W Garret Burks, Youngjae Lee, Kelly Gordon, Alison N Tegge, Peter J Apel
{"title":"The Role of Noninferiority Studies in Orthopaedic Surgery: Determining Whether Outcomes Are the Same, No Worse, or Simply Not Different.","authors":"W Garret Burks, Youngjae Lee, Kelly Gordon, Alison N Tegge, Peter J Apel","doi":"10.2106/JBJS.24.01333","DOIUrl":"10.2106/JBJS.24.01333","url":null,"abstract":"<p><p>➢ With any study, readers should be cautious and critical when the conclusion is that \"these treatments are the same.\"➢ If only superiority testing was performed, failing to find a difference does not mean that the treatments are the same, even when the study was adequately powered.➢ Noninferiority analysis is the correct method to compare treatments that researchers and clinicians think may be \"the same\" for the primary outcome.➢ The most important aspect of a noninferiority analysis is the selection of the noninferiority margin, which is the minimum difference between groups that would be considered meaningful.➢ To perform noninferiority testing, the difference in an outcome measure of interest between experimental and control groups must be examined with respect to the noninferiority margin of the same outcome measure. Assuming that a greater value indicates improvement in an outcome measure, if the lower bound of a 95% confidence interval of a difference in means based on a 1-sided test is greater than the noninferiority margin, then the experimental treatment can be considered noninferior to the control.</p>","PeriodicalId":15273,"journal":{"name":"Journal of Bone and Joint Surgery, American Volume","volume":" ","pages":"2208-2215"},"PeriodicalIF":4.3,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144955317","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
P Lam, E P Murphy, M J Chua, R Ray, C Watt, P W Robinson, W Montgomery, M Dalmau-Pastor, T L Lewis
{"title":"Fourth-Generation Percutaneous Transverse Osteotomies for Hallux Valgus.","authors":"P Lam, E P Murphy, M J Chua, R Ray, C Watt, P W Robinson, W Montgomery, M Dalmau-Pastor, T L Lewis","doi":"10.2106/JBJS.24.01326","DOIUrl":"10.2106/JBJS.24.01326","url":null,"abstract":"<p><strong>Background: </strong>Fourth-generation percutaneous, or minimally invasive, hallux valgus surgery utilizes a transverse osteotomy to achieve deformity correction. There are only a small number of studies reporting the clinical and radiographic outcomes of transverse osteotomies, many of which have methodological limitations such as small sample size, limited radiographic follow-up, or use of non-validated outcome measures. The aim of this study was to provide a methodologically robust investigation of percutaneous transverse osteotomies for hallux valgus deformity.</p><p><strong>Methods: </strong>We studied a prospective series of consecutive patients undergoing fourth-generation metatarsal extracapsular transverse osteotomy performed by a single surgeon (P.L.) between November 2017 and January 2023. The primary outcome was clinical foot function assessed using the Manchester-Oxford Foot Questionnaire (MOXFQ), a validated patient-reported outcome measure. Secondary outcomes included the radiographic deformity (the hallux valgus angle [HVA], 1-2 intermetatarsal angle [IMA], and sesamoid position) assessed according to American Orthopaedic Foot & Ankle Society (AOFAS) guidelines as well as a visual analog scale for pain and radiographic evidence of deformity recurrence (defined as an HVA of >20° at final radiographic follow-up). P values of <0.05 were considered significant.</p><p><strong>Results: </strong>Seven hundred and twenty-nine feet (483 patients; 456 female and 27 male; mean age, 57.9 ± 11.9 years) underwent fourth-generation metatarsal extracapsular transverse osteotomy. Radiographic data were available at a vminimum of 12 months postoperatively for 99.7% of the feet, which were followed for a mean of 2.6 ± 1.3 years (range, 1.0 to 5.7 years). There was a significant improvement (p < 0.05) in both the HVA (from 29.5° ± 8.5° preoperatively to 7.3° ± 6.7° at final follow-up) and the IMA (from 12.9° ± 3.3° to 4.6° ± 2.5°). All MOXFQ domains showed significant improvement (p < 0.05), with the MOXFQ Index improving from 36.9 ± 18.9 to 13.4 ± 15.8, Pain improving from 40.5 ± 22.0 to 17.2 ± 18.3, Walking/Standing improving from 32.3 ± 23.1 to 12.0 ± 18.2, and Social Interaction improving from 40.4 ± 20.4 to 11.0 ± 15.2. The recurrence rate was 4.5% (n = 33). The complication rate was 6.1%, which included a screw removal rate of 2.9%.</p><p><strong>Conclusions: </strong>This study, which was the largest consecutive series of any percutaneous osteotomy technique used to correct hallux valgus deformity, demonstrated significant improvement in clinical and radiographic outcomes with a low rate of recurrence.</p><p><strong>Level of evidence: </strong>Therapeutic Level IV . See Instructions for Authors for a complete description of levels of evidence.</p>","PeriodicalId":15273,"journal":{"name":"Journal of Bone and Joint Surgery, American Volume","volume":" ","pages":"2185-2196"},"PeriodicalIF":4.3,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12462676/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144955769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Peyman Mirghaderi, Negar Ahmadi, Alireza Azarboo, Mohammad Mirahmadi Eraghi, Mia S Hagen, Majid Chalian
