Data from the Indian drug regulator and from Clinical Trials Registry-India does not always match.

Introduction: In India, regulatory trials, which require the drug regulator's permission, must be registered with the Clinical Trials Registry-India (CTRI) as of 19 March 2019. In this study, for about 300 trials, we aimed to identify the CTRI record that matched the trial for which the regulator had given permission. After identifying 'true pairs', our goal was to determine whether the sites and Principal Investigators mentioned in the permission letter were the same as those mentioned in the CTRI record. Methods: We developed a methodology to compare the regulator's permission letters with CTRI records. We manually validated 151 true pairs by comparing the titles, the drug interventions, and the indications. We then examined discrepancies in their trial sites and Principal Investigators. Results: Our findings revealed substantial variations in the number and identity of sites and Principal Investigators between the permission letters and the CTRI records. Discussion: These discrepancies raise concerns about the accuracy and transparency of regulatory trials in India. We recommend easier data extraction from regulatory documents, cross-referencing regulatory documents and CTRI records, making public the changes to approval letters, and enforcing oversight by Institutional Ethics Committees for site additions or deletions. These steps will increase transparency around regulatory trials running in India.

Low Rates of Postoperative Complications and Revision Surgery After Primary Medial Elbow Ulnar Collateral Ligament Repair.

Purpose: To evaluate the incidence of early postoperative complications and revision surgery in patients who underwent primary medial ulnar collateral ligament (MUCL) repair with minimum of 2-year follow-up. Methods: A retrospective review of a national insurance database was conducted to identify patients with MUCL injuries who underwent primary MUCL repair between 2015 to 2020 with minimum 2-year follow-up. Patients >40 years of age and those who had concomitant elbow fractures or dislocations, lateral UCL injures, medial epicondylitis, elbow arthritis, or a history of previous elbow injury/surgery were excluded. The number of patients who underwent a concomitant ulnar nerve procedure (transposition or decompression) during the primary MUCL repair was recorded. Complications within 90 days of surgery and the incidence and timing of subsequent ipsilateral ulnar nerve surgery or revision MUCL surgery were assessed. Results: A total of 313 patients (63.6% male) were included. The mean age was 20.3 ± 6.9 years, and mean follow-up was 3.7 ± 1.3 years. Concomitant ulnar nerve transposition or decompression was performed in 34.2% (N = 107). The early postoperative complication rate was 7.3% (N = 23). The most common complication was ulnar neuropathy (5.8%, N = 18). Wound complications, elbow stiffness, and medial epicondyle fractures were much less common (N = 5). Sixteen of 18 (88.9%) patients with postoperative ulnar neuropathy underwent transposition or decompression at the time of primary repair. Of these 18 patients, 5 (27.8%) underwent a subsequent ulnar nerve surgery (1 primary and 4 secondary), with the majority occurring within 6 months. The incidence of revision MUCL surgery was low (1.0%, N=3), with all 3 patients undergoing MUCL reconstruction. Conclusion: There was a low incidence of early postoperative complications (7.3%) and 2-year revision MUCL surgery (1.0%) in young patients who underwent primary MUCL repair with no additional ligamentous, fracture, and dislocation-related diagnoses. All 3 (1.0%) MUCL revisions underwent reconstruction. Level of Evidence: Level IV, therapeutic case series.

Increased Host Bone Marrow Edema on 6-Month MRI Is a Risk Factor for Osteochondral Allograft Failure.

