence of more complex glenohumeral pathology resulting in instability, posttraumatic, or capsulorrhaphy arthropathy, and multiple prior arthroscopic and open stabilization procedures.

At final follow-up, only 33% of our patients were still on activity duty, 37.5% had completed or were completing medical separation from the military after surgery for persistent shoulder disability, and 37.5% were retired from the military. Five patients (20.8%) deployed after surgery. This young, active cohort of service members who had TSA for glenohumeral arthritis faced a unique set of tremendous physical demands. A retrospective case series investigated return to sport in 100 consecutive patients (mean age, 68.9 years) who were participating in recreational and competitive athletics and underwent unilateral TSA.²¹ The patients were engaged most commonly in swimming (20.4%), golf (16.3%), cycling (16.3%), and fitness training (16.3%). The authors found that, at a mean follow-up of 2.8 years, 49 patients (89%) were able to continue in sports, though 36.7% thought their sport activity was restricted after TSA. In another retrospective case series (61 TSAs), McCarty and colleagues¹⁹ found that 48 patients (71%) were improved in their sports participation, and 50% increased their frequency of participation after surgery.

There are no specific recommendations on returning to military service or high-level sport after surgery. Recommendations on returning to sport after TSA have been based largely on small case series involving specific sports^46,47 and surveys of expert opinion.^17,18 In a survey on postoperative physical activity in young patients after TSA conducted by Healy and colleagues,¹⁷ 35 American Shoulder and Elbow Surgeons members recommended avoiding contact and impact sports while permitting return to nonimpact sports, such as swimming, which may still impart significant stress to the glenohumeral joint. In an international survey of 101 shoulder and elbow surgeons, Magnussen and colleagues¹⁸ also found that most recommended avoiding a return to impact sports that require intensive upper extremity demands and permitting full return to sports at preoperative levels. This likely is a result of the perception that most of these patients having TSA are older and have less rigorous involvement in sports at the outset and a lower propensity for adverse patient outcomes. However, these recommendations may place a younger, more high-demand patient at significantly greater risk. The active-duty cohort engages in daily physical training, including push-ups and frequent overhead lifting, which could account for the high failure rates and low incidence of postoperative deployment. Although TSA seems to demonstrate good initial results in terms of return to high-demand activities, the return-to-duty profile in our study highlights the potential pitfalls of TSA in active individuals attempting to return to high-demand preoperative function.

Our analysis was limited by the fact that we used a small patient cohort, contributing to underpowered analysis of the potential risk factors predictive of reoperation and medical discharge. Although our minimum follow-up was 12 months, with the exception of 1 patient who was medically separated at 11.6 months because of shoulder disability, we captured 5 patients (19.2%) who underwent medical separation but who would otherwise be excluded. Therefore, this limitation is not major in that, with a longer minimum follow-up, we would be excluding a significant number of patients with such persistent disability after TSA that they would not be able to return to duty at anywhere near their previous level. In this retrospective study, we were additionally limited to analysis of the data in the medical records and could not control for variables such as surgeon technique, implant choice, and experience. Complete radiographic images were not available, limiting analysis of radiographic outcomes. Given the lack of a standardized preoperative imaging protocol, we could not evaluate glenoid version on axial imaging. It is possible that some patients with early aseptic glenoid loosening had posterior subluxation or a Walch B2 glenoid, which has a higher failure rate.⁴⁸ The strengths of this study include its unique analysis of a homogeneous young, active, high-risk patient cohort within a closed healthcare system. In the military, these patients are subject to intense daily physical and occupational demands. In addition, the clinical and functional outcomes we studied are patient-centered and therefore relevant during preoperative counseling. Further investigations might focus on validated outcome measures and on midterm to long-term TSA outcomes in an active military population vis-à-vis other alternatives for clinical management.

Conclusion

By a mean follow-up of 3.5 years, only a third of the service members had returned to active duty, roughly a third had retired, and more than a third had been medically discharged because of persistent disability attributable to the shoulder. Despite initial improvements in ROM and pain, midterm outcomes were poor. The short-term complication rate (46.2%) and the rate of reoperation for component failure (23.1%) should be emphasized during preoperative counseling.

Although total shoulder arthroplasty (TSA) has proved to be a reliable solution in older patients, treatment in younger patients with glenohumeral arthritis remains controversial, and there are still few reliable long-term surgical options.^1-8 These options include abrasion arthroplasty and arthroscopic management,^9,10 biologic glenoid resurfacing,^11,12 and humeral hemiarthroplasty with¹³ or without^14,15 glenoid treatment and anatomical TSA.

In the younger cohort, 20-year TSA survivorship rates up to 84% have been reported, and unsatisfactory subjective outcomes have been unacceptably high.¹⁶ In addition, there is a paucity of literature addressing the impact of TSA on return to sport. Recommendations on returning to an athletic life style are based largely on surveys of expert opinion^17,18 and heterogeneous studies of either older patients (eg, age >50-55 years) who are active^19-21 or younger patients with no defined level of activity.^{5,7,8,16,22-24}

To our knowledge, no one has evaluated the short-term morbidity and clinical outcomes within a young, high-demand patient population, such as the US military. Therefore, we conducted a study to evaluate the clinical success and complications of TSA performed for glenohumeral arthritis in a young, active population. We hypothesized that patients who had undergone TSA would have a low rate of return to duty, an increased rate of component failure, and a higher reoperation rate because of increased upper extremity demands.

Materials and Methods

After obtaining protocol approval from the William Beaumont Army Medical Center Institutional Review Board, we searched the Military Health System (MHS) Management Analysis and Reporting Tool (M2) database to retrospectively review the cases of all tri-service US military service members who had undergone primary anatomical TSA (Current Procedural Terminology code 23472) between January 1, 2007 and June 31, 2014. This was a multisurgeon, multicenter study. Patient exclusion criteria were nonmilitary or retired status at time of surgery; primary surgery consisting of limited glenohumeral resurfacing procedure, hemiarthroplasty, or reverse TSA; surgery for acute proximal humerus fracture; rotator cuff deficiency diagnosed before or during surgery; and insufficient follow-up (eg, <12 months, unless medically separated beforehand).

The M2 database is an established tool that has been used for clinical outcomes research on treatment of a variety of orthopedic conditions.25,26 The Medical Data Repository, which is operated by MHS, is populated by its military healthcare providers. The MHS, which offers worldwide coverage for all beneficiaries either at Department of Defense facilities or purchased using civilian providers, is among the largest known closed healthcare systems.

All active-duty US military service members are uniformly required to adhere to stringent and regularly evaluated physical fitness standards, which typically exceed those of average civilians. Routine physical training is required in the form of aerobic fitness, weight training, tactical field exercises, and core military tasks, such as the ability to march at least 2 miles while carrying heavy fighting loads. In addition to satisfying required height and weight standards, all service members are subject to semiannual service-specific physical fitness evaluations inclusive of timed push-ups, sit-ups, and an aerobic event. Service members may also be required to maintain a level of physical training above these baseline standards, contingent on their branch of service, rank, and military occupational specialty. If a service member is unable to maintain these standards, medical separation may be initiated.

Demographic and occupational data were extracted from the database. These data included age, sex, military rank, and branch of service. Line-by-line analysis of the Armed Forces Health Longitudinal Technology Application (Version 22; 3M) electronic medical record was then performed to confirm the underlying diagnosis, surgical procedure, and surgery date. Further chart review yielded additional patient-based factors (eg, laterality, hand dominance, presence and type of prior shoulder surgeries) and surgical factors (eg, surgery indication, implant design). We evaluated clinical and functional outcomes as well as perioperative complications, including both major and minor systemic and local complications as previously described^27,28; preoperative and postoperative range of motion (ROM) and self-reported pain score (SRPS, scale 1-10) as measured by physical therapist and surgeon at follow-up; secondary surgical interventions; timing of return to duty; and postoperative deployment history. The primary outcome measures were revision reoperation after index procedure, and military discharge for persistent shoulder-related disability. Clinical failure was defined as component failure or reoperation. Medical Evaluation Board (MEB) is a formal separation from the military in which it is deemed that a service member is no longer able to fulfill his or her duty because of a medical condition.

Statistical Analysis

Continuous variables were compared using statistical means with 95% confidence intervals (CIs) and/or SDs. Categorical data were reported as frequencies or percentages. Univariate analysis was performed to assess the correlation between possible risk factors and the primary outcome measures. P < .05 was considered statistically significant.

Results

Demographics

We identified 24 service members (26 shoulders) who had undergone anatomical TSA during the study period (Table 1). Mean (SD) age was 45.8 (4.5) years (range, 35-54 years), and the cohort was predominately male (25/26 shoulders; 96.2%). Most cohort members were of senior enlisted rank (14, 58.3%), and the US Army was the predominant branch of military service (13, 54.2%). The right side was the operative extremity in 7 cases (26.9%), and the dominant shoulder was involved in 6 cases (23.1%). Two patients (8.3%) underwent staged bilateral TSA. Most patients (76.9%) underwent TSA on the nondominant extremity.

Surgical Variables

TSA was indicated for post-instability arthropathy in 13 cases (50.0%), posttraumatic osteoarthritis in 7 cases (26.9%), and unspecified glenohumeral arthritis, which includes primary glenohumeral osteoarthritis, in 5 cases (19.2%) (Table 2). One case was attributed to iatrogenically induced chondrolysis secondary to intra-articular lidocaine pump. Twelve patients (46.2%) had at least 1 previous surgery. Of the shoulders with instability, 10 (76.9%) had undergone a total of 14 surgical stabilization procedures—10 anterior labral repairs, 2 posterior labral repairs, and 2 capsular plications. The other shoulders had undergone a total of 18 procedures, which included 4 rotator cuff repairs and 3 cartilage restoration procedures.

Clinical Outcomes

Mean (SD) follow-up was 41.0 (21.3) months (range, 11.6-97.6 months). All but 1 shoulder (96.2%) had follow-up of 12 months or more (the only patient with shorter follow-up was because of MEB), and 76.9% of patients had follow-up of 24 months or more (4 of the 6 patients with follow-up under 24 months were medically separated) (Table 3). In all cases, mean ROM improved with respect to flexion, abduction, and external rotation. At final follow-up, mean (SD) ROM was 138° (36°) forward flexion (range, 60°-180°), 125° (39°) abduction (range, 45°-180°), 48° (19°) external rotation at 0° abduction (range, 20°-90°), and 80° (9.4°) external rotation at 90° abduction (range, 70°-90°). Preoperative flexion, abduction, and external rotation at 0° and 90° abduction were all improved at final follow-up. The most improvement in ROM occurred within 6 months after surgery.

Overall patient satisfaction with surgery was 92.3% (n = 24). Ultimately, 18 (72.0%) of 25 shoulders with follow-up of 1 year or more were able to return to active duty within 1 year after surgery, though only 10 (45.5%) of 22 with follow-up of 2 years or more remained active 2 years after surgery. Furthermore, 5 patients (20.8%) were deployed after surgery, and all were still on active duty at final follow-up. By final follow-up, 9 (37.5%) of 24 service members were unable to return to military function; 7 had been medically discharged from the military for persistent shoulder disability, and 2 were in the process of being medically discharged.

In all cases, SRPS improved from before surgery (5.2 out of 10) to final follow-up (1.4). At final follow-up, 22 patients (88.0%) reported mild pain (0-3), and no one had pain above 6.

Complications

Nine patients had a total of 12 postoperative complications (46.2%): 6 component failures (23.1%), 2 neurologic injuries (7.7%; 1 permanent axillary nerve injury, 1 transient brachial plexus neuritis), 2 cases of adhesive capsulitis (7.7%), and 2 episodes of venous thrombosis (7.7%; 1 superficial, 1 deep) (Table 4). There were no documented infections. Six reoperations (23.1%) were performed for the 6 component failures (2 traumatic dislocations of prosthesis resulting in acute glenoid component failure, 3 cases of atraumatic glenoid loosening, 1 case of humeral stem loosening after periprosthetic fracture). Atraumatic glenoid component loosening occurred a mean (SD) of 40.6 (14.2) months after surgery (range, 20.8-54.2 months).

Surgical Failures

Eight service members underwent MEB. Six patients experienced component failure. Factors contributing to both clinical failure and separation from active duty by means of MEB were evaluated with univariate analysis (Table 5). No statistically significant risk factors, including surgical revision and presence of perioperative complications, were identified.

Discussion

We confirmed that our cohort of young service members (mean age, 45.8 years), who had undergone TSA for glenohumeral arthritis, had a relatively higher rate of component failure (23.1%) and a higher reoperation rate (23.1%) with low rates of return to military duty at short-term to midterm follow-up. Our results parallel those of a limited series with a younger cohort (Table 6).^{7,16,19,21,23,24} The high demand and increased life expectancy of the younger patients with glenohumeral arthritis potentiates the risk of complications, component loosening, and ultimate failure.²⁹ To our knowledge, the present article is the first to report clinical and functional outcomes and perioperative risk profiles in a homogenously young, active military cohort after TSA.

The mean age of our study population (46 years) is one of the lowest in the literature. TSA in younger patients (age, <50-55 years) and older, active patients (>55 years) has received increased attention as a result of the expanding indications and growing popularity of TSA in these groups. Other studies have upheld the efficacy of TSA in achieving predictable pain relief and functional improvement in a diverse and predominantly elderly population.^15,30-34 Alternative treatments, including humeral head resurfacing^15,30,35 and soft-tissue interposition,^15,36-40 have also shown inferior short- and long-term results in terms of longevity and degree of clinical or functional improvement.^31-34,41 In addition, the ream-and-run technique has had promising early results by improving glenohumeral kinematics, pain relief, and shoulder function.^13,42,43 However, although implantation of a glenoid component is avoided in young, active people because of reduced longevity and higher rates of component failure, the trade-offs are inadequately treated glenoid disease, suboptimal pain relief, and progression of glenoid arthritis eventually requiring revision. Furthermore, midterm and long-term survivorship of TSA in general is unknown, and there remain few good options for treating end-stage arthritis in young, active patients.

Our cohort had high rates of complications (46.2%) and revisions (23.1%). Two in 5 patients had postoperative complications, most commonly component failure resulting in reoperation. In the literature, complication rates among young patients who underwent TSA are much lower (4.8%-10.9%).^16,23,24 Our cohort’s most common complication was component failure (23.1%), which was most often attributed to atraumatic, aseptic glenoid component loosening and required reoperation. Previously reported revision rates in a young population that underwent TSA (0%-11%)^16,23,24 were also significantly lower than those in the present analysis (23.1%), underscoring the impact of operative indications, postoperative activity levels, and occupational demands on ultimate failure rates. Interestingly, all revisions in our study were for component failure, whereas previous reports have described a higher rate for infection.²² However, the same studies also found glenoid lucency rates as high as 76% at 10-year follow-up.¹⁶ Furthermore, in a review of 136 TSAs with unsatisfactory outcomes, glenoid loosening was the most common reason for presenting to clinic after surgery.⁴⁴ Specifically, our population had a high rate of glenohumeral arthritis secondary to instability (50.0%) and posttraumatic osteoarthritis (26.9%). For many reasons, outcomes were worse in younger patients with a history of glenohumeral instability³³ than in older patients without a high incidence of instability.⁴⁵ This young cohort with higher demands may have had accelerated polyethylene wear patterns caused by repetitive overhead activity, which may have arisen because of a higher functional profile after surgery and greater patient expectations after arthroplasty. In addition, patients with a history of instability may have altered glenohumeral anatomy, especially with previous arthroscopic or open stabilization procedures. Anatomical changes include excessive posterior glenoid wear, internal rotation contracture, patulous capsular tissue, static or dynamic posterior humeral subluxation, and possible overconstraint after prior stabilization procedures. Almost half of our population had a previous surgery; our patients averaged 1.7 previous surgeries each.

Although estimates of component survivorship at a high-volume civilian tertiary-referral center were as high as 97% at 10 years and 84% at 20 years,^7,16 10-year survivorship in patients with a history of instability was only 61%.3 TSA survivorship in our young, active cohort is already foreseeably dramatically reduced, given the 23.1% revision rate at 28.5-month follow-up. This consideration must be addressed during preoperative counseling with the young patient with glenohumeral arthritis and a history of shoulder instability.

Despite the high rates of complications and revisions in our study, 92.3% of patients were satisfied with surgery, 88.0% experienced minimal persistence of pain (mean 3.8-point decrease on SRPS), and 100% maintained improved ROM at final follow-up. Satisfaction in the young population has varied significantly, from 52% to 95%, generally on the basis of physical activity.^16,22-24 The reasonable rate of postoperative satisfaction in the present analysis is comparable to what has been reported in patients of a similar age (Table 6).^7,16,22 However, despite high satisfaction and pain relief, patients were inconsistently able to return to the upper limits of physical activity required of active-duty military service. In addition, we cannot exclude secondary gain motivations for pursuing medical retirement, similar to that seen in patients receiving worker’s compensation.

Other authors have conversely found more favorable functional outcomes and survivorship rates.^23,24 In a retrospective review of 46 TSAs in patients 55 years or younger, Bartelt and colleagues²⁴ found sustained improvements in pain, ROM, and satisfaction at 7-year follow-up.24 Raiss and colleagues²³ conducted a prospective study of TSA outcomes in 21 patients with a mean age of 55 years and a mean follow-up of 7 years and reported no revisions and only 1 minor complication, a transient brachial plexus palsy.²³ The discrepancy between these studies may reflect different activity levels and underlying pathology between cohorts. The present population is unique in that it represents a particularly difficult confluence of factors for shoulder arthroplasty surgeons. The high activity, significant overhead and lifting occupational demands, and discordant patient expectations of this military cohort place a significant functional burden on the implants, the glenoid component in particular. Furthermore, this patient group has a higher incidence of more complex glenohumeral pathology resulting in instability, posttraumatic, or capsulorrhaphy arthropathy, and multiple prior arthroscopic and open stabilization procedures.

At final follow-up, only 33% of our patients were still on activity duty, 37.5% had completed or were completing medical separation from the military after surgery for persistent shoulder disability, and 37.5% were retired from the military. Five patients (20.8%) deployed after surgery. This young, active cohort of service members who had TSA for glenohumeral arthritis faced a unique set of tremendous physical demands. A retrospective case series investigated return to sport in 100 consecutive patients (mean age, 68.9 years) who were participating in recreational and competitive athletics and underwent unilateral TSA.²¹ The patients were engaged most commonly in swimming (20.4%), golf (16.3%), cycling (16.3%), and fitness training (16.3%). The authors found that, at a mean follow-up of 2.8 years, 49 patients (89%) were able to continue in sports, though 36.7% thought their sport activity was restricted after TSA. In another retrospective case series (61 TSAs), McCarty and colleagues¹⁹ found that 48 patients (71%) were improved in their sports participation, and 50% increased their frequency of participation after surgery.

There are no specific recommendations on returning to military service or high-level sport after surgery. Recommendations on returning to sport after TSA have been based largely on small case series involving specific sports^46,47 and surveys of expert opinion.^17,18 In a survey on postoperative physical activity in young patients after TSA conducted by Healy and colleagues,¹⁷ 35 American Shoulder and Elbow Surgeons members recommended avoiding contact and impact sports while permitting return to nonimpact sports, such as swimming, which may still impart significant stress to the glenohumeral joint. In an international survey of 101 shoulder and elbow surgeons, Magnussen and colleagues¹⁸ also found that most recommended avoiding a return to impact sports that require intensive upper extremity demands and permitting full return to sports at preoperative levels. This likely is a result of the perception that most of these patients having TSA are older and have less rigorous involvement in sports at the outset and a lower propensity for adverse patient outcomes. However, these recommendations may place a younger, more high-demand patient at significantly greater risk. The active-duty cohort engages in daily physical training, including push-ups and frequent overhead lifting, which could account for the high failure rates and low incidence of postoperative deployment. Although TSA seems to demonstrate good initial results in terms of return to high-demand activities, the return-to-duty profile in our study highlights the potential pitfalls of TSA in active individuals attempting to return to high-demand preoperative function.

Our analysis was limited by the fact that we used a small patient cohort, contributing to underpowered analysis of the potential risk factors predictive of reoperation and medical discharge. Although our minimum follow-up was 12 months, with the exception of 1 patient who was medically separated at 11.6 months because of shoulder disability, we captured 5 patients (19.2%) who underwent medical separation but who would otherwise be excluded. Therefore, this limitation is not major in that, with a longer minimum follow-up, we would be excluding a significant number of patients with such persistent disability after TSA that they would not be able to return to duty at anywhere near their previous level. In this retrospective study, we were additionally limited to analysis of the data in the medical records and could not control for variables such as surgeon technique, implant choice, and experience. Complete radiographic images were not available, limiting analysis of radiographic outcomes. Given the lack of a standardized preoperative imaging protocol, we could not evaluate glenoid version on axial imaging. It is possible that some patients with early aseptic glenoid loosening had posterior subluxation or a Walch B2 glenoid, which has a higher failure rate.⁴⁸ The strengths of this study include its unique analysis of a homogeneous young, active, high-risk patient cohort within a closed healthcare system. In the military, these patients are subject to intense daily physical and occupational demands. In addition, the clinical and functional outcomes we studied are patient-centered and therefore relevant during preoperative counseling. Further investigations might focus on validated outcome measures and on midterm to long-term TSA outcomes in an active military population vis-à-vis other alternatives for clinical management.

Conclusion

By a mean follow-up of 3.5 years, only a third of the service members had returned to active duty, roughly a third had retired, and more than a third had been medically discharged because of persistent disability attributable to the shoulder. Despite initial improvements in ROM and pain, midterm outcomes were poor. The short-term complication rate (46.2%) and the rate of reoperation for component failure (23.1%) should be emphasized during preoperative counseling.

The humeral avulsion of glenohumeral ligament (HAGL) lesion has been recognized as a cause of recurrent shoulder instability. In 1942, Nicola¹ was the first to describe this lesion, in a small case series of avulsions of the anterior band of the inferior glenohumeral ligament from the humeral neck secondary to a dislocation injury. In 1988, Bach and colleagues² described it in 2 patients with recurrent anterior dislocations. Wolf and colleagues³ were the first to apply the term HAGL to the injury, in 1995.

HAGL lesion incidence ranges from 1% to 9%, but many authors think the lesion is underdiagnosed.^3-5 It occurs in isolation or in combination with other injuries, and it is commonly identified on recurrence of instability. Bui-Mansfield and colleagues⁶ found that 11% of patients with a diagnosis of HAGL lesion previously had surgery on the same shoulder, whereas for 62% the lesion was associated with other, concurrent lesions, including labral tears (18, 25%), rotator cuff tears (16, 23%), and Hill-Sachs deformities (12, 17%).

Most young athletes who undergo nonoperative therapy for a HAGL lesion continue to experience pain and/or instability that then requires surgical intervention.⁴ To our knowledge, there are no reports of return to full function in young competitive athletes or return to manual labor after nonoperative management of a HAGL lesion.

In this article, we report the case of a US Navy SEAL who sustained a traction injury causing an axillary nerve injury and a HAGL lesion. Successful nonoperative management allowed him to return to full duty. The patient provided written informed consent for print and electronic publication of this case report.

Case Report

An otherwise healthy 26-year-old Navy SEAL presented with pain and significant weakness in the right (dominant) upper extremity after an injury in a training exercise. The shoulder sustained a traction injury when the man’s fast-moving marine attack craft was in a collision and he was trying not to be thrown off. He reported having a sense of dislocation yet never required a reduction.

Physical examination revealed severe weakness with shoulder abduction, external rotation, and forward flexion; inability to contract the deltoid muscle; and complete numbness along the cutaneous distribution of the axillary nerve. On neurovascular examination, the right upper extremity was otherwise intact. The patient had complete passive range of motion (ROM) with apprehension in abduction with external rotation along with anterior laxity and normal posterior stability.

Standard shoulder radiographs showed no bony abnormalities and a concentrically reduced glenohumeral joint. Magnetic resonance imaging (MRI), reviewed by a staff musculoskeletal radiologist and a sports fellowship–trained orthopedic surgeon, showed a greater tuberosity contusion, a partial tear of the infraspinatus, and a HAGL lesion (Figure 1).

The patient was counseled toward surgical intervention to prevent symptoms of recurrent instability. A detailed discussion ensued about whether to proceed with surgery immediately or to pursue temporary nonoperative treatment to allow for assessment and return of deltoid function. Patient and surgeon decided to delay operative intervention because of concerns about the patient’s ability to effectively rehabilitate while still having a compromised axillary nerve after surgery. The recommendation was to delay initial electromyographic (EMG) and nerve conduction velocity testing at least 4 weeks to allow for completion of Wallerian degeneration and more accurate assessment of the axillary nerve.⁷ Physical therapy for gentle ROM (excluding external rotation) and isometric rotator cuff exercises were initiated.

Five weeks after injury, the patient left the area to attend a 2-month nonphysical training course and continued rehabilitation and orthopedic follow-up at another military medical facility. Six weeks after injury, initial EMG testing revealed the expected axillary neuropraxia. In addition, some marginal improvement in ROM was noted, but deltoid function was still very limited.

Ten weeks after injury, clinical inspection revealed deltoid wasting. Active shoulder ROM was limited, and deltoid strength was 3/5, though the patient was able to perform a standard push-up without difficulty and showed no sign of laxity or apprehension on shoulder examination. Repeat EMG testing revealed axillary nerve denervation with no sign of regeneration. Twelve weeks after injury, MRA showed reorganization and partial healing of the HAGL lesion relative to the prior study (Figure 2).

On the patient’s return from training, 15 weeks after injury, he had improved active ROM and 4+/5 deltoid strength. Axillary nerve sensation was still decreased but markedly improved. Physical examination revealed no significant shoulder laxity or apprehension, and the patient denied feelings of instability. Activities were advanced to include an organized strengthening program.

Six months after injury, the patient was cleared to return to his unit with only mild physical restriction. Function continued to steadily improve. After 9 months, he was cleared for full, unrestricted duty. Although he still demonstrated slight asymmetric weakness in the right deltoid with continued muscular atrophy, examination findings were otherwise normal, and he was back to full activities without significant symptoms.

Eleven months after injury, MRI showed healing of the HAGL lesion (Figure 3). At 17 months, EMG testing revealed significant interval improvement in axillary motor unit potentials but still about a 50% decrement compared with the noninjured side. The patient denied any motor or sensory deficits and any instability events since his injury. He continued with full function as an active-duty Navy SEAL.

