Analysis of Terminated Hand and Wrist-Related Clinical Trials.

Purpose: While clinical trials provide high-quality evidence guiding medical decision-making, early trial termination can result in both lost time and resources. Our purpose was to investigate the rate of and reasons for clinical trial termination for hand and wrist-related conditions and identify study characteristics associated with early trial termination. Methods: The ClinicalTrials.gov database was queried for all hand and wrist-related clinical trials. All terminated and completed trials were reviewed, with characteristics and reasons for termination recorded. Study characteristics included type, purpose, intervention assessed, enrollment, group allocation, blinding, trial phase, sponsor type, and geographic region. Chi-square test was used to identify associations between trial characteristics and terminated versus completed status. Results: A total of 793 hand and wrist-related clinical trials were identified, with 77 trials (10%) terminated prior to completion. The most common reason for termination was "recruitment/retention difficulty," reported in 37 (48%) terminated trials. In comparing competed versus terminated trials, primary purpose (nonobservational studies), enrollment (<50 patients), and geographic region (North America) were all significantly more likely to be terminated. Terminated trials were more likely to have an intervention type investigating a specific device or drug. Conclusions: Early trial termination for hand and wrist-related conditions is common (10%), with patient recruitment and retention identified as the leading cause of termination. Trials involving potential commercial incentives (those investigating a device or drug) were associated with an increased rate of trial termination. Clinical relevance: An emphasis on patient enrollment during study design may aid in mitigating the most common cause of early clinical trial termination.

The Effect of an Intraoperative Real-Time Counter on Radiation Exposure Events During Operative Treatment of Distal Radius Fractures.

PURPOSE: Occupational radiation exposure can have adverse health consequences for surgeons. The purpose of this study was to determine if utilization of an intraoperative, real-time radiograph counter results in decreased radiation exposure events (REEs) during open reduction and internal fixation (ORIF) of distal radius fractures (DRFs). METHODS: We reviewed all cases of isolated ORIF DRFs performed at a single center from January 2021 to February 2023. All cases performed on or after January 1, 2022 used an intraoperative radiograph counter, referred to as a "shot-clock" (SC) group. Cases prior to this date were performed without a SC and served as a control group (NoSC group). Baseline demographics, fracture, and surgical characteristics were recorded. Final intraoperative radiographs were reviewed to record reduction parameters (radial inclination, volar tilt, and ulnar variance). REEs, fluoroscopy exposure times, and total radiation doses milligray (mGy) were compared between groups. RESULTS: A total of 160 ORIF DRF cases were included in the NoSC group, and 135 were included in the SC group. The NoSC group had significantly more extra-articular fractures compared with the SC group. Reduction parameters after ORIF were similar between groups. The mean number of REEs decreased by 48% in the SC group. Cases performed with the SC group had significantly lower total radiation doses (0.8 vs 0.5 mGy) and radiation exposure times (41.9 vs 24.2 seconds). Mean operative times also decreased for the SC group (70 minutes) compared with that for the NoSC group (81 minutes). CONCLUSIONS: A real-time intraoperative radiograph counter was associated with decreased REEs, exposure times, and total radiation doses during ORIF DRFs. Cases performed with a SC had significantly shorter operative times without compromising reduction quality. Using an intraoperative SC counter during cases requiring fluoroscopy may aid in decreasing radiation exposure, which serves as an occupational hazard for hand and upper-extremity surgeons. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic II.

Impact of Bracing and Therapy Services on Perioperative Costs for Patients Undergoing Distal Biceps Tendon Repair.