PURPOSE: To evaluate the presence of host bone marrow edema (BME) surrounding osteochondral allograft (OCA) plugs on routine 6-month postoperative magnetic resonance imaging (MRI) and to determine whether such BME is correlated with subsequent failure. METHODS: The present study was approved under our institutional review board-approved database (#2020-2123). We included patients who underwent cartilage repair with OCA for focal chondral and osteochondral defects of the distal femur by 2 senior surgeons between January 2016 and May 2021 with minimum 2-year follow-up. OCA is frequently performed with concomitant procedures, and therefore ligament reconstruction, meniscal surgery, and osteotomy were not exclusion criteria. Failure was defined as (1) poor clinical outcome with graft collapse on follow-up MRI or second-look arthroscopy, (2) primary OCA removal or revision, or (3) conversion to unicompartmental or total knee arthroplasty. Routine MRI scans were performed at 6 ± 2 months postoperatively. All postoperative MRI scans were reviewed from our imaging record by 2 blinded fellowship-trained orthopaedic surgeons. Patients were divided for analyses into 2 groups: BME ≥10 cm3 versus BME <10 cm3. RESULTS: Of the 85 patients eligible for the study, 56 patients (30 female, mean age 31.69 ± 11.34 years) had a minimum 2-year follow-up. Nonfailure cases had a mean clinical follow-up of 3.13 ± 0.93 years. The mean time from surgery to failure in our cohort was 1.67 ± 0.91 years. There were 12 (21.4%) patients with BME ≥10 cm³ and 44 (78.6%) patients with BME <10 cm³. No statistically significant differences were found between groups when compared for sex, age, body mass index, OCA size, time to MRI, mean follow-up, number of plugs, graft location, diagnosis, previous surgeries, or concomitant procedures. All OCA failures of the study cohort were in the BME ≥10 cm³ group, representing 50% of this group (P < .001). Kaplan-Meier survival analysis with the log-rank test demonstrated significant difference in survival distributions between groups (P < .001). Patients who ultimately failed had a mean BME volume of 18.49 ± 5.82 cm3, while the nonfailure group had a mean volume of 4.66 ± 4.97 cm3 (P < .001). Cutoff values around 10 cm³ in receiver operating characteristic curve analysis demonstrated 100% sensitivity and close to 90% specificity for OCA failure diagnosis. CONCLUSION: Host BME with a volume greater than 10 cm³ on 6-month postoperative MRI is predictive of an increased subsequent failure rate after OCA transplantation with a failure rate of 50%. LEVEL OF EVIDENCE: Level III, cohort study.

Editorial Commentary: Nonoperative Management Is the First Line of Treatment for Hip Femoroacetabular Impingement in Adolescents: Children Are Not Little Adults!

Adult patients undergoing hip arthroscopy who experience preoperative symptoms for a longer duration have worse outcomes postoperatively compared with those symptomatic for a shorter duration. Ongoing femoroacetabular impingement (FAI) may lead to worse damage that may not be fully reparable and could be used as evidence for early surgery. However, the same reasoning may not be applicable to adolescents for whom nonoperative treatment remains the first line of treatment for FAI. Many newly symptomatic FAI patients may actually have biomechanically treatable pathology of their hip, core, or spine, making their FAI symptomatic, and if these biomechanical factors can be corrected, the FAI may become asymptomatic. Patients with low pelvic incidence are "hip users" who compensate for their pelvic issue by increasing hip range of motion, making them more prone to symptomatic FAI and leading to degenerative changes from impingement. Only after failure to improve after a full course of physical therapy is established should adolescent patients and parents be counseled on hip arthroscopy as an appropriate treatment option.

Representation from India in multinational, interventional, phase 2 or 3 trials registered in Clinical Trials Registry-India: A cross-sectional study.

In multinational trials that have run in India, we wished to determine whether there was too much (60% or higher) recruitment from India. We downloaded all trial records from Clinical Trials Registry-India, CTRI, and stored them in a local SQLite database. We queried records registered in a recent 8-year period, ie 2013-2020 and evaluated the fraction of local participants in interventional Phase 2 or Phase 3 studies. 62 trials were completed, with completion dates available. Five trials (8%) had 60% or more planned recruitment from India. Four of the five (7% of 62) had a foreign sponsor, and therefore there was an unfair burden-benefit ratio on the Indian population. Seven trials (11%), of which six (10% of 62) had foreign sponsors, had 60% or more (of the total) actual recruitment from India, and for two trials (both with foreign sponsors), the data were meaningless. There were 362 studies that were listed as not completed, although, given their start date and estimated duration, some of them ought to have been. Twenty five cases (7% of 362) had 60% or more planned recruitment from India. Of these, 18 (5% of 362) had foreign sponsors and were potentially problematic. Even allowing for some delays in completion, 128 (35% of 362) studies ought to have been completed by the time of our study. As such, we identified several problematic trials for which the planned recruitment from India in multinational studies was 60% or more. We also identified trials in which the actual recruitment was significantly higher than the planned recruitment. Further, the records of several studies that were probably completed were not updated in CTRI in a timely manner. The Indian drug regulator needs to be particularly alert to the planned, or actual, over-recruitment of participants from India. Further, CTRI, alone or in collaboration with the regulator, needs to ensure that multinational trial records for the enrollment fields in particular are updated, in a timely manner.

Ethnic representation in interventional clinical trials run in India.

