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Clin. Orthop. Relat. Res. [JOURNAL]

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Can Orthopaedic Surgery Go Green? Environmental Footprint of Disposable Versus Reusable Instruments in TKA.

Monadjemi S, Villatte G, Erivan R … +1 more , Descamps S

Clin Orthop Relat Res · 2026 Jun · PMID 41758803 · Publisher ↗

BACKGROUND: The environmental impact of surgical instruments and procedures is attracting increasing attention. Single-use instruments are gaining adoption across various healthcare settings, including in orthopaedic sur... BACKGROUND: The environmental impact of surgical instruments and procedures is attracting increasing attention. Single-use instruments are gaining adoption across various healthcare settings, including in orthopaedic surgery, because of their convenience and immediate availability. However, the replacement of reusable instruments, whether kept in stock (RI-S) or procured on loan (RI-L), with single-use instruments has raised obvious ecologic concerns, such as waste management, greenhouse gas emissions, and resource depletion. QUESTIONS/PURPOSES: Our study aimed (1) to assess the environmental impact (as estimated by acidification, climate change, freshwater eutrophication, water depletion, and resource depletion) of both single-use instruments and RI-S or RI-L employed in TKA procedures and (2) to identify whether one option is more ecologically sustainable (as determined by a life cycle assessment [LCA]). METHODS: A comprehensive LCA was conducted according to ISO 14040/44 guidelines to calculate the environmental impact of single-use instruments and reusable instruments by considering raw material extraction, manufacturing, distribution, reprocessing (where applicable), and end-of-life waste management. Data were collected both from a 5-year retrospective audit of the manufacturer and from our hospital's sterile facility. Reusable instruments were assessed under two scenarios: RI-S and RI-L. To determine which option was more ecologically sustainable, environmental impacts were quantified using the LCA software GaBi 6 TS and the LCA database Ecoinvent 3.5 and analyzed according to the International Reference Life Cycle Data System. RESULTS: Our analysis of environmental impacts indicates that, per procedure, RI-S, RI-L, and single-use instruments were associated with 44.3, 66.5, and 62.9 kg CO 2 equivalent (eq), respectively. Single-use instruments had the lowest contribution to water depletion (6.3·10 -1 m 3 eq), while RI-S and RI-L accounted for 2.1 and 3 m 3 eq, respectively. Finally, regarding resource depletion, RI-S, RI-L, and single-use instruments corresponded to 5.2·10 -3 , 7.7·10 -3 , and 2.2·10 -3 kg Sb eq, respectively. The environmental impact of single-use instruments was mainly attributed to raw material production, which contributed to 73% of its carbon footprint and 64% of its total resource depletion impact. On the other hand, for reusable instruments, the sterilization phase was a major contributor to water depletion, accounting for 71% in RI-S and 80% in RI-L, as well as for carbon footprint, where it accounted for 35% in RI-S and 38% in RI-L. No single scenario outperformed across all environmental categories, with RI-L being the least favorable option. Both single-use instruments and RI-S involved tradeoffs. In comparison to RI-S, single-use instruments generated an additional 18.6 kg CO 2 eq per procedure, which is equivalent to an 85-km trip with a fuel-powered car, but saved 1.5 m 3 of water (corresponding to eight bathtubs). CONCLUSION: Our analysis suggests that the RI-L should be avoided and that certain compromises should be made, whether utilizing RI-S or single-use instruments, because the environmental impact must be considered as a whole by looking at all impact categories. One approach would be to reduce the number of items in reusable instrument trays through patient-specific surgical planning. The other would be to use single-use instruments while trying to minimize other disposable consumables. CLINICAL RELEVANCE: Given the high volume of orthopaedic surgeries, surgeons can contribute to environment protection by implementing greener practices. Strategies include using bespoke reusable instrument trays containing only the essential items for each procedure or employing single-use instruments while limiting other disposable consumables.

Clinical Faceoff: What Is the Role of Robotics in Reverse Shoulder Arthroplasty?

