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.

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.

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.

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.

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.

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.

Labral Morphology and Number of Preoperative Dislocations Are Associated With Recurrent Instability After Arthroscopic Bankart Repair.

PURPOSE: To develop a method to measure capsule and labral volume on preoperative magnetic resonance imaging to predict surgical failure after primary Bankart repair. METHODS: A retrospective case-control study was conducted on patients undergoing primary anterior arthroscopic shoulder stabilization. Surgical failure was defined as a recurrent dislocation event. Cases were matched to controls based on age and sex in a 1:2 ratio. Preoperative magnetic resonance (MR) arthrograms were analyzed by 2 trained reviewers using Vitrea software to measure labral and capsular volume with a 3-dimensional model. Labral size was also qualitatively measured on axial images. A "diffusely small" labrum was defined as labral height less than the width of the glenoid tidemark cartilage. RESULTS: Of the 289 patients who had an arthroscopic Bankart repair from 2006 to 2015, 33 who had a postoperative dislocation met the inclusion criteria and were matched to 62 control patients who did not. There was no difference between groups with regard to age (P = .88), sex (P = .82), contact sport participation (P = .79), proportion of overhead athletes (P = .33), proportion of throwers (P = 1), surgical positioning in lateral decubitus (P = .18), or number of repair anchors used (P = .91). The average number of preoperative dislocations was significantly higher in the failure group (3.2 vs. 2.0, P < .0001). In patients with normal labrum morphology, the odds of having surgical failure increased by 26% for a 1-unit increase in the number of prior dislocations (odds ratio [OR] 1.26, 95% confidence interval [CI] 1.02 to 1.55). The case and control groups had similar labral and capsular volume as measured in Vitrea. The failure group had a significantly higher proportion of patients with a diffusely small labral morphology (47% vs. 17%, P = .03). Controlling for number of preoperative dislocations, the odds of having a diffusely small labral morphology was 3.2 times more likely in the case group than the control group (95% CI 1.259 to 8.188). Interrater reliability between 2 independent reviewers was excellent for measurement of capsule volume (r = 0.91) and good for measurement of labral volume (r = 0.74). CONCLUSIONS: This study presents a novel method of measuring labral and capsule volume with high interrater reliability. An increased number of recurrent dislocations prior to primary Bankart repair was associated with increased odds of recurrent instability after surgery. The OR for failure also increased with increasing number of preoperative dislocations. Diffusely small labral morphology was associated with having a postoperative redislocation. LEVEL OF EVIDENCE: III (case-control study).

Knee Flexion Angle During Graft Fixation for Medial Patellofemoral Ligament Reconstruction: A Systematic Review of Outcomes and Complications.

PURPOSE: To determine the effect of knee flexion angle during graft fixation on outcomes and complications following medial patellofemoral ligament (MPFL) reconstruction. METHODS: Three databases (PubMed, EMBASE, and MEDLINE) were searched from database inception to January 2018. After screening based on inclusion and exclusion criteria, patient demographics, fixation technique, graft selection, outcomes, and complications were extracted from the included studies. The studies were grouped based on flexion angle used during graft fixation: low (0°-30°) and high (45°-90°) flexion angle group. Methodological Index for Non-Randomized Studies criteria were used to assess the quality of each included study. Descriptive statistics are presented. RESULTS: Seventeen studies (of 3,399) were included and were either cohort (n = 1) or case series (n = 17) study designs. A total of 556 patients with a mean age of 23.6 years (range, 10-60 years) underwent MPFL reconstructions, with 458 patients in the 0° to 30° fixation group and 98 in the 45° to 90° fixation group. The mean Kujala score improved from 45 to 72.9 (365 patients) preoperatively to 83 to 94.5 (460 patients) postoperatively for the 0° to 30° fixation group and from 53.3 to 72 preoperatively to 92.2 to 95.2 postoperatively for the 45° to 90° fixation group (98 patients). CONCLUSIONS: The knee flexion angle during MPFL graft fixation ranges from 20° to 90°. Graft fixation at low and high knee flexion angles during MPFL reconstruction showed excellent patient-reported outcomes and low patellar redislocation rates overall, with no clear differences between the 2 groups based on the currently available data. LEVEL OF EVIDENCE: Level IV, systematic review of Level III-IV studies.