Globally, the need to enhance the diversity of trial participants is receiving increasingly urgent attention. We wanted to know whether trials run in India had adequately sampled the country's enormous ethnic diversity. We accessed the Clinical Trials Registry-India website to determine whether each interventional drug or biologic Phase 2 or 3 study, registered in a recent five-year period had run in each of six geographic zones. As regards Phase 3 trials conducted only in India, 61.4% ran in a single zone and just 6.8% were conducted in all six zones. Multinational Phase 3 trials had a better distribution since 3.6% had run in just one zone and 7.1% in all six. India's diverse ethnic groups are underrepresented in the majority of trials covered in this study. A trial that is conducted on non-representative groups and later discovered to be harmful or ineffective in parts of the population, is unethical. We propose various remedial steps.

Unreported protocol deviations - The tip of the research-berg.

Introduction: Failure to stay within an ethics committee (EC)-approved protocol limits is termed protocol deviation or violation (PD/PV), depending on the seriousness of the transgression and its attendant risks and/or harms. PD/PVs arise in the post-approval phase of the research and are often missed. Current guidelines expect ECs to detect, report and recommend suitable actions such that research participants' risks and harms are mitigated, to the extent possible. Objective: Yenepoya Ethics Committee-1 conducted an internal audit of ongoing postgraduate dissertations involving human participants to assess the occurrence of PD/PVs. Materials and Methods: 54 out of 80 postgraduates responded to our request for filling out a self-reported checklist. These responses were followed up with physical verification of the protocol-related documents. Results: Protocol transgressions were classified as non-compliance (administrative issues), protocol deviations (minor transgressions with minimal or less than minimal increase in attendant risk to participants) and protocol violations (serious transgressions with more than minimal increase in attendant risk to participants). The non-compliances included non-reporting for audit and non-reporting of PDs. Protocol deviations included non-conformance to EC validity, sample size, approved methodology, informed consent process and documentation and suboptimal data storage. No protocol violations were observed. Conclusion: We report PD/PVs from these 54 protocols - with our assessment on the negative impact it may have on scientific validity, harm to participants, EC functioning and credibility of the institution - in the hope that our readers appreciate this important aspect of the post-approval process in the functioning of an EC.

No Difference in Complication or Reoperation Rates Between Arthroscopic and Open Debridement for Lateral Epicondylitis: A National Database Study.

PURPOSE: To compare complication rates and 5-year reoperation rates between open debridement (OD) and arthroscopic debridement (AD) for lateral epicondylitis. METHODS: The PearlDiver MUExtr database (2010-2019) was reviewed for patients diagnosed with lateral epicondylitis (queried by International Classification of Diseases, Ninth Revision and International Classification of Diseases, Tenth Revision [ICD-10] codes) undergoing OD or AD of the common extensor tendon without repair (queried by Current Procedural Terminology codes). Patients were stratified into 2 cohorts: those who underwent AD and those who underwent OD. Nonoperative treatment modalities were reported for both groups within 1 year before index procedure. The rates of 90-day postoperative complications were compared, and multivariate logistic regression analysis was used to identify risk factors for complications. The 5-year reoperation rates, using laterality-specific ICD-10 codes, were also compared between the 2 groups. RESULTS: In total, 19,280 patients (OD = 17,139, AD = 2,141) were analyzed in this study. The most common nonoperative treatments for patients who underwent OD or AD were corticosteroid injections (49.5% vs 43.2%), physical therapy (24.8% vs 25.7%), bracing (2.8% vs 3.2%), and platelet-rich plasma injections (1.3% vs 1.0%). There were no significant differences in radial nerve injuries, hematomas, surgical site infections, wound dehiscence, and sepsis events between the 2 procedures (P = .50). The 5-year reoperation rate was not significantly different between the AD (5.0%) and OD (3.9%) cohorts (P = .10). CONCLUSIONS: For lateral epicondylitis, both AD and OD of the extensor carpi radialis brevis (without repair) were found to have low rates of 90-day adverse events, with no significant differences between the 2 approaches. Similarly, the 5-year reoperation rate was low and not statistically different for those treated with OD or AD. LEVEL OF EVIDENCE: Level III, cross-sectional study.

The Outcome of Hip Arthroscopy in the Setting of Lumbar Spine Disease Is Beneficial, Yet Limited: A Systematic Review of Existing Evidence.