Discussion

Nonoperative management has been used for injuries to the inferior glenohumeral ligament complex when there is no humeral detachment but generally has been reserved for low-demand patients and patients who cannot tolerate surgical intervention.⁴ Detached lesions may initially be managed nonoperatively with physical therapy and rehabilitation, but the rate of recurrent instability after nonoperative management of a known HAGL lesion remains unknown.⁴ Most active young people are expected to have persistent pain and/or instability and require surgical intervention. Both arthroscopic and open methods have been used successfully.^3,8-15 Persistent instability is often the primary complaint leading to a diagnosis of a HAGL lesion.⁴ The patient in this case report neither demonstrated nor reported any instability event after his 6-month period of nonoperative management, despite his young age and elite physical requirements.

To our knowledge, there are no reports of successful nonoperative management of a known symptomatic HAGL lesion in a high-demand athlete. Although we do not routinely recommend nonoperative treatment for cases such as the one reported here, the decision to delay this Navy SEAL’s surgical management was made out of concern about potential complications of postoperative rehabilitation given the concurrent axillary nerve injury.

With anterior shoulder dislocations, multiple concomitant shoulder injuries, including a HAGL lesion, are not uncommon.^6,16 With HAGL lesions, associated rotator cuff injuries occur at a rate as high as 23%.⁶ Our patient had a concurrent partial rotator cuff tear but also an axillary nerve traction injury. To our knowledge, the literature has not described axillary nerve injury specifically in association with a HAGL lesion, though it is well documented and maintained as a possible concurrent injury with anterior shoulder instability events.¹⁷ Robinson and colleagues¹⁶ found a 5.8% incidence of a clinically apparent neurologic deficit after traumatic anterior shoulder dislocation in 3633 dislocations, about 75% of which were isolated axillary nerve injuries. They also reported a 25.7% rate of rotator cuff tear or greater tuberosity fracture, either of which significantly increased the likelihood of a neurologic deficit in their study.

When nerve continuity remains, functional recovery occurs after 3 to 6 months, or within weeks in some cases.^18-20 Nerve injuries in continuity but with persistent, severe clinical deficits may require surgical exploration with subsequent neurolysis and/or repair.^19-21 Our patient showed gradual axillary nerve recovery from a clinical standpoint. By 6 months after injury, despite continued muscle atrophy and decreased axillary nerve sensation, he had returned to full duty as a Navy SEAL. By 17 months, atrophy was markedly improved, and strength and ROM had subjectively returned, despite there being significant conduction amplitude losses, up to 50% of the contralateral side, on EMG testing.

This case represents a scenario in which likely initial surgical management was precluded by a concomitant injury, and the patient had a serendipitous outcome. It is possible the axillary neuropraxia and subsequent temporary deltoid dysfunction provided a unique environment that was conducive to the healing of the HAGL lesion. With classic Bankart lesions, many surgeons prefer to use aggressive early surgical treatment in first-time dislocators, especially elite athletes, in an attempt to avoid recurrent instability.^22-26 However, some have suggested that initial immobilization after acute injury may lead to successful nonoperative management.²⁷ Perhaps our case report raises the question as to whether a prolonged period of initial immobilization can prove successful in management of a HAGL lesion. Prospective studies comparing early surgical and nonoperative treatment of these challenging lesions are warranted.

We have reported a case of successful nonoperative management of a HAGL lesion in an active-duty Navy SEAL with concomitant shoulder injuries. This case could suggest that a trial of initial nonoperative management should be considered for injuries that involve a HAGL lesion when there are concerns about the patient’s ability to complete functional rehabilitation because of the combined injuries of the shoulder.

The humeral avulsion of glenohumeral ligament (HAGL) lesion has been recognized as a cause of recurrent shoulder instability. In 1942, Nicola¹ was the first to describe this lesion, in a small case series of avulsions of the anterior band of the inferior glenohumeral ligament from the humeral neck secondary to a dislocation injury. In 1988, Bach and colleagues² described it in 2 patients with recurrent anterior dislocations. Wolf and colleagues³ were the first to apply the term HAGL to the injury, in 1995.

HAGL lesion incidence ranges from 1% to 9%, but many authors think the lesion is underdiagnosed.^3-5 It occurs in isolation or in combination with other injuries, and it is commonly identified on recurrence of instability. Bui-Mansfield and colleagues⁶ found that 11% of patients with a diagnosis of HAGL lesion previously had surgery on the same shoulder, whereas for 62% the lesion was associated with other, concurrent lesions, including labral tears (18, 25%), rotator cuff tears (16, 23%), and Hill-Sachs deformities (12, 17%).

Most young athletes who undergo nonoperative therapy for a HAGL lesion continue to experience pain and/or instability that then requires surgical intervention.⁴ To our knowledge, there are no reports of return to full function in young competitive athletes or return to manual labor after nonoperative management of a HAGL lesion.

In this article, we report the case of a US Navy SEAL who sustained a traction injury causing an axillary nerve injury and a HAGL lesion. Successful nonoperative management allowed him to return to full duty. The patient provided written informed consent for print and electronic publication of this case report.

Case Report

An otherwise healthy 26-year-old Navy SEAL presented with pain and significant weakness in the right (dominant) upper extremity after an injury in a training exercise. The shoulder sustained a traction injury when the man’s fast-moving marine attack craft was in a collision and he was trying not to be thrown off. He reported having a sense of dislocation yet never required a reduction.

Physical examination revealed severe weakness with shoulder abduction, external rotation, and forward flexion; inability to contract the deltoid muscle; and complete numbness along the cutaneous distribution of the axillary nerve. On neurovascular examination, the right upper extremity was otherwise intact. The patient had complete passive range of motion (ROM) with apprehension in abduction with external rotation along with anterior laxity and normal posterior stability.

Standard shoulder radiographs showed no bony abnormalities and a concentrically reduced glenohumeral joint. Magnetic resonance imaging (MRI), reviewed by a staff musculoskeletal radiologist and a sports fellowship–trained orthopedic surgeon, showed a greater tuberosity contusion, a partial tear of the infraspinatus, and a HAGL lesion (Figure 1).

The patient was counseled toward surgical intervention to prevent symptoms of recurrent instability. A detailed discussion ensued about whether to proceed with surgery immediately or to pursue temporary nonoperative treatment to allow for assessment and return of deltoid function. Patient and surgeon decided to delay operative intervention because of concerns about the patient’s ability to effectively rehabilitate while still having a compromised axillary nerve after surgery. The recommendation was to delay initial electromyographic (EMG) and nerve conduction velocity testing at least 4 weeks to allow for completion of Wallerian degeneration and more accurate assessment of the axillary nerve.⁷ Physical therapy for gentle ROM (excluding external rotation) and isometric rotator cuff exercises were initiated.

Five weeks after injury, the patient left the area to attend a 2-month nonphysical training course and continued rehabilitation and orthopedic follow-up at another military medical facility. Six weeks after injury, initial EMG testing revealed the expected axillary neuropraxia. In addition, some marginal improvement in ROM was noted, but deltoid function was still very limited.

Ten weeks after injury, clinical inspection revealed deltoid wasting. Active shoulder ROM was limited, and deltoid strength was 3/5, though the patient was able to perform a standard push-up without difficulty and showed no sign of laxity or apprehension on shoulder examination. Repeat EMG testing revealed axillary nerve denervation with no sign of regeneration. Twelve weeks after injury, MRA showed reorganization and partial healing of the HAGL lesion relative to the prior study (Figure 2).

On the patient’s return from training, 15 weeks after injury, he had improved active ROM and 4+/5 deltoid strength. Axillary nerve sensation was still decreased but markedly improved. Physical examination revealed no significant shoulder laxity or apprehension, and the patient denied feelings of instability. Activities were advanced to include an organized strengthening program.

Six months after injury, the patient was cleared to return to his unit with only mild physical restriction. Function continued to steadily improve. After 9 months, he was cleared for full, unrestricted duty. Although he still demonstrated slight asymmetric weakness in the right deltoid with continued muscular atrophy, examination findings were otherwise normal, and he was back to full activities without significant symptoms.

Eleven months after injury, MRI showed healing of the HAGL lesion (Figure 3). At 17 months, EMG testing revealed significant interval improvement in axillary motor unit potentials but still about a 50% decrement compared with the noninjured side. The patient denied any motor or sensory deficits and any instability events since his injury. He continued with full function as an active-duty Navy SEAL.

Discussion

Nonoperative management has been used for injuries to the inferior glenohumeral ligament complex when there is no humeral detachment but generally has been reserved for low-demand patients and patients who cannot tolerate surgical intervention.⁴ Detached lesions may initially be managed nonoperatively with physical therapy and rehabilitation, but the rate of recurrent instability after nonoperative management of a known HAGL lesion remains unknown.⁴ Most active young people are expected to have persistent pain and/or instability and require surgical intervention. Both arthroscopic and open methods have been used successfully.^3,8-15 Persistent instability is often the primary complaint leading to a diagnosis of a HAGL lesion.⁴ The patient in this case report neither demonstrated nor reported any instability event after his 6-month period of nonoperative management, despite his young age and elite physical requirements.

To our knowledge, there are no reports of successful nonoperative management of a known symptomatic HAGL lesion in a high-demand athlete. Although we do not routinely recommend nonoperative treatment for cases such as the one reported here, the decision to delay this Navy SEAL’s surgical management was made out of concern about potential complications of postoperative rehabilitation given the concurrent axillary nerve injury.

With anterior shoulder dislocations, multiple concomitant shoulder injuries, including a HAGL lesion, are not uncommon.^6,16 With HAGL lesions, associated rotator cuff injuries occur at a rate as high as 23%.⁶ Our patient had a concurrent partial rotator cuff tear but also an axillary nerve traction injury. To our knowledge, the literature has not described axillary nerve injury specifically in association with a HAGL lesion, though it is well documented and maintained as a possible concurrent injury with anterior shoulder instability events.¹⁷ Robinson and colleagues¹⁶ found a 5.8% incidence of a clinically apparent neurologic deficit after traumatic anterior shoulder dislocation in 3633 dislocations, about 75% of which were isolated axillary nerve injuries. They also reported a 25.7% rate of rotator cuff tear or greater tuberosity fracture, either of which significantly increased the likelihood of a neurologic deficit in their study.

When nerve continuity remains, functional recovery occurs after 3 to 6 months, or within weeks in some cases.^18-20 Nerve injuries in continuity but with persistent, severe clinical deficits may require surgical exploration with subsequent neurolysis and/or repair.^19-21 Our patient showed gradual axillary nerve recovery from a clinical standpoint. By 6 months after injury, despite continued muscle atrophy and decreased axillary nerve sensation, he had returned to full duty as a Navy SEAL. By 17 months, atrophy was markedly improved, and strength and ROM had subjectively returned, despite there being significant conduction amplitude losses, up to 50% of the contralateral side, on EMG testing.

This case represents a scenario in which likely initial surgical management was precluded by a concomitant injury, and the patient had a serendipitous outcome. It is possible the axillary neuropraxia and subsequent temporary deltoid dysfunction provided a unique environment that was conducive to the healing of the HAGL lesion. With classic Bankart lesions, many surgeons prefer to use aggressive early surgical treatment in first-time dislocators, especially elite athletes, in an attempt to avoid recurrent instability.^22-26 However, some have suggested that initial immobilization after acute injury may lead to successful nonoperative management.²⁷ Perhaps our case report raises the question as to whether a prolonged period of initial immobilization can prove successful in management of a HAGL lesion. Prospective studies comparing early surgical and nonoperative treatment of these challenging lesions are warranted.

We have reported a case of successful nonoperative management of a HAGL lesion in an active-duty Navy SEAL with concomitant shoulder injuries. This case could suggest that a trial of initial nonoperative management should be considered for injuries that involve a HAGL lesion when there are concerns about the patient’s ability to complete functional rehabilitation because of the combined injuries of the shoulder.

The humeral avulsion of glenohumeral ligament (HAGL) lesion has been recognized as a cause of recurrent shoulder instability. In 1942, Nicola¹ was the first to describe this lesion, in a small case series of avulsions of the anterior band of the inferior glenohumeral ligament from the humeral neck secondary to a dislocation injury. In 1988, Bach and colleagues² described it in 2 patients with recurrent anterior dislocations. Wolf and colleagues³ were the first to apply the term HAGL to the injury, in 1995.

HAGL lesion incidence ranges from 1% to 9%, but many authors think the lesion is underdiagnosed.^3-5 It occurs in isolation or in combination with other injuries, and it is commonly identified on recurrence of instability. Bui-Mansfield and colleagues⁶ found that 11% of patients with a diagnosis of HAGL lesion previously had surgery on the same shoulder, whereas for 62% the lesion was associated with other, concurrent lesions, including labral tears (18, 25%), rotator cuff tears (16, 23%), and Hill-Sachs deformities (12, 17%).

Most young athletes who undergo nonoperative therapy for a HAGL lesion continue to experience pain and/or instability that then requires surgical intervention.⁴ To our knowledge, there are no reports of return to full function in young competitive athletes or return to manual labor after nonoperative management of a HAGL lesion.

In this article, we report the case of a US Navy SEAL who sustained a traction injury causing an axillary nerve injury and a HAGL lesion. Successful nonoperative management allowed him to return to full duty. The patient provided written informed consent for print and electronic publication of this case report.

Case Report

An otherwise healthy 26-year-old Navy SEAL presented with pain and significant weakness in the right (dominant) upper extremity after an injury in a training exercise. The shoulder sustained a traction injury when the man’s fast-moving marine attack craft was in a collision and he was trying not to be thrown off. He reported having a sense of dislocation yet never required a reduction.

Physical examination revealed severe weakness with shoulder abduction, external rotation, and forward flexion; inability to contract the deltoid muscle; and complete numbness along the cutaneous distribution of the axillary nerve. On neurovascular examination, the right upper extremity was otherwise intact. The patient had complete passive range of motion (ROM) with apprehension in abduction with external rotation along with anterior laxity and normal posterior stability.

Standard shoulder radiographs showed no bony abnormalities and a concentrically reduced glenohumeral joint. Magnetic resonance imaging (MRI), reviewed by a staff musculoskeletal radiologist and a sports fellowship–trained orthopedic surgeon, showed a greater tuberosity contusion, a partial tear of the infraspinatus, and a HAGL lesion (Figure 1).

The patient was counseled toward surgical intervention to prevent symptoms of recurrent instability. A detailed discussion ensued about whether to proceed with surgery immediately or to pursue temporary nonoperative treatment to allow for assessment and return of deltoid function. Patient and surgeon decided to delay operative intervention because of concerns about the patient’s ability to effectively rehabilitate while still having a compromised axillary nerve after surgery. The recommendation was to delay initial electromyographic (EMG) and nerve conduction velocity testing at least 4 weeks to allow for completion of Wallerian degeneration and more accurate assessment of the axillary nerve.⁷ Physical therapy for gentle ROM (excluding external rotation) and isometric rotator cuff exercises were initiated.

Five weeks after injury, the patient left the area to attend a 2-month nonphysical training course and continued rehabilitation and orthopedic follow-up at another military medical facility. Six weeks after injury, initial EMG testing revealed the expected axillary neuropraxia. In addition, some marginal improvement in ROM was noted, but deltoid function was still very limited.

Ten weeks after injury, clinical inspection revealed deltoid wasting. Active shoulder ROM was limited, and deltoid strength was 3/5, though the patient was able to perform a standard push-up without difficulty and showed no sign of laxity or apprehension on shoulder examination. Repeat EMG testing revealed axillary nerve denervation with no sign of regeneration. Twelve weeks after injury, MRA showed reorganization and partial healing of the HAGL lesion relative to the prior study (Figure 2).

On the patient’s return from training, 15 weeks after injury, he had improved active ROM and 4+/5 deltoid strength. Axillary nerve sensation was still decreased but markedly improved. Physical examination revealed no significant shoulder laxity or apprehension, and the patient denied feelings of instability. Activities were advanced to include an organized strengthening program.

Six months after injury, the patient was cleared to return to his unit with only mild physical restriction. Function continued to steadily improve. After 9 months, he was cleared for full, unrestricted duty. Although he still demonstrated slight asymmetric weakness in the right deltoid with continued muscular atrophy, examination findings were otherwise normal, and he was back to full activities without significant symptoms.

Eleven months after injury, MRI showed healing of the HAGL lesion (Figure 3). At 17 months, EMG testing revealed significant interval improvement in axillary motor unit potentials but still about a 50% decrement compared with the noninjured side. The patient denied any motor or sensory deficits and any instability events since his injury. He continued with full function as an active-duty Navy SEAL.

Discussion

Nonoperative management has been used for injuries to the inferior glenohumeral ligament complex when there is no humeral detachment but generally has been reserved for low-demand patients and patients who cannot tolerate surgical intervention.⁴ Detached lesions may initially be managed nonoperatively with physical therapy and rehabilitation, but the rate of recurrent instability after nonoperative management of a known HAGL lesion remains unknown.⁴ Most active young people are expected to have persistent pain and/or instability and require surgical intervention. Both arthroscopic and open methods have been used successfully.^3,8-15 Persistent instability is often the primary complaint leading to a diagnosis of a HAGL lesion.⁴ The patient in this case report neither demonstrated nor reported any instability event after his 6-month period of nonoperative management, despite his young age and elite physical requirements.

To our knowledge, there are no reports of successful nonoperative management of a known symptomatic HAGL lesion in a high-demand athlete. Although we do not routinely recommend nonoperative treatment for cases such as the one reported here, the decision to delay this Navy SEAL’s surgical management was made out of concern about potential complications of postoperative rehabilitation given the concurrent axillary nerve injury.

With anterior shoulder dislocations, multiple concomitant shoulder injuries, including a HAGL lesion, are not uncommon.^6,16 With HAGL lesions, associated rotator cuff injuries occur at a rate as high as 23%.⁶ Our patient had a concurrent partial rotator cuff tear but also an axillary nerve traction injury. To our knowledge, the literature has not described axillary nerve injury specifically in association with a HAGL lesion, though it is well documented and maintained as a possible concurrent injury with anterior shoulder instability events.¹⁷ Robinson and colleagues¹⁶ found a 5.8% incidence of a clinically apparent neurologic deficit after traumatic anterior shoulder dislocation in 3633 dislocations, about 75% of which were isolated axillary nerve injuries. They also reported a 25.7% rate of rotator cuff tear or greater tuberosity fracture, either of which significantly increased the likelihood of a neurologic deficit in their study.

When nerve continuity remains, functional recovery occurs after 3 to 6 months, or within weeks in some cases.^18-20 Nerve injuries in continuity but with persistent, severe clinical deficits may require surgical exploration with subsequent neurolysis and/or repair.^19-21 Our patient showed gradual axillary nerve recovery from a clinical standpoint. By 6 months after injury, despite continued muscle atrophy and decreased axillary nerve sensation, he had returned to full duty as a Navy SEAL. By 17 months, atrophy was markedly improved, and strength and ROM had subjectively returned, despite there being significant conduction amplitude losses, up to 50% of the contralateral side, on EMG testing.

This case represents a scenario in which likely initial surgical management was precluded by a concomitant injury, and the patient had a serendipitous outcome. It is possible the axillary neuropraxia and subsequent temporary deltoid dysfunction provided a unique environment that was conducive to the healing of the HAGL lesion. With classic Bankart lesions, many surgeons prefer to use aggressive early surgical treatment in first-time dislocators, especially elite athletes, in an attempt to avoid recurrent instability.^22-26 However, some have suggested that initial immobilization after acute injury may lead to successful nonoperative management.²⁷ Perhaps our case report raises the question as to whether a prolonged period of initial immobilization can prove successful in management of a HAGL lesion. Prospective studies comparing early surgical and nonoperative treatment of these challenging lesions are warranted.

We have reported a case of successful nonoperative management of a HAGL lesion in an active-duty Navy SEAL with concomitant shoulder injuries. This case could suggest that a trial of initial nonoperative management should be considered for injuries that involve a HAGL lesion when there are concerns about the patient’s ability to complete functional rehabilitation because of the combined injuries of the shoulder.

LONDON – The European League Against Rheumatism and the European Federation of National Associations of Orthopaedics and Traumatology have joined forces to develop recommendations for the prevention and management of fragility fractures.

Such fractures are common in men and women over the age of 50 years and can lead to repeat fracture in some patients. The recommendations are unique as they are the first to consider both acute orthopedic and postfracture rheumatologic care, said Willem F. Lems, MD, PhD, of the Amsterdam Rheumatology and Immunology Centre.

At the European Congress of Rheumatology, Dr. Lems provided an overview of the draft recommendations, noting that there would be several overarching principles, one of which recognized the multidisciplinary nature of caring for someone with a fragility fracture. An important point is not who is taking care of the patient, but that the patient is given the best possible care within the multidisciplinary framework.

Wikimedia Commons/Sjoehest/ CC BY-llSA 3.0

What constitutes optimal care of course depends on the clinical situation, notably the type of fracture and the age of the patient, and optimal care in all phases of presentation (pre-, peri- and postoperative) can have an important effect on a patient’s outcome. The prevention of subsequent fractures is a key focus, with the recommendation that all patients should be investigated systematically and those deemed at high risk for another fracture should be prescribed both pharmacologic and nonpharmacologic interventions as appropriate. Patient education is also considered important.

As for all EULAR-developed recommendations, standard procedures were followed that involved convening an expert scientific advisory committee and using the Delphi technique to come up with the most important research questions that would be used to formulate the final 10 recommendations. Four of the recommendations cover the acute care setting and six provide advice on postfracture care.

The first of the acute care recommendations looks at pre- and perioperative management of a fragility fracture and highlights that, within 24-48 hours of admission, patients should receive adequate pain and fluid management and treatment, including early surgery if appropriate. This is based on evidence that better outcomes can be achieved in terms of both morbidity and mortality if patients can be seen and managed quickly.

Another of the acute care recommendations focuses on orthogeriatric care, noting that the orthopedic surgeon and a dedicated orthogeriatric team should work together, particularly for elderly patients who have suffered a hip fracture. Key elements here are the management of and prevention of delirium, deep vein thrombosis, pressure sores, and malnutrition.

As for actual fracture treatment, a balanced approach is advised when deciding upon a surgical or nonsurgical approach, especially because this is likely to be an older population with other comorbidities. Only one in three vertebral fractures are symptomatic and only about 10% of patients will be hospitalized for pain. Analgesics, modifying activities, and bracing can be options here. Surgical options for distal radial fracture, hip fracture, and trochanteric and femoral neck fractures are included.

The fourth recommendation looks at the organization of postfracture care and the need for a systematic approach to identify those who may be at risk for subsequent fractures, starting with the suggestion that any patient older than 50 years with a recent fracture should be assessed. The fifth recommendation addresses ways to evaluate this risk, such as looking at the clinical risk factors, performing bone scans and imaging, and screening for underlying osteoporosis or metabolic disorders.

Implementation is the next step, and the sixth recommendation suggests ways these recommendations could be integrated into routine practice. Often one of the biggest barriers to effective postfracture care is the lack of patient, and sometimes clinician, awareness of the risk for a subsequent fracture. This recommendation looks at the role of a possible local fracture liaison service or facilitator to coordinate between the various members of the multidisciplinary team from secondary (orthopedic surgeons, rheumatologists, endocrinologists, and geriatricians) to primary care.

The seventh recommendation addresses rehabilitation and the need to initiate physical training and muscle strengthening as early as possible after the initial fracture, with long-term continuation of balance training and fall prevention.

The final three recommendations focus on how to educate patients about their risk factors, need for follow-up, and the duration of any pharmacologic or nonpharmacologic therapy that they may need. Nonpharmacologic options might include stopping smoking, limiting alcohol intake, as well as taking supplements such as calcium or vitamin D. There will be specific guidance on the use of calcium and vitamin D, which have both pros and cons, but the optimal dosage appears to be 1,000–1,200 mg/day for calcium and 800 IU/day for vitamin D.

Pharmacologic options to prevent subsequent fragility fractures include the bisphosphonates alendronate, risedronate, and zoledronic acid (Reclast), and also the monoclonal antibody denosumab (Prolia). These are the only drugs that have been shown to reduced the risk for vertebral, nonvertebral, and hip fractures in primary analyses. Adherence, tolerance, and regular monitoring are key, and a five-step plan is suggested to aid clinical decision making that covers case finding, risk evaluation, differential diagnosis, treatment, and follow-up.

The recommendations are being finalized and should be available for publication later this year. The recommendations task force also plans to propose a research agenda.

Dr. Lems had no relevant disclosures.

LONDON – The European League Against Rheumatism and the European Federation of National Associations of Orthopaedics and Traumatology have joined forces to develop recommendations for the prevention and management of fragility fractures.

Such fractures are common in men and women over the age of 50 years and can lead to repeat fracture in some patients. The recommendations are unique as they are the first to consider both acute orthopedic and postfracture rheumatologic care, said Willem F. Lems, MD, PhD, of the Amsterdam Rheumatology and Immunology Centre.

At the European Congress of Rheumatology, Dr. Lems provided an overview of the draft recommendations, noting that there would be several overarching principles, one of which recognized the multidisciplinary nature of caring for someone with a fragility fracture. An important point is not who is taking care of the patient, but that the patient is given the best possible care within the multidisciplinary framework.

Wikimedia Commons/Sjoehest/ CC BY-llSA 3.0

What constitutes optimal care of course depends on the clinical situation, notably the type of fracture and the age of the patient, and optimal care in all phases of presentation (pre-, peri- and postoperative) can have an important effect on a patient’s outcome. The prevention of subsequent fractures is a key focus, with the recommendation that all patients should be investigated systematically and those deemed at high risk for another fracture should be prescribed both pharmacologic and nonpharmacologic interventions as appropriate. Patient education is also considered important.

As for all EULAR-developed recommendations, standard procedures were followed that involved convening an expert scientific advisory committee and using the Delphi technique to come up with the most important research questions that would be used to formulate the final 10 recommendations. Four of the recommendations cover the acute care setting and six provide advice on postfracture care.

The first of the acute care recommendations looks at pre- and perioperative management of a fragility fracture and highlights that, within 24-48 hours of admission, patients should receive adequate pain and fluid management and treatment, including early surgery if appropriate. This is based on evidence that better outcomes can be achieved in terms of both morbidity and mortality if patients can be seen and managed quickly.

Another of the acute care recommendations focuses on orthogeriatric care, noting that the orthopedic surgeon and a dedicated orthogeriatric team should work together, particularly for elderly patients who have suffered a hip fracture. Key elements here are the management of and prevention of delirium, deep vein thrombosis, pressure sores, and malnutrition.