PURPOSE: This study aimed to quantify and assess perioperative costs in an integrated healthcare system for patients undergoing distal biceps tendon (DBT) repair with and without the use of postoperative bracing and formal physical (PT) or occupational (OT) therapy services. In addition, we aimed to define clinical outcomes after DBT repair using a brace-free, therapy-free protocol. METHODS: We retrospectively reviewed all cases of DBT repairs within our integrated system from 2015 to 2021. We performed a retrospective review of a series of DBT repairs utilizing the brace-free, therapy-free protocol. For patients with our integrated insurance plan, a cost analysis was conducted. Claims were subdivided to assess total charges, costs to the insurer, and patient costs. Three groups were created for comparisons of total costs: (1) patients who had both postoperative bracing and PT/OT, (2) patients who had either postoperative bracing or PT/OT, and (3) patients who had neither postoperative bracing nor PT/OT. RESULTS: A total of 36 patients had our institutional insurance plan and were included in the cost analysis. For patients using both bracing and PT/OT, these services contributed 12% and 8% of the total perioperative costs, respectively. Implant costs accounted for 28% of the overall cost. Forty-four patients were included in the retrospective review with a mean follow-up of 17 months. The overall QuickDASH was 12; two cases resulted in unresolved neuropraxia, and there were no cases of re-rupture, infection, or reoperation. CONCLUSIONS: Within an integrated healthcare system, postoperative bracing and PT/OT services increase the cost of care for DBT repair and account for 20% of the total perioperative charges in cases where bracing and therapy are used. Considering the results of prior investigations indicating that formal PT/OT and bracing offer no clinical advantages over immediate range of motion (ROM) and self-directed rehabilitation, upper-extremity surgeons should forego routine brace and PT/OT utilization after DBT repair. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.

An Analysis of Gender Diversity in Hand and Upper Extremity Surgery Webinars.

PURPOSE: Some female upper extremity (UE) surgeons face unique barriers to participation at in-person academic and professional society meetings due to disparate childcare and household duties relative to male surgeons. Webinars may alleviate some of this travel burden and allow for more balanced participation. Our purpose was to evaluate gender diversity within academic webinars with a focus on UE surgery. METHODS: We queried webinars conducted by the following professional societies: American Academy of Orthopaedic Surgeons, American Society for Surgery of the Hand (ASSH), American Association for Hand Surgery, and American Shoulder and Elbow Surgeons societies. Webinars with an UE focus produced between January 2020 and June 2022 were included. Demographic characteristics, including sex and race, were recorded for webinar speakers and moderators. RESULTS: A total of 175 UE webinars were identified, with 173 of 175 (99%) having functioning video links. The 173 webinars had 706 speakers and 173 (25%) were women. Female representation in professional society webinars exceeded their overall participation in their sponsoring organizations. Although women comprise 6% and 15% of the overall American Academy of Orthopaedic Surgeons and ASSH membership, respectively, they accounted for 26% of American Academy of Orthopaedic Surgeons webinar speakers and 19% of ASSH webinar speakers. CONCLUSIONS: Between 2020 and 2022, women comprised 25% of speakers for professional society academic webinars with a focus on UE surgery, which exceeds the proportion of women in the individual sponsoring professional societies. CLINICAL RELEVANCE: Online webinars may mitigate some of the barriers that female UE surgeons face with respect to professional development and academic advancement. Although female participation in UE webinars often exceeded the current rates of female members in the individual professional societies, women remain underrepresented in UE surgery, relative to the percentage of female medical students.

Race and Ethnicity Reporting in Randomized Controlled Trials Published in Upper-Extremity Journals.

PURPOSE: Hand surgery remains one of the least racially and ethnically diverse subspecialties in all of medicine, and minority patients demonstrate overall worse health care outcomes compared with White patients. Our purpose was to determine the frequency of race and ethnicity reporting in randomized controlled trials (RCTs) published in journals with an upper-extremity (UE) focus. METHODS: A systematic review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines by searching EMBASE and MEDLINE for RCTs contained in peer-reviewed journals with an UE focus. All articles from 2000 to 2021 were included. Information such as article sample size, center type, funding, and location was recorded. We assessed each article to determine whether demographic information, including race and ethnicity, was reported for study participants. RESULTS: A total of 481 RCTs in 9 UE journals were included. For UE RCTs, 96% of studies reported age, 90% reported sex, and 5% reported either race or ethnicity. Demographic information about economic status, insurance status, mental health, educational level, and marital status were each reported in <10% of RCTs. Racial representation was highest for White participants (80%) and lowest among American Indian participants. Of studies conducted within the United States, all racial groups except for White patients were underrepresented compared with census data. CONCLUSIONS: Demographic data related to race and ethnicity for patients involved in UE RCTs are infrequently reported. When reported, the racial demographics of UE RCT patients do not match the demographics of the patients in United States. Black patients remain underrepresented in RCTs. CLINICAL RELEVANCE: Academic journals mandating the reporting of demographic data related to race may aid in improved reporting and allow for subsequent aggregation within systematic reviews to assess outcomes for racial minorities.