{"title":"Impact of Tourniquet Use on Arthroscopic Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.","authors":"Peyman Mirghaderi, Negar Ahmadi, Alireza Azarboo, Mohammad Mirahmadi Eraghi, Mia S Hagen, Majid Chalian","doi":"10.2106/JBJS.24.00792","DOIUrl":"10.2106/JBJS.24.00792","url":null,"abstract":"<p><strong>Background: </strong>Anterior cruciate ligament tears are a common injury that is often treated with arthroscopic anterior cruciate ligament reconstruction (ACLR). This meta-analysis investigates the impact of tourniquet use on ACLR and the outcomes of this procedure.</p><p><strong>Methods: </strong>Searches were conducted across 4 databases: Embase, PubMed, Scopus, and the Web of Science. The quality of the included studies was assessed using the Consolidated Standards Of Reporting Trials (CONSORT) 2010 checklist. A meta-analysis was performed to compare the outcomes between patients who underwent ACLR with versus without a tourniquet.</p><p><strong>Results: </strong>Eight studies were eligible for systematic review; of these, 6 were eligible for meta-analysis. The CONSORT scores for the studies ranged from 22 to 37. No significant differences were found between the groups in terms of intraoperative blood loss (standardized mean difference, with versus without a tourniquet [SMD], -2.15; 95% confidence interval [CI]: -5.87, 1.58; I 2 = 99%), surgery time (SMD, -0.57; 95% CI: -1.32, 0.18; I 2 = 94%), or Lysholm knee scores after 1 year (SMD, -0.06; 95% CI: -0.33, 0.21; I 2 = 0%). The quality of the arthroscopic visual field varied across the studies. Postoperative pain levels were significantly higher in the tourniquet group (SMD 6-hour follow-up , 1.77; 95% CI: 0.07, 3.47; I 2 = 93%), although morphine consumption did not differ significantly between the groups (SMD, 0.25; 95% CI: -0.83, 1.33; I 2 = 93%). The no-tourniquet group had significantly greater thigh (SMD, -0.46; 95% CI: -0.79, -0.14; I 2 = 36%) and calf (SMD, -0.26; 95% CI: -0.49, -0.03; I 2 = 70%) circumferences postoperatively.</p><p><strong>Conclusions: </strong>Tourniquet use during ACLR did not significantly impact intraoperative blood loss, hemoglobin levels, or surgery time but was associated with increased postoperative pain. The use of epinephrine solution may be a viable alternative to the use of a tourniquet to improve visualization.</p><p><strong>Level of evidence: </strong>Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.</p>","PeriodicalId":15273,"journal":{"name":"Journal of Bone and Joint Surgery, American Volume","volume":" ","pages":"2197-2207"},"PeriodicalIF":4.3,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144742205","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Presidential Installation: Institutional Trust and Leadership.","authors":"Alexander J Ghanayem","doi":"10.2106/JBJS.25.00505","DOIUrl":"https://doi.org/10.2106/JBJS.25.00505","url":null,"abstract":"","PeriodicalId":15273,"journal":{"name":"Journal of Bone and Joint Surgery, American Volume","volume":"107 19","pages":"2216-2219"},"PeriodicalIF":4.3,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145199564","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Erratum: What's Important (Arts & Humanities): Lessons Learned in Medicine and Life.","authors":"Robert C Schenck","doi":"10.2106/JBJS.ER.24.01334","DOIUrl":"https://doi.org/10.2106/JBJS.ER.24.01334","url":null,"abstract":"","PeriodicalId":15273,"journal":{"name":"Journal of Bone and Joint Surgery, American Volume","volume":"107 18","pages":"e93"},"PeriodicalIF":4.3,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145075100","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"ABOS Partnerships and Collaboration.","authors":"Terrance D Peabody, Judith F Baumhauer","doi":"10.2106/JBJS.24.00613","DOIUrl":"https://doi.org/10.2106/JBJS.24.00613","url":null,"abstract":"","PeriodicalId":15273,"journal":{"name":"Journal of Bone and Joint Surgery, American Volume","volume":"107 Suppl 2","pages":"39-40"},"PeriodicalIF":4.3,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145075166","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jeffrey N Katz, Yuchiao Chang, Jon Dhani, Katharine Fox, Leslie J Bisson, Morgan H Jones, Andrea Carland, Tiffany Thavisin, Kyna Long, Faith Selzer, Katherine Krupa, Kelly Jordan, Elizabeth G Matzkin, Michael A Rauh, Logan Huff, Richard Wilk, Adam Olsen, Nomi S Weiss-Laxer