PURPOSE: To compare hip arthroscopy outcomes in femoroacetabular impingement (FAI) patients with concurrent symptomatic lumbar spine disease to the outcomes of arthroscopic FAI patients without spine disease. METHODS: A systematic review was performed according to PRISMA guidelines via PubMed, Cochrane, Embase, and Google Scholar databases. Studies were valid for inclusion if they had an average follow-up ≥12 months and compared patient-reported outcome measures (PROMs) in hip arthroscopy patients with and without concurrent spinal disease. Data collected included study characteristics, patient demographics, follow-up intervals, surgical indications, spinal pathology, PROMs, and reoperation rates. RESULTS: Twelve studies were included in this systematic review. 3,107 patients who underwent hip arthroscopy were evaluated: 1,056 with coexisting lumbar spine disease (spine cohort) and 2,051 control subjects without spine disease (control cohort). The average follow-up period was 24 months. Across included studies, there were 35 instances wherein postoperative PROM scores reported by each cohort were compared. In all 35 instances, the spine cohort reported inferior postoperative PROM scores with the difference being significant (P < .05) on 23 PROMs. Collectively, 23 cases were available contrasting the proportion of each cohort to achieve the minimal clinically important difference (MCID). In 22 (95.65%) of these cases, the spine cohort achieved the MCID at a lower rate than the control cohort. There were 14 PROMs, wherein intragroup analyses were reported that compared the preoperative and postoperative score reported by the spine cohort. On all 14 PROMs, the spine cohort reported significant (P < .05) improvement after arthroscopic intervention. CONCLUSION: FAI patients with coexisting lumbar spine pathology experience significant improvement from baseline state after arthroscopic intervention. However, the postoperative outcomes reported are inferior, and the improvement from arthroscopy was limited when compared to surgical control subjects with FAI and normal spinal anatomy. LEVEL OF EVIDENCE: Level IV: systematic review of Level II, III, and IV studies.

Open Debridement Alone Versus Open Debridement With Tendon Repair for Lateral Epicondylitis: A Comparison of Complications and 5-Year Reoperation Rates From a Large Insurance Database.

Background: Open debridement (OD) of the extensor carpi radialis brevis tendon, both with and without repair to the lateral epicondyle, are effective treatments for recalcitrant lateral epicondylitis. However, few comparative studies exist within the literature. Purpose: To (1) compare the 5-year reoperation rates of patients who underwent OD alone versus OD with tendon repair (ODR) and (2) identify the 90-day adverse event rates, total same-day reimbursement amounts, and national usage trends for these 2 procedures from 2010 to 2019. Study Design: Cohort study; Level of evidence, 3. Methods: The PearlDiver MUExtr database was reviewed for patients diagnosed with lateral epicondylitis who underwent OD alone and ODR or reattachment between January 2010 and December 2019. These patients were stratified into 2 cohorts: the OD cohort and ODR cohort. The 5-year reoperation rates were assessed and compared, and the incidence of 90-day postoperative complications and risk factors were identified. The number of ODs and ODRs performed each year and the mean same-day reimbursement amounts (in US$) for both procedures were assessed. Results: Overall, 41,932 lateral epicondylitis patients who underwent debridement were identified, with 17,139 OD patients and 24,793 ODR patients. There were no significant changes in the proportion of OD versus ODR procedures performed during the study period (P = .18). A significantly higher incidence of hematoma was seen after OD compared with ODR (0.19% vs 0.12%; P = .04), but ODR had a significantly lower 5-year reoperation rate than OD (2.8% vs 3.9%; P = .006), with an absolute risk reduction of 1.1% and a number needed to treat of 91. Finally, ODR ($1683.17 ± $12.15) had a higher mean same-day reimbursement than OD ($1479.05 ± $15.78) (P = .001). Conclusion: Both OD and ODR had low complication rates. The 5-year reoperation rates were low for both procedures, but they were significantly higher for OD. Over the 10-year study period, there were no significant changes in the relative percentages of OD versus ODR performed. ODR had a significantly higher mean same-day reimbursement.

Medial Ulnar Collateral Ligament Injuries in Contact Athletes.