Long-Term Survival Analysis and Outcomes of Meniscal Allograft Transplantation With Minimum 10-Year Follow-Up: A Systematic Review.

PURPOSE: To investigate the long-term survivorship rates and functional outcomes of meniscal allograft transplantation (MAT) in patients with minimum 10-year postoperative follow-up. METHODS: Two reviewers independently searched EMBASE, MEDLINE, and PubMed from database inception for literature related to MAT according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist. Data are reported in a narrative summary fashion with descriptive statistics. RESULTS: Eleven studies with a total of 658 patients and 688 MATs were included. Mean age of patients was 33.1 years (range 14-66), of whom 63% were male. Mean survivorship rates were 73.5% at 10-year and 60.3% at 15-year follow-up, with 2 studies reporting 19- and 24-year survivorship of 50% and 15.1%, respectively. Pre- and postoperative Lysholm scores ranged from 36 to 60.5 and 61 to 75, respectively. Pre- and postoperative Tegner scores ranged from 1 to 3 and 2.5 to 4.6, respectively. Postoperative Knee injury and Osteoarthritis Outcome Score subset scores were as follows: Pain: 61.6 to 76.3; Symptoms: 57.9 to 61.8; Function in Daily Living: 68.5 to 79.9; Sport and Recreation: 33.9 to 49.3; Quality of Life: 37.3 to 45.9. Postoperative International Knee Documentation Committee scores ranged from 46 to 77. Regarding surgical technique, 194 MAT bone-fixation technique (53.8%) and 165 MAT suture-only fixation techniques (46.2%) were reported. The most common type of allograft used was cryopreserved (54.5% of the allografts). The most frequent concomitant procedures performed with MAT were to address chondral (20.8% of the cases) and ligament injuries (12.4% of the cases), and realignment procedures (9.4% of the cases). The most common complications observed that were not directly related to concomitant procedures were meniscal allograft partial tears (11.1%), arthrofibrosis (3.6%), and infection (2.0%). Several criteria were used among studies to define failure of MAT, the most common parameters being removal of meniscal allograft (8/11 studies) and conversion to total knee arthroplasty (7/11 studies). CONCLUSIONS: MAT can yield good long-term survivorship rates, with 73.5% and 60.3% of allografts remaining functional after 10 and 15 years, respectively. Functional outcomes 10 years after MAT were fair and improved compared with preoperative scores. LEVEL OF EVIDENCE: Level IV, systematic review of Level III and IV studies.

Non-adherence to subcutaneous allergen immunotherapy: inadequate health insurance coverage is the leading cause.

BACKGROUND: To sustain the long-lasting beneficial effects of subcutaneous allergen immunotherapy, the recommended duration of treatment is 3 to 5 years. Nevertheless, many patients discontinue allergy injections prematurely and therefore might not appreciate the full therapeutic benefit. OBJECTIVE: To examine factors leading to premature discontinuation of subcutaneous allergen immunotherapy (cessation before completion of the recommended duration). METHODS: Patients who discontinued immunotherapy before the completion of the prescribed duration and received their final injection from January 2008 through September 2013 were contacted to identify the reason for stopping the allergy injections. Phase of treatment (escalation or maintenance) was used to measure the duration of treatment at the time of cessation and patients were grouped accordingly. RESULTS: The study population consisted of 555 patients with allergic rhinitis and/or asthma who terminated immunotherapy prematurely. Two hundred thirteen (38%) were men and 342 (62%) were women. The following reasons were cited by patients for non-adherence to immunotherapy: requirement of copayment for allergy injections and/or payment for allergen extract by their health insurer (40%); inconvenience of travel (15%); change of residence (8%); concurrent health problems (5%); patient-perceived ineffectiveness (4%); patient-perceived lack of need to continue immunotherapy (2%); adverse effects from injection (local reaction 1%; systemic allergic reaction 0.5%); and trial of alternative medicine (0.1%). The remaining 24.4% did not provide a reason for discontinuation. CONCLUSION: Of the various factors, inadequate reimbursement for allergen extract and allergy injections by health insurers is the most common reason cited for non-adherence to subcutaneous allergen immunotherapy.

