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Background: The American Academy of Orthopaedic Surgeons (AAOS) publishes clinical practice guidelines (CPGs) for various pathologies. An extension to the Consolidated Standards for Reporting (CONSORT