PURPOSE OF REVIEW: The purpose of this article is to review medial ulnar collateral ligament (UCL) injuries in contact athletes. UCL injuries in overhead throwing athletes are typically chronic attenuation due to repetitive valgus stress on the elbow during the throwing motion. As such, UCL reconstruction is commonly performed for these athletes. In contrast, UCL injuries in contact athletes are usually acute ligament tears or avulsions of a ligament with otherwise normal tissue. Nonoperative treatment is typically the first-line treatment for partial injuries. UCL repair may work well for acute complete injuries and may avoid the donor site morbidity of UCL reconstruction. RECENT FINDINGS: Most of the literature regarding UCL injuries have been performed in baseball players. Historically, UCL repair has had poor outcomes in baseball players due to the chronic ligament attenuation. Therefore, much of the recent literature has focused on outcomes of UCL reconstruction, which are generally excellent. However, there is a paucity of literature studying outcomes of UCL injuries in contact athletes and those studying UCL repair. One recent study looked at a new technique for UCL repair with collagen-coated fiber tape augmentation in baseball players and found good short-term outcomes. UCL injuries in contact athletes occur typically as acute tears or avulsions. While UCL reconstruction has typically been recommended as the accepted treatment for UCL tears that require operative treatment, UCL repair may be a good alternative in contact athletes.

Hip-Spine Syndrome in the Nonarthritic Patient.

Hip-spine syndrome refers to concurrent hip and spine pathology with overlapping symptoms. Most of the literature has studied it in relation to total hip arthroplasty literature and has been shown to increase dislocation risk. Lumbar spine and pelvic mobility have been studied less frequently in relation to nonarthritic pathologic hip states. Understanding the biomechanical relationship between the lumbar spine, pelvis, and hip can help elucidate how hip-spine syndrome affects the nonarthritic hip and how it impacts outcomes of hip arthroscopy. Changes in lumbar spine motion may be the reason certain predisposed patients develop symptomatic femoroacetabular impingement (FAI) or ischiofemoral impingement. Some athletes may be "hip users" with a low pelvic incidence, making them more reliant on hip motion due to less-intrinsic lumbopelvic motion. When these patients have FAI morphology, their increased reliance on hip motion makes them prone to experiencing femoroacetabular contact and concurrent symptoms. Other athletes may be "spine users," with larger pelvic incidence and more baseline lumbopelvic motion, making them less reliant on hip motion and therefore less prone to experiencing hip impingement even with hip FAI morphology. Hip-spine syndrome also appears to have an impact on patient selection, role of nonoperative treatment, and hip arthroscopy surgical outcomes. Identifying patients with concurrent pathology may allow surgeons to recommend targeted physical therapy or counsel patients better on their expectations after surgery.

Hypertrophy of the sublime tubercle in elbow ulnar collateral ligament injuries: a case series of baseball pitchers undergoing ulnar collateral ligament reconstruction with short-term follow-up.

Background: The ulnar collateral ligament (UCL) of the elbow is subject to repetitive stress in overhead throwing athletes. This can lead to morphologic changes at the bony attachments of the UCL and hypertrophy of the sublime tubercle. The purpose of this case series is to describe the surgical details and clinical outcomes of a series of competitive baseball pitchers with hypertrophic sublime tubercles who underwent UCL reconstruction (UCLR). Methods: All baseball pitchers who were treated for UCL injuries with significant hypertrophy of the sublime tubercle on preoperative imaging were included in the series. Clinical history, preoperative imaging, intraoperative findings during UCLR, and postoperative outcomes measured with the Conway scale were described. Results: Ten players (average age of 22.9 years [range 13-39]) were included (average follow-up 20.4 months [range 3-38 months]). Five patients also had symptoms of ulnar nerve compression, with 4 requiring transposition at the time of ULCR and 1 at 3 months postoperatively. Bony hypertrophy of the sublime tubercle was confirmed intraoperatively in all cases and excised before UCLR with the docking technique. Of the 7 patients with at least 12-month follow-up postoperatively, 6 had excellent outcomes, and 1 had a fair outcome. Conclusion: Although UCLR in the setting of hypertrophic sublime tubercle can be more complex than typical UCLR, excellent outcomes are achievable with preoperative recognition and surgical planning.

Non-anatomic tunnel position increases the risk of revision anterior cruciate ligament reconstruction.