Menendez ME, Matsen FA, Athwal GS

Clin Orthop Relat Res · 2026 Apr · PMID 41758765 · Publisher ↗

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Is Arm Dominance Associated With Clinically Meaningful Differences in Outcomes After Shoulder Arthroplasty?

Lazaridou A, Giannakis P, Schneller T … +7 more , Hofer CK, Poeran J, Sideris A, Memtsoudis SG, Marx RG, Gulotta LV, Scheibel M

Clin Orthop Relat Res · 2026 Jul · PMID 41758764 · Publisher ↗

BACKGROUND: Limited available evidence seems to suggest that the increased use of the dominant (versus nondominant) limb may allow for earlier return to function and better ROM in the dominant limb at 12-month follow-up... BACKGROUND: Limited available evidence seems to suggest that the increased use of the dominant (versus nondominant) limb may allow for earlier return to function and better ROM in the dominant limb at 12-month follow-up after anatomic or reverse total shoulder arthroplasty (TSA). Nevertheless, whether the earlier achievement of physical therapy milestones is associated with a clinically meaningful difference in patient-reported outcome measures (PROMs) is yet to be determined. QUESTIONS/PURPOSES: (1) What are the 12-month minimum clinically important difference (MCID) and patient acceptable symptom state (PASS) thresholds for the Shoulder Pain and Disability Index (SPADI), QuickDASH, numeric rating scale (NRS) for pain, and Constant-Murley score? (2) Is there a difference between the dominant- and nondominant-side TSAs in terms of the proportions of patients achieving an MCID or PASS at 12-month follow-up? METHODS: This retrospective, comparative study analyzed data from a longitudinally maintained shoulder arthroplasty registry at a specialized orthopaedic institution. Patients were eligible for inclusion if they underwent primary anatomic or reverse TSA from 2006 to 2024 for cuff tear arthropathy or primary osteoarthritis and had 12-month follow-up for at least one PROM. We collected relevant baseline patient-related and procedure-related characteristics. The main association of interest was operated limb relative to limb dominance, and shoulders were stratified into the dominant-side or nondominant-side group. A total of 2152 shoulders, 65% (1404) of which were in the dominant-side group, were analyzed. The mean age was 73 years, and the majority of patients were women in both groups. In the dominant group, more patients were treated for cuff tear arthropathy, and a larger proportion received a reverse TSA. Loss to follow-up at 12 months did not differ between groups, reaching 13% for the dominant group and 16% for the nondominant group. The PROMs collected were the SPADI, QuickDASH, NRS for pain, and Constant-Murley score. These were administered at baseline and at 12 months postoperatively. The MCID and PASS thresholds for the PROMs of interest were estimated using a distribution-based approach. A sensitivity analysis was performed using the best available evidence for anchor-based MCIDs (20 for the SPADI, 12 for the QuickDASH, 2.2 for the NRS for pain, and 9 for the Constant-Murley score). Adjusted comparisons of distribution-based MCID estimates and PASS proportions between dominant- and nondominant-side procedures were conducted using generalized linear mixed-effects logistic regression models. Models were adjusted for admission type, surgical indication, procedure type, cuff tear severity, BMI, baseline ROM (forward flexion, abduction, external rotation), and baseline QuickDASH, with a random intercept for patient ID to account for within-patient clustering. Results are reported as ORs with 95% confidence intervals (CIs). RESULTS: Distribution-based absolute MCID estimates were 16 for SPADI, 13 for QuickDASH, 1.5 (reduction) for NRS for pain, and 12 for Constant-Murley score. Distribution-based absolute PASS estimates were 19 for SPADI, 5 for QuickDASH, 1.8 (reduction) for NRS for pain, and 20 for Constant-Murley score. At 12 months, MCID and PASS responder proportions did not differ in clinically important ways between dominant and nondominant shoulders, but approximately 25% (509 of 2120) of shoulders did not achieve the MCID for the QuickDASH, more than 10% (247 of 2123) did not achieve it for pain, and approximately 15% did not achieve a PASS for one or more outcomes tool. All absolute risk differences and 95% CIs fell within the prespecified ± 10% smallest important difference margin, indicating no clinically important dominance effect. In adjusted mixed-effects logistic regression models, dominance was not associated with meaningful differences in the odds of achieving MCID or PASS for SPADI, QuickDASH, NRS for pain, or Constant-Murley score (ORs near 1.0, with all CIs crossing unity). Across all sensitivity analyses, arm dominance demonstrated no association with 12-month MCID or PASS after TSA. CONCLUSION: Arm dominance was not meaningfully associated with an increased or decreased likelihood of achieving MCID or PASS across multiple PROMs. However, as many as 1 in 4 patients did not reach MCID or PASS thresholds after TSA, irrespective of arm dominance. These findings indicate that, in typical clinical practice, dominance should not be considered a major determinant of postoperative recovery expectations. LEVEL OF EVIDENCE: Level III, therapeutic study.