Perceptions of people living with HIV/AIDS regarding access to health care.

Although the health care is replete with technology in the present day, it is not freely accessible in a developing country. The situation could be even more compromised in the case of people living with HIV/AIDS, with the added dimension of stigma and discrimination. What are the factors that act as barriers to health care? This study was conducted to look into perceptions of people living with HIV/AIDS with regard to access to health care. The study looked into accessibility of general health vis-à-vis access to antiretroviral therapy. Demographic variables like age, gender, income were studied in relation to factors such as counseling, confidentiality, stigma and discrimination, which are known to influence access to health care. People living with HIV/AIDS perceive general health care as more accessible than care for HIV treatment. Discrimination by health care workers causes a barrier to accessibility.

Perspectives on Spare Embryos amongst IVF users: An Exploratory Study from a Selected District of the Southern Indian State of Karnataka.

Perspectives of IVF users on their spare embryos is a less explored subject in the Indian context despite the country's population and abundance of IVF clinics. We conducted a qualitative study using in-depth interviews in a selected district of the Indian state of Karnataka. Seven individuals were recruited independently of any assistance from an IVF clinic. The interviews explored participants' knowledge and perception of the spare embryos using a set of guiding questions exploring the theme of the informed consent process, views on research, preferences for embryo donation, the role of family and the dynamics of decision-making, amongst other things. The interviews were qualitatively analysed using Corbin and Strauss's grounded theory approach. Our findings reveal that the participants do not learn about the prospects of spare embryos from the very start of their IVF journeys, and they may not be informed about the various options available to decide the fate of the spare embryos. Irrespective of their views on research and moral perceptions of embryos, participants expressed a sense of responsibility and ownership towards their embryos and a general reluctance to donate them. Our findings have implications for guiding future inquiries on this subject, which can better the informed consent process and unravel the role of ownership in the ethics of spare embryos in the Indian context.

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.

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.

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.

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.

Safety, efficiency, and cost-effectiveness of a multidisciplinary percutaneous tracheostomy program.

OBJECTIVE: The frequency of bedside percutaneous tracheostomies is increasing in intensive care medicine, and both safety and efficiency of care are critical elements in continuing success of this procedure. Prioritizing patient safety, a tracheostomy team was created at our institution to provide bedside expertise in surgery, anesthesiology, respiratory, and technical support. This study was performed to evaluate the metrics of patient outcome, efficiency of care, and cost-benefit analysis of the multidisciplinary Johns Hopkins Percutaneous Tracheostomy Program. DESIGN: A review was performed for patients who received tracheostomies in 2004, the year before the Johns Hopkins Percutaneous Tracheostomy Program was established, and those who received tracheostomies in 2008, the year following the program's establishment. Comparative outcomes were evaluated, including the efficiency of procedure and intensive care unit length of stay, complication rate including bleeding, hypoxia, loss of airway, and a financial cost-benefit analysis. SETTING: Single-center, major university hospital. PATIENTS: The sample consisted of 363 patients who received a tracheostomy in the years 2004 and 2008. MEASUREMENTS AND MAIN RESULTS: The number of percutaneous procedures increased from 59 of 126 tracheostomy patients in 2004, to 183 of 237 in 2008. There were significant decreases in the prevalence of procedural complications, particularly in the realm of airway injuries and physiologic disturbances. Regarding efficiency, the structured program reduced the time to tracheostomy and overall procedural time. The intensive care unit length of stay in nonpulmonary patients and improvement in intensive care unit and operating room back-fill efficiency contributed to an overall institutional financial benefit. CONCLUSIONS: An institutionally subsidized, multi-disciplinary percutaneous tracheostomy program can improve the quality of care in a cost-effective manner by decreasing the incidence of tracheostomy complications and improving both the time to tracheostomy, duration of procedure, and postprocedural intensive care unit stay.