PURPOSE: Anterior cruciate ligament (ACL) graft failure is a complication that may require revision ACL reconstruction (ACL-R). Non-anatomic placement of the femoral tunnel is thought to be a frequent cause of graft failure; however, there is a lack of evidence to support this belief. The purpose of this study was to determine if non-anatomic femoral tunnel placement is associated with increased risk of revision ACL-R. METHODS: After screening all 315 consecutive patients who underwent primary single-bundle ACL-R by a single senior orthopedic surgeon between January 2012 and January 2017, 58 patients were found to have both strict lateral radiographs and a minimum of 24 months follow-up without revision. From a group of 456 consecutive revision ACL-R, patients were screened for strictly lateral radiographs and 59 patients were included in the revision group. Femoral tunnel placement for each patient was determined using a strict lateral radiograph taken after the primary ACL-R using the quadrant method. The center of the femoral tunnel was measured in both the posterior-anterior (PA) and proximal-distal (PD) dimensions and represented as a percentage of the total distance (normal center of anatomic footprint: PA 25% and PD 29%). RESULTS: In the PA dimension, the revision group had significantly more anterior femoral tunnel placement compared with the primary group (38% ± 11% vs. 28% ± 6%, p < 0.01). Among patients who underwent revision; those with non-traumatic chronic failure had statistically significant more anterior femoral tunnel placement than those who experienced traumatic failure (41% ± 13% vs. 35% ± 8%, p < 0.03). In the PD dimension, the revision group had significantly more proximal femoral tunnel placement compared with the primary group (30% ± 9% vs 38% ± 9%, p < 0.01). CONCLUSION: In this retrospective study of 58 patients with successful primary ACL-R compared with 59 patients with failed ACL-R, anterior and proximal (high) femoral tunnels for ACL-R were shown to be independent risk factors for ACL revision surgery. As revision ACL-R is associated with patient- and economic burden, particular attention should be given to achieving an individualized, anatomic primary ACL-R. Surgeons may reduce the risk of revision ACL-R by placing the center of the femoral tunnel within the anatomic ACL footprint. LEVEL OF EVIDENCE: Level III.

Failure rates and clinical outcomes after treatment for long-head biceps brachii tendon pathology: a comparison of three treatment types.

HYPOTHESIS/BACKGROUND: Treatment options for the biceps brachii tendon include tenotomy, arthroscopic tenodesis, and open tenodesis. Few studies to date have compared all treatment options in the context of a rotator cuff repair. METHODS: A retrospective review of 100 patients who underwent arthroscopic supraspinatus repair between 2013 and 2018 with a minimum of one-year follow-up was performed. Patients were separated into the following 4 groups: (1) 57 had isolated supraspinatus repair with no biceps tendon surgery (SSP); (2) 16 had supraspinatus repair and biceps tenotomy; (3) 18 had supraspinatus repair and arthroscopic biceps tenodesis; (4) 9 had supraspinatus repair and an open biceps tenodesis (SSP + OT). The primary outcome was operative time. The secondary outcomes were cost analysis, complications, patient-reported outcome measures, range of motion, and strength testing. RESULTS: The operative time for the SSP + OT group was significantly longer than that of the SSP group (P < .05) but was not significantly longer than that of the other groups. The cost for the SSP group was significantly less than the cost for the SSP + OT and supraspinatus repair and arthroscopic biceps tenodesis groups (P < .05 for both), whereas the cost for the supraspinatus repair and biceps tenotomy group was significantly less than the cost for the SSP + OT group (P < .05). There were no significant differences between groups for complications, all patient-reported outcome measues, all range of motion, and all strength parameters. DISCUSSION/CONCLUSION: Operative time is the longest in open biceps tenodesis and is significantly longer than that of isolated supraspinatus repair. No significant differences in operative times or costs were identified in patients undergoing arthroscopic vs. open biceps tenodesis. All patients, irrespective of the type of biceps tendon procedure, had excellent clinical and functional outcomes at least one year after surgery. There was no difference in clinical or functional outcomes, or complications, among the 4 groups.

Glenoid Radius of Curvature and Humeral Head Volume Are Associated With Postoperative Dislocation After Arthroscopic Bankart Repair.