CORR Insights®: Could the Scapular Spike Sign Be Used as a Radiographic Proxy for Surgical Indications?

Schiffman C

Clin Orthop Relat Res · 2026 Jun · PMID 41758744 · Publisher ↗

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Synthesis and Characterization of an Antimicrobial Honey-based Composite Bone Cement.

Kemp LE, Delgado-Alvarado I, Rossiter TE … +3 more , Chen AF, Tower RJ, Tatara AM

Clin Orthop Relat Res · 2026 Feb · PMID 41758684 · Publisher ↗

BACKGROUND: Orthopaedic infections are a major cause of morbidity and mortality with increasing prevalence. Antibiotics are often added to bone cement or polymethyl methacrylate (PMMA) for local delivery to prevent or tr... BACKGROUND: Orthopaedic infections are a major cause of morbidity and mortality with increasing prevalence. Antibiotics are often added to bone cement or polymethyl methacrylate (PMMA) for local delivery to prevent or treat infection. However, PMMA is not inherently antimicrobial and has poor antibiotic elution kinetics. A biomaterial composite of PMMA and antimicrobial medical-grade honey (PMMA-H) could address some of these shortcomings of current bone cements to better inhibit bacteria. QUESTIONS/PURPOSES: (1) How does honey affect the architecture and static mechanical properties of bone cement? (2) How does honey affect antibiotic elution? (3) What is the in vitro antimicrobial activity of PMMA-H with and without antibiotics? METHODS: Three different formulations of bone cements were created by mixing a generic dental bone cement without honey (0 wt%), with a low amount of medical-grade manuka honey (15 wt%), or with a high amount of honey (30 wt%). Vancomycin or gentamicin were added to the three formulations at a typical cement loading dose (3 wt%) or no additional antibiotic for a total of nine formulations. We characterized the subsequent total porosity and percentage of open porosity of constructs synthesized from the nine formulations using microcomputed tomography. Both the compressive and bending yield strength and modulus were measured by mechanical testing. Constructs were placed in media, and the concentration of eluted vancomycin and gentamicin was measured over 168 hours via liquid chromatography-mass spectrometry using unloaded formulations as negative controls. To better understand the impact of the addition of honey alone as well as the effect of both honey and antibiotic, we evaluated the efficacy of all nine different formulations of PMMA, PMMA-H, and antibiotic-loaded combinations in vitro against three different common organisms by measuring the zones of inhibition produced during Kirby-Bauer testing, as well as the bacterial burden in biofilm on the constructs and in the environment during a Staphylococcus aureus high inoculum challenge. RESULTS: The addition of honey increased the total porosity of the constructs from a mean ± SD of 1% ± 0.4% (0 wt% honey) to 13% ± 5% (mean difference 12% [95% confidence interval (CI) 4.0% to 20.8%]; p = 0.006) for 15 wt% honey and to 27% ± 6% (mean difference 26% [95% CI 18.3% to 35.1%]; p < 0.001) for 30 wt% honey. Honey-based formulations were mechanically weaker; for example, the mean compressive yield strength of unloaded PMMA (80.8 ± 9.9 MPa) decreased to 22.5 ± 6.1 MPa with 30 wt% honey (mean difference 58.3 MPa [95% CI -47.9 to -68.7]; p < 0.001). The addition of honey increased the elution of antibiotics; for example, 86% ± 28% of loaded gentamicin had been released from 30 wt% honey PMMA versus only 25% ± 5% of loaded gentamicin from PMMA without honey (mean difference 61% [95% CI 31.6% to 89.8%]; p < 0.001) over 168 hours. PMMA-H without antibiotics resulted in zones of inhibition against S. aureus and Staphylococcus epidermidis, and this inhibition was more potent with antibiotic loading. In a high inoculum challenge, PMMA with 30 wt% honey reduced environmental bacterial burden by > 20,000-fold compared with PMMA, with mean ± SD burdens of 6.4 ± 4.3 log colony-forming units (CFU)/mL and 12.8 ± 0.1 log CFU/mL, respectively (mean difference 6.4 CFU/mL [95% CI 1.77 to 11.03]; p = 0.007). CONCLUSION: PMMA-H is a promising biomaterial that takes advantage of the antimicrobial mechanisms of honey to introduce new properties to bone cement with improved antibiotic elution and bacterial inhibition compared with conventional bone cement. CLINICAL RELEVANCE: This proof-of-concept study demonstrates the enhanced antimicrobial activity of PMMA with honey in vitro and warrants further investigation in preclinical models of osteomyelitis.

