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Objective: The aim of this study is to both quantify and qualify the way insurance companies justify their coverage policies for autologous chondrocyte implantation (ACI) and determine whether these policies align with recent research on the subject., Design: The top 11 national commercial health insurance payers for ACI were identified. Coverage policy documents were recovered for 8 payers. These documents were examined, and the type of reference and the level of evidence (LOE) were recorded for each applicable reference. Specific coverage criteria for each individual payer were then extracted and assessed for similarities among commercial payers. Finally, all references cited by each payer were examined to determine whether they mentioned the specific payer criteria., Results: This study found that the majority of cited references were primary journal articles (86, 58.1%) and that only 30 (20.2%) references were level I or level II evidence. This study also found significant homogeneity among payer coverage criteria. Cited sources inconsistently mentioned specific payer coverage criteria. In addition, payer criteria tended to be poorly supported by current evidence on ACI., Conclusions: This study demonstrates that commercial insurance payers' coverage policies for ACI poorly cite references, cite a majority of references with low LOE, and cite references which infrequently mention their specific coverage criteria. In addition, payer coverage policies have a high degree of homogeneity and many of their specific criteria are poorly supported by current research on ACI., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Limited evidence exists regarding the influence of mental health disorders (MHDs) on opioid use and complications after total shoulder arthroplasty (TSA). We aimed to identify the prevalence of common MHDs among patients undergoing anatomic TSA (aTSA) and reverse TSA (rTSA)., Materials and Methods: The Premier Healthcare Database was queried for patients undergoing primary aTSA and rTSA from 2016 to 2020. International Classification of Diseases, Tenth Revision, diagnosis codes were used to identify MHDs. Primary outcomes included the prevalence of MHDs, perioperative opioid consumption, and 90-day risk of postoperative complications, revision, and readmission. Bivariate and multivariate regression analyses were performed to assess 90-day risk of primary endpoints while controlling for potential confounders. Statistical significance was defined as P <.05., Results: From 2016 to 2020, 49,997 of 144,725 (34.55%) patients undergoing primary TSA had at least one diagnosed MHD. The most prevalent were depression (17.03%), anxiety (16.75%), and substance use disorder (10.20%). Patients with a MHD had higher mean hospital costs ($75,984±$43,129 vs $73,316±$39,046, P <.0001), longer mean length of stay (1.95±2.25 days vs 1.61±1.51 days, P <.0001), and higher mean total postoperative opioid use (72.00±231.55 morphine milligram equivalents [MMEs] vs 59.32±127.31 MMEs, P <.0001). Periprosthetic fractures (odds ratio, 1.20; P =.041), dislocation (odds ratio, 1.12; P =.042), and 90-day readmission rates (odds ratio, 1.26; P <.001) were significantly higher among patients with a MHD., Conclusion: This study found that MHDs are associated with significantly increased perioperative opioid consumption, medical and surgical complication rates, and risk of readmission after TSA. Recognition and optimization of MHDs is critical to minimizing complications and opioid consumption after TSA. [ Orthopedics . 202x;4x(x):xx-xx.].

Purpose: To perform a systematic review to evaluate the effect of industry affiliation on the outcomes of randomized controlled trials (RCTs) for platelet-rich plasma (PRP) injections in rotator cuff tears., Methods: PubMed, SPORTdiscus, and Scopus databases were searched from 2010 to the present for terms "rotator cuff" and "platelet-rich plasma." Inclusion criteria were RCTs comparing PRP to controls for treatment of rotator cuff tears and exclusion criteria were systematic reviews, meta-analyses, case reports, cohort studies, basic science studies, other level 3 and below studies, and studies not in English. Degree of industry affiliation was categorized into three groups: direct, indirect, and not affiliated. Direct affiliation required the study or its authors to receive financial support from the company manufacturing the devices used in the study to prepare or administer PRP. Indirect affiliation required financial association with a different company that produces or administers PRP than the one used in the study. Studies were classified as favorable if study outcomes achieved significance (p < 0.05) of PRP over the control, or analogous if there was no statistical significance between PRP and control. Data was analyzed using chi-squared and fisher's exact tests., Results: Of the 47 studies selected for analysis, 8 (17.0%) had no direct industry affiliation, 9 (19.1%) indirect affiliation and 30 (63.8%) no industry affiliation. 22 (46.8%) studies reported favorable results with PRP compared to the control and 25 (53.2%) showed analogous results between PRP and control. Degree of industry affiliation was significantly associated with increased likelihood of reporting favorable study outcomes (p = 0.041). Directly affiliated studies had a significantly increased likelihood of reporting favorable results (p = 0.024) compared to indirectly affiliated., Conclusions: Studies that used PRP produced by companies that directly fund the study or were financially affiliated with the authors were significantly more likely to report favorable results., Level of Evidence: Systematic review of Level I and II studies., (Copyright © 2024. Published by Elsevier Inc.)

Background: This research aims to determine the influence of industry on the outcomes of randomized controlled trials (RCTs) for Mesenchymal Stem Cell (MSC) treatments in knee osteoarthritis (OA)., Methods: PubMed, Scopus, and Web of Science were searched from 2010 onwards using the terms "knee osteoarthritis" and "mesenchymal stem cells". After identifying relevant RCTs, studies were categorized as industry-affiliated or non-industry-affiliated. They were also classified as favorable if they achieved statistically significant (p < 0.05) results with MSC injections compared to control. Chi-squared tests were employed to analyze the relationship between industry affiliation and study outcome., Results: Post exclusion criteria, 38 studies were analyzed. Of these, there were 20 (52.6%) industry affiliated (IA) and 18 (47.4%) non-industry affiliated (NIA) studies. Among the 20 IA studies, 17 (85.0%) reported favorable outcomes for MSC treatment arm, with the remaining 3 (15.0%) showing analogous (no difference between treatment arms) results. For the 18 NIA studies, 15 (83.3%) were favorable, and 3 (16.6%) were analogous. No significant difference in outcomes was observed between IA and NIA studies (p = 0.888). Analysis of patient reported outcomes also revealed no significant difference. Of note, studies using allogeneic MSCs were more likely to be IA than studies using autologous MSCs (p = 0.005) CONCLUSION: This study demonstrated no strong association between industry affiliation and the outcomes of RCTs for MSC treatments in knee OA. Despite this, the potential influence of industry ties should always be considered when applying study findings to new treatment modalities for patient care., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: ‘Frank A Petrigliano reports a relationship with Exactech Inc that includes: consulting or advisory. Frank A Petrigliano reports a relationship with Stryker Orthopaedics that includes: consulting or advisory. Frank A Petrigliano reports a relationship with OSSIO Inc that includes: consulting or advisory. Joseph N Liu reports a relationship with Stryker Orthopaedics that includes: speaking and lecture fees. Joseph N Liu reports a relationship with Innocoll Biotherapeutics NA Inc that includes: travel reimbursement. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.’., (Copyright © 2024 Elsevier B.V. All rights reserved.)