PURPOSE: To measure bony morphologic parameters and identify their association with arthroscopic Bankart repair failure. METHODS: This was a retrospective comparative study. The inclusion criteria were primary arthroscopic Bankart repair, no prior shoulder surgery, traumatic cause, and had a Bankart (soft tissue and bony) lesion evident on magnetic resonance imaging (MRI). The exclusion criteria were posterior labral pathology, multidirectional instability, connective tissue disorder, rotator cuff pathology, and those who underwent concomitant shoulder procedures. Patients who had a postoperative redislocation (unstable group) were compared with matched patients who did not (stable group). Data were obtained by chart review and from preoperative MRI. Comparisons were made using the Student t test, Fisher exact test, or χ2 test. Statistical significance was defined as P < .05. Inter-rater reliability was measured between reviewers. RESULTS: A total of 45 patients experienced a postoperative dislocation and were matched to 90 patients without a postoperative dislocation. There were no differences in demographic and radiographic variables. The radius of curvature (ROC) of the glenoid was larger (shallower) in the unstable group (23.6 mm vs 22.6 mm, P = .05). The humeral head volume (HHV) trended higher in the unstable group (68.9 mL vs 62.9 mL, P = .06). The glenoid volume was not significantly different. A greater percentage of patients with a glenoid ROC of 24.5 mm or greater (62.1% vs 26.4%, P = .0003) and an HHV of 80 mm3 or greater (60.8% vs 28.9%, P = .003) experienced a redislocation compared with patients without these factors. Patients with a glenoid ROC of 24.5 mm or more and an HHV of 80 mm3 or more had greater than 4 times the odds of redislocation (odds ratio, 4.56; 95% confidence interval, 1.44-14.43; P = .0098). Strong inter-rater reliability was found for the HHV, glenoid volume, glenoid ROC, and humeral head ROC measurements (r = 0.94, r = 0.88, r = 0.89, and r = 0.95, respectively). CONCLUSIONS: This study shows that large ROC (shallow) glenoids in conjunction with large humeral heads may predispose patients to failure after arthroscopic Bankart repair. LEVEL OF EVIDENCE: Level III, retrospective comparative trial.

Risk Factors Associated With Complications After Operative Treatment of Multiligament Knee Injury.

BACKGROUND: Many factors can affect clinical outcomes and complications after a complex multiligament knee injury (MLKI). Certain aspects of the treatment algorithm for MLKI, such as the timing of surgery, remain controversial. PURPOSE: To determine the risk factors for common complications after MLKI reconstruction. STUDY DESIGN: Case-control study; Level of evidence, 3. METHODS: A retrospective review was conducted on 134 patients with MLKI who underwent reconstruction between 2011 and 2018 at a single academic center. Patients included in the review had a planned surgical reconstruction of >1 ligament based on clinical examination and magnetic resonance imaging. Complications were categorized as (1) wound infection requiring irrigation and debridement, (2) arthrofibrosis requiring manipulation under anesthesia and/or lysis of adhesions, (3) deep venous thrombosis, (4) need for removal of hardware, and (5) revision ligament surgery. The potential risk factors for complications included patient characteristics, injury pattern categorized according to Schenck classification (knee dislocation [KD] I-KD IV), and timing of surgery. Significant risk factors for complications were analyzed by t test, chi-square test, and Fisher exact test. RESULTS: A total of 108 patients met the inclusion criteria; of these, 29.6% experienced at least 1 complication. Smoking (odds ratio [OR], 3.20 [95% CI, 1.28-8.02]; P = .01) and planned staged surgery (OR, 2.71 [95% CI, 1.04-7.04]; P = .04) significantly increased the overall risk of complication, while increased time from injury to surgery (OR, 0.99 [95% CI, 0.98-0.998]; P < .01) significantly decreased the risk. Increasing time from injury to surgery (OR, 0.99 [95% CI, 0.97-0.998]; P = .02) also led to a slightly but significantly decreased risk for arthrofibrosis. CONCLUSION: The study findings suggest that smoking, decreased time from injury to initial surgery, and planned staged procedures may increase the rate of complications. Further studies are needed to determine which changes in the treatment algorithm are most effective to reduce the complication rate in patients.

Repair of high-grade partial thickness supraspinatus tears after surgical completion of the tear have a lower retear rate when compared to full-thickness tear repair.