CORR Insights®: Frame-based Draping Technique for Standard Table Direct Anterior Approach THA: Efficient and Safe?

Meermans G

Clin Orthop Relat Res · 2026 May · PMID 41758680 · Publisher ↗

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Which Neighborhood-level Metric Is Most Appropriate for Pediatric Sports Medicine Disparities Research?

Maxwell BE, Raffman ES, Navarro MB … +3 more , Rosenberg SI, Merritt EH, Patel NM

Clin Orthop Relat Res · 2026 Feb · PMID 41758679 · Full text

BACKGROUND: Neighborhood conditions are associated with access to care and outcomes. The Child Opportunity Index (COI) and Area Deprivation Index (ADI) are commonly used in pediatric research but without a clear rational... BACKGROUND: Neighborhood conditions are associated with access to care and outcomes. The Child Opportunity Index (COI) and Area Deprivation Index (ADI) are commonly used in pediatric research but without a clear rationale as to why one is chosen over the other. Despite an increasing volume of health equity research, there is little evidence that has directly compared the ADI and COI's associations with previously established pediatric orthopaedic disparities. Thus, the most appropriate neighborhood-level measure for pediatric orthopaedic research remains unclear. QUESTIONS/PURPOSES: (1) Do COI and ADI correlate with each other? (2) How do COI and ADI compare in their associations with previously established pediatric orthopaedic disparities, including time to ACL reconstruction (ACLR) and the presence of concomitant meniscal and chondral pathology? METHODS: This is a retrospective, comparative study of patients aged 18 years or younger who underwent primary ACLR between 2010 and 2023 at one tertiary center. We excluded patients who were missing COI or ADI data. Patients who underwent multiligament reconstruction, revision ACLR, intentionally staged or delayed procedures, or previous surgery on either knee were also excluded. We initially considered 806 patients, of whom 9% (72) were excluded for prespecified reasons. Consequently, 734 patients were included in the study (mean ± SD age was 16 ± 2 years and 52% [382] were boys). The median (IQR) time between injury and surgery was 74 days (82). Fifty-five percent (401) of patients had public insurance (Medicaid), 42% (306) had private insurance, and 4% (27) had no insurance or other types of insurance. The COI and ADI scores were assigned by address at the time of surgery. The COI quantifies neighborhood resources with 44 indicators across three domains: education, health and environment, as well as social and economic. It is scored from 0 to 100, with 0 indicating the lowest level of neighborhood resources. The ADI quantifies socioeconomic deprivation with 17 indicators across four domains: education, income, employment, and housing quality. It is also scored from 1 to 100, with 100 indicating the highest level of deprivation. Only national-level COI and ADI scores were used, given that the ADI does not provide continuous data at the state and metropolitan levels. The mean ± SD COI and ADI scores for the study population were 50 ± 29 and 44 ± 22, respectively. Outcomes of interest included time to surgery and intraoperative concomitant pathology. The Pearson correlation coefficients (r) were calculated for the comparison of continuous variables. Negative r values indicate inverse relationships (for example, a negative value suggests that as the value of one variable increases, the other decreases). By convention, an