As for actual fracture treatment, a balanced approach is advised when deciding upon a surgical or nonsurgical approach, especially because this is likely to be an older population with other comorbidities. Only one in three vertebral fractures are symptomatic and only about 10% of patients will be hospitalized for pain. Analgesics, modifying activities, and bracing can be options here. Surgical options for distal radial fracture, hip fracture, and trochanteric and femoral neck fractures are included.

The fourth recommendation looks at the organization of postfracture care and the need for a systematic approach to identify those who may be at risk for subsequent fractures, starting with the suggestion that any patient older than 50 years with a recent fracture should be assessed. The fifth recommendation addresses ways to evaluate this risk, such as looking at the clinical risk factors, performing bone scans and imaging, and screening for underlying osteoporosis or metabolic disorders.

Implementation is the next step, and the sixth recommendation suggests ways these recommendations could be integrated into routine practice. Often one of the biggest barriers to effective postfracture care is the lack of patient, and sometimes clinician, awareness of the risk for a subsequent fracture. This recommendation looks at the role of a possible local fracture liaison service or facilitator to coordinate between the various members of the multidisciplinary team from secondary (orthopedic surgeons, rheumatologists, endocrinologists, and geriatricians) to primary care.

The seventh recommendation addresses rehabilitation and the need to initiate physical training and muscle strengthening as early as possible after the initial fracture, with long-term continuation of balance training and fall prevention.

The final three recommendations focus on how to educate patients about their risk factors, need for follow-up, and the duration of any pharmacologic or nonpharmacologic therapy that they may need. Nonpharmacologic options might include stopping smoking, limiting alcohol intake, as well as taking supplements such as calcium or vitamin D. There will be specific guidance on the use of calcium and vitamin D, which have both pros and cons, but the optimal dosage appears to be 1,000–1,200 mg/day for calcium and 800 IU/day for vitamin D.

Pharmacologic options to prevent subsequent fragility fractures include the bisphosphonates alendronate, risedronate, and zoledronic acid (Reclast), and also the monoclonal antibody denosumab (Prolia). These are the only drugs that have been shown to reduced the risk for vertebral, nonvertebral, and hip fractures in primary analyses. Adherence, tolerance, and regular monitoring are key, and a five-step plan is suggested to aid clinical decision making that covers case finding, risk evaluation, differential diagnosis, treatment, and follow-up.

The recommendations are being finalized and should be available for publication later this year. The recommendations task force also plans to propose a research agenda.

Dr. Lems had no relevant disclosures.

LONDON – The European League Against Rheumatism and the European Federation of National Associations of Orthopaedics and Traumatology have joined forces to develop recommendations for the prevention and management of fragility fractures.

Such fractures are common in men and women over the age of 50 years and can lead to repeat fracture in some patients. The recommendations are unique as they are the first to consider both acute orthopedic and postfracture rheumatologic care, said Willem F. Lems, MD, PhD, of the Amsterdam Rheumatology and Immunology Centre.

At the European Congress of Rheumatology, Dr. Lems provided an overview of the draft recommendations, noting that there would be several overarching principles, one of which recognized the multidisciplinary nature of caring for someone with a fragility fracture. An important point is not who is taking care of the patient, but that the patient is given the best possible care within the multidisciplinary framework.

Wikimedia Commons/Sjoehest/ CC BY-llSA 3.0

What constitutes optimal care of course depends on the clinical situation, notably the type of fracture and the age of the patient, and optimal care in all phases of presentation (pre-, peri- and postoperative) can have an important effect on a patient’s outcome. The prevention of subsequent fractures is a key focus, with the recommendation that all patients should be investigated systematically and those deemed at high risk for another fracture should be prescribed both pharmacologic and nonpharmacologic interventions as appropriate. Patient education is also considered important.

As for all EULAR-developed recommendations, standard procedures were followed that involved convening an expert scientific advisory committee and using the Delphi technique to come up with the most important research questions that would be used to formulate the final 10 recommendations. Four of the recommendations cover the acute care setting and six provide advice on postfracture care.

The first of the acute care recommendations looks at pre- and perioperative management of a fragility fracture and highlights that, within 24-48 hours of admission, patients should receive adequate pain and fluid management and treatment, including early surgery if appropriate. This is based on evidence that better outcomes can be achieved in terms of both morbidity and mortality if patients can be seen and managed quickly.

Another of the acute care recommendations focuses on orthogeriatric care, noting that the orthopedic surgeon and a dedicated orthogeriatric team should work together, particularly for elderly patients who have suffered a hip fracture. Key elements here are the management of and prevention of delirium, deep vein thrombosis, pressure sores, and malnutrition.

As for actual fracture treatment, a balanced approach is advised when deciding upon a surgical or nonsurgical approach, especially because this is likely to be an older population with other comorbidities. Only one in three vertebral fractures are symptomatic and only about 10% of patients will be hospitalized for pain. Analgesics, modifying activities, and bracing can be options here. Surgical options for distal radial fracture, hip fracture, and trochanteric and femoral neck fractures are included.

The fourth recommendation looks at the organization of postfracture care and the need for a systematic approach to identify those who may be at risk for subsequent fractures, starting with the suggestion that any patient older than 50 years with a recent fracture should be assessed. The fifth recommendation addresses ways to evaluate this risk, such as looking at the clinical risk factors, performing bone scans and imaging, and screening for underlying osteoporosis or metabolic disorders.

Implementation is the next step, and the sixth recommendation suggests ways these recommendations could be integrated into routine practice. Often one of the biggest barriers to effective postfracture care is the lack of patient, and sometimes clinician, awareness of the risk for a subsequent fracture. This recommendation looks at the role of a possible local fracture liaison service or facilitator to coordinate between the various members of the multidisciplinary team from secondary (orthopedic surgeons, rheumatologists, endocrinologists, and geriatricians) to primary care.

The seventh recommendation addresses rehabilitation and the need to initiate physical training and muscle strengthening as early as possible after the initial fracture, with long-term continuation of balance training and fall prevention.

The final three recommendations focus on how to educate patients about their risk factors, need for follow-up, and the duration of any pharmacologic or nonpharmacologic therapy that they may need. Nonpharmacologic options might include stopping smoking, limiting alcohol intake, as well as taking supplements such as calcium or vitamin D. There will be specific guidance on the use of calcium and vitamin D, which have both pros and cons, but the optimal dosage appears to be 1,000–1,200 mg/day for calcium and 800 IU/day for vitamin D.

Pharmacologic options to prevent subsequent fragility fractures include the bisphosphonates alendronate, risedronate, and zoledronic acid (Reclast), and also the monoclonal antibody denosumab (Prolia). These are the only drugs that have been shown to reduced the risk for vertebral, nonvertebral, and hip fractures in primary analyses. Adherence, tolerance, and regular monitoring are key, and a five-step plan is suggested to aid clinical decision making that covers case finding, risk evaluation, differential diagnosis, treatment, and follow-up.

The recommendations are being finalized and should be available for publication later this year. The recommendations task force also plans to propose a research agenda.

Dr. Lems had no relevant disclosures.

Struan H. Coleman, MD, PhD

Associate Editor for Practice Management/Economics

Dr. Coleman is a board-certified orthopedic surgeon specializing in hip preservation and sports medicine at the Hospital for Special Surgery in New York and the Vincera Institute in Philadelphia, and currently is the Head Team Physician for the New York Mets. He earned a medical degree from Columbia College of Physicians and Surgeons and holds a D.Phil in Microbiology from Oxford University in England. He completed his residency in Orthopedic Surgery and a fellowship in Sports Medicine at the Hospital for Special Surgery. Dr. Coleman focuses on the treatment of sports-related injuries of the hip, knee, and shoulder with a particular interest in hip arthroscopy and hip preservation. He has published multiple articles and book chapters, and holds numerous patents for technologies that are utilized by sports medicine physicians and surgeons.

Jack Farr II, MD

Associate Editor for Patellofemoral

Dr. Farr is a board-certified orthopedic surgeon and has a subspecialty practice in knee and cartilage restoration. He is affiliated with the OrthoIndy Hospital and Community Hospital South. He is also the Vice President of the Patellofemoral Foundation, is on the board for the International Cartilage Repair Society, holds a board position with the Cartilage Research Foundation, and holds a voluntary clinical full professorship in Orthopedic Surgery at the Indiana University Medical Center. Dr. Farr earned his medical degree from Indiana University, and completed his Orthopedic Surgery residency at Indiana University Medical Center. He was a design surgeon for a meniscal allograft transplant system and 2 knee patellofemoral osteotomy systems. He is also a member of the American Academy of Orthopaedic Surgeons (AAOS), the Arthroscopy Association of North America (AANA), and the European Society of Sports Traumatology, Knee Surgery and Arthroscopy (ESSKA).

Kenneth Montgomery, MD

Associate Editor for Professional Sports

Dr. Montgomery is an orthopedic surgeon who is fellowship-trained in sports medicine and hand and upper extremity surgery. He is currently practicing at Tri-County Orthopedics and Sports Medicine in Morristown, New Jersey. He is also the Head Team Physician and Medical Director for the New York Jets. He served as a team orthopedist with the New York Islanders from 1997-2009, and was formerly the section chief of Sports Medicine at ProHEALTH Care Associates in Lake Success, New York. Dr. Montgomery completed his residency in Orthopedic Surgery at the Hospital for Special Surgery, and completed a Sports Medicine fellowship at Lenox Hill Hospital. He also completed a Hand and Upper Extremity fellowship at Harvard. He is one of the founders for OrthoNations, a nonprofit organization that helps educate orthopedic surgeons in developing countries. He is also one of the founding surgeons for Cayenne Medical, a medical device company specializing in sports medicine implants.

Struan H. Coleman, MD, PhD

Associate Editor for Practice Management/Economics

Dr. Coleman is a board-certified orthopedic surgeon specializing in hip preservation and sports medicine at the Hospital for Special Surgery in New York and the Vincera Institute in Philadelphia, and currently is the Head Team Physician for the New York Mets. He earned a medical degree from Columbia College of Physicians and Surgeons and holds a D.Phil in Microbiology from Oxford University in England. He completed his residency in Orthopedic Surgery and a fellowship in Sports Medicine at the Hospital for Special Surgery. Dr. Coleman focuses on the treatment of sports-related injuries of the hip, knee, and shoulder with a particular interest in hip arthroscopy and hip preservation. He has published multiple articles and book chapters, and holds numerous patents for technologies that are utilized by sports medicine physicians and surgeons.

Jack Farr II, MD

Associate Editor for Patellofemoral

Dr. Farr is a board-certified orthopedic surgeon and has a subspecialty practice in knee and cartilage restoration. He is affiliated with the OrthoIndy Hospital and Community Hospital South. He is also the Vice President of the Patellofemoral Foundation, is on the board for the International Cartilage Repair Society, holds a board position with the Cartilage Research Foundation, and holds a voluntary clinical full professorship in Orthopedic Surgery at the Indiana University Medical Center. Dr. Farr earned his medical degree from Indiana University, and completed his Orthopedic Surgery residency at Indiana University Medical Center. He was a design surgeon for a meniscal allograft transplant system and 2 knee patellofemoral osteotomy systems. He is also a member of the American Academy of Orthopaedic Surgeons (AAOS), the Arthroscopy Association of North America (AANA), and the European Society of Sports Traumatology, Knee Surgery and Arthroscopy (ESSKA).

Kenneth Montgomery, MD

Associate Editor for Professional Sports

Dr. Montgomery is an orthopedic surgeon who is fellowship-trained in sports medicine and hand and upper extremity surgery. He is currently practicing at Tri-County Orthopedics and Sports Medicine in Morristown, New Jersey. He is also the Head Team Physician and Medical Director for the New York Jets. He served as a team orthopedist with the New York Islanders from 1997-2009, and was formerly the section chief of Sports Medicine at ProHEALTH Care Associates in Lake Success, New York. Dr. Montgomery completed his residency in Orthopedic Surgery at the Hospital for Special Surgery, and completed a Sports Medicine fellowship at Lenox Hill Hospital. He also completed a Hand and Upper Extremity fellowship at Harvard. He is one of the founders for OrthoNations, a nonprofit organization that helps educate orthopedic surgeons in developing countries. He is also one of the founding surgeons for Cayenne Medical, a medical device company specializing in sports medicine implants.

Struan H. Coleman, MD, PhD

Associate Editor for Practice Management/Economics

Dr. Coleman is a board-certified orthopedic surgeon specializing in hip preservation and sports medicine at the Hospital for Special Surgery in New York and the Vincera Institute in Philadelphia, and currently is the Head Team Physician for the New York Mets. He earned a medical degree from Columbia College of Physicians and Surgeons and holds a D.Phil in Microbiology from Oxford University in England. He completed his residency in Orthopedic Surgery and a fellowship in Sports Medicine at the Hospital for Special Surgery. Dr. Coleman focuses on the treatment of sports-related injuries of the hip, knee, and shoulder with a particular interest in hip arthroscopy and hip preservation. He has published multiple articles and book chapters, and holds numerous patents for technologies that are utilized by sports medicine physicians and surgeons.

Jack Farr II, MD

Associate Editor for Patellofemoral

Dr. Farr is a board-certified orthopedic surgeon and has a subspecialty practice in knee and cartilage restoration. He is affiliated with the OrthoIndy Hospital and Community Hospital South. He is also the Vice President of the Patellofemoral Foundation, is on the board for the International Cartilage Repair Society, holds a board position with the Cartilage Research Foundation, and holds a voluntary clinical full professorship in Orthopedic Surgery at the Indiana University Medical Center. Dr. Farr earned his medical degree from Indiana University, and completed his Orthopedic Surgery residency at Indiana University Medical Center. He was a design surgeon for a meniscal allograft transplant system and 2 knee patellofemoral osteotomy systems. He is also a member of the American Academy of Orthopaedic Surgeons (AAOS), the Arthroscopy Association of North America (AANA), and the European Society of Sports Traumatology, Knee Surgery and Arthroscopy (ESSKA).

Kenneth Montgomery, MD

Associate Editor for Professional Sports

Dr. Montgomery is an orthopedic surgeon who is fellowship-trained in sports medicine and hand and upper extremity surgery. He is currently practicing at Tri-County Orthopedics and Sports Medicine in Morristown, New Jersey. He is also the Head Team Physician and Medical Director for the New York Jets. He served as a team orthopedist with the New York Islanders from 1997-2009, and was formerly the section chief of Sports Medicine at ProHEALTH Care Associates in Lake Success, New York. Dr. Montgomery completed his residency in Orthopedic Surgery at the Hospital for Special Surgery, and completed a Sports Medicine fellowship at Lenox Hill Hospital. He also completed a Hand and Upper Extremity fellowship at Harvard. He is one of the founders for OrthoNations, a nonprofit organization that helps educate orthopedic surgeons in developing countries. He is also one of the founding surgeons for Cayenne Medical, a medical device company specializing in sports medicine implants.

Exactech

Optecure+ccc

(http://www.exac.com/products/biologics/optecure-optecure-ccc)

Autogenous bone graft remains the standard for augmenting the surgical care of severe fractures, promoting spinal fusion, filling bone voids, and treating nonunions. However, lingering problems with donor site morbidity, volume limitation, increased operative time, and increased case complexity have led to the growing use of bone graft substitutes.¹ These alternatives include allograft bone, demineralized bone matrix, calcium sulfate and calcium phosphate, bioglass, growth factors (rhBMP-2, rhBMP-7, rhPDGF, and PRP [platelet-rich plasma]), collagen matrix, and new cellular-based compounds using mesenchymal stem cells. Since each individual class of bone substitute falls short of the optimal blend of osteoconduction, osteoinduction, and osteogenesis, novel composite grafts have been developed to combine the convenience, durability, and flexibility of synthetic grafts with the biologic activity of native bone.

Optecure+ccc (Exactech) is an engineered composite bone graft that contains demineralized bone mixed with gamma irradiated cortical cancellous chips in an absorbable synthetic hydrogel matrix (Figure). When mixed with saline, blood, autogenous bone, bone marrow aspirate, or PRP, it becomes a surprisingly robust and malleable 3-dimensional matrix that allows easy bone void filling with excellent osteoconductive and osteoinductive characteristics. Each individual lot is tested for sterility and endotoxin levels to confirm safety as well as in vivo testing in athymic mice to confirm osteoinductive potential. Optecure+ccc has been successfully used to augment healing when combined with bone marrow aspirate in minimally invasive spine fusion surgery.²

Surgical pearl: I treat a large number of bicycle injuries on Nantucket; many are quite serious. I have found Optecure+ccc to be particularly useful during locked volar plating of severe distal radius wrist fractures as a way to restore and support radial length when autogenous bone access is limited. In this application, Optecure’s ability to expand and mold into a functional bone scaffold is critical to create a stable, stress-resistant fracture construct.

After exposure of the comminuted fracture line of the distal radius, gentle axial traction is applied and a small osteotome or freer is used to carefully wedge open the cortex to allow metaphyseal window access. The Optecure+ccc is mixed with either blood or bone marrow aspirate to reach a “grape nuts cereal”-like consistency and then carefully packed into the metaphyseal window to backfill the void. Multiplanar fluoroscopy is used to monitor graft placement and gradual joint line restoration. Traction is then released after the void is filled sufficiently to support the provisional reduction. Additional grafting with standard Optecure without bone chips can be used to fill more difficult-to-access areas. Both forms of Optecure are resistant to diluent migration, giving them good intraoperative behavior. Excess graft can be easily wiped away from the fracture site prior to plate application.

After elevation and restoration of the joint line, the locking volar plate is then affixed, wrist alignment confirmed fluoroscopically, and the procedure completed. The result is a well-filled void and an improved fracture construct. While Optecure+ccc has proven its battle readiness in wrist fracture surgery, I have also found it very helpful in reconstructing complex proximal humerus and clavicle fractures. Its unique combination of intraoperative versatility and durability provides a welcome edge in challenging cases.

Exactech

Optecure+ccc

(http://www.exac.com/products/biologics/optecure-optecure-ccc)

Autogenous bone graft remains the standard for augmenting the surgical care of severe fractures, promoting spinal fusion, filling bone voids, and treating nonunions. However, lingering problems with donor site morbidity, volume limitation, increased operative time, and increased case complexity have led to the growing use of bone graft substitutes.¹ These alternatives include allograft bone, demineralized bone matrix, calcium sulfate and calcium phosphate, bioglass, growth factors (rhBMP-2, rhBMP-7, rhPDGF, and PRP [platelet-rich plasma]), collagen matrix, and new cellular-based compounds using mesenchymal stem cells. Since each individual class of bone substitute falls short of the optimal blend of osteoconduction, osteoinduction, and osteogenesis, novel composite grafts have been developed to combine the convenience, durability, and flexibility of synthetic grafts with the biologic activity of native bone.

Optecure+ccc (Exactech) is an engineered composite bone graft that contains demineralized bone mixed with gamma irradiated cortical cancellous chips in an absorbable synthetic hydrogel matrix (Figure). When mixed with saline, blood, autogenous bone, bone marrow aspirate, or PRP, it becomes a surprisingly robust and malleable 3-dimensional matrix that allows easy bone void filling with excellent osteoconductive and osteoinductive characteristics. Each individual lot is tested for sterility and endotoxin levels to confirm safety as well as in vivo testing in athymic mice to confirm osteoinductive potential. Optecure+ccc has been successfully used to augment healing when combined with bone marrow aspirate in minimally invasive spine fusion surgery.²

Surgical pearl: I treat a large number of bicycle injuries on Nantucket; many are quite serious. I have found Optecure+ccc to be particularly useful during locked volar plating of severe distal radius wrist fractures as a way to restore and support radial length when autogenous bone access is limited. In this application, Optecure’s ability to expand and mold into a functional bone scaffold is critical to create a stable, stress-resistant fracture construct.

After exposure of the comminuted fracture line of the distal radius, gentle axial traction is applied and a small osteotome or freer is used to carefully wedge open the cortex to allow metaphyseal window access. The Optecure+ccc is mixed with either blood or bone marrow aspirate to reach a “grape nuts cereal”-like consistency and then carefully packed into the metaphyseal window to backfill the void. Multiplanar fluoroscopy is used to monitor graft placement and gradual joint line restoration. Traction is then released after the void is filled sufficiently to support the provisional reduction. Additional grafting with standard Optecure without bone chips can be used to fill more difficult-to-access areas. Both forms of Optecure are resistant to diluent migration, giving them good intraoperative behavior. Excess graft can be easily wiped away from the fracture site prior to plate application.

After elevation and restoration of the joint line, the locking volar plate is then affixed, wrist alignment confirmed fluoroscopically, and the procedure completed. The result is a well-filled void and an improved fracture construct. While Optecure+ccc has proven its battle readiness in wrist fracture surgery, I have also found it very helpful in reconstructing complex proximal humerus and clavicle fractures. Its unique combination of intraoperative versatility and durability provides a welcome edge in challenging cases.

Exactech

Optecure+ccc

(http://www.exac.com/products/biologics/optecure-optecure-ccc)

Autogenous bone graft remains the standard for augmenting the surgical care of severe fractures, promoting spinal fusion, filling bone voids, and treating nonunions. However, lingering problems with donor site morbidity, volume limitation, increased operative time, and increased case complexity have led to the growing use of bone graft substitutes.¹ These alternatives include allograft bone, demineralized bone matrix, calcium sulfate and calcium phosphate, bioglass, growth factors (rhBMP-2, rhBMP-7, rhPDGF, and PRP [platelet-rich plasma]), collagen matrix, and new cellular-based compounds using mesenchymal stem cells. Since each individual class of bone substitute falls short of the optimal blend of osteoconduction, osteoinduction, and osteogenesis, novel composite grafts have been developed to combine the convenience, durability, and flexibility of synthetic grafts with the biologic activity of native bone.

Optecure+ccc (Exactech) is an engineered composite bone graft that contains demineralized bone mixed with gamma irradiated cortical cancellous chips in an absorbable synthetic hydrogel matrix (Figure). When mixed with saline, blood, autogenous bone, bone marrow aspirate, or PRP, it becomes a surprisingly robust and malleable 3-dimensional matrix that allows easy bone void filling with excellent osteoconductive and osteoinductive characteristics. Each individual lot is tested for sterility and endotoxin levels to confirm safety as well as in vivo testing in athymic mice to confirm osteoinductive potential. Optecure+ccc has been successfully used to augment healing when combined with bone marrow aspirate in minimally invasive spine fusion surgery.²

Surgical pearl: I treat a large number of bicycle injuries on Nantucket; many are quite serious. I have found Optecure+ccc to be particularly useful during locked volar plating of severe distal radius wrist fractures as a way to restore and support radial length when autogenous bone access is limited. In this application, Optecure’s ability to expand and mold into a functional bone scaffold is critical to create a stable, stress-resistant fracture construct.

After exposure of the comminuted fracture line of the distal radius, gentle axial traction is applied and a small osteotome or freer is used to carefully wedge open the cortex to allow metaphyseal window access. The Optecure+ccc is mixed with either blood or bone marrow aspirate to reach a “grape nuts cereal”-like consistency and then carefully packed into the metaphyseal window to backfill the void. Multiplanar fluoroscopy is used to monitor graft placement and gradual joint line restoration. Traction is then released after the void is filled sufficiently to support the provisional reduction. Additional grafting with standard Optecure without bone chips can be used to fill more difficult-to-access areas. Both forms of Optecure are resistant to diluent migration, giving them good intraoperative behavior. Excess graft can be easily wiped away from the fracture site prior to plate application.

After elevation and restoration of the joint line, the locking volar plate is then affixed, wrist alignment confirmed fluoroscopically, and the procedure completed. The result is a well-filled void and an improved fracture construct. While Optecure+ccc has proven its battle readiness in wrist fracture surgery, I have also found it very helpful in reconstructing complex proximal humerus and clavicle fractures. Its unique combination of intraoperative versatility and durability provides a welcome edge in challenging cases.

Rotator cuff tears are very common, and 250,000 to 500,000 rotator cuff repairs are performed in the United States each year.^1,2 In most cases, a complete repair of even large or massive tears can be achieved. However, a subset of patients exist in whom the glenohumeral joint has minimal degenerative changes and the rotator cuff tendon is either irreparable or very poor quality and unlikely to heal (ie, failed previous cuff repair). Some authors have advocated for reverse shoulder arthroplasty (RSA) in these patients despite the lack of glenohumeral arthritis. However, due to the permanent destruction of the glenohumeral articular surfaces, complication rates, and concerns about implant longevity with RSA, we believe the superior capsular reconstruction (SCR) is a viable alternative in patients in whom joint preservation is appropriate based on age limitations and/or activity requirements.³

The SCR was first described by Mihata and colleagues4 as a means to reconstruct the superior capsule in shoulders with large, irreparable posterosuperior rotator cuff tears. Originally described using a fascia lata autograft, our technique has been adapted to incorporate a dermal allograft, which limits donor site morbidity and operative time. In most cases, the dermal allograft is fixed to the normal anatomic attachments of the superior glenoid just medial to the superior labrum, laterally to the greater tuberosity, and posteriorly with side-to-side sutures to the remaining rotator cuff. If there is a robust band of “comma” tissue anteriorly, we fix the anterior margin of the dermal graft to this with side-to-side sutures. The comma tissue represents the medial sling of the biceps tendon and connects the upper subscapularis tendon to the anterior supraspinatus. In most cases, this tissue is intact after repair of the subscapularis tendon.

Technique

The patient is positioned in either the lateral decubitus or beach chair position. The arm is positioned in 20° to 30° of abduction and 20° to 30° of forward flexion. A diagnostic arthroscopy is performed through a posterior glenohumeral viewing portal. The subscapularis is visualized and repaired if torn. A biceps tenodesis is performed in most cases, as there is often a tear of the subscapularis, tear or instability of the biceps tendon, and/or a compromised attachment of the biceps root.

Attention is turned to the subacromial space. Posterior viewing and lateral working portals are established. A 10-mm flexible cannula (PassPort; Arthrex) is placed in the lateral portal to aid with suture management and graft passage. A limited subacromial decompression is performed that preserves the coracoacromial arch. The rotator cuff is carefully dissected and freed from the internal deltoid fascia. The scapular spine is identified to visualize the raphé between the supraspinatus and infraspinatus. The infraspinatus is mobilized and repaired as much as possible.

If we think that the tear might be reparable by gaining added excursion from a posterior interval slide, or if it is clearly not reparable but the remaining rim of rotator cuff obscures clear visualization of the superior glenoid, we perform a posterior interval slide. If the additional excursion that is achieved by the posterior slide is adequate for a complete repair, we proceed with the repair. However, if the tear is not reparable even after the posterior interval slide, we have found that the exposure and preparation of the superior glenoid is greatly improved after the posterior slide. After fixation of the dermal graft, we typically perform a partial side-to-side repair of the supraspinatus to the infraspinatus over the top of the graft.