PURPOSE: High-grade partial thickness rotator cuff tears (i.e., those involving at least 50% of the tendon thickness) are especially challenging to treat and various treatment strategies have been described. Prior studies have demonstrated equivalent outcomes between in situ tear fixation and tear completion repair techniques. However, it is unknown how repair of completed high-grade partial thickness tears to full tears compares to repair of full-thickness tears. The purpose of this study was to compare clinical outcome measures at least 1 year postoperatively between patients who had completion of a high-grade partial thickness supraspinatus tear to a full-thickness tear (PT) and those who had an isolated full-thickness supraspinatus tear (FT). The hypothesis of this study was equivalent retear rates as well as equivalent clinical and patient-reported outcomes between the two groups. METHODS: A retrospective review of 100 patients who underwent isolated arthroscopic supraspinatus repair between 2013 and 2018 with a minimum of 1 year follow-up was performed. Patients were separated into two groups based on their treatment: 56 had completion of a partial thickness supraspinatus tear to full-thickness tear with repair (PT) and 44 had isolated full-thickness supraspinatus repairs (FT). The primary outcome was rotator cuff retear, which was defined as a supraspinatus retear requiring revision repair. Secondary outcomes were patient-reported outcome measures (PROs) including visual analog pain scale (VAS) and subjective shoulder value (SSV), range of motion (ROM) and strength in forward flexion (FF), external rotation (ER), and internal rotation (IR). RESULTS: There was a significantly lower rate of retear between the PT versus FT groups (3.6% vs. 16.3%, p = 0.040). There were no significant differences between groups for all PROs, all ROM parameters, and all strength parameters (all n.s.). DISCUSSION: The data from this study demonstrated that the PT group had a significantly lower retear rate at 1 year follow-up than the FT group, while PROs, ROM, and strength were similar between the two groups. Patients with PT supraspinatus tears can have excellent outcomes, equivalent to FT tears, after completion of the tear, and subsequent repair with low retear rates. These findings may aid the treating surgeon when choosing between in situ fixation of the PT supraspinatus tear or completion of the tear and subsequent repair, as it allows the treating surgeon to choose the procedure based on comfort and experience level. LEVEL OF EVIDENCE: Level III.

Risk Factors for Revision Posterior Shoulder Stabilization in Throwing Athletes.

BACKGROUND: Revision posterior shoulder capsulolabral repair has inferior outcomes compared with primary surgery. Risk factors for revision in throwing athletes are unknown. PURPOSE/HYPOTHESIS: The purpose of this study was to characterize the revision rate and risk factors for revision surgery in throwing athletes. It was hypothesized that female athletes and those with smaller glenoid bone width would be at higher risk for revision surgery. STUDY DESIGN: Case-control study; Level of evidence, 3. METHODS: A total of 105 throwing athletes who underwent arthroscopic posterior capsulolabral repair of their throwing shoulder were reviewed at a minimum of 2-year follow-up, and patients who required a revision were compared with those who did not. Collected data compared between the revision and no-revision groups included age, sex, contact sport participation, and return to sport (RTS). American Shoulder and Elbow Surgeons (ASES) score, Kerlan-Jobe Orthopaedic Clinic (KJOC) score, stability, pain, strength, range of motion (ROM), and patient satisfaction. Radiographic parameters including glenoid bone version, cartilage version, labral version, bone width, labral width, glenoid labral version and width weight were also compared between both groups. RESULTS: Nine throwers required revision (8.6%) at an average of 2.8 years postoperatively. There were more female athletes in the revision than no-revision group (55.5% vs 23.4%; P = .03). There was no significant difference in age, proportion of contact athletes, rotator cuff tears, glenoid bone version, cartilage version, labral version, labral version weight, bone width, labral width, or labral width weight. Both groups had similar preoperative, postoperative, and change in ASES, KJOC, pain, strength, stability, and ROM scores. The proportion of patients with full strength and with full ROM, as well as patients who were satisfied with outcomes was similar between groups. Fewer patients in the revision group returned to sports compared with those in the no-revision group (14.3% vs 83.6%; P < .001), although return to sports at same level was not significantly different between groups (14.3% vs 37.2%; P = .41). CONCLUSION: The revision rate of arthroscopic posterior shoulder stabilization in throwers was 8.6%. Female athletes were at higher risk for revision, and return to sports was lower in patients who underwent revision surgery.

Anterior Cruciate Ligament Reconstruction With a Partial-Thickness Quadriceps Tendon Graft Secured With a Continuous-Loop Fixation Device.

Anterior cruciate ligament reconstruction using quadriceps tendon (QT) autograft has recently gained popularity because newer techniques allow harvest of a robust graft with little soft-tissue dissection or donor-site morbidity. The QT graft can provide a safe, reproducible, and versatile option for primary and revision anterior cruciate ligament reconstruction with equivalent outcomes and failure rates to those of bone-patellar tendon-bone and hamstring tendon grafts. Therefore, continued improvement in surgical technique may help to further improve patient outcomes. This study introduces a modification of current QT techniques using a partial-thickness graft with continuous-loop EndoButton fixation (Smith & Nephew, Andover, MA).