The Impact of Cement Mantle Characteristics on Early Loosening in Primary Total Elbow Arthroplasty.

PURPOSE: To assess the association between cement mantle characteristics and early radiographic loosening in total elbow arthroplasty (TEA). We aimed to determine whether shorter mantle heights (<20 mm) were associated with loosening. METHODS: We reviewed primary TEAs from a single healthcare system from 2006 to 2020. TEAs complicated by infection or performed for oncologic conditions were excluded. Initial postoperative radiographs were reviewed to determine cement mantle and component characteristics (mantle quality, mantle height, and component angulation). One-year postoperative radiographs were reviewed to assess for implant loosening, and we compared demographics and radiographic criteria for cases with and without early loosening. We noted whether cases underwent subsequent revision for aseptic osteolysis. RESULTS: A total of 54 TEA cases were included. Forty percent of ulnar and 24% of humeral mantles were classified as short (between 1 and 19 mm). According to the Morrey classification, 6 (11%) cases had an inadequate cement mantle Twenty-four (45%) cases had radiographic evidence of loosening at 1 year. Of the cases with early loosening, 6 (25%) had initial inadequate mantle quality. There were no inadequate mantles in the group without loosening. There were no statistically significant differences in mantle heights for cases with and without loosening at 1 year after surgery. Eight (33%) cases underwent revision in the group with early loosening compared with 1 (3%) case without early loosening. CONCLUSIONS: Inadequate cement mantle quality was associated with an increased risk of early aseptic loosening after primary TEA. Cement mantles that extended past the tip of the prosthesis were not associated with loosening. Considering the potential need for future revision and morbidity of cement removal, surgeons should focus on mantle quality and carefully plan mantle height because shorter heights may not be associated with early implant failure. TYPE OF STUDY/LEVEL OF EVIDENCE: Prognostic II.

A Comparison of Acute Versus Chronic Thumb Ulnar Collateral Ligament Surgery Using Primary Suture Anchor Repair and Local Soft Tissue Advancement.

Purpose: To assess patient satisfaction and functional outcomes of primary suture anchor repair with local soft tissue advancement for both acute and chronic thumb ulnar collateral ligament (UCL) injuries. Methods: We retrospectively reviewed patient charts who had undergone operative UCL repair between 2006 and 2013. Patients who had more than 8 weeks between the time of injury and surgery were classified as having chronic injuries. In both acute and chronic cases, a primary suture anchor repair of the ligament was performed with local soft tissue advancement. For each patient, baseline demographics, operative complications, and associated injuries were recorded along with visual analog scale pain scores; Quick Disabilities of the Arm, Shoulder, and Hand scores; and their return to work or sport status. Comparisons of outcomes and complications were made between the groups (acute vs chronic injuries). Results: Among the 36 patients who met our inclusion criteria, both the acute (n = 19) and chronic (n = 17) groups were similar with regards to major or minor comorbidities, visual analog scale scores; Quick Disabilities of the Arm, Shoulder, and Hand scores; return to work or sport status; or patient satisfaction. Conclusions: Patients with both acute and chronic thumb UCL injuries have similarly acceptable functional outcomes, postoperative pain, and satisfaction. Primary suture anchor repair without ligament reconstruction appears to be a safe and effective treatment option for patients' thumb UCL injuries, even in the chronic setting. Type of study/level of evidence: Therapeutic III.