The bone beds of the greater tuberosity and just medial to the superior glenoid labrum are prepared with a shaver and motorized burr. Two anchors (3.0-mm BioComposite SutureTak; Arthrex) are placed in the superior glenoid neck at about the 10 o’clock and 2 o’clock positions approximately 5 mm medial to the superior labrum. Note: the placement medial to the labrum is chosen because this is the normal origin of the superior capsule and because of the angle of approach, these percutaneous portals are often more medial than typical portals for placing anchors during SLAP (superior labral anterior to posterior) repair. Next, 2 threaded anchors (4.75-mm BioComposite SwiveLock; Arthrex) preloaded with suture tape are placed in the greater tuberosity along the articular margin (Figure 1). However, if a biceps tenodesis with an interference screw is placed at the top of the bicipital groove, this anchor preloaded with suture tape can also serve as the anteromedial anchor in the greater tuberosity footprint. The distances between all 4 anchors are carefully measured with a calibrated probe (Figures 2A-2D).

We use a 3.0-mm acellular dermal allograft (ArthroFlex; Arthrex) to reconstruct the superior capsule. The positions of the 4 anchors are carefully marked on the dermal allograft. We routinely add an additional 5 mm of tissue to the medial, anterior, and posterior margins to decrease the risk of suture cut out. An additional 10 mm of tissue is added laterally to cover the greater tuberosity. The final contoured graft is typically trapezoidal in shape.

The sutures from the 4 anchors are then sequentially retrieved through the lateral cannula. The sutures from the greater tuberosity anchors are passed through their respective holes in the graft. However, the suture limbs from each of the glenoid anchors are individually passed 2 mm anterior and 2 mm posterior to their respective marks on the graft with an antegrade suture passer (Figure 3). It is important to have an assistant apply tension to each of the sutures after they are passed through the graft to decrease the chance of crossing and tangling the sutures.

The eyelets of the medial anchors are utilized as pulleys to deliver the dermal allograft into the shoulder. One suture limb from each of the glenoid anchors is tied to the other over a switching stick (Figure 4A). The 2 remaining (untied) suture limbs are then pulled, which introduces the graft to the orifice of the cannula (Figure 4B). A tissue grasper is then used to fold the dermal allograft along its long axis and introduce the graft into the joint (Figure 4C). Once the medial portion of the graft is positioned onto the superior glenoid the 2 remaining (untied) suture limbs are tied to each other as a static knot in the subacromial space (Figure 4D).

The redundancy in the suture tapes can be removed by sequentially sliding a retriever down each suture and tensioning the suture as the nose of the instrument pushes the dermal graft down to the tuberosity bone bed. The suture tapes are crisscrossed and secured laterally with 2 additional knotless threaded anchors (Figure 5). One may also place cinch stitches at the anterolateral and posterolateral corners of the graft that are incorporated into the lateral anchors. These sutures can be useful for pulling the graft back out of the subacromial space in the event of any suture tangles, and can be used for controlling the lateral aspect of the graft during lateral anchor placement.

At this point in the procedure, additional glenoid anchors can be placed both anterior and posterior to the superior glenoid anchors if additional glenoid fixation is desired. Finally, 2 to 3 side-to-side sutures are placed posteriorly attaching the anterior aspect of the infraspinatus to the posterior aspect of the dermal allograft (Figures 6A-6C). If rotator interval tissue (comma tissue) is present, anterior side-to-side sutures may be placed. However, we do not recommend placing anterior side-to-side sutures directly from the dermal allograft to the subscapularis as this may deform the graft, over- constrain the shoulder, and restrict motion.

Discussion

Reconstruction of the superior capsule has been shown to restore the normal restraint to superior translation of the humeral head and reestablish a stable fulcrum at the glenohumeral joint.⁵ It should be mentioned that we do not perform the SCR in patients with advanced glenohumeral arthritis. The short-term results of this novel procedure have been encouraging, including our own series of patients, in which most patients have had a significant reduction in pain, improvement in function, and very few complications (P. J. Denard, MD, S. S. Burkhart, MD, P. C. Brady, MD, J. Tokish, MD, C. R. Adams, MD, unpublished data, May 2016).

The early success of this procedure suggests that a robust superior capsule is necessary, in addition to functional muscle-tendon units, to restore the stable fulcrum and force couples that are necessary for normal shoulder function. Perhaps we have not paid enough attention to the integrity of the superior capsule in the past. In cases of revision cuff repair, we pay special attention to the quality of the capsular layer deep to the cuff tendon. If the capsule is poor quality, we sometimes reconstruct the capsule with a dermal allograft (SCR) and then do a rotator cuff repair (partial or complete) over the top of the SCR to maintain the normal anatomic deep to superficial layering of the capsule and rotator cuff.

We are very conservative with our postoperative rehabilitation program after a SCR. We know that the rate of stiffness with a conservative program after an arthroscopic rotator cuff repair, even in the revision setting, is very low.⁶ Furthermore, both basic science on healing of soft tissue to bone and radiographic analysis of healing after postoperative rotator cuff repairs support a slow rehabilitation program.^7,8 A canine model specifically evaluating acellular dermal allografts in the shoulder suggests that these grafts undergo significant remodeling and become weaker before they get stronger.⁹ We would rather err on the side of healing of the SCR with potentially a slight increase in the rate of shoulder stiffness than to regain early motion at the expense of graft failure. Therefore, we have the patient wear a sling with no shoulder motion for 6 weeks. Passive motion is started at 6 weeks postoperative and strengthening is delayed until 12 to 16 weeks postoperative.

Rotator cuff tears are very common, and 250,000 to 500,000 rotator cuff repairs are performed in the United States each year.^1,2 In most cases, a complete repair of even large or massive tears can be achieved. However, a subset of patients exist in whom the glenohumeral joint has minimal degenerative changes and the rotator cuff tendon is either irreparable or very poor quality and unlikely to heal (ie, failed previous cuff repair). Some authors have advocated for reverse shoulder arthroplasty (RSA) in these patients despite the lack of glenohumeral arthritis. However, due to the permanent destruction of the glenohumeral articular surfaces, complication rates, and concerns about implant longevity with RSA, we believe the superior capsular reconstruction (SCR) is a viable alternative in patients in whom joint preservation is appropriate based on age limitations and/or activity requirements.³

The SCR was first described by Mihata and colleagues4 as a means to reconstruct the superior capsule in shoulders with large, irreparable posterosuperior rotator cuff tears. Originally described using a fascia lata autograft, our technique has been adapted to incorporate a dermal allograft, which limits donor site morbidity and operative time. In most cases, the dermal allograft is fixed to the normal anatomic attachments of the superior glenoid just medial to the superior labrum, laterally to the greater tuberosity, and posteriorly with side-to-side sutures to the remaining rotator cuff. If there is a robust band of “comma” tissue anteriorly, we fix the anterior margin of the dermal graft to this with side-to-side sutures. The comma tissue represents the medial sling of the biceps tendon and connects the upper subscapularis tendon to the anterior supraspinatus. In most cases, this tissue is intact after repair of the subscapularis tendon.

Technique

The patient is positioned in either the lateral decubitus or beach chair position. The arm is positioned in 20° to 30° of abduction and 20° to 30° of forward flexion. A diagnostic arthroscopy is performed through a posterior glenohumeral viewing portal. The subscapularis is visualized and repaired if torn. A biceps tenodesis is performed in most cases, as there is often a tear of the subscapularis, tear or instability of the biceps tendon, and/or a compromised attachment of the biceps root.

Attention is turned to the subacromial space. Posterior viewing and lateral working portals are established. A 10-mm flexible cannula (PassPort; Arthrex) is placed in the lateral portal to aid with suture management and graft passage. A limited subacromial decompression is performed that preserves the coracoacromial arch. The rotator cuff is carefully dissected and freed from the internal deltoid fascia. The scapular spine is identified to visualize the raphé between the supraspinatus and infraspinatus. The infraspinatus is mobilized and repaired as much as possible.

If we think that the tear might be reparable by gaining added excursion from a posterior interval slide, or if it is clearly not reparable but the remaining rim of rotator cuff obscures clear visualization of the superior glenoid, we perform a posterior interval slide. If the additional excursion that is achieved by the posterior slide is adequate for a complete repair, we proceed with the repair. However, if the tear is not reparable even after the posterior interval slide, we have found that the exposure and preparation of the superior glenoid is greatly improved after the posterior slide. After fixation of the dermal graft, we typically perform a partial side-to-side repair of the supraspinatus to the infraspinatus over the top of the graft.

The bone beds of the greater tuberosity and just medial to the superior glenoid labrum are prepared with a shaver and motorized burr. Two anchors (3.0-mm BioComposite SutureTak; Arthrex) are placed in the superior glenoid neck at about the 10 o’clock and 2 o’clock positions approximately 5 mm medial to the superior labrum. Note: the placement medial to the labrum is chosen because this is the normal origin of the superior capsule and because of the angle of approach, these percutaneous portals are often more medial than typical portals for placing anchors during SLAP (superior labral anterior to posterior) repair. Next, 2 threaded anchors (4.75-mm BioComposite SwiveLock; Arthrex) preloaded with suture tape are placed in the greater tuberosity along the articular margin (Figure 1). However, if a biceps tenodesis with an interference screw is placed at the top of the bicipital groove, this anchor preloaded with suture tape can also serve as the anteromedial anchor in the greater tuberosity footprint. The distances between all 4 anchors are carefully measured with a calibrated probe (Figures 2A-2D).

We use a 3.0-mm acellular dermal allograft (ArthroFlex; Arthrex) to reconstruct the superior capsule. The positions of the 4 anchors are carefully marked on the dermal allograft. We routinely add an additional 5 mm of tissue to the medial, anterior, and posterior margins to decrease the risk of suture cut out. An additional 10 mm of tissue is added laterally to cover the greater tuberosity. The final contoured graft is typically trapezoidal in shape.

The sutures from the 4 anchors are then sequentially retrieved through the lateral cannula. The sutures from the greater tuberosity anchors are passed through their respective holes in the graft. However, the suture limbs from each of the glenoid anchors are individually passed 2 mm anterior and 2 mm posterior to their respective marks on the graft with an antegrade suture passer (Figure 3). It is important to have an assistant apply tension to each of the sutures after they are passed through the graft to decrease the chance of crossing and tangling the sutures.

The eyelets of the medial anchors are utilized as pulleys to deliver the dermal allograft into the shoulder. One suture limb from each of the glenoid anchors is tied to the other over a switching stick (Figure 4A). The 2 remaining (untied) suture limbs are then pulled, which introduces the graft to the orifice of the cannula (Figure 4B). A tissue grasper is then used to fold the dermal allograft along its long axis and introduce the graft into the joint (Figure 4C). Once the medial portion of the graft is positioned onto the superior glenoid the 2 remaining (untied) suture limbs are tied to each other as a static knot in the subacromial space (Figure 4D).

The redundancy in the suture tapes can be removed by sequentially sliding a retriever down each suture and tensioning the suture as the nose of the instrument pushes the dermal graft down to the tuberosity bone bed. The suture tapes are crisscrossed and secured laterally with 2 additional knotless threaded anchors (Figure 5). One may also place cinch stitches at the anterolateral and posterolateral corners of the graft that are incorporated into the lateral anchors. These sutures can be useful for pulling the graft back out of the subacromial space in the event of any suture tangles, and can be used for controlling the lateral aspect of the graft during lateral anchor placement.

At this point in the procedure, additional glenoid anchors can be placed both anterior and posterior to the superior glenoid anchors if additional glenoid fixation is desired. Finally, 2 to 3 side-to-side sutures are placed posteriorly attaching the anterior aspect of the infraspinatus to the posterior aspect of the dermal allograft (Figures 6A-6C). If rotator interval tissue (comma tissue) is present, anterior side-to-side sutures may be placed. However, we do not recommend placing anterior side-to-side sutures directly from the dermal allograft to the subscapularis as this may deform the graft, over- constrain the shoulder, and restrict motion.

Discussion

Reconstruction of the superior capsule has been shown to restore the normal restraint to superior translation of the humeral head and reestablish a stable fulcrum at the glenohumeral joint.⁵ It should be mentioned that we do not perform the SCR in patients with advanced glenohumeral arthritis. The short-term results of this novel procedure have been encouraging, including our own series of patients, in which most patients have had a significant reduction in pain, improvement in function, and very few complications (P. J. Denard, MD, S. S. Burkhart, MD, P. C. Brady, MD, J. Tokish, MD, C. R. Adams, MD, unpublished data, May 2016).

The early success of this procedure suggests that a robust superior capsule is necessary, in addition to functional muscle-tendon units, to restore the stable fulcrum and force couples that are necessary for normal shoulder function. Perhaps we have not paid enough attention to the integrity of the superior capsule in the past. In cases of revision cuff repair, we pay special attention to the quality of the capsular layer deep to the cuff tendon. If the capsule is poor quality, we sometimes reconstruct the capsule with a dermal allograft (SCR) and then do a rotator cuff repair (partial or complete) over the top of the SCR to maintain the normal anatomic deep to superficial layering of the capsule and rotator cuff.

We are very conservative with our postoperative rehabilitation program after a SCR. We know that the rate of stiffness with a conservative program after an arthroscopic rotator cuff repair, even in the revision setting, is very low.⁶ Furthermore, both basic science on healing of soft tissue to bone and radiographic analysis of healing after postoperative rotator cuff repairs support a slow rehabilitation program.^7,8 A canine model specifically evaluating acellular dermal allografts in the shoulder suggests that these grafts undergo significant remodeling and become weaker before they get stronger.⁹ We would rather err on the side of healing of the SCR with potentially a slight increase in the rate of shoulder stiffness than to regain early motion at the expense of graft failure. Therefore, we have the patient wear a sling with no shoulder motion for 6 weeks. Passive motion is started at 6 weeks postoperative and strengthening is delayed until 12 to 16 weeks postoperative.

Rotator cuff tears are very common, and 250,000 to 500,000 rotator cuff repairs are performed in the United States each year.^1,2 In most cases, a complete repair of even large or massive tears can be achieved. However, a subset of patients exist in whom the glenohumeral joint has minimal degenerative changes and the rotator cuff tendon is either irreparable or very poor quality and unlikely to heal (ie, failed previous cuff repair). Some authors have advocated for reverse shoulder arthroplasty (RSA) in these patients despite the lack of glenohumeral arthritis. However, due to the permanent destruction of the glenohumeral articular surfaces, complication rates, and concerns about implant longevity with RSA, we believe the superior capsular reconstruction (SCR) is a viable alternative in patients in whom joint preservation is appropriate based on age limitations and/or activity requirements.³

The SCR was first described by Mihata and colleagues4 as a means to reconstruct the superior capsule in shoulders with large, irreparable posterosuperior rotator cuff tears. Originally described using a fascia lata autograft, our technique has been adapted to incorporate a dermal allograft, which limits donor site morbidity and operative time. In most cases, the dermal allograft is fixed to the normal anatomic attachments of the superior glenoid just medial to the superior labrum, laterally to the greater tuberosity, and posteriorly with side-to-side sutures to the remaining rotator cuff. If there is a robust band of “comma” tissue anteriorly, we fix the anterior margin of the dermal graft to this with side-to-side sutures. The comma tissue represents the medial sling of the biceps tendon and connects the upper subscapularis tendon to the anterior supraspinatus. In most cases, this tissue is intact after repair of the subscapularis tendon.

Technique

The patient is positioned in either the lateral decubitus or beach chair position. The arm is positioned in 20° to 30° of abduction and 20° to 30° of forward flexion. A diagnostic arthroscopy is performed through a posterior glenohumeral viewing portal. The subscapularis is visualized and repaired if torn. A biceps tenodesis is performed in most cases, as there is often a tear of the subscapularis, tear or instability of the biceps tendon, and/or a compromised attachment of the biceps root.

Attention is turned to the subacromial space. Posterior viewing and lateral working portals are established. A 10-mm flexible cannula (PassPort; Arthrex) is placed in the lateral portal to aid with suture management and graft passage. A limited subacromial decompression is performed that preserves the coracoacromial arch. The rotator cuff is carefully dissected and freed from the internal deltoid fascia. The scapular spine is identified to visualize the raphé between the supraspinatus and infraspinatus. The infraspinatus is mobilized and repaired as much as possible.

If we think that the tear might be reparable by gaining added excursion from a posterior interval slide, or if it is clearly not reparable but the remaining rim of rotator cuff obscures clear visualization of the superior glenoid, we perform a posterior interval slide. If the additional excursion that is achieved by the posterior slide is adequate for a complete repair, we proceed with the repair. However, if the tear is not reparable even after the posterior interval slide, we have found that the exposure and preparation of the superior glenoid is greatly improved after the posterior slide. After fixation of the dermal graft, we typically perform a partial side-to-side repair of the supraspinatus to the infraspinatus over the top of the graft.

The bone beds of the greater tuberosity and just medial to the superior glenoid labrum are prepared with a shaver and motorized burr. Two anchors (3.0-mm BioComposite SutureTak; Arthrex) are placed in the superior glenoid neck at about the 10 o’clock and 2 o’clock positions approximately 5 mm medial to the superior labrum. Note: the placement medial to the labrum is chosen because this is the normal origin of the superior capsule and because of the angle of approach, these percutaneous portals are often more medial than typical portals for placing anchors during SLAP (superior labral anterior to posterior) repair. Next, 2 threaded anchors (4.75-mm BioComposite SwiveLock; Arthrex) preloaded with suture tape are placed in the greater tuberosity along the articular margin (Figure 1). However, if a biceps tenodesis with an interference screw is placed at the top of the bicipital groove, this anchor preloaded with suture tape can also serve as the anteromedial anchor in the greater tuberosity footprint. The distances between all 4 anchors are carefully measured with a calibrated probe (Figures 2A-2D).

We use a 3.0-mm acellular dermal allograft (ArthroFlex; Arthrex) to reconstruct the superior capsule. The positions of the 4 anchors are carefully marked on the dermal allograft. We routinely add an additional 5 mm of tissue to the medial, anterior, and posterior margins to decrease the risk of suture cut out. An additional 10 mm of tissue is added laterally to cover the greater tuberosity. The final contoured graft is typically trapezoidal in shape.

The sutures from the 4 anchors are then sequentially retrieved through the lateral cannula. The sutures from the greater tuberosity anchors are passed through their respective holes in the graft. However, the suture limbs from each of the glenoid anchors are individually passed 2 mm anterior and 2 mm posterior to their respective marks on the graft with an antegrade suture passer (Figure 3). It is important to have an assistant apply tension to each of the sutures after they are passed through the graft to decrease the chance of crossing and tangling the sutures.

The eyelets of the medial anchors are utilized as pulleys to deliver the dermal allograft into the shoulder. One suture limb from each of the glenoid anchors is tied to the other over a switching stick (Figure 4A). The 2 remaining (untied) suture limbs are then pulled, which introduces the graft to the orifice of the cannula (Figure 4B). A tissue grasper is then used to fold the dermal allograft along its long axis and introduce the graft into the joint (Figure 4C). Once the medial portion of the graft is positioned onto the superior glenoid the 2 remaining (untied) suture limbs are tied to each other as a static knot in the subacromial space (Figure 4D).

The redundancy in the suture tapes can be removed by sequentially sliding a retriever down each suture and tensioning the suture as the nose of the instrument pushes the dermal graft down to the tuberosity bone bed. The suture tapes are crisscrossed and secured laterally with 2 additional knotless threaded anchors (Figure 5). One may also place cinch stitches at the anterolateral and posterolateral corners of the graft that are incorporated into the lateral anchors. These sutures can be useful for pulling the graft back out of the subacromial space in the event of any suture tangles, and can be used for controlling the lateral aspect of the graft during lateral anchor placement.

At this point in the procedure, additional glenoid anchors can be placed both anterior and posterior to the superior glenoid anchors if additional glenoid fixation is desired. Finally, 2 to 3 side-to-side sutures are placed posteriorly attaching the anterior aspect of the infraspinatus to the posterior aspect of the dermal allograft (Figures 6A-6C). If rotator interval tissue (comma tissue) is present, anterior side-to-side sutures may be placed. However, we do not recommend placing anterior side-to-side sutures directly from the dermal allograft to the subscapularis as this may deform the graft, over- constrain the shoulder, and restrict motion.

Discussion

Reconstruction of the superior capsule has been shown to restore the normal restraint to superior translation of the humeral head and reestablish a stable fulcrum at the glenohumeral joint.⁵ It should be mentioned that we do not perform the SCR in patients with advanced glenohumeral arthritis. The short-term results of this novel procedure have been encouraging, including our own series of patients, in which most patients have had a significant reduction in pain, improvement in function, and very few complications (P. J. Denard, MD, S. S. Burkhart, MD, P. C. Brady, MD, J. Tokish, MD, C. R. Adams, MD, unpublished data, May 2016).

The early success of this procedure suggests that a robust superior capsule is necessary, in addition to functional muscle-tendon units, to restore the stable fulcrum and force couples that are necessary for normal shoulder function. Perhaps we have not paid enough attention to the integrity of the superior capsule in the past. In cases of revision cuff repair, we pay special attention to the quality of the capsular layer deep to the cuff tendon. If the capsule is poor quality, we sometimes reconstruct the capsule with a dermal allograft (SCR) and then do a rotator cuff repair (partial or complete) over the top of the SCR to maintain the normal anatomic deep to superficial layering of the capsule and rotator cuff.

We are very conservative with our postoperative rehabilitation program after a SCR. We know that the rate of stiffness with a conservative program after an arthroscopic rotator cuff repair, even in the revision setting, is very low.⁶ Furthermore, both basic science on healing of soft tissue to bone and radiographic analysis of healing after postoperative rotator cuff repairs support a slow rehabilitation program.^7,8 A canine model specifically evaluating acellular dermal allografts in the shoulder suggests that these grafts undergo significant remodeling and become weaker before they get stronger.⁹ We would rather err on the side of healing of the SCR with potentially a slight increase in the rate of shoulder stiffness than to regain early motion at the expense of graft failure. Therefore, we have the patient wear a sling with no shoulder motion for 6 weeks. Passive motion is started at 6 weeks postoperative and strengthening is delayed until 12 to 16 weeks postoperative.

Lumbar radiculopathy is a common problem encountered by orthopedic surgeons, and typically presents with lower back or buttock pain radiating down the leg.¹ While the most common causes of lumbar radiculopathy are lumbar disc herniation and spinal stenosis, the differential diagnosis for lower extremity pain is broad and can be musculoskeletal, vascular, neurologic, or inflammatory in nature.^1,2 Differentiating between orthopedic, neurologic, and vascular causes of leg pain, such as peripheral artery disease (PAD), can sometimes be challenging. This is especially true in aortoiliac PAD, which can present with hip, buttock, and thigh pain. Dorsalis pedis pulses can be palpable due to collateral circulation. A careful history and physical examination is crucial to the correct diagnosis. The history should clearly document the nature of the pain, details of walking impairment, and the alleviating effects of standing still or positional changes. A complete neurovascular examination should include observations regarding the skin, hair, and nails, examination of dorsal pedis, popliteal, and femoral pulses in comparison to the contralateral side, and documentation of dural tension signs. Misdiagnoses can send the patient down a path of unnecessary tests, unindicated procedures, and ultimately, a delay in definitive diagnosis and treatment.¹

To our knowledge, this is the first report on a series of patients with thigh pain initially diagnosed as radiculopathy who underwent unproductive diagnostic tests and procedures, and ultimately were given delayed diagnoses of aortoiliac PAD. The patients provided written informed consent for print and electronic publication of these case reports.

Case 1

An 81-year-old woman with a medical history notable for hypertension, hyperlipidemia, and stroke initially presented to an outside orthopedic institution with complaints of several months of lower back and right hip, thigh, and leg pain when walking. She did not report any history of night pain, weakness, or numbness. Examination at the time was notable for painful back extension, 4/5 hip flexion strength on the right compared to 5/5 on the left, but symmetric reflexes and negative dural tension signs. X-rays showed multilevel degenerative disc disease of the lumbar spine, and magnetic resonance imaging (MRI) showed a small L3/4 disc protrusion causing impingement of the L4 nerve root.

A transforaminal epidural steroid injection at the L4 level was performed with minimal resolution of symptoms. Several months later, right-sided intra-articular facet injections were performed at the L4/5 and L5/S1 levels, again with minimal relief of symptoms. At this point, the patient was sent for further physical therapy.

Over a year after symptom onset, the patient presented to our institution and was evaluated by a vascular surgeon. Physical examination was notable for 1+ femoral artery and dorsal pedis pulses on the right side, compared to 2+ on the left. An aortoiliac duplex ultrasound showed severe significant stenosis of the right common iliac artery (>75%).

The patient underwent a right common iliac artery angioplasty and stenting (Figures 1A, 1B), which resolved her symptoms.

Case 2

A 65-year-old man, who is a former smoker with a medical history notable for hyperlipidemia and coronary artery disease status post myocardial infarction, presented with a long history of right leg pain. He underwent a L5/S1 anterior posterior fusion at an outside institution and did well for about 5 years after the procedure (Figures 2A, 2B). The pain returned and he underwent several years of physical therapy, epidural steroid injections, and implantation of a spinal cord stimulator with no improvement. He reported right leg pain with minimal back pain, primarily in the thigh and not radiating to the feet and toes. The pain limited him from walking more than 1 block. On examination, strength was 5/5 bilaterally. Pulse examination was notable for lack of dorsalis pedis/posterior tibial pulses bilaterally. He had no bowel or bladder dysfunction.

Computed tomography myelogram showed a moderate amount of stenosis at L3/4 and L4/5. He was sent for evaluation by a vascular surgeon. Arterial duplex ultrasound showed significant stenosis of the right common iliac artery.

Angioplasty was attempted but vascular surgery was unable to cross the lesion (Figures 3A, 3B), and the patient ultimately had a femoral-femoral bypass, which resolved his leg pain.

Case 3

A 78-year-old woman, nonsmoker, presented with a 1-year history of left buttock and thigh pain exacerbated by ambulation. Ambulation was limited to 2 blocks. The patient was being worked up for spinal and hip etiologies of pain at an outside hospital. MRI revealed a mild posterior disc herniation at L3/4 and L4/5 and moderate narrowing of the spinal canal. She underwent 2 epidural steroid injections with no improvement. The patient’s relative, a physician, suggested that the patient receive a vascular surgery consultation, and the patient ultimately presented to our institution for evaluation by vascular surgery.