r value of 1 is a perfect correlation, 0.7 < r < 1 is a strong correlation, 0.3 < r < 0.7 is a moderate correlation, and 0 < r < 0.3 is a weak correlation. Regression analyses, reported with regression coefficients or ORs and 95% confidence intervals (CIs), assessed the association of the COI or ADI with clinical outcomes (timing of surgery and concomitant meniscal or chondral pathology) while controlling for confounders. RESULTS: The COI and ADI demonstrated moderate correlation with each other (r = -0.69; p < 0.001), indicating that an increasing COI score (for example, more neighborhood opportunity) correlates with a decreasing ADI score (for instance, less neighborhood deprivation). After controlling for insurance and time to surgery, when applicable, a higher COI score (indicating higher level of neighborhood opportunity) was associated with a shorter time to ACLR (regression coefficient -0.56 [95% CI -0.95 to -0.16]; p = 0.006); lower odds of concomitant meniscectomy (OR 0.99 [95% CI 0.98 to 0.99]; p = 0.02); and surgery beyond 60 days (OR 0.99 [95% CI 0.98 to 0.99]; p < 0.001), beyond 90 days (OR 0.99 [95% CI 0.98 to 0.99]; p < 0.001), and beyond 180 days (OR 0.99 [95% CI 0.98 to 0.99]; p = 0.02) after injury. In separate multivariable models, a higher ADI score (indicating a higher level of deprivation) was associated with increased odds of surgery beyond 60 days (OR 1.02 [95% CI 1.01 to 1.03]; p < 0.001) and 90 days (OR 1.02 [95% CI 1.01 to 1.02]; p < 0.001) after injury, but no other outcomes that we assessed. CONCLUSION: In the context of pediatric ACLR, the results suggest that the COI may be more appropriate than the ADI in identifying pediatric-specific disparities in sports medicine. This may be due to differences in the types and number of underlying indicators contributing to each index and the underlying methodologies used in each index's development. Additionally, continuous ADI data are only available on the national scale. CLINICAL RELEVANCE: These findings highlight the importance of selecting appropriate neighborhood-level indices when conducting disparities research. Consideration should be given to the underlying components of these indices and their potential relevance to the population of interest and research question. Future research should focus on comparing the COI and ADI in other clinical contexts to assess the generalizability of these findings and better inform future research methodology.

Erratum to: Classifications in Brief: The Dorr Classification of Femoral Bone.

Wilkerson J, Fernando ND

Clin Orthop Relat Res · 2026 Mar · PMID 41749314 · Publisher ↗

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Reply to the Letter to the Editor: Editor's Spotlight/Take 5: CORR Synthesis: What Is the Role of Robotic-assisted Technology in Knee Arthroplasty?

Richards AW, Marcus RE

Clin Orthop Relat Res · 2026 Mar · PMID 41749313 · Publisher ↗

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Reply to the Letter to the Editor: Is a Response to Intraoperative Electrical Nerve Stimulation Associated With Recovery After Stretch Injury in the Rat Median Nerve?

Schroen CA, Hausman MR, Cagle PJ

Clin Orthop Relat Res · 2026 Mar · PMID 41749312 · Publisher ↗

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What Is the Association Between Radiographic Measurements of Initial and Residual Fracture Displacement, Tibial Alignment, and Recovery in Terms of Patient-reported Outcome After Surgical Treatment of Tibial Plateau Fractures?