{"title":"Will Investigators Enroll Particular Subjects in a Randomized Controlled Trial?: A Mixed-Methods Study to Gauge Investigator Equipoise in a Trial of Surgery Versus Nonoperative Therapy in Subjects with Meniscal Tear and Persistent Pain Following Physical Therapy.","authors":"Jeffrey N Katz, Yuchiao Chang, Jon Dhani, Katharine Fox, Leslie J Bisson, Morgan H Jones, Andrea Carland, Tiffany Thavisin, Kyna Long, Faith Selzer, Katherine Krupa, Kelly Jordan, Elizabeth G Matzkin, Michael A Rauh, Logan Huff, Richard Wilk, Adam Olsen, Nomi S Weiss-Laxer","doi":"10.2106/JBJS.24.01575","DOIUrl":"10.2106/JBJS.24.01575","url":null,"abstract":"<p><strong>Background: </strong>Clinician equipoise-indifference between treatment arms-provides an ethical foundation for clinician participation in randomized controlled trials (RCTs). In preparation for an RCT comparing arthroscopic partial meniscectomy versus enhanced nonoperative therapy for patients with a meniscal tear and knee osteoarthritis (OA) who remain symptomatic after a course of physical therapy, we conducted a mixed-methods study to assess equipoise among potential enrolling clinicians.</p><p><strong>Methods: </strong>Fifteen clinicians with experience managing meniscal tears assessed 29 vignettes of hypothetical patients who met trial eligibility criteria. We randomly varied 13 vignette features (e.g., age, sex, radiographic severity, tear morphology). Clinicians expressed their willingness to enroll each hypothetical patient. After polling, we recorded and transcribed a moderated discussion to document clinician thought processes. We performed a quantitative analysis to identify clinical features associated with the likelihood of enrollment and an exploratory thematic analysis of the transcribed discussion to explicate the quantitative findings.</p><p><strong>Results: </strong>The 15 orthopaedic surgeons and physician assistants assessed 29 vignettes describing hypothetical patients. Eight votes were missing, leaving 427 vignettes, of which the clinicians were willing to enroll 302 (71%) (range, 24% to 100%) in the trial. Three clinicians were willing to enroll <50% of vignettes. Clinicians were willing to enroll just 39% of vignettes with bucket-handle tears. In logistic regression analyses, a bucket-handle tear (adjusted odds ratio [aOR], 0.12; 95% confidence interval [CI], 0.04 to 0.37) and Kellgren-Lawrence 3 radiographs (aOR, 0.54; 95% CI, 0.36 to 0.82) were independently associated with clinician unwillingness to randomize. The qualitative analysis confirmed that clinicians believed that bucket-handle tears should be managed operatively, whereas combinations of greater age, severe OA, inability to walk 200 yards, and higher body mass index (BMI) pushed clinicians toward nonoperative therapy.</p><p><strong>Conclusions: </strong>This methodology can be used to identify clinicians who should be engaged in discussions and interventions to support equipoise. It can also inform development of exclusion criteria (e.g., exclude bucket-handle tears) to increase the proportion of eligible subjects referred for enrollment.</p><p><strong>Clinical relevance: </strong>Orthopedic surgeons play crucial roles in randomized controlled trials, the foundation of clinical practice guidelines, by enrolling patients from their practices. This article examines clinician equipoise, a key determinant of the willingness of clinicians to enroll eligible patients in trials.</p>","PeriodicalId":15273,"journal":{"name":"Journal of Bone and Joint Surgery, American Volume","volume":" ","pages":"2077-2084"},"PeriodicalIF":4.3,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144846651","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Frederick M Azar, Michelle A James, David F Martin, Michael S Bednar
{"title":"Foreword.","authors":"Frederick M Azar, Michelle A James, David F Martin, Michael S Bednar","doi":"10.2106/JBJS.25.00261","DOIUrl":"https://doi.org/10.2106/JBJS.25.00261","url":null,"abstract":"","PeriodicalId":15273,"journal":{"name":"Journal of Bone and Joint Surgery, American Volume","volume":"107 Suppl 2","pages":"1"},"PeriodicalIF":4.3,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145075142","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Volunteerism in the ABOS.","authors":"Michael S Bednar, David F Martin","doi":"10.2106/JBJS.24.00756","DOIUrl":"https://doi.org/10.2106/JBJS.24.00756","url":null,"abstract":"","PeriodicalId":15273,"journal":{"name":"Journal of Bone and Joint Surgery, American Volume","volume":"107 Suppl 2","pages":"36-38"},"PeriodicalIF":4.3,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145075301","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"What's New in Hip Surgery.","authors":"Lisa C Howard, K T Matthew Seah","doi":"10.2106/JBJS.25.00532","DOIUrl":"10.2106/JBJS.25.00532","url":null,"abstract":"","PeriodicalId":15273,"journal":{"name":"Journal of Bone and Joint Surgery, American Volume","volume":" ","pages":"1992-1999"},"PeriodicalIF":4.3,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144731164","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}