The physical examination was significant for a 1+ dorsal pedis pulse on the left compared to 2+ on the right. Moreover, the patient only demonstrated trace L femoral pulse compared to the right. Strength was 5/5 bilaterally.

The patient was taken to the operating room for angioplasty and stenting of the left common iliac artery (Figures 4A, 4B). This provided immediate symptom relief, and she has remained asymptomatic.

Discussion

Lumbar radiculopathy is a common diagnosis encountered by orthopedic surgeons. Although the diagnosis can appear to be straightforward in a patient presenting with lower back and leg pain, the etiology of lower back and leg pain can be extremely varied, and can be musculoskeletal, neurologic, vascular, rheumatologic, or oncologic in origin.¹ In particular, differentiating between radiculopathy and vascular claudication can sometimes be challenging.

The 2 most common causes of lumbar radiculopathy are lumbar disc herniation and spinal stenosis.¹ Lumbar disc herniation results from tear in the annulus of the intervertebral disc, resulting in herniation of disc material into the spinal canal causing compression and irritation of spinal nerve roots.¹ Spinal stenosis is narrowing of the spinal canal that produces compression of neural elements before they exit the neural foramen.³ Adult degenerative spinal stenosis is most often caused by osteophytes from the facet joints or hypertrophy of the ligamentum flavum, and can be broadly categorized into central spinal stenosis or lateral spinal stenosis.

PAD is defined as progressive stenosis or occlusion, or aneurysmal dilation of noncoronary arteries.² When PAD affects the vessels of the lower extremities, the symptoms typically manifest as intermittent claudication, which is exercise-induced ischemic pain in the lower extremity that is relieved by rest.² As the disease progresses, symptoms can progress to rest pain, ulceration, and, eventually, gangrene. The most common cause of PAD is atherosclerosis, and the risk factors include smoking, hypertension, diabetes, and hyperlipidemia. The prevalence of PAD rises sharply with age, starting from <3% in ages less than 60 years to >20% in ages 75 years and older.⁴

A detailed and pertinent history from the patient provides important information for differentiating radiculopathy and neurogenic claudication from vascular claudication. Patients with lumbar radiculopathy typically report pain in the lower back radiating down the leg past the knee in a dermatomal distribution. The pain often begins soon if not immediately after activity, but often takes time for relief onset after rest. Positional changes in the back such as flexion can provide relief.² Patients with neurogenic claudication from central spinal stenosis can present with bilateral thigh pain from prolonged standing and activity that is alleviated with flexion or stooping.³ Patients may admit to a positive “shopping cart sign,” with increased walking comfort stooped forward with hands on a shopping cart.

In contrast, patients with vascular claudication often report pain in the calf, thigh, or hip, but rarely in the foot. The location of pain varies with area of stenosis; generally, patients with superficial femoral artery occlusion present with calf claudication, while patients with aortoiliac disease present with buttock and thigh pain. The pain typically occurs after a very reproducible length of walking, and is relieved by cessation of walking, often even if the patient remains standing. Back positioning should have no effect on the pain.^2-5

Physical examination should begin with observation of the patient’s gait and posture, which may be hunched over in the setting of spinal stenosis. Examination of the patient’s skin may show loss of hair, shiny skin, or atrophic changes suggestive of vascular disease (Figure 5).¹ Prior to proceeding to a spine examination, palpating the trochanteric bursa and testing for hip range of motion is important to rule out intra-articular hip pathology and trochanteric bursitis as common causes of pain in the area. Patients with radiculopathy may show sensory disturbances in a dermatomal distribution, muscular weakness at the corresponding spinal level, and decreased deep tendon reflexes. The straight leg raise test can elicit signs of nerve root tension. A careful examination of bilateral lower extremity pulses at the dorsal pedis, popliteal, and femoral levels can help identify any asymmetric or decreased pulses that would indicate peripheral vascular disease. With chronic aortoiliac disease, it is important to check for femoral pulses, given the dorsal pedis pulse can be present due to collateral circulation. And finally, the ankle brachial index (ABI), measured as the ratio of the systolic pressure at the ankle divided by the systolic pressure at the arm, is a good screening test for PAD.⁶ A normal ABI is >1.

A thorough history and physical examination can elicit important information that is helpful in evaluating orthopedic patients, especially to differentiate between spinal and vascular causes of leg pain. This can help avoid misdiagnoses, which result in unnecessary tests, procedures, and wasted time. Don’t forget the pulses!

Lumbar radiculopathy is a common problem encountered by orthopedic surgeons, and typically presents with lower back or buttock pain radiating down the leg.¹ While the most common causes of lumbar radiculopathy are lumbar disc herniation and spinal stenosis, the differential diagnosis for lower extremity pain is broad and can be musculoskeletal, vascular, neurologic, or inflammatory in nature.^1,2 Differentiating between orthopedic, neurologic, and vascular causes of leg pain, such as peripheral artery disease (PAD), can sometimes be challenging. This is especially true in aortoiliac PAD, which can present with hip, buttock, and thigh pain. Dorsalis pedis pulses can be palpable due to collateral circulation. A careful history and physical examination is crucial to the correct diagnosis. The history should clearly document the nature of the pain, details of walking impairment, and the alleviating effects of standing still or positional changes. A complete neurovascular examination should include observations regarding the skin, hair, and nails, examination of dorsal pedis, popliteal, and femoral pulses in comparison to the contralateral side, and documentation of dural tension signs. Misdiagnoses can send the patient down a path of unnecessary tests, unindicated procedures, and ultimately, a delay in definitive diagnosis and treatment.¹

To our knowledge, this is the first report on a series of patients with thigh pain initially diagnosed as radiculopathy who underwent unproductive diagnostic tests and procedures, and ultimately were given delayed diagnoses of aortoiliac PAD. The patients provided written informed consent for print and electronic publication of these case reports.

Case 1

An 81-year-old woman with a medical history notable for hypertension, hyperlipidemia, and stroke initially presented to an outside orthopedic institution with complaints of several months of lower back and right hip, thigh, and leg pain when walking. She did not report any history of night pain, weakness, or numbness. Examination at the time was notable for painful back extension, 4/5 hip flexion strength on the right compared to 5/5 on the left, but symmetric reflexes and negative dural tension signs. X-rays showed multilevel degenerative disc disease of the lumbar spine, and magnetic resonance imaging (MRI) showed a small L3/4 disc protrusion causing impingement of the L4 nerve root.

A transforaminal epidural steroid injection at the L4 level was performed with minimal resolution of symptoms. Several months later, right-sided intra-articular facet injections were performed at the L4/5 and L5/S1 levels, again with minimal relief of symptoms. At this point, the patient was sent for further physical therapy.

Over a year after symptom onset, the patient presented to our institution and was evaluated by a vascular surgeon. Physical examination was notable for 1+ femoral artery and dorsal pedis pulses on the right side, compared to 2+ on the left. An aortoiliac duplex ultrasound showed severe significant stenosis of the right common iliac artery (>75%).

The patient underwent a right common iliac artery angioplasty and stenting (Figures 1A, 1B), which resolved her symptoms.

Case 2

A 65-year-old man, who is a former smoker with a medical history notable for hyperlipidemia and coronary artery disease status post myocardial infarction, presented with a long history of right leg pain. He underwent a L5/S1 anterior posterior fusion at an outside institution and did well for about 5 years after the procedure (Figures 2A, 2B). The pain returned and he underwent several years of physical therapy, epidural steroid injections, and implantation of a spinal cord stimulator with no improvement. He reported right leg pain with minimal back pain, primarily in the thigh and not radiating to the feet and toes. The pain limited him from walking more than 1 block. On examination, strength was 5/5 bilaterally. Pulse examination was notable for lack of dorsalis pedis/posterior tibial pulses bilaterally. He had no bowel or bladder dysfunction.

Computed tomography myelogram showed a moderate amount of stenosis at L3/4 and L4/5. He was sent for evaluation by a vascular surgeon. Arterial duplex ultrasound showed significant stenosis of the right common iliac artery.

Angioplasty was attempted but vascular surgery was unable to cross the lesion (Figures 3A, 3B), and the patient ultimately had a femoral-femoral bypass, which resolved his leg pain.

Case 3

A 78-year-old woman, nonsmoker, presented with a 1-year history of left buttock and thigh pain exacerbated by ambulation. Ambulation was limited to 2 blocks. The patient was being worked up for spinal and hip etiologies of pain at an outside hospital. MRI revealed a mild posterior disc herniation at L3/4 and L4/5 and moderate narrowing of the spinal canal. She underwent 2 epidural steroid injections with no improvement. The patient’s relative, a physician, suggested that the patient receive a vascular surgery consultation, and the patient ultimately presented to our institution for evaluation by vascular surgery.

The physical examination was significant for a 1+ dorsal pedis pulse on the left compared to 2+ on the right. Moreover, the patient only demonstrated trace L femoral pulse compared to the right. Strength was 5/5 bilaterally.

The patient was taken to the operating room for angioplasty and stenting of the left common iliac artery (Figures 4A, 4B). This provided immediate symptom relief, and she has remained asymptomatic.

Discussion

Lumbar radiculopathy is a common diagnosis encountered by orthopedic surgeons. Although the diagnosis can appear to be straightforward in a patient presenting with lower back and leg pain, the etiology of lower back and leg pain can be extremely varied, and can be musculoskeletal, neurologic, vascular, rheumatologic, or oncologic in origin.¹ In particular, differentiating between radiculopathy and vascular claudication can sometimes be challenging.

The 2 most common causes of lumbar radiculopathy are lumbar disc herniation and spinal stenosis.¹ Lumbar disc herniation results from tear in the annulus of the intervertebral disc, resulting in herniation of disc material into the spinal canal causing compression and irritation of spinal nerve roots.¹ Spinal stenosis is narrowing of the spinal canal that produces compression of neural elements before they exit the neural foramen.³ Adult degenerative spinal stenosis is most often caused by osteophytes from the facet joints or hypertrophy of the ligamentum flavum, and can be broadly categorized into central spinal stenosis or lateral spinal stenosis.

PAD is defined as progressive stenosis or occlusion, or aneurysmal dilation of noncoronary arteries.² When PAD affects the vessels of the lower extremities, the symptoms typically manifest as intermittent claudication, which is exercise-induced ischemic pain in the lower extremity that is relieved by rest.² As the disease progresses, symptoms can progress to rest pain, ulceration, and, eventually, gangrene. The most common cause of PAD is atherosclerosis, and the risk factors include smoking, hypertension, diabetes, and hyperlipidemia. The prevalence of PAD rises sharply with age, starting from <3% in ages less than 60 years to >20% in ages 75 years and older.⁴

A detailed and pertinent history from the patient provides important information for differentiating radiculopathy and neurogenic claudication from vascular claudication. Patients with lumbar radiculopathy typically report pain in the lower back radiating down the leg past the knee in a dermatomal distribution. The pain often begins soon if not immediately after activity, but often takes time for relief onset after rest. Positional changes in the back such as flexion can provide relief.² Patients with neurogenic claudication from central spinal stenosis can present with bilateral thigh pain from prolonged standing and activity that is alleviated with flexion or stooping.³ Patients may admit to a positive “shopping cart sign,” with increased walking comfort stooped forward with hands on a shopping cart.

In contrast, patients with vascular claudication often report pain in the calf, thigh, or hip, but rarely in the foot. The location of pain varies with area of stenosis; generally, patients with superficial femoral artery occlusion present with calf claudication, while patients with aortoiliac disease present with buttock and thigh pain. The pain typically occurs after a very reproducible length of walking, and is relieved by cessation of walking, often even if the patient remains standing. Back positioning should have no effect on the pain.^2-5

Physical examination should begin with observation of the patient’s gait and posture, which may be hunched over in the setting of spinal stenosis. Examination of the patient’s skin may show loss of hair, shiny skin, or atrophic changes suggestive of vascular disease (Figure 5).¹ Prior to proceeding to a spine examination, palpating the trochanteric bursa and testing for hip range of motion is important to rule out intra-articular hip pathology and trochanteric bursitis as common causes of pain in the area. Patients with radiculopathy may show sensory disturbances in a dermatomal distribution, muscular weakness at the corresponding spinal level, and decreased deep tendon reflexes. The straight leg raise test can elicit signs of nerve root tension. A careful examination of bilateral lower extremity pulses at the dorsal pedis, popliteal, and femoral levels can help identify any asymmetric or decreased pulses that would indicate peripheral vascular disease. With chronic aortoiliac disease, it is important to check for femoral pulses, given the dorsal pedis pulse can be present due to collateral circulation. And finally, the ankle brachial index (ABI), measured as the ratio of the systolic pressure at the ankle divided by the systolic pressure at the arm, is a good screening test for PAD.⁶ A normal ABI is >1.

A thorough history and physical examination can elicit important information that is helpful in evaluating orthopedic patients, especially to differentiate between spinal and vascular causes of leg pain. This can help avoid misdiagnoses, which result in unnecessary tests, procedures, and wasted time. Don’t forget the pulses!

Lumbar radiculopathy is a common problem encountered by orthopedic surgeons, and typically presents with lower back or buttock pain radiating down the leg.¹ While the most common causes of lumbar radiculopathy are lumbar disc herniation and spinal stenosis, the differential diagnosis for lower extremity pain is broad and can be musculoskeletal, vascular, neurologic, or inflammatory in nature.^1,2 Differentiating between orthopedic, neurologic, and vascular causes of leg pain, such as peripheral artery disease (PAD), can sometimes be challenging. This is especially true in aortoiliac PAD, which can present with hip, buttock, and thigh pain. Dorsalis pedis pulses can be palpable due to collateral circulation. A careful history and physical examination is crucial to the correct diagnosis. The history should clearly document the nature of the pain, details of walking impairment, and the alleviating effects of standing still or positional changes. A complete neurovascular examination should include observations regarding the skin, hair, and nails, examination of dorsal pedis, popliteal, and femoral pulses in comparison to the contralateral side, and documentation of dural tension signs. Misdiagnoses can send the patient down a path of unnecessary tests, unindicated procedures, and ultimately, a delay in definitive diagnosis and treatment.¹

To our knowledge, this is the first report on a series of patients with thigh pain initially diagnosed as radiculopathy who underwent unproductive diagnostic tests and procedures, and ultimately were given delayed diagnoses of aortoiliac PAD. The patients provided written informed consent for print and electronic publication of these case reports.

Case 1

An 81-year-old woman with a medical history notable for hypertension, hyperlipidemia, and stroke initially presented to an outside orthopedic institution with complaints of several months of lower back and right hip, thigh, and leg pain when walking. She did not report any history of night pain, weakness, or numbness. Examination at the time was notable for painful back extension, 4/5 hip flexion strength on the right compared to 5/5 on the left, but symmetric reflexes and negative dural tension signs. X-rays showed multilevel degenerative disc disease of the lumbar spine, and magnetic resonance imaging (MRI) showed a small L3/4 disc protrusion causing impingement of the L4 nerve root.

A transforaminal epidural steroid injection at the L4 level was performed with minimal resolution of symptoms. Several months later, right-sided intra-articular facet injections were performed at the L4/5 and L5/S1 levels, again with minimal relief of symptoms. At this point, the patient was sent for further physical therapy.

Over a year after symptom onset, the patient presented to our institution and was evaluated by a vascular surgeon. Physical examination was notable for 1+ femoral artery and dorsal pedis pulses on the right side, compared to 2+ on the left. An aortoiliac duplex ultrasound showed severe significant stenosis of the right common iliac artery (>75%).

The patient underwent a right common iliac artery angioplasty and stenting (Figures 1A, 1B), which resolved her symptoms.

Case 2

A 65-year-old man, who is a former smoker with a medical history notable for hyperlipidemia and coronary artery disease status post myocardial infarction, presented with a long history of right leg pain. He underwent a L5/S1 anterior posterior fusion at an outside institution and did well for about 5 years after the procedure (Figures 2A, 2B). The pain returned and he underwent several years of physical therapy, epidural steroid injections, and implantation of a spinal cord stimulator with no improvement. He reported right leg pain with minimal back pain, primarily in the thigh and not radiating to the feet and toes. The pain limited him from walking more than 1 block. On examination, strength was 5/5 bilaterally. Pulse examination was notable for lack of dorsalis pedis/posterior tibial pulses bilaterally. He had no bowel or bladder dysfunction.

Computed tomography myelogram showed a moderate amount of stenosis at L3/4 and L4/5. He was sent for evaluation by a vascular surgeon. Arterial duplex ultrasound showed significant stenosis of the right common iliac artery.

Angioplasty was attempted but vascular surgery was unable to cross the lesion (Figures 3A, 3B), and the patient ultimately had a femoral-femoral bypass, which resolved his leg pain.

Case 3

A 78-year-old woman, nonsmoker, presented with a 1-year history of left buttock and thigh pain exacerbated by ambulation. Ambulation was limited to 2 blocks. The patient was being worked up for spinal and hip etiologies of pain at an outside hospital. MRI revealed a mild posterior disc herniation at L3/4 and L4/5 and moderate narrowing of the spinal canal. She underwent 2 epidural steroid injections with no improvement. The patient’s relative, a physician, suggested that the patient receive a vascular surgery consultation, and the patient ultimately presented to our institution for evaluation by vascular surgery.

The physical examination was significant for a 1+ dorsal pedis pulse on the left compared to 2+ on the right. Moreover, the patient only demonstrated trace L femoral pulse compared to the right. Strength was 5/5 bilaterally.

The patient was taken to the operating room for angioplasty and stenting of the left common iliac artery (Figures 4A, 4B). This provided immediate symptom relief, and she has remained asymptomatic.

Discussion

Lumbar radiculopathy is a common diagnosis encountered by orthopedic surgeons. Although the diagnosis can appear to be straightforward in a patient presenting with lower back and leg pain, the etiology of lower back and leg pain can be extremely varied, and can be musculoskeletal, neurologic, vascular, rheumatologic, or oncologic in origin.¹ In particular, differentiating between radiculopathy and vascular claudication can sometimes be challenging.

The 2 most common causes of lumbar radiculopathy are lumbar disc herniation and spinal stenosis.¹ Lumbar disc herniation results from tear in the annulus of the intervertebral disc, resulting in herniation of disc material into the spinal canal causing compression and irritation of spinal nerve roots.¹ Spinal stenosis is narrowing of the spinal canal that produces compression of neural elements before they exit the neural foramen.³ Adult degenerative spinal stenosis is most often caused by osteophytes from the facet joints or hypertrophy of the ligamentum flavum, and can be broadly categorized into central spinal stenosis or lateral spinal stenosis.

PAD is defined as progressive stenosis or occlusion, or aneurysmal dilation of noncoronary arteries.² When PAD affects the vessels of the lower extremities, the symptoms typically manifest as intermittent claudication, which is exercise-induced ischemic pain in the lower extremity that is relieved by rest.² As the disease progresses, symptoms can progress to rest pain, ulceration, and, eventually, gangrene. The most common cause of PAD is atherosclerosis, and the risk factors include smoking, hypertension, diabetes, and hyperlipidemia. The prevalence of PAD rises sharply with age, starting from <3% in ages less than 60 years to >20% in ages 75 years and older.⁴

A detailed and pertinent history from the patient provides important information for differentiating radiculopathy and neurogenic claudication from vascular claudication. Patients with lumbar radiculopathy typically report pain in the lower back radiating down the leg past the knee in a dermatomal distribution. The pain often begins soon if not immediately after activity, but often takes time for relief onset after rest. Positional changes in the back such as flexion can provide relief.² Patients with neurogenic claudication from central spinal stenosis can present with bilateral thigh pain from prolonged standing and activity that is alleviated with flexion or stooping.³ Patients may admit to a positive “shopping cart sign,” with increased walking comfort stooped forward with hands on a shopping cart.

In contrast, patients with vascular claudication often report pain in the calf, thigh, or hip, but rarely in the foot. The location of pain varies with area of stenosis; generally, patients with superficial femoral artery occlusion present with calf claudication, while patients with aortoiliac disease present with buttock and thigh pain. The pain typically occurs after a very reproducible length of walking, and is relieved by cessation of walking, often even if the patient remains standing. Back positioning should have no effect on the pain.^2-5

Physical examination should begin with observation of the patient’s gait and posture, which may be hunched over in the setting of spinal stenosis. Examination of the patient’s skin may show loss of hair, shiny skin, or atrophic changes suggestive of vascular disease (Figure 5).¹ Prior to proceeding to a spine examination, palpating the trochanteric bursa and testing for hip range of motion is important to rule out intra-articular hip pathology and trochanteric bursitis as common causes of pain in the area. Patients with radiculopathy may show sensory disturbances in a dermatomal distribution, muscular weakness at the corresponding spinal level, and decreased deep tendon reflexes. The straight leg raise test can elicit signs of nerve root tension. A careful examination of bilateral lower extremity pulses at the dorsal pedis, popliteal, and femoral levels can help identify any asymmetric or decreased pulses that would indicate peripheral vascular disease. With chronic aortoiliac disease, it is important to check for femoral pulses, given the dorsal pedis pulse can be present due to collateral circulation. And finally, the ankle brachial index (ABI), measured as the ratio of the systolic pressure at the ankle divided by the systolic pressure at the arm, is a good screening test for PAD.⁶ A normal ABI is >1.

A thorough history and physical examination can elicit important information that is helpful in evaluating orthopedic patients, especially to differentiate between spinal and vascular causes of leg pain. This can help avoid misdiagnoses, which result in unnecessary tests, procedures, and wasted time. Don’t forget the pulses!

Knee osteoarthritis (OA) is a progressive, degenerative joint disease characterized by pain and dysfunction. OA is a leading cause of disability in middle-aged and older adults,¹ affecting an estimated 27 million Americans.² With the continued aging of the baby boomer population and rising obesity rates, the incidence of OA is estimated to increase by 40% by 2025.³ The clinical and economic burdens of OA on our society—medical costs and workdays lost—are significant and will continue to be a problem for years to come.⁴

Total knee arthroplasty (TKA) is an option for severe end-stage OA. Most patients with mild to moderate OA follow nonsurgical strategies in an attempt to avoid invasive procedures. As there is no established cure, initial treatment of knee OA is geared toward alleviating pain and improving function. A multimodal approach is typically used and recommended.^5,6 Nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and narcotic analgesics are commonly prescribed. NSAIDs can be effective⁷ but have well-known cardiovascular, renal, and gastrointestinal risks. If possible, narcotic analgesics should be avoided because of the risk of addiction and the problems associated with dependence. Intra-articular injections of corticosteroids or hyaluronic acid (viscosupplementation) are often recommended to reduce pain associated with arthritis. Braces designed to “off-load” the more diseased medial or lateral compartment of the knee have also been used in an effort to provide symptomatic relief. These low-risk, noninvasive unloader braces have increasingly been advanced as a conservative treatment modality for knee OA,^6,8-10despite modest evidence and lack of appropriately powered randomized controlled trials.¹¹ As more research on the efficacy of these braces is needed, we conducted a study to determine whether an unloader brace is an acceptable and valid treatment modality for knee OA.

Patients and Methods

This was a prospective, randomized, controlled trial of patients with symptomatic, predominantly unicompartmental OA involving the medial compartment of the knee. The study protocol was approved by the Institutional Review Board at Baptist Hospital in Pensacola, Florida. Patients were excluded if they had a rheumatologic disorder other than OA; a history of knee surgery other than a routine arthroscopic procedure; any soft-tissue, neurologic, or vascular compromise preventing long-term brace use; or obesity preventing effective or comfortable brace use. It is generally felt that unloader bracing may not be effective for patients with severe contractures or significant knee deformity; therefore, those lacking more than 10° of extension or 20° of flexion, or those who had a varus deformity of more than 8° of varus, were not offered enrollment.

Ideal sizes for the proposed study groups were determined through power analysis using standard deviations from prior similar investigations. The target was 30 patients per group.

Patients gave informed consent to the work. A computer-generated randomization schedule was used to randomize patients either to receive a medial unloader brace (Fusion OA; Breg, Inc) or not to receive a brace. Patients in these brace and control groups were allowed to continue their standard conservative OA treatment modalities, including NSAID use, home exercises, and joint supplement use. Patients were restricted from receiving any injection therapy or narcotic pain medication in an effort to isolate the effects of bracing on relief of pain and other symptoms.

All patients were examined by an orthopedic surgeon or fellowship-trained primary care sports medicine specialist. Age, sex, height, and weight data were recorded. Body mass index was calculated. Anteroposterior, lateral, flexion weight-bearing, and long-leg standing radiographs were obtained. Two orthopedic surgeons blindly graded OA¹² and calculated knee varus angles.¹³ Values were averaged, and intraobserver reliability and interobserver reliability were calculated.

Prospective subjective outcomes were evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS), administered on study entry and at 4, 8, 16, and 24 weeks during the study. The KOOS has 5 subscales: Pain, Symptoms, Function in Daily Living, Function in Sport and Recreation, and Knee-Related Quality of Life. Each subscale is scored separately. Items are rated 0 (extreme problems) to 100 (no problems). Patients were also asked to complete a weekly diary, which included visual analog scale (VAS) ratings of pain, NSAID use, sleep, and activity level. VAS items were rated 1 (extreme problems) to 100 (no problems). For brace-group patients, hours of brace use per day were recorded. Patients were required to use the brace for a minimum of 4 hours per day.

KOOS and VAS data were analyzed with repeated-measures analysis of variance. Significance level was set at P < .05.

Results

Of the 50 patients randomized, 31 (16 brace, 15 control) completed the study. Of the 19 dropouts, 10 were in the brace group (4 dropped out because of brace discomfort) and 9 in the control group (5 dropped out because of significant pain and the desire for more aggressive treatment with injections). The target patient numbers based on the power analysis were not achieved because of patient enrollment difficulties resulting from the strict criteria established in the study design.

The brace group consisted of 8 men and 8 women. Braces were worn an average of 6.7 hours per day. The control group consisted of 8 men and 7 women. The groups were not significantly different in age, height, weight, body mass index, measured varus knee angle, or arthritis grade (Table 1).

Radiographs were assessed by 2 orthopedic surgeons. Varus angle measurements showed high interobserver reliability (.904, P = .03) and high intraobserver reliability (.969, P = .05); arthritis grades showed low interobserver reliability (.469, P = .59) and high intraobserver reliability (.810, P = .001).

KOOS results showed that, compared with control patients, brace patients had significantly less pain (P < .001), fewer arthritis symptoms (P = .007), better ability to engage in activities of daily living (ADLs) (P = .008), and better total knee function (P = .004) (Figures 1-4). The groups did not differ in ability to engage in sport and recreation (P = .402) or in knee-related quality of life (P = .718), but each parameter showed a trend to be better in the brace group. There was no effect of time in any KOOS subscale. Confidence intervals for these data are listed in Table 2.