Vaartjes TP, Bosma E, van Helden SH … +7 more , Ten Brinke JG, de Groot R, Reininga IHF, Doornberg JN, Hoekstra H, Assink N, IJpma FFA

Clin Orthop Relat Res · 2026 Mar · PMID 41749309 · Publisher ↗

BACKGROUND: In tibial plateau fracture surgery, radiographic measurements are used to assess preoperative fracture displacement and postoperative results. However, the association between these values and patients' clini... BACKGROUND: In tibial plateau fracture surgery, radiographic measurements are used to assess preoperative fracture displacement and postoperative results. However, the association between these values and patients' clinical outcomes remains unclear. QUESTIONS/PURPOSES: (1) What is the association between preoperative fracture displacement (gap and stepoff), as assessed on CT scans, and full recovery in terms of patient-reported outcome (Knee injury and Osteoarthritis Outcome Score [KOOS] scores within the minimum clinically important difference [MCID] range of population-based normative values)? (2) What is the association between postoperative fracture reduction and knee alignment, as assessed on radiographs, and full recovery in terms of patient-reported outcome? METHODS: A multicenter cross-sectional study was performed including all patients with tibial plateau fractures who were treated surgically between 2003 and 2019 in five trauma centers. During that time, 1121 patients had surgery for these injuries; all were asked to complete the KOOS questionnaire, measured on a scale of 0 to 100 points (100 indicating no problems and 0 indicating severe problems). The general indications for surgery during this time were an initial gap and/or stepoff greater than 2 mm and inadequate coronal and sagittal tibial alignment. In all, 58% (645 of 1121) of patients responded after a mean ± SD follow-up of 7 ± 4 years, the mean age was 52 ± 14 years, and 68% (436 of 645) were women. Nonresponse analysis showed no substantial differences in patient characteristics and fracture classification between those who did and who did not respond. Independent observers reassessed and classified all pre- and postoperative CT images and radiographs according to the Schatzker classification. Initial fracture displacement (gap and stepoff) was measured on preoperative CT scans. The gap was defined as a separation between fracture fragments along the articular surface, and the stepoff was defined as a separation of fracture fragments perpendicular to the articular surface. Residual incongruence (maximum gap and/or stepoff), condylar widening, and tibial alignment (medial proximal tibial angle [MPTA]), as well as posterior proximal tibial angle [PPTA]), were measured on postoperative radiographs. Patients were classified as having achieved full recovery when KOOS scores were within the MCID range of KOOS scores from normative data from the general population (data from age-related peers). Binary logistic regression analyses were performed to assess the association between preoperative fracture displacement or postoperative fracture reduction and full recovery (KOOS scores within the MCID range of population-based normative values). The models were adjusted for gender, Schatzker classification, BMI, complications, postoperative fracture reduction, and follow-up time. RESULTS: Preoperative radiographic assessment demonstrated that substantial initial fracture displacement (> 10 mm gap or > 8 mm stepoff) was independently associated with increased odds of not reaching full recovery, again defined as achieving KOOS scores within the MCID range of population-based normative values (initial gap: OR 2.5 [95% CI 1.3 to 4.7]; p = 0.006 and initial stepoff: OR 4.3 [95% CI 1.8 to 10.2]; p = 0.001). Postoperative radiographic assessment demonstrated that substantial residual fracture displacement (4 to 6 mm incongruence: OR 3.3 [95% CI 1.7 to 6.5]; p = < 0.001 and > 6 mm: OR 5.2 [95% CI 1.7 to 15.8]; p = 0.004) and inadequate tibial alignment (MPTA < 82° or > 92°: OR 1.5 [95% CI 1.0 to 2.3]; p = 0.04 and PPTA < 4° or > 14°: OR 1.9 [95% CI 1.3 to 3.0]; p = 0.003) were associated with increased odds of not reaching full recovery. CONCLUSION: In tibial plateau fracture surgery, having a substantial preoperative initial gap > 10 mm or stepoff > 8 mm is associated with an increased odds of not reaching full recovery. In clinical practice, these findings support more informed patient counseling about prognosis. Postoperatively, both residual incongruence > 4 mm (gap and/or stepoff) and inadequate tibial malalignment (MPTA or PPTA) increased these odds, emphasizing the need for meticulous reduction and alignment as well as thoughtful decision-making regarding revision surgery. LEVEL OF EVIDENCE: Level III, therapeutic study.

Women Are Unequally Represented Among Clinical Trial Leadership by Orthopaedic Subspecialty.