VAS results showed that, compared with control patients, brace patients had significantly less pain throughout the day (P = .021) and better activity levels (P = .035) (Figures 5, 6). The groups did not differ in ability to sleep (P = .117) or NSAID use (P = .138), but each parameter showed a trend to be better in the brace group. There was no effect of time in either VAS.

Discussion

We conducted this study to determine the efficacy of a medial unloader brace in reducing the pain and symptoms associated with varus knee OA.

Although TKA is an option for patients with significant end-stage knee OA, mild OA and moderate OA typically are managed with nonoperative modalities. These modalities can be effective and may delay or eliminate the need for surgery, which poses a small but definite risk. Delaying surgery, especially in younger, active patients, has the potential to reduce the number of wear-related revision surgeries.¹⁴

Braces designed to off-load the more diseased medial or lateral compartment of the knee have been used in an effort to provide relief from symptomatic OA. There is a lack of appropriately powered, randomized controlled studies on the efficacy of these braces. With the evidence being inconclusive, the American Academy of Orthopaedic Surgeons is unable to recommend for or against use of a brace in medial unicompartmental OA.¹¹ More research on the efficacy of these braces is needed. In the present study, we asked 2 questions: Does use of an unloader brace lessen the pain associated with knee OA? Is the unloader brace an acceptable and valid treatment modality for knee OA?

The 2 clinical outcome tools used in this study showed significant improvement in pain in brace patients compared with control patients. KOOS results showed reduced pain and arthritis symptoms. VAS results showed less pain experienced throughout the day. Pain reduction is probably the most important benefit of any nonoperative modality for knee OA. Pain typically is the driving force and the major indication for TKA. Other investigators have found pain reduced with use of unloader braces, but few long-term prospective randomized trials have been conducted. Ramsey and colleagues¹⁵ compared a neutral stabilizing brace with a medial unloading brace and found that both helped reduce pain and functional disability. This led to discussion about the 2 major potential mechanisms for symptom relief. One theory holds that bracing unloads the diseased portion of the joint and thereby helps improve symptoms.^16-18 According to the other theory, bracing stabilizes the knee, reducing muscle cocontractions and joint compression.^15,19,20 Draganich and colleagues²¹ found that both off-the-shelf and adjustable unloader braces reduced pain. In a short-term (8-week) study, Barnes and colleagues²² found substantial improvement in knee pain with use of an unloader brace. In one of the larger, better designed, prospective studies, Brouwer and colleagues²³ found borderline but significant improvements in pain. Larsen and colleagues,²⁴ in another short-term study, found no improvement in pain but did report improved activity levels with use of a medial unloader brace.

In addition to demonstrating pain reduction, our results showed that, compared with control patients, brace patients had fewer arthritis symptoms, better ability to engage in ADLs, and increased activity levels. Other studies have identified additional benefits of bracing for knee arthritis. Larsen and colleagues²⁴ found that valgus bracing for medial compartment knee OA improved walking and sit-to-stand activities. Although pain relief results were modest, Brouwer and colleagues²³ found significantly better knee function and longer walking distances for patients who used a medial unloader brace. Hewett and colleagues²⁵ found that pain, ADLs, and walking distance were all improved after 9 weeks of brace wear.

Our study had a few limitations. Although injections and narcotic pain medications were not allowed, NSAIDs, home exercises, and other modalities were permitted. We did not think it was reasonable to eliminate every nonoperative modality during the 6-month study period. Therefore, it is possible that some of the study population’s improvements are attributable to these other modalities, which were not rigidly controlled.

Patient enrollment was difficult because of the strict inclusion and exclusion criteria used. The result was a smaller than anticipated patient population. Although there were many excellent study candidates, most declined enrollment when they learned they could be randomized to the control group. These patients were not willing to forgo injections or bracing for 6 months. We thought it was important to maintain our study design because it allowed us to evaluate the true effect of brace use while eliminating confounding variables. Nearly equal numbers of brace and control patients dropped out of the study. The majority of control group dropouts wanted more treatment options, indicating that NSAIDs and exercises alone were not controlling patients’ symptoms. This finding supports recommendations for a multimodal approach to treatment. As expected, some patients dropped out because their brace was uncomfortable—an important finding that should be considered when counseling patients about treatment options for OA.

Not all patients are candidates for braces. Braces can be irritating and uncomfortable for obese patients and patients with skin or vascular issues. Some patients find braces inconvenient. As discussed, a multimodal OA treatment approach is encouraged, but not every mode fits every patient. Physician and patient should thoroughly discuss the benefits and potential problems of brace use before prescribing. Our study results showed trends toward better improvements for brace patients (compared with control patients) in quality of life, ability to engage in sport and recreation, ability to sleep, and need for NSAIDs. Had we enrolled more patients, we might have found statistical significance for these trends. Despite the challenges with patient enrollment and study population size, the data make clear that unloader braces can benefit appropriate patients.

Our findings support use of a medial unloader brace as an acceptable and valid treatment modality for mild and moderate knee OA. The medial unloader brace should be considered a reasonable alternative, as part of a multimodal approach, to more invasive options, such as TKA.

Knee osteoarthritis (OA) is a progressive, degenerative joint disease characterized by pain and dysfunction. OA is a leading cause of disability in middle-aged and older adults,¹ affecting an estimated 27 million Americans.² With the continued aging of the baby boomer population and rising obesity rates, the incidence of OA is estimated to increase by 40% by 2025.³ The clinical and economic burdens of OA on our society—medical costs and workdays lost—are significant and will continue to be a problem for years to come.⁴

Total knee arthroplasty (TKA) is an option for severe end-stage OA. Most patients with mild to moderate OA follow nonsurgical strategies in an attempt to avoid invasive procedures. As there is no established cure, initial treatment of knee OA is geared toward alleviating pain and improving function. A multimodal approach is typically used and recommended.^5,6 Nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and narcotic analgesics are commonly prescribed. NSAIDs can be effective⁷ but have well-known cardiovascular, renal, and gastrointestinal risks. If possible, narcotic analgesics should be avoided because of the risk of addiction and the problems associated with dependence. Intra-articular injections of corticosteroids or hyaluronic acid (viscosupplementation) are often recommended to reduce pain associated with arthritis. Braces designed to “off-load” the more diseased medial or lateral compartment of the knee have also been used in an effort to provide symptomatic relief. These low-risk, noninvasive unloader braces have increasingly been advanced as a conservative treatment modality for knee OA,^6,8-10despite modest evidence and lack of appropriately powered randomized controlled trials.¹¹ As more research on the efficacy of these braces is needed, we conducted a study to determine whether an unloader brace is an acceptable and valid treatment modality for knee OA.

Patients and Methods

This was a prospective, randomized, controlled trial of patients with symptomatic, predominantly unicompartmental OA involving the medial compartment of the knee. The study protocol was approved by the Institutional Review Board at Baptist Hospital in Pensacola, Florida. Patients were excluded if they had a rheumatologic disorder other than OA; a history of knee surgery other than a routine arthroscopic procedure; any soft-tissue, neurologic, or vascular compromise preventing long-term brace use; or obesity preventing effective or comfortable brace use. It is generally felt that unloader bracing may not be effective for patients with severe contractures or significant knee deformity; therefore, those lacking more than 10° of extension or 20° of flexion, or those who had a varus deformity of more than 8° of varus, were not offered enrollment.

Ideal sizes for the proposed study groups were determined through power analysis using standard deviations from prior similar investigations. The target was 30 patients per group.

Patients gave informed consent to the work. A computer-generated randomization schedule was used to randomize patients either to receive a medial unloader brace (Fusion OA; Breg, Inc) or not to receive a brace. Patients in these brace and control groups were allowed to continue their standard conservative OA treatment modalities, including NSAID use, home exercises, and joint supplement use. Patients were restricted from receiving any injection therapy or narcotic pain medication in an effort to isolate the effects of bracing on relief of pain and other symptoms.

All patients were examined by an orthopedic surgeon or fellowship-trained primary care sports medicine specialist. Age, sex, height, and weight data were recorded. Body mass index was calculated. Anteroposterior, lateral, flexion weight-bearing, and long-leg standing radiographs were obtained. Two orthopedic surgeons blindly graded OA¹² and calculated knee varus angles.¹³ Values were averaged, and intraobserver reliability and interobserver reliability were calculated.

Prospective subjective outcomes were evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS), administered on study entry and at 4, 8, 16, and 24 weeks during the study. The KOOS has 5 subscales: Pain, Symptoms, Function in Daily Living, Function in Sport and Recreation, and Knee-Related Quality of Life. Each subscale is scored separately. Items are rated 0 (extreme problems) to 100 (no problems). Patients were also asked to complete a weekly diary, which included visual analog scale (VAS) ratings of pain, NSAID use, sleep, and activity level. VAS items were rated 1 (extreme problems) to 100 (no problems). For brace-group patients, hours of brace use per day were recorded. Patients were required to use the brace for a minimum of 4 hours per day.

KOOS and VAS data were analyzed with repeated-measures analysis of variance. Significance level was set at P < .05.

Results

Of the 50 patients randomized, 31 (16 brace, 15 control) completed the study. Of the 19 dropouts, 10 were in the brace group (4 dropped out because of brace discomfort) and 9 in the control group (5 dropped out because of significant pain and the desire for more aggressive treatment with injections). The target patient numbers based on the power analysis were not achieved because of patient enrollment difficulties resulting from the strict criteria established in the study design.

The brace group consisted of 8 men and 8 women. Braces were worn an average of 6.7 hours per day. The control group consisted of 8 men and 7 women. The groups were not significantly different in age, height, weight, body mass index, measured varus knee angle, or arthritis grade (Table 1).

Radiographs were assessed by 2 orthopedic surgeons. Varus angle measurements showed high interobserver reliability (.904, P = .03) and high intraobserver reliability (.969, P = .05); arthritis grades showed low interobserver reliability (.469, P = .59) and high intraobserver reliability (.810, P = .001).

KOOS results showed that, compared with control patients, brace patients had significantly less pain (P < .001), fewer arthritis symptoms (P = .007), better ability to engage in activities of daily living (ADLs) (P = .008), and better total knee function (P = .004) (Figures 1-4). The groups did not differ in ability to engage in sport and recreation (P = .402) or in knee-related quality of life (P = .718), but each parameter showed a trend to be better in the brace group. There was no effect of time in any KOOS subscale. Confidence intervals for these data are listed in Table 2.

VAS results showed that, compared with control patients, brace patients had significantly less pain throughout the day (P = .021) and better activity levels (P = .035) (Figures 5, 6). The groups did not differ in ability to sleep (P = .117) or NSAID use (P = .138), but each parameter showed a trend to be better in the brace group. There was no effect of time in either VAS.

Discussion

We conducted this study to determine the efficacy of a medial unloader brace in reducing the pain and symptoms associated with varus knee OA.

Although TKA is an option for patients with significant end-stage knee OA, mild OA and moderate OA typically are managed with nonoperative modalities. These modalities can be effective and may delay or eliminate the need for surgery, which poses a small but definite risk. Delaying surgery, especially in younger, active patients, has the potential to reduce the number of wear-related revision surgeries.¹⁴

Braces designed to off-load the more diseased medial or lateral compartment of the knee have been used in an effort to provide relief from symptomatic OA. There is a lack of appropriately powered, randomized controlled studies on the efficacy of these braces. With the evidence being inconclusive, the American Academy of Orthopaedic Surgeons is unable to recommend for or against use of a brace in medial unicompartmental OA.¹¹ More research on the efficacy of these braces is needed. In the present study, we asked 2 questions: Does use of an unloader brace lessen the pain associated with knee OA? Is the unloader brace an acceptable and valid treatment modality for knee OA?

The 2 clinical outcome tools used in this study showed significant improvement in pain in brace patients compared with control patients. KOOS results showed reduced pain and arthritis symptoms. VAS results showed less pain experienced throughout the day. Pain reduction is probably the most important benefit of any nonoperative modality for knee OA. Pain typically is the driving force and the major indication for TKA. Other investigators have found pain reduced with use of unloader braces, but few long-term prospective randomized trials have been conducted. Ramsey and colleagues¹⁵ compared a neutral stabilizing brace with a medial unloading brace and found that both helped reduce pain and functional disability. This led to discussion about the 2 major potential mechanisms for symptom relief. One theory holds that bracing unloads the diseased portion of the joint and thereby helps improve symptoms.^16-18 According to the other theory, bracing stabilizes the knee, reducing muscle cocontractions and joint compression.^15,19,20 Draganich and colleagues²¹ found that both off-the-shelf and adjustable unloader braces reduced pain. In a short-term (8-week) study, Barnes and colleagues²² found substantial improvement in knee pain with use of an unloader brace. In one of the larger, better designed, prospective studies, Brouwer and colleagues²³ found borderline but significant improvements in pain. Larsen and colleagues,²⁴ in another short-term study, found no improvement in pain but did report improved activity levels with use of a medial unloader brace.

In addition to demonstrating pain reduction, our results showed that, compared with control patients, brace patients had fewer arthritis symptoms, better ability to engage in ADLs, and increased activity levels. Other studies have identified additional benefits of bracing for knee arthritis. Larsen and colleagues²⁴ found that valgus bracing for medial compartment knee OA improved walking and sit-to-stand activities. Although pain relief results were modest, Brouwer and colleagues²³ found significantly better knee function and longer walking distances for patients who used a medial unloader brace. Hewett and colleagues²⁵ found that pain, ADLs, and walking distance were all improved after 9 weeks of brace wear.

Our study had a few limitations. Although injections and narcotic pain medications were not allowed, NSAIDs, home exercises, and other modalities were permitted. We did not think it was reasonable to eliminate every nonoperative modality during the 6-month study period. Therefore, it is possible that some of the study population’s improvements are attributable to these other modalities, which were not rigidly controlled.

Patient enrollment was difficult because of the strict inclusion and exclusion criteria used. The result was a smaller than anticipated patient population. Although there were many excellent study candidates, most declined enrollment when they learned they could be randomized to the control group. These patients were not willing to forgo injections or bracing for 6 months. We thought it was important to maintain our study design because it allowed us to evaluate the true effect of brace use while eliminating confounding variables. Nearly equal numbers of brace and control patients dropped out of the study. The majority of control group dropouts wanted more treatment options, indicating that NSAIDs and exercises alone were not controlling patients’ symptoms. This finding supports recommendations for a multimodal approach to treatment. As expected, some patients dropped out because their brace was uncomfortable—an important finding that should be considered when counseling patients about treatment options for OA.

Not all patients are candidates for braces. Braces can be irritating and uncomfortable for obese patients and patients with skin or vascular issues. Some patients find braces inconvenient. As discussed, a multimodal OA treatment approach is encouraged, but not every mode fits every patient. Physician and patient should thoroughly discuss the benefits and potential problems of brace use before prescribing. Our study results showed trends toward better improvements for brace patients (compared with control patients) in quality of life, ability to engage in sport and recreation, ability to sleep, and need for NSAIDs. Had we enrolled more patients, we might have found statistical significance for these trends. Despite the challenges with patient enrollment and study population size, the data make clear that unloader braces can benefit appropriate patients.

Our findings support use of a medial unloader brace as an acceptable and valid treatment modality for mild and moderate knee OA. The medial unloader brace should be considered a reasonable alternative, as part of a multimodal approach, to more invasive options, such as TKA.

Knee osteoarthritis (OA) is a progressive, degenerative joint disease characterized by pain and dysfunction. OA is a leading cause of disability in middle-aged and older adults,¹ affecting an estimated 27 million Americans.² With the continued aging of the baby boomer population and rising obesity rates, the incidence of OA is estimated to increase by 40% by 2025.³ The clinical and economic burdens of OA on our society—medical costs and workdays lost—are significant and will continue to be a problem for years to come.⁴

Total knee arthroplasty (TKA) is an option for severe end-stage OA. Most patients with mild to moderate OA follow nonsurgical strategies in an attempt to avoid invasive procedures. As there is no established cure, initial treatment of knee OA is geared toward alleviating pain and improving function. A multimodal approach is typically used and recommended.^5,6 Nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and narcotic analgesics are commonly prescribed. NSAIDs can be effective⁷ but have well-known cardiovascular, renal, and gastrointestinal risks. If possible, narcotic analgesics should be avoided because of the risk of addiction and the problems associated with dependence. Intra-articular injections of corticosteroids or hyaluronic acid (viscosupplementation) are often recommended to reduce pain associated with arthritis. Braces designed to “off-load” the more diseased medial or lateral compartment of the knee have also been used in an effort to provide symptomatic relief. These low-risk, noninvasive unloader braces have increasingly been advanced as a conservative treatment modality for knee OA,^6,8-10despite modest evidence and lack of appropriately powered randomized controlled trials.¹¹ As more research on the efficacy of these braces is needed, we conducted a study to determine whether an unloader brace is an acceptable and valid treatment modality for knee OA.

Patients and Methods

This was a prospective, randomized, controlled trial of patients with symptomatic, predominantly unicompartmental OA involving the medial compartment of the knee. The study protocol was approved by the Institutional Review Board at Baptist Hospital in Pensacola, Florida. Patients were excluded if they had a rheumatologic disorder other than OA; a history of knee surgery other than a routine arthroscopic procedure; any soft-tissue, neurologic, or vascular compromise preventing long-term brace use; or obesity preventing effective or comfortable brace use. It is generally felt that unloader bracing may not be effective for patients with severe contractures or significant knee deformity; therefore, those lacking more than 10° of extension or 20° of flexion, or those who had a varus deformity of more than 8° of varus, were not offered enrollment.

Ideal sizes for the proposed study groups were determined through power analysis using standard deviations from prior similar investigations. The target was 30 patients per group.

Patients gave informed consent to the work. A computer-generated randomization schedule was used to randomize patients either to receive a medial unloader brace (Fusion OA; Breg, Inc) or not to receive a brace. Patients in these brace and control groups were allowed to continue their standard conservative OA treatment modalities, including NSAID use, home exercises, and joint supplement use. Patients were restricted from receiving any injection therapy or narcotic pain medication in an effort to isolate the effects of bracing on relief of pain and other symptoms.

All patients were examined by an orthopedic surgeon or fellowship-trained primary care sports medicine specialist. Age, sex, height, and weight data were recorded. Body mass index was calculated. Anteroposterior, lateral, flexion weight-bearing, and long-leg standing radiographs were obtained. Two orthopedic surgeons blindly graded OA¹² and calculated knee varus angles.¹³ Values were averaged, and intraobserver reliability and interobserver reliability were calculated.

Prospective subjective outcomes were evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS), administered on study entry and at 4, 8, 16, and 24 weeks during the study. The KOOS has 5 subscales: Pain, Symptoms, Function in Daily Living, Function in Sport and Recreation, and Knee-Related Quality of Life. Each subscale is scored separately. Items are rated 0 (extreme problems) to 100 (no problems). Patients were also asked to complete a weekly diary, which included visual analog scale (VAS) ratings of pain, NSAID use, sleep, and activity level. VAS items were rated 1 (extreme problems) to 100 (no problems). For brace-group patients, hours of brace use per day were recorded. Patients were required to use the brace for a minimum of 4 hours per day.

KOOS and VAS data were analyzed with repeated-measures analysis of variance. Significance level was set at P < .05.

Results

Of the 50 patients randomized, 31 (16 brace, 15 control) completed the study. Of the 19 dropouts, 10 were in the brace group (4 dropped out because of brace discomfort) and 9 in the control group (5 dropped out because of significant pain and the desire for more aggressive treatment with injections). The target patient numbers based on the power analysis were not achieved because of patient enrollment difficulties resulting from the strict criteria established in the study design.

The brace group consisted of 8 men and 8 women. Braces were worn an average of 6.7 hours per day. The control group consisted of 8 men and 7 women. The groups were not significantly different in age, height, weight, body mass index, measured varus knee angle, or arthritis grade (Table 1).

Radiographs were assessed by 2 orthopedic surgeons. Varus angle measurements showed high interobserver reliability (.904, P = .03) and high intraobserver reliability (.969, P = .05); arthritis grades showed low interobserver reliability (.469, P = .59) and high intraobserver reliability (.810, P = .001).

KOOS results showed that, compared with control patients, brace patients had significantly less pain (P < .001), fewer arthritis symptoms (P = .007), better ability to engage in activities of daily living (ADLs) (P = .008), and better total knee function (P = .004) (Figures 1-4). The groups did not differ in ability to engage in sport and recreation (P = .402) or in knee-related quality of life (P = .718), but each parameter showed a trend to be better in the brace group. There was no effect of time in any KOOS subscale. Confidence intervals for these data are listed in Table 2.

VAS results showed that, compared with control patients, brace patients had significantly less pain throughout the day (P = .021) and better activity levels (P = .035) (Figures 5, 6). The groups did not differ in ability to sleep (P = .117) or NSAID use (P = .138), but each parameter showed a trend to be better in the brace group. There was no effect of time in either VAS.

Discussion

We conducted this study to determine the efficacy of a medial unloader brace in reducing the pain and symptoms associated with varus knee OA.

Although TKA is an option for patients with significant end-stage knee OA, mild OA and moderate OA typically are managed with nonoperative modalities. These modalities can be effective and may delay or eliminate the need for surgery, which poses a small but definite risk. Delaying surgery, especially in younger, active patients, has the potential to reduce the number of wear-related revision surgeries.¹⁴

Braces designed to off-load the more diseased medial or lateral compartment of the knee have been used in an effort to provide relief from symptomatic OA. There is a lack of appropriately powered, randomized controlled studies on the efficacy of these braces. With the evidence being inconclusive, the American Academy of Orthopaedic Surgeons is unable to recommend for or against use of a brace in medial unicompartmental OA.¹¹ More research on the efficacy of these braces is needed. In the present study, we asked 2 questions: Does use of an unloader brace lessen the pain associated with knee OA? Is the unloader brace an acceptable and valid treatment modality for knee OA?

The 2 clinical outcome tools used in this study showed significant improvement in pain in brace patients compared with control patients. KOOS results showed reduced pain and arthritis symptoms. VAS results showed less pain experienced throughout the day. Pain reduction is probably the most important benefit of any nonoperative modality for knee OA. Pain typically is the driving force and the major indication for TKA. Other investigators have found pain reduced with use of unloader braces, but few long-term prospective randomized trials have been conducted. Ramsey and colleagues¹⁵ compared a neutral stabilizing brace with a medial unloading brace and found that both helped reduce pain and functional disability. This led to discussion about the 2 major potential mechanisms for symptom relief. One theory holds that bracing unloads the diseased portion of the joint and thereby helps improve symptoms.^16-18 According to the other theory, bracing stabilizes the knee, reducing muscle cocontractions and joint compression.^15,19,20 Draganich and colleagues²¹ found that both off-the-shelf and adjustable unloader braces reduced pain. In a short-term (8-week) study, Barnes and colleagues²² found substantial improvement in knee pain with use of an unloader brace. In one of the larger, better designed, prospective studies, Brouwer and colleagues²³ found borderline but significant improvements in pain. Larsen and colleagues,²⁴ in another short-term study, found no improvement in pain but did report improved activity levels with use of a medial unloader brace.

In addition to demonstrating pain reduction, our results showed that, compared with control patients, brace patients had fewer arthritis symptoms, better ability to engage in ADLs, and increased activity levels. Other studies have identified additional benefits of bracing for knee arthritis. Larsen and colleagues²⁴ found that valgus bracing for medial compartment knee OA improved walking and sit-to-stand activities. Although pain relief results were modest, Brouwer and colleagues²³ found significantly better knee function and longer walking distances for patients who used a medial unloader brace. Hewett and colleagues²⁵ found that pain, ADLs, and walking distance were all improved after 9 weeks of brace wear.

Our study had a few limitations. Although injections and narcotic pain medications were not allowed, NSAIDs, home exercises, and other modalities were permitted. We did not think it was reasonable to eliminate every nonoperative modality during the 6-month study period. Therefore, it is possible that some of the study population’s improvements are attributable to these other modalities, which were not rigidly controlled.

Patient enrollment was difficult because of the strict inclusion and exclusion criteria used. The result was a smaller than anticipated patient population. Although there were many excellent study candidates, most declined enrollment when they learned they could be randomized to the control group. These patients were not willing to forgo injections or bracing for 6 months. We thought it was important to maintain our study design because it allowed us to evaluate the true effect of brace use while eliminating confounding variables. Nearly equal numbers of brace and control patients dropped out of the study. The majority of control group dropouts wanted more treatment options, indicating that NSAIDs and exercises alone were not controlling patients’ symptoms. This finding supports recommendations for a multimodal approach to treatment. As expected, some patients dropped out because their brace was uncomfortable—an important finding that should be considered when counseling patients about treatment options for OA.

Not all patients are candidates for braces. Braces can be irritating and uncomfortable for obese patients and patients with skin or vascular issues. Some patients find braces inconvenient. As discussed, a multimodal OA treatment approach is encouraged, but not every mode fits every patient. Physician and patient should thoroughly discuss the benefits and potential problems of brace use before prescribing. Our study results showed trends toward better improvements for brace patients (compared with control patients) in quality of life, ability to engage in sport and recreation, ability to sleep, and need for NSAIDs. Had we enrolled more patients, we might have found statistical significance for these trends. Despite the challenges with patient enrollment and study population size, the data make clear that unloader braces can benefit appropriate patients.

Our findings support use of a medial unloader brace as an acceptable and valid treatment modality for mild and moderate knee OA. The medial unloader brace should be considered a reasonable alternative, as part of a multimodal approach, to more invasive options, such as TKA.

For overhead athletes, elbow ulnar collateral ligament (UCL) insufficiency is a potential career-ending injury. Baseball players with UCL insufficiency typically complain of medial-sided elbow pain that affects their ability to throw. Loss of velocity, loss of control, difficulty warming up, and pain while throwing are all symptoms of UCL injury.

Classically, nonoperative treatment of UCL injuries involves activity modification, use of anti-inflammatory medication, and a structured physical therapy program. Asymptomatic players can return to throwing after a structured interval throwing program. Rettig and colleagues¹ found a 42% rate of success in conservatively treating UCL injuries in throwing athletes. UCL reconstruction is reserved for players with complete tears of the UCL or with partial tears after failed conservative treatment. Several techniques have been used to reconstruct the ligament, but successful outcomes depend on a long rehabilitation process. According to most published series, 85% to 90% of athletes who had UCL reconstruction returned to their previous level of play, but it took, on average, 9 to 12 months.^2,3 This prolonged recovery period is one reason that some older professional baseball players, as well as casual high school and college players, elect to forgo surgery.

Over the past few years, platelet-rich plasma (PRP) has garnered attention as a bridge between conservative treatment and surgery. PRP refers to a sample of autologous blood that contains a platelet concentration higher than baseline levels. This sample often has a 3 to 5 times increase in growth factor concentration.^4-6 Initial studies focused on its ability to successfully treat lateral epicondylitis.^7-9 More recent clinical work has shown that PRP can potentially enhance healing after anterior cruciate ligament reconstruction,^10-14 rotator cuff repair,^15-17 and subacromial decompression.^11,18-23 If PRP could be used to successfully treat UCL insufficiency that is refractory to conservative treatment, then year-long recovery periods could be avoided. This could potentially prolong certain athletes’ careers or, at the very least, allow them to return to play much sooner. In the present case series, we hypothesized that PRP injections could be used to successfully treat partial UCL tears in high-level throwing athletes, obviating the need for surgery and its associated prolonged recovery period.

Materials and Methods

Institutional Review Board approval was obtained for this retrospective study of 44 baseball players treated with PRP injections for partial-thickness UCL tears.

Patients provided written informed consent. They were diagnosed with UCL insufficiency by physical examination, and findings were confirmed by magnetic resonance imaging (MRI). After diagnosis, all throwers underwent a trial of conservative treatment that included rest, activity modification, use of anti-inflammatory medication, and physical therapy followed by an attempt to return to throwing using an interval throwing program.

Study inclusion criteria were physical examinations and MRI results consistent with UCL insufficiency, and failure of the conservative treatment plan described.

Patients were injected using the Autologous Conditioned Plasma system (Arthrex). PRP solutions were prepared according to manufacturer guidelines. After the elbow was prepared sterilely, the UCL was injected at the location of the tear. Typically, 3 mL of PRP was injected into the elbow. Sixteen patients had 1 injection, 6 had 2, and 22 had 3. Repeat injections were considered for recalcitrant pain after 3 weeks.

After injection, patients used acetaminophen and ice for pain control. Anti-inflammatory medications were avoided for a minimum of 2 weeks after injection. Typical postinjection therapy protocol consisted of rest followed by progressive stretching and strengthening for about 4 to 6 weeks before the start of an interval throwing program. Although there is no well-defined postinjection recovery protocol, as a general rule rest was prescribed for the first 2 weeks, followed by a progressive stretching and strengthening program for the next month. Patients who were asymptomatic subjectively and clinically—negative moving valgus stress test, negative milking maneuver, no pain with valgus stress—were started on an interval throwing program.

Final follow-up involved a physical examination. Results were classified according to a modified version of the Conway Scale^12,24-26: excellent (return to preinjury level of competition or performance), good (return to play at a lower level of competition or performance or, specifically for baseball players, ability to throw in daily batting practice), fair (able to play recreationally), and poor (unable to return to previous sport at any level).

By final follow-up, all patients had completed their postoperative rehabilitation protocol, and all had at least tried to return to their previous activities. No patients were lost to follow-up.

Results

Of the 44 baseball players, 6 were professional, 14 were in college, and 24 were in high school. There were 36 pitchers and 8 position players. Mean age was 17.3 years (range, 16-28 years). All patients were available for follow-up after injection (mean, 11 months). Fifteen of the 44 players had an excellent outcome (34%), 17 had a good outcome, 2 had a fair outcome, and 10 had a poor outcome. After injection, 4 (67%) of the 6 professional baseball players returned to professional play. Five (36%) of the 14 college players had an excellent outcome, and 4 (17%) of the 24 high school players had an excellent outcome. Of the 8 position players, 4 had an excellent outcome, 3 had a good outcome, and 1 had a poor outcome.

Before treatment, all patients had medial-sided elbow pain over the UCL inhibiting their ability to throw. Mean duration of symptoms before injection was 8.8 months (range, 1-36 months). There was no correlation between symptom duration and any outcome measure. On MRI, 29 patients showed partial tears: 22 proximally based and 7 distally based. The other 15 patients had diffuse signal without partial tear. All 7 patients with distally based partial tears and 3 of the patients with proximally based partial tears had a poor outcome. Overall, there were 6 excellent, 7 good, and 2 fair outcomes in the partial-tear group. In the patients with diffuse signal without partial tear, there were 9 excellent and 10 good outcomes.

Mean time from injection to return to throwing was 5 weeks, and mean time to return to competition was 12 weeks (range, 5-24 weeks). The 1 player who returned at 5 weeks was a professional relief pitcher whose team was in the playoffs. He has now pitched for an additional 2 baseball seasons without elbow difficulty.

There were no injection-related complications.

Discussion

To our knowledge, this is the first report documenting successful PRP treatment of UCL insufficiency. In this study, 73% of players who had failed a course of conservative treatment had good to excellent outcomes with PRP injection.

Data on successful nonoperative treatment of UCL injuries are limited. Rettig and colleagues¹ treated 31 throwing athletes’ UCL injuries with a supervised rehabilitation program. Treatment included rest, use of anti-inflammatory medication, progressive strengthening, and an interval throwing program. Only 41% of the athletes returned to their previous level of play, and it took, on average, 24.5 weeks. There was no significant difference in age or in duration or acuity of symptoms between those who returned to play and those whose conservative treatment failed.

Surgical reconstruction of UCL injuries has been very successful, with upward of 90% of athletes returning to previous level of play.^3,27The procedure, however, is not without associated complications, including retear of the ligament, stiffness, ulnar nerve injury, and fracture.^27-29 In addition, even when successful, the procedure requires that athletes take 9 to 12 months to recover before returning to competition at their previous level.

Savoie and colleagues,³⁰ in their recent study on UCL repairs, highlighted an important fact that is often overlooked when reviewing the literature on UCL tears. Most of the literature on these injuries focuses on college and professional baseball players in whom ligament damage is often extensive, precluding repair. In contrast to prior reports, Savoie and colleagues³⁰ found excellent results in 93% of their young athletes who underwent UCL repair. It is possible that their results can be attributed to the fact that many of their athletes had tears isolated to one area of the ligament, as opposed to generalized ligament incompetence. Our improved results vis-à-vis other reports on conservative management may be attributable to the same phenomenon.

PRP has garnered much attention in the literature and media because of its potential to enhance healing of tendons and ligaments; in some cases, it can obviate the need for surgery. After failure of other nonoperative measures in 15 patients with elbow epicondylitis, Mishra and Pavelko⁸ treated each patient with a single PRP injection. They prepared the PRP using the GPS III system (Biomet). At final follow-up, 93% improvement was seen. Clearly, their experiment had design flaws: It was nonblinded, and 3 of the 5 patients in the control group treated with bupivacaine injection withdrew from the experiment. Despite its shortcomings, their study became the impetus for several other studies.

A larger, double-blinded, randomized controlled trial comparing PRP and cortisone injections for lateral epicondylitis in 100 patients is under way, and preliminary results have been published.⁹ A minimum of 6 months after injection, patients who received PRP showed more improvement in visual analog scale (VAS) pain scores and Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire scores. In another large, double-blinded, randomized controlled trial, patients with chronic lateral epicondylitis had significant improvements in VAS pain scores and DASH scores relative to patients injected with corticosteroids with a 2-year follow-up.³¹ Similarly, Thanasas and colleagues³² found significantly reduced VAS pain scores in patients injected with PRP versus autologous whole blood. Another study demonstrated improved tendon morphology using ultrasound imaging 6 months after PRP injection.³³

Contrary to these positive results, Krogh and colleagues³⁴ found that a single injection of PRP or glucocorticoid was not significantly superior to a saline injection for reducing pain and disability over a 3-month period in patients with lateral epicondylitis. Their study, however, had major flaws. Its original design called for a 12-month follow-up, but there was massive dropout in all 3 treatment arms, necessitating reporting of only 3-month data. In addition, 60% of the patients in the glucocorticoid group were not naïve to this treatment, so definitive conclusions about the efficacy of glucocorticoids could not be made.

In the present study, we successfully treated partial ligament tears with PRP injections. Sixty-seven percent of our baseball players returned to play at a mean of 4 months, much earlier than the 9 to 12 months typically required after ligament reconstruction. Many athletes, such as high school baseball players or aging veteran professional baseball players, do not have the luxury of 12 months for recovery. Therefore, this select group of patients clearly has a limited window of opportunity to return to play. In fact, these patients might be ideal candidates for PRP injections for UCL injuries. Return-to-play rates, however, differed significantly among professional players and nonprofessional players. The difference may be attributable to professional players’ conditioning, quality of physical therapy, extrinsic motivation, and other intangible factors. Four (67%) of our 6 professional baseball players returned to professional play after injection, whereas only 36% of college players and 17% of high school players had excellent outcomes.

Limitations

The present study had several weaknesses, several of which are inherent to PRP studies conducted so far. It was not a prospective, randomized controlled trial. It is important to note that PRP treatment in diseased tissue may have some drawbacks, as its success depends on the ability of healing tissue to use concentrated growth factors and cytokines to proliferate.³⁵ Thus, a chronically injured ligament with depleted active cells may have a diminished response to PRP. Another limitation of this study is that we evaluated outcomes based on return to play using the Conway Scale, which is well reported but not validated. Despite the potential weaknesses of this outcome scale, it has become the benchmark for measuring the success of outcomes of UCL reconstruction. Furthermore, we did not measure patients’ satisfaction with the treatment. Players who could not return to their preinjury level of play may have considered the treatment a failure regardless of their ability to continue throwing. Last, MRI was not repeated to document ligament healing. We did not routinely perform a second MRI because we thought it would not affect treatment. Several series have found a high incidence of abnormal signal in baseball players’ UCLs. In this group of patients, the most important outcome is return to previous level of competition.

This study raised several questions. Is one PRP brand better than another? Should more than 1 injection be given? What is the ideal postinjection protocol? Clearly, larger, prospective, randomized controlled studies are needed to truly elucidate the potential role of PRP in the treatment algorithm for UCL injury. Nevertheless, in certain cases in which traditional conservative measures have failed and patients do not have the luxury of rehabilitating for 9 to 12 months after surgery, PRP may be a viable treatment option.

Conclusion

In this study, use of PRP in the treatment of UCL insufficiency produced outcomes much better than earlier reported outcomes of conservative treatment of these injuries. PRP injections may be particularly beneficial in young athletes who have sustained acute damage to an isolated part of the ligament and in athletes unwilling or unable to undergo the extended rehabilitation required after surgical reconstruction of the ligament.

For overhead athletes, elbow ulnar collateral ligament (UCL) insufficiency is a potential career-ending injury. Baseball players with UCL insufficiency typically complain of medial-sided elbow pain that affects their ability to throw. Loss of velocity, loss of control, difficulty warming up, and pain while throwing are all symptoms of UCL injury.

Classically, nonoperative treatment of UCL injuries involves activity modification, use of anti-inflammatory medication, and a structured physical therapy program. Asymptomatic players can return to throwing after a structured interval throwing program. Rettig and colleagues¹ found a 42% rate of success in conservatively treating UCL injuries in throwing athletes. UCL reconstruction is reserved for players with complete tears of the UCL or with partial tears after failed conservative treatment. Several techniques have been used to reconstruct the ligament, but successful outcomes depend on a long rehabilitation process. According to most published series, 85% to 90% of athletes who had UCL reconstruction returned to their previous level of play, but it took, on average, 9 to 12 months.^2,3 This prolonged recovery period is one reason that some older professional baseball players, as well as casual high school and college players, elect to forgo surgery.

Over the past few years, platelet-rich plasma (PRP) has garnered attention as a bridge between conservative treatment and surgery. PRP refers to a sample of autologous blood that contains a platelet concentration higher than baseline levels. This sample often has a 3 to 5 times increase in growth factor concentration.^4-6 Initial studies focused on its ability to successfully treat lateral epicondylitis.^7-9 More recent clinical work has shown that PRP can potentially enhance healing after anterior cruciate ligament reconstruction,^10-14 rotator cuff repair,^15-17 and subacromial decompression.^11,18-23 If PRP could be used to successfully treat UCL insufficiency that is refractory to conservative treatment, then year-long recovery periods could be avoided. This could potentially prolong certain athletes’ careers or, at the very least, allow them to return to play much sooner. In the present case series, we hypothesized that PRP injections could be used to successfully treat partial UCL tears in high-level throwing athletes, obviating the need for surgery and its associated prolonged recovery period.

Materials and Methods

Institutional Review Board approval was obtained for this retrospective study of 44 baseball players treated with PRP injections for partial-thickness UCL tears.

Patients provided written informed consent. They were diagnosed with UCL insufficiency by physical examination, and findings were confirmed by magnetic resonance imaging (MRI). After diagnosis, all throwers underwent a trial of conservative treatment that included rest, activity modification, use of anti-inflammatory medication, and physical therapy followed by an attempt to return to throwing using an interval throwing program.

Study inclusion criteria were physical examinations and MRI results consistent with UCL insufficiency, and failure of the conservative treatment plan described.

Patients were injected using the Autologous Conditioned Plasma system (Arthrex). PRP solutions were prepared according to manufacturer guidelines. After the elbow was prepared sterilely, the UCL was injected at the location of the tear. Typically, 3 mL of PRP was injected into the elbow. Sixteen patients had 1 injection, 6 had 2, and 22 had 3. Repeat injections were considered for recalcitrant pain after 3 weeks.

After injection, patients used acetaminophen and ice for pain control. Anti-inflammatory medications were avoided for a minimum of 2 weeks after injection. Typical postinjection therapy protocol consisted of rest followed by progressive stretching and strengthening for about 4 to 6 weeks before the start of an interval throwing program. Although there is no well-defined postinjection recovery protocol, as a general rule rest was prescribed for the first 2 weeks, followed by a progressive stretching and strengthening program for the next month. Patients who were asymptomatic subjectively and clinically—negative moving valgus stress test, negative milking maneuver, no pain with valgus stress—were started on an interval throwing program.

Final follow-up involved a physical examination. Results were classified according to a modified version of the Conway Scale^12,24-26: excellent (return to preinjury level of competition or performance), good (return to play at a lower level of competition or performance or, specifically for baseball players, ability to throw in daily batting practice), fair (able to play recreationally), and poor (unable to return to previous sport at any level).

By final follow-up, all patients had completed their postoperative rehabilitation protocol, and all had at least tried to return to their previous activities. No patients were lost to follow-up.

Results

Of the 44 baseball players, 6 were professional, 14 were in college, and 24 were in high school. There were 36 pitchers and 8 position players. Mean age was 17.3 years (range, 16-28 years). All patients were available for follow-up after injection (mean, 11 months). Fifteen of the 44 players had an excellent outcome (34%), 17 had a good outcome, 2 had a fair outcome, and 10 had a poor outcome. After injection, 4 (67%) of the 6 professional baseball players returned to professional play. Five (36%) of the 14 college players had an excellent outcome, and 4 (17%) of the 24 high school players had an excellent outcome. Of the 8 position players, 4 had an excellent outcome, 3 had a good outcome, and 1 had a poor outcome.

Before treatment, all patients had medial-sided elbow pain over the UCL inhibiting their ability to throw. Mean duration of symptoms before injection was 8.8 months (range, 1-36 months). There was no correlation between symptom duration and any outcome measure. On MRI, 29 patients showed partial tears: 22 proximally based and 7 distally based. The other 15 patients had diffuse signal without partial tear. All 7 patients with distally based partial tears and 3 of the patients with proximally based partial tears had a poor outcome. Overall, there were 6 excellent, 7 good, and 2 fair outcomes in the partial-tear group. In the patients with diffuse signal without partial tear, there were 9 excellent and 10 good outcomes.

Mean time from injection to return to throwing was 5 weeks, and mean time to return to competition was 12 weeks (range, 5-24 weeks). The 1 player who returned at 5 weeks was a professional relief pitcher whose team was in the playoffs. He has now pitched for an additional 2 baseball seasons without elbow difficulty.

There were no injection-related complications.

Discussion

To our knowledge, this is the first report documenting successful PRP treatment of UCL insufficiency. In this study, 73% of players who had failed a course of conservative treatment had good to excellent outcomes with PRP injection.

Data on successful nonoperative treatment of UCL injuries are limited. Rettig and colleagues¹ treated 31 throwing athletes’ UCL injuries with a supervised rehabilitation program. Treatment included rest, use of anti-inflammatory medication, progressive strengthening, and an interval throwing program. Only 41% of the athletes returned to their previous level of play, and it took, on average, 24.5 weeks. There was no significant difference in age or in duration or acuity of symptoms between those who returned to play and those whose conservative treatment failed.

Surgical reconstruction of UCL injuries has been very successful, with upward of 90% of athletes returning to previous level of play.^3,27The procedure, however, is not without associated complications, including retear of the ligament, stiffness, ulnar nerve injury, and fracture.^27-29 In addition, even when successful, the procedure requires that athletes take 9 to 12 months to recover before returning to competition at their previous level.

Savoie and colleagues,³⁰ in their recent study on UCL repairs, highlighted an important fact that is often overlooked when reviewing the literature on UCL tears. Most of the literature on these injuries focuses on college and professional baseball players in whom ligament damage is often extensive, precluding repair. In contrast to prior reports, Savoie and colleagues³⁰ found excellent results in 93% of their young athletes who underwent UCL repair. It is possible that their results can be attributed to the fact that many of their athletes had tears isolated to one area of the ligament, as opposed to generalized ligament incompetence. Our improved results vis-à-vis other reports on conservative management may be attributable to the same phenomenon.

PRP has garnered much attention in the literature and media because of its potential to enhance healing of tendons and ligaments; in some cases, it can obviate the need for surgery. After failure of other nonoperative measures in 15 patients with elbow epicondylitis, Mishra and Pavelko⁸ treated each patient with a single PRP injection. They prepared the PRP using the GPS III system (Biomet). At final follow-up, 93% improvement was seen. Clearly, their experiment had design flaws: It was nonblinded, and 3 of the 5 patients in the control group treated with bupivacaine injection withdrew from the experiment. Despite its shortcomings, their study became the impetus for several other studies.

A larger, double-blinded, randomized controlled trial comparing PRP and cortisone injections for lateral epicondylitis in 100 patients is under way, and preliminary results have been published.⁹ A minimum of 6 months after injection, patients who received PRP showed more improvement in visual analog scale (VAS) pain scores and Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire scores. In another large, double-blinded, randomized controlled trial, patients with chronic lateral epicondylitis had significant improvements in VAS pain scores and DASH scores relative to patients injected with corticosteroids with a 2-year follow-up.³¹ Similarly, Thanasas and colleagues³² found significantly reduced VAS pain scores in patients injected with PRP versus autologous whole blood. Another study demonstrated improved tendon morphology using ultrasound imaging 6 months after PRP injection.³³

Contrary to these positive results, Krogh and colleagues³⁴ found that a single injection of PRP or glucocorticoid was not significantly superior to a saline injection for reducing pain and disability over a 3-month period in patients with lateral epicondylitis. Their study, however, had major flaws. Its original design called for a 12-month follow-up, but there was massive dropout in all 3 treatment arms, necessitating reporting of only 3-month data. In addition, 60% of the patients in the glucocorticoid group were not naïve to this treatment, so definitive conclusions about the efficacy of glucocorticoids could not be made.

In the present study, we successfully treated partial ligament tears with PRP injections. Sixty-seven percent of our baseball players returned to play at a mean of 4 months, much earlier than the 9 to 12 months typically required after ligament reconstruction. Many athletes, such as high school baseball players or aging veteran professional baseball players, do not have the luxury of 12 months for recovery. Therefore, this select group of patients clearly has a limited window of opportunity to return to play. In fact, these patients might be ideal candidates for PRP injections for UCL injuries. Return-to-play rates, however, differed significantly among professional players and nonprofessional players. The difference may be attributable to professional players’ conditioning, quality of physical therapy, extrinsic motivation, and other intangible factors. Four (67%) of our 6 professional baseball players returned to professional play after injection, whereas only 36% of college players and 17% of high school players had excellent outcomes.

Limitations

The present study had several weaknesses, several of which are inherent to PRP studies conducted so far. It was not a prospective, randomized controlled trial. It is important to note that PRP treatment in diseased tissue may have some drawbacks, as its success depends on the ability of healing tissue to use concentrated growth factors and cytokines to proliferate.³⁵ Thus, a chronically injured ligament with depleted active cells may have a diminished response to PRP. Another limitation of this study is that we evaluated outcomes based on return to play using the Conway Scale, which is well reported but not validated. Despite the potential weaknesses of this outcome scale, it has become the benchmark for measuring the success of outcomes of UCL reconstruction. Furthermore, we did not measure patients’ satisfaction with the treatment. Players who could not return to their preinjury level of play may have considered the treatment a failure regardless of their ability to continue throwing. Last, MRI was not repeated to document ligament healing. We did not routinely perform a second MRI because we thought it would not affect treatment. Several series have found a high incidence of abnormal signal in baseball players’ UCLs. In this group of patients, the most important outcome is return to previous level of competition.

This study raised several questions. Is one PRP brand better than another? Should more than 1 injection be given? What is the ideal postinjection protocol? Clearly, larger, prospective, randomized controlled studies are needed to truly elucidate the potential role of PRP in the treatment algorithm for UCL injury. Nevertheless, in certain cases in which traditional conservative measures have failed and patients do not have the luxury of rehabilitating for 9 to 12 months after surgery, PRP may be a viable treatment option.

Conclusion

In this study, use of PRP in the treatment of UCL insufficiency produced outcomes much better than earlier reported outcomes of conservative treatment of these injuries. PRP injections may be particularly beneficial in young athletes who have sustained acute damage to an isolated part of the ligament and in athletes unwilling or unable to undergo the extended rehabilitation required after surgical reconstruction of the ligament.

For overhead athletes, elbow ulnar collateral ligament (UCL) insufficiency is a potential career-ending injury. Baseball players with UCL insufficiency typically complain of medial-sided elbow pain that affects their ability to throw. Loss of velocity, loss of control, difficulty warming up, and pain while throwing are all symptoms of UCL injury.

Classically, nonoperative treatment of UCL injuries involves activity modification, use of anti-inflammatory medication, and a structured physical therapy program. Asymptomatic players can return to throwing after a structured interval throwing program. Rettig and colleagues¹ found a 42% rate of success in conservatively treating UCL injuries in throwing athletes. UCL reconstruction is reserved for players with complete tears of the UCL or with partial tears after failed conservative treatment. Several techniques have been used to reconstruct the ligament, but successful outcomes depend on a long rehabilitation process. According to most published series, 85% to 90% of athletes who had UCL reconstruction returned to their previous level of play, but it took, on average, 9 to 12 months.^2,3 This prolonged recovery period is one reason that some older professional baseball players, as well as casual high school and college players, elect to forgo surgery.

Over the past few years, platelet-rich plasma (PRP) has garnered attention as a bridge between conservative treatment and surgery. PRP refers to a sample of autologous blood that contains a platelet concentration higher than baseline levels. This sample often has a 3 to 5 times increase in growth factor concentration.^4-6 Initial studies focused on its ability to successfully treat lateral epicondylitis.^7-9 More recent clinical work has shown that PRP can potentially enhance healing after anterior cruciate ligament reconstruction,^10-14 rotator cuff repair,^15-17 and subacromial decompression.^11,18-23 If PRP could be used to successfully treat UCL insufficiency that is refractory to conservative treatment, then year-long recovery periods could be avoided. This could potentially prolong certain athletes’ careers or, at the very least, allow them to return to play much sooner. In the present case series, we hypothesized that PRP injections could be used to successfully treat partial UCL tears in high-level throwing athletes, obviating the need for surgery and its associated prolonged recovery period.

Materials and Methods

Institutional Review Board approval was obtained for this retrospective study of 44 baseball players treated with PRP injections for partial-thickness UCL tears.

Patients provided written informed consent. They were diagnosed with UCL insufficiency by physical examination, and findings were confirmed by magnetic resonance imaging (MRI). After diagnosis, all throwers underwent a trial of conservative treatment that included rest, activity modification, use of anti-inflammatory medication, and physical therapy followed by an attempt to return to throwing using an interval throwing program.

Study inclusion criteria were physical examinations and MRI results consistent with UCL insufficiency, and failure of the conservative treatment plan described.

Patients were injected using the Autologous Conditioned Plasma system (Arthrex). PRP solutions were prepared according to manufacturer guidelines. After the elbow was prepared sterilely, the UCL was injected at the location of the tear. Typically, 3 mL of PRP was injected into the elbow. Sixteen patients had 1 injection, 6 had 2, and 22 had 3. Repeat injections were considered for recalcitrant pain after 3 weeks.

After injection, patients used acetaminophen and ice for pain control. Anti-inflammatory medications were avoided for a minimum of 2 weeks after injection. Typical postinjection therapy protocol consisted of rest followed by progressive stretching and strengthening for about 4 to 6 weeks before the start of an interval throwing program. Although there is no well-defined postinjection recovery protocol, as a general rule rest was prescribed for the first 2 weeks, followed by a progressive stretching and strengthening program for the next month. Patients who were asymptomatic subjectively and clinically—negative moving valgus stress test, negative milking maneuver, no pain with valgus stress—were started on an interval throwing program.

Final follow-up involved a physical examination. Results were classified according to a modified version of the Conway Scale^12,24-26: excellent (return to preinjury level of competition or performance), good (return to play at a lower level of competition or performance or, specifically for baseball players, ability to throw in daily batting practice), fair (able to play recreationally), and poor (unable to return to previous sport at any level).

By final follow-up, all patients had completed their postoperative rehabilitation protocol, and all had at least tried to return to their previous activities. No patients were lost to follow-up.

Results

Of the 44 baseball players, 6 were professional, 14 were in college, and 24 were in high school. There were 36 pitchers and 8 position players. Mean age was 17.3 years (range, 16-28 years). All patients were available for follow-up after injection (mean, 11 months). Fifteen of the 44 players had an excellent outcome (34%), 17 had a good outcome, 2 had a fair outcome, and 10 had a poor outcome. After injection, 4 (67%) of the 6 professional baseball players returned to professional play. Five (36%) of the 14 college players had an excellent outcome, and 4 (17%) of the 24 high school players had an excellent outcome. Of the 8 position players, 4 had an excellent outcome, 3 had a good outcome, and 1 had a poor outcome.

Before treatment, all patients had medial-sided elbow pain over the UCL inhibiting their ability to throw. Mean duration of symptoms before injection was 8.8 months (range, 1-36 months). There was no correlation between symptom duration and any outcome measure. On MRI, 29 patients showed partial tears: 22 proximally based and 7 distally based. The other 15 patients had diffuse signal without partial tear. All 7 patients with distally based partial tears and 3 of the patients with proximally based partial tears had a poor outcome. Overall, there were 6 excellent, 7 good, and 2 fair outcomes in the partial-tear group. In the patients with diffuse signal without partial tear, there were 9 excellent and 10 good outcomes.