Mao E, Glenn ER, Ryu D … +3 more , Chang B, LaPorte DM, Aiyer A

Clin Orthop Relat Res · 2026 Feb · PMID 41699696 · Publisher ↗

BACKGROUND: Although men substantially outnumber women in orthopaedic surgery, prior studies have demonstrated that authorship disparities persist even after adjusting for this imbalance. If comparable patterns occur in... BACKGROUND: Although men substantially outnumber women in orthopaedic surgery, prior studies have demonstrated that authorship disparities persist even after adjusting for this imbalance. If comparable patterns occur in clinical trial leadership, they may hinder women's academic advancement in our field. However, to our knowledge, no studies to date have examined proportional representation in this context. QUESTIONS/PURPOSES: (1) Does the proportion of woman-led clinical trials differ among orthopaedic subspecialties? (2) Are women proportionally represented as PIs after adjusting for the percentage of women in each specialty? (3) Is the proportion of woman-led orthopaedic clinical trials associated with other characteristics, such as trial location or type of intervention? METHODS: A retrospective analysis of orthopaedic surgery clinical trials registered on ClinicalTrials.gov from 2007 to 2025 was performed. Trials were manually reviewed for subspecialty relevance and PI identity. PI gender was determined via genderize.io, a validated online application that assigns a predicted gender to user-input names. Trials without orthopaedic surgeons as PIs and those with low-confidence gender predictions via genderize.io were excluded. Of the trials initially identified, 26% (1510 of 5842) met inclusion criteria, of which 55% (837 of 1510) were US-based and 42% (637 of 1510) were international studies. Chi-square tests were used to compare the proportion of women PIs across nine orthopaedic subspecialities and five intervention types (procedural, device, drug, behavioral, and other). Chi-square tests were also used to compare representation in trial leadership across regions within the United States and across continents. A US-specific analysis utilized prevalence to participation ratios (PPRs) to assess whether there was equitable representation of women among trial leadership after normalizing to the underlying proportion of women surgeons in each subspecialty. These proportions were obtained by reviewing public websites to identify academic surgeons at institutions affiliated with orthopaedic residency programs. Subspecialties were considered to have underrepresentation of a gender when that gender led less than 80% of the trials expected based on its share of the workforce (PPR < 0.80) and overrepresentation when a gender led more than 120% of the expected trials (PPR > 1.20). RESULTS: Gender representation among trial leadership varied by subspecialty (p < 0.001), with pediatric orthopaedic trials demonstrating the highest proportion led by women (20% [19 of 95]) and sports medicine demonstrating the lowest (4% [7 of 172]). After adjusting for the underlying demographics of each subspecialty's workforce, women were proportionally underrepresented in foot and ankle (PPR = 0.20), trauma (PPR = 0.51), pediatrics (PPR = 0.58), hand (PPR = 0.38), shoulder and elbow (PPR = 0.795), oncology (PPR = 0.72), and sports medicine (PPR = 0.71) trial leadership. Women were overrepresented among trial leadership in spine (PPR = 1.27) and proportionally represented among hip and knee (PPR = 0.83) trial leadership. Gender representation varied by world region (p = 0.02), with Europe showing the highest proportion of women investigators (12% [45 of 378]) and "Other" regions (that is, those outside of Europe, Asia, and the Americas) showing the least (0% [0 of 27]). Representation also differed by study intervention (p < 0.001), with behavioral intervention trials having the highest proportion of women PIs (29% [12 of 41]) and device trials having the lowest proportion (6% [22 of 373]), and by study type (p = 0.03), as observational studies included a greater proportion of woman-led trials (11% [41 of 380]) than interventional studies (7% [82 of 1130]). CONCLUSION: As proportional underrepresentation of women in trial leadership is concentrated in specific subspecialties, PI development initiatives in these areas may have greater impact than generic, field-wide efforts. Understanding why some subspecialties have achieved proportional representation whereas others lag behind should be a priority for future work, as fields with proportional or higher-than-expected representation may provide models worth emulating. CLINICAL RELEVANCE: Improving the proportional representation of women in trial leadership roles ensures that research leadership in orthopaedics reflects the gender diversity of our workforce and our patients. Doing so may also help strengthen the academic pipeline for women orthopaedic surgeons.
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