Mean time from injection to return to throwing was 5 weeks, and mean time to return to competition was 12 weeks (range, 5-24 weeks). The 1 player who returned at 5 weeks was a professional relief pitcher whose team was in the playoffs. He has now pitched for an additional 2 baseball seasons without elbow difficulty.

There were no injection-related complications.

Discussion

To our knowledge, this is the first report documenting successful PRP treatment of UCL insufficiency. In this study, 73% of players who had failed a course of conservative treatment had good to excellent outcomes with PRP injection.

Data on successful nonoperative treatment of UCL injuries are limited. Rettig and colleagues¹ treated 31 throwing athletes’ UCL injuries with a supervised rehabilitation program. Treatment included rest, use of anti-inflammatory medication, progressive strengthening, and an interval throwing program. Only 41% of the athletes returned to their previous level of play, and it took, on average, 24.5 weeks. There was no significant difference in age or in duration or acuity of symptoms between those who returned to play and those whose conservative treatment failed.

Surgical reconstruction of UCL injuries has been very successful, with upward of 90% of athletes returning to previous level of play.^3,27The procedure, however, is not without associated complications, including retear of the ligament, stiffness, ulnar nerve injury, and fracture.^27-29 In addition, even when successful, the procedure requires that athletes take 9 to 12 months to recover before returning to competition at their previous level.

Savoie and colleagues,³⁰ in their recent study on UCL repairs, highlighted an important fact that is often overlooked when reviewing the literature on UCL tears. Most of the literature on these injuries focuses on college and professional baseball players in whom ligament damage is often extensive, precluding repair. In contrast to prior reports, Savoie and colleagues³⁰ found excellent results in 93% of their young athletes who underwent UCL repair. It is possible that their results can be attributed to the fact that many of their athletes had tears isolated to one area of the ligament, as opposed to generalized ligament incompetence. Our improved results vis-à-vis other reports on conservative management may be attributable to the same phenomenon.

PRP has garnered much attention in the literature and media because of its potential to enhance healing of tendons and ligaments; in some cases, it can obviate the need for surgery. After failure of other nonoperative measures in 15 patients with elbow epicondylitis, Mishra and Pavelko⁸ treated each patient with a single PRP injection. They prepared the PRP using the GPS III system (Biomet). At final follow-up, 93% improvement was seen. Clearly, their experiment had design flaws: It was nonblinded, and 3 of the 5 patients in the control group treated with bupivacaine injection withdrew from the experiment. Despite its shortcomings, their study became the impetus for several other studies.

A larger, double-blinded, randomized controlled trial comparing PRP and cortisone injections for lateral epicondylitis in 100 patients is under way, and preliminary results have been published.⁹ A minimum of 6 months after injection, patients who received PRP showed more improvement in visual analog scale (VAS) pain scores and Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire scores. In another large, double-blinded, randomized controlled trial, patients with chronic lateral epicondylitis had significant improvements in VAS pain scores and DASH scores relative to patients injected with corticosteroids with a 2-year follow-up.³¹ Similarly, Thanasas and colleagues³² found significantly reduced VAS pain scores in patients injected with PRP versus autologous whole blood. Another study demonstrated improved tendon morphology using ultrasound imaging 6 months after PRP injection.³³

Contrary to these positive results, Krogh and colleagues³⁴ found that a single injection of PRP or glucocorticoid was not significantly superior to a saline injection for reducing pain and disability over a 3-month period in patients with lateral epicondylitis. Their study, however, had major flaws. Its original design called for a 12-month follow-up, but there was massive dropout in all 3 treatment arms, necessitating reporting of only 3-month data. In addition, 60% of the patients in the glucocorticoid group were not naïve to this treatment, so definitive conclusions about the efficacy of glucocorticoids could not be made.

In the present study, we successfully treated partial ligament tears with PRP injections. Sixty-seven percent of our baseball players returned to play at a mean of 4 months, much earlier than the 9 to 12 months typically required after ligament reconstruction. Many athletes, such as high school baseball players or aging veteran professional baseball players, do not have the luxury of 12 months for recovery. Therefore, this select group of patients clearly has a limited window of opportunity to return to play. In fact, these patients might be ideal candidates for PRP injections for UCL injuries. Return-to-play rates, however, differed significantly among professional players and nonprofessional players. The difference may be attributable to professional players’ conditioning, quality of physical therapy, extrinsic motivation, and other intangible factors. Four (67%) of our 6 professional baseball players returned to professional play after injection, whereas only 36% of college players and 17% of high school players had excellent outcomes.

Limitations

The present study had several weaknesses, several of which are inherent to PRP studies conducted so far. It was not a prospective, randomized controlled trial. It is important to note that PRP treatment in diseased tissue may have some drawbacks, as its success depends on the ability of healing tissue to use concentrated growth factors and cytokines to proliferate.³⁵ Thus, a chronically injured ligament with depleted active cells may have a diminished response to PRP. Another limitation of this study is that we evaluated outcomes based on return to play using the Conway Scale, which is well reported but not validated. Despite the potential weaknesses of this outcome scale, it has become the benchmark for measuring the success of outcomes of UCL reconstruction. Furthermore, we did not measure patients’ satisfaction with the treatment. Players who could not return to their preinjury level of play may have considered the treatment a failure regardless of their ability to continue throwing. Last, MRI was not repeated to document ligament healing. We did not routinely perform a second MRI because we thought it would not affect treatment. Several series have found a high incidence of abnormal signal in baseball players’ UCLs. In this group of patients, the most important outcome is return to previous level of competition.

This study raised several questions. Is one PRP brand better than another? Should more than 1 injection be given? What is the ideal postinjection protocol? Clearly, larger, prospective, randomized controlled studies are needed to truly elucidate the potential role of PRP in the treatment algorithm for UCL injury. Nevertheless, in certain cases in which traditional conservative measures have failed and patients do not have the luxury of rehabilitating for 9 to 12 months after surgery, PRP may be a viable treatment option.

Conclusion

In this study, use of PRP in the treatment of UCL insufficiency produced outcomes much better than earlier reported outcomes of conservative treatment of these injuries. PRP injections may be particularly beneficial in young athletes who have sustained acute damage to an isolated part of the ligament and in athletes unwilling or unable to undergo the extended rehabilitation required after surgical reconstruction of the ligament.

Rotator cuff repairs (RCRs) can be challenging due to poor tendon quality and the inability of tendon to heal to bone. Smoking, age over 63 years, fatty infiltration, and massive cuff tears are all factors implicated in increased failure rates.^1-3 Tears >3 cm have a structural failure rate ranging from 11% to 95% in the literature.^1-5 Massive tears (tears >5 cm or involving 2 or more tendons) are even more complex and have failure rates of 20% to 90%.^5,6 The weakest link in the RCR construct is the suture-tendon interface, and suture pullout through the tendon is thought to be the most common method of failure.⁶ The purpose of this review is to examine whether literature supports the use of acellular dermal matrices (ADMs) in rotator cuff surgery.

The high rate of structural failures after RCR has led surgeons to seek means to augment repairs and new means of reconstruction for irreparable tears. Freeze dried allograft tendons have been used historically with mixed results, including reports of complete graft failures and foreign body reaction.^7-10 Porcine intestinal submucosal membrane “patches” gained popularity due to off-the- shelf availability of the graft. However, these were found to have poor outcomes with early graft rejection and intense inflammatory reaction.^11,12 Recently, ADMs have gained significant interest due to favorable biomechanical properties and clinical outcomes.^13-19

An ADM is an allograft composed of mostly type I collagen that is processed to remove donor cells while preserving the extracellular matrix. There are several commercially available ADMs with different methods of processing and sterilization, as well as handling characteristics.^20,21 In vivo studies have demonstrated that removing the cellular components allows infiltration of native cellular agents, such as fibroblasts, vascular tissue, and tenocytes, while causing minimal host inflammatory reaction.^21-23 In addition, superior suture pullout strength has been demonstrated by multiple benchtop and preclinical studies.^23,24 Therefore, ADMs play a dual role of strengthening the repair while allowing infiltration of host cells and growth factors to potentially promote healing at the repair site.

Emerging Evidence

Multiple biomechanical studies have evaluated ADMs in RC models.^24-28 Barber and colleagues²⁴ demonstrated that ADM had significantly higher loads to failure (229 N) than porcine skin (128 N), bovine skin (76 N), and porcine small intestine submucosa (32 N) (P < .001). In another study, Barber and colleagues²⁵ subsequently demonstrated, in a cadaver RC tear model, an increase in mean failure strength in augmented repairs with ADM (325 N) compared to cadaveric controls (273 N) (P = .047).

A subsequent study by Barber and Aziz-Jacobo²⁶ compared ADMs to a control model of allograft RC. The ADMs had significantly higher tensile modulus (P < .001) and higher suture retention measure by a single-pull destructive test of a simple vertical stitch (P < .05) than the RC allograft. The ultimate load to failure of the ADM model was higher than the RC allograft control (523±154 N vs 208±115 N); however, this difference did not reach statistical significance.²⁶ Beitzel and colleagues²⁷ evaluated ADM augmentation in a cadaver RC model and found a statistically significant increase in load to failure in ADM augmented repairs vs nonaugmented controls, (575.8 N vs 348.9 N, P = .025). Ely and colleagues²⁸ also demonstrated that repairs augmented with ADM had a higher load to failure (643 N vs 551 N) and less gap formation (2.2 mm vs 2.8 mm) compared to controls, although this difference was not statistically significant.

These biomechanical studies have been translated to clinical findings. A level II, prospective, randomized controlled study by Barber and colleagues²⁹ evaluated 42 patients with >3 cm, 2-tendon RCTs repaired arthroscopically.Twenty-two patients were randomized to single-row arthroscopic repair, and 20 patients to single-row arthroscopic repair augmented by ADM by an onlay technique (Figure 1) as described by Labbé.³⁰ At average follow-up of 24 months, 85% of the augmented repairs were intact on magnetic resonance imaging (MRI) at follow-up, compared to 40% in the control group (P < .05). Agrawal³¹ retrospectively reviewed 14 patients with either RCTs >3 cm or recurrent RCT (may be <3 cm) that were arthroscopically repaired with a double-row technique with ADM augmentation. Postoperative MRI obtained at average of 16.8 months revealed 85.7% of repairs to be intact, with 14.3% having recurrent tears of <1 cm. Rotini and colleagues³² evaluated a smaller subset of 5 patients with large/massive primary cuff tears, arthroscopically repaired with double-row technique and ADM augmentation. Follow-up MRI at an average of 1 year demonstrated 3 intact repairs, 1 partial recurrence, and 1 complete recurrence. These clinical studies demonstrate that RCRs augmented with ADM have a much higher rate of structural integrity on postoperative imaging compared to what has been previously reported in the literature.^1-6

Although an “off-label” indication, the use of ADM in massive RC tears has been described with good clinical results.^14,17,19,33 The ADM is used to bridge the gap by suturing it to the edge of the retracted tendon and anchoring it to the tuberosity (Figures 2A-2E). Improvement in pain, function, and active range of motion can be achieved. Burkhead and colleagues¹⁴ obtained postoperative MRIs at average follow-up of 1.2 years and found only 3 of 11 repairs with evidence of re-tear, all noted to be smaller than preoperative tears. Gupta and colleagues¹⁷ obtained postoperative ultrasounds in 24 patients at average 3 years and showed 76% of tears to be fully intact, with the remaining 24% having only a partial tear, and 0% with full re-tears. Venouziou and colleagues¹⁹ evaluated 14 patients with minimum 18-month follow-up and Kokkalis and colleagues³³ evaluated 21 patients with a 29-month follow-up; both described successful clinical outcomes but did not provide postoperative imaging evaluation. Multiple studies have adapted this technique to a fully arthroscopic method and have had similarly positive results clinically and with MRI.^{13,16,18,34,35} Bond and colleagues¹³ reported 16 cases with massive irreparable tears repaired arthroscopically with ADM to span the tendon gap. At an average follow-up of 26.8 months, 75% had good or excellent clinical results, and at an average of 1 year postoperatively 13 of 16 cases had an intact repair on gadolinium enhanced MRI.¹³ These studies suggest that ADM can be used for bridging massive irreparable RC tears with good clinical and radiographic outcomes.

Superior capsule reconstruction is a biomechanically proven concept that has been described in previous studies.^36,37 In the original technique, autologous tensor fascia lata (TFL) is anchored from the glenoid margin to the greater tuberosity footprint to restore the superior stability of the glenohumeral joint, without altering the native glenohumeral contact forces.³⁸ This concept has gained popularity in the United States, but with the use of an ADM instead of harvesting TFL (Figures 3A, 3B). However, there are no published biomechanical or clinical studies with the use of ADM in superior capsular reconstruction.

Conclusion

The use of ADM is an emerging solution for augmenting primary RCRs and the treatment of irreparable RC tears. The biomechanical and clinical studies summarized support the use of ADM in RC surgery. Further randomized studies are needed to add to the growing evidence on the use of ADMs.

Rotator cuff repairs (RCRs) can be challenging due to poor tendon quality and the inability of tendon to heal to bone. Smoking, age over 63 years, fatty infiltration, and massive cuff tears are all factors implicated in increased failure rates.^1-3 Tears >3 cm have a structural failure rate ranging from 11% to 95% in the literature.^1-5 Massive tears (tears >5 cm or involving 2 or more tendons) are even more complex and have failure rates of 20% to 90%.^5,6 The weakest link in the RCR construct is the suture-tendon interface, and suture pullout through the tendon is thought to be the most common method of failure.⁶ The purpose of this review is to examine whether literature supports the use of acellular dermal matrices (ADMs) in rotator cuff surgery.

The high rate of structural failures after RCR has led surgeons to seek means to augment repairs and new means of reconstruction for irreparable tears. Freeze dried allograft tendons have been used historically with mixed results, including reports of complete graft failures and foreign body reaction.^7-10 Porcine intestinal submucosal membrane “patches” gained popularity due to off-the- shelf availability of the graft. However, these were found to have poor outcomes with early graft rejection and intense inflammatory reaction.^11,12 Recently, ADMs have gained significant interest due to favorable biomechanical properties and clinical outcomes.^13-19

An ADM is an allograft composed of mostly type I collagen that is processed to remove donor cells while preserving the extracellular matrix. There are several commercially available ADMs with different methods of processing and sterilization, as well as handling characteristics.^20,21 In vivo studies have demonstrated that removing the cellular components allows infiltration of native cellular agents, such as fibroblasts, vascular tissue, and tenocytes, while causing minimal host inflammatory reaction.^21-23 In addition, superior suture pullout strength has been demonstrated by multiple benchtop and preclinical studies.^23,24 Therefore, ADMs play a dual role of strengthening the repair while allowing infiltration of host cells and growth factors to potentially promote healing at the repair site.

Emerging Evidence

Multiple biomechanical studies have evaluated ADMs in RC models.^24-28 Barber and colleagues²⁴ demonstrated that ADM had significantly higher loads to failure (229 N) than porcine skin (128 N), bovine skin (76 N), and porcine small intestine submucosa (32 N) (P < .001). In another study, Barber and colleagues²⁵ subsequently demonstrated, in a cadaver RC tear model, an increase in mean failure strength in augmented repairs with ADM (325 N) compared to cadaveric controls (273 N) (P = .047).

A subsequent study by Barber and Aziz-Jacobo²⁶ compared ADMs to a control model of allograft RC. The ADMs had significantly higher tensile modulus (P < .001) and higher suture retention measure by a single-pull destructive test of a simple vertical stitch (P < .05) than the RC allograft. The ultimate load to failure of the ADM model was higher than the RC allograft control (523±154 N vs 208±115 N); however, this difference did not reach statistical significance.²⁶ Beitzel and colleagues²⁷ evaluated ADM augmentation in a cadaver RC model and found a statistically significant increase in load to failure in ADM augmented repairs vs nonaugmented controls, (575.8 N vs 348.9 N, P = .025). Ely and colleagues²⁸ also demonstrated that repairs augmented with ADM had a higher load to failure (643 N vs 551 N) and less gap formation (2.2 mm vs 2.8 mm) compared to controls, although this difference was not statistically significant.

These biomechanical studies have been translated to clinical findings. A level II, prospective, randomized controlled study by Barber and colleagues²⁹ evaluated 42 patients with >3 cm, 2-tendon RCTs repaired arthroscopically.Twenty-two patients were randomized to single-row arthroscopic repair, and 20 patients to single-row arthroscopic repair augmented by ADM by an onlay technique (Figure 1) as described by Labbé.³⁰ At average follow-up of 24 months, 85% of the augmented repairs were intact on magnetic resonance imaging (MRI) at follow-up, compared to 40% in the control group (P < .05). Agrawal³¹ retrospectively reviewed 14 patients with either RCTs >3 cm or recurrent RCT (may be <3 cm) that were arthroscopically repaired with a double-row technique with ADM augmentation. Postoperative MRI obtained at average of 16.8 months revealed 85.7% of repairs to be intact, with 14.3% having recurrent tears of <1 cm. Rotini and colleagues³² evaluated a smaller subset of 5 patients with large/massive primary cuff tears, arthroscopically repaired with double-row technique and ADM augmentation. Follow-up MRI at an average of 1 year demonstrated 3 intact repairs, 1 partial recurrence, and 1 complete recurrence. These clinical studies demonstrate that RCRs augmented with ADM have a much higher rate of structural integrity on postoperative imaging compared to what has been previously reported in the literature.^1-6

Although an “off-label” indication, the use of ADM in massive RC tears has been described with good clinical results.^14,17,19,33 The ADM is used to bridge the gap by suturing it to the edge of the retracted tendon and anchoring it to the tuberosity (Figures 2A-2E). Improvement in pain, function, and active range of motion can be achieved. Burkhead and colleagues¹⁴ obtained postoperative MRIs at average follow-up of 1.2 years and found only 3 of 11 repairs with evidence of re-tear, all noted to be smaller than preoperative tears. Gupta and colleagues¹⁷ obtained postoperative ultrasounds in 24 patients at average 3 years and showed 76% of tears to be fully intact, with the remaining 24% having only a partial tear, and 0% with full re-tears. Venouziou and colleagues¹⁹ evaluated 14 patients with minimum 18-month follow-up and Kokkalis and colleagues³³ evaluated 21 patients with a 29-month follow-up; both described successful clinical outcomes but did not provide postoperative imaging evaluation. Multiple studies have adapted this technique to a fully arthroscopic method and have had similarly positive results clinically and with MRI.^{13,16,18,34,35} Bond and colleagues¹³ reported 16 cases with massive irreparable tears repaired arthroscopically with ADM to span the tendon gap. At an average follow-up of 26.8 months, 75% had good or excellent clinical results, and at an average of 1 year postoperatively 13 of 16 cases had an intact repair on gadolinium enhanced MRI.¹³ These studies suggest that ADM can be used for bridging massive irreparable RC tears with good clinical and radiographic outcomes.

Superior capsule reconstruction is a biomechanically proven concept that has been described in previous studies.^36,37 In the original technique, autologous tensor fascia lata (TFL) is anchored from the glenoid margin to the greater tuberosity footprint to restore the superior stability of the glenohumeral joint, without altering the native glenohumeral contact forces.³⁸ This concept has gained popularity in the United States, but with the use of an ADM instead of harvesting TFL (Figures 3A, 3B). However, there are no published biomechanical or clinical studies with the use of ADM in superior capsular reconstruction.

Conclusion

The use of ADM is an emerging solution for augmenting primary RCRs and the treatment of irreparable RC tears. The biomechanical and clinical studies summarized support the use of ADM in RC surgery. Further randomized studies are needed to add to the growing evidence on the use of ADMs.

Rotator cuff repairs (RCRs) can be challenging due to poor tendon quality and the inability of tendon to heal to bone. Smoking, age over 63 years, fatty infiltration, and massive cuff tears are all factors implicated in increased failure rates.^1-3 Tears >3 cm have a structural failure rate ranging from 11% to 95% in the literature.^1-5 Massive tears (tears >5 cm or involving 2 or more tendons) are even more complex and have failure rates of 20% to 90%.^5,6 The weakest link in the RCR construct is the suture-tendon interface, and suture pullout through the tendon is thought to be the most common method of failure.⁶ The purpose of this review is to examine whether literature supports the use of acellular dermal matrices (ADMs) in rotator cuff surgery.

The high rate of structural failures after RCR has led surgeons to seek means to augment repairs and new means of reconstruction for irreparable tears. Freeze dried allograft tendons have been used historically with mixed results, including reports of complete graft failures and foreign body reaction.^7-10 Porcine intestinal submucosal membrane “patches” gained popularity due to off-the- shelf availability of the graft. However, these were found to have poor outcomes with early graft rejection and intense inflammatory reaction.^11,12 Recently, ADMs have gained significant interest due to favorable biomechanical properties and clinical outcomes.^13-19

An ADM is an allograft composed of mostly type I collagen that is processed to remove donor cells while preserving the extracellular matrix. There are several commercially available ADMs with different methods of processing and sterilization, as well as handling characteristics.^20,21 In vivo studies have demonstrated that removing the cellular components allows infiltration of native cellular agents, such as fibroblasts, vascular tissue, and tenocytes, while causing minimal host inflammatory reaction.^21-23 In addition, superior suture pullout strength has been demonstrated by multiple benchtop and preclinical studies.^23,24 Therefore, ADMs play a dual role of strengthening the repair while allowing infiltration of host cells and growth factors to potentially promote healing at the repair site.

Emerging Evidence

Multiple biomechanical studies have evaluated ADMs in RC models.^24-28 Barber and colleagues²⁴ demonstrated that ADM had significantly higher loads to failure (229 N) than porcine skin (128 N), bovine skin (76 N), and porcine small intestine submucosa (32 N) (P < .001). In another study, Barber and colleagues²⁵ subsequently demonstrated, in a cadaver RC tear model, an increase in mean failure strength in augmented repairs with ADM (325 N) compared to cadaveric controls (273 N) (P = .047).

A subsequent study by Barber and Aziz-Jacobo²⁶ compared ADMs to a control model of allograft RC. The ADMs had significantly higher tensile modulus (P < .001) and higher suture retention measure by a single-pull destructive test of a simple vertical stitch (P < .05) than the RC allograft. The ultimate load to failure of the ADM model was higher than the RC allograft control (523±154 N vs 208±115 N); however, this difference did not reach statistical significance.²⁶ Beitzel and colleagues²⁷ evaluated ADM augmentation in a cadaver RC model and found a statistically significant increase in load to failure in ADM augmented repairs vs nonaugmented controls, (575.8 N vs 348.9 N, P = .025). Ely and colleagues²⁸ also demonstrated that repairs augmented with ADM had a higher load to failure (643 N vs 551 N) and less gap formation (2.2 mm vs 2.8 mm) compared to controls, although this difference was not statistically significant.

These biomechanical studies have been translated to clinical findings. A level II, prospective, randomized controlled study by Barber and colleagues²⁹ evaluated 42 patients with >3 cm, 2-tendon RCTs repaired arthroscopically.Twenty-two patients were randomized to single-row arthroscopic repair, and 20 patients to single-row arthroscopic repair augmented by ADM by an onlay technique (Figure 1) as described by Labbé.³⁰ At average follow-up of 24 months, 85% of the augmented repairs were intact on magnetic resonance imaging (MRI) at follow-up, compared to 40% in the control group (P < .05). Agrawal³¹ retrospectively reviewed 14 patients with either RCTs >3 cm or recurrent RCT (may be <3 cm) that were arthroscopically repaired with a double-row technique with ADM augmentation. Postoperative MRI obtained at average of 16.8 months revealed 85.7% of repairs to be intact, with 14.3% having recurrent tears of <1 cm. Rotini and colleagues³² evaluated a smaller subset of 5 patients with large/massive primary cuff tears, arthroscopically repaired with double-row technique and ADM augmentation. Follow-up MRI at an average of 1 year demonstrated 3 intact repairs, 1 partial recurrence, and 1 complete recurrence. These clinical studies demonstrate that RCRs augmented with ADM have a much higher rate of structural integrity on postoperative imaging compared to what has been previously reported in the literature.^1-6

Although an “off-label” indication, the use of ADM in massive RC tears has been described with good clinical results.^14,17,19,33 The ADM is used to bridge the gap by suturing it to the edge of the retracted tendon and anchoring it to the tuberosity (Figures 2A-2E). Improvement in pain, function, and active range of motion can be achieved. Burkhead and colleagues¹⁴ obtained postoperative MRIs at average follow-up of 1.2 years and found only 3 of 11 repairs with evidence of re-tear, all noted to be smaller than preoperative tears. Gupta and colleagues¹⁷ obtained postoperative ultrasounds in 24 patients at average 3 years and showed 76% of tears to be fully intact, with the remaining 24% having only a partial tear, and 0% with full re-tears. Venouziou and colleagues¹⁹ evaluated 14 patients with minimum 18-month follow-up and Kokkalis and colleagues³³ evaluated 21 patients with a 29-month follow-up; both described successful clinical outcomes but did not provide postoperative imaging evaluation. Multiple studies have adapted this technique to a fully arthroscopic method and have had similarly positive results clinically and with MRI.^{13,16,18,34,35} Bond and colleagues¹³ reported 16 cases with massive irreparable tears repaired arthroscopically with ADM to span the tendon gap. At an average follow-up of 26.8 months, 75% had good or excellent clinical results, and at an average of 1 year postoperatively 13 of 16 cases had an intact repair on gadolinium enhanced MRI.¹³ These studies suggest that ADM can be used for bridging massive irreparable RC tears with good clinical and radiographic outcomes.

Superior capsule reconstruction is a biomechanically proven concept that has been described in previous studies.^36,37 In the original technique, autologous tensor fascia lata (TFL) is anchored from the glenoid margin to the greater tuberosity footprint to restore the superior stability of the glenohumeral joint, without altering the native glenohumeral contact forces.³⁸ This concept has gained popularity in the United States, but with the use of an ADM instead of harvesting TFL (Figures 3A, 3B). However, there are no published biomechanical or clinical studies with the use of ADM in superior capsular reconstruction.

Conclusion

The use of ADM is an emerging solution for augmenting primary RCRs and the treatment of irreparable RC tears. The biomechanical and clinical studies summarized support the use of ADM in RC surgery. Further randomized studies are needed to add to the growing evidence on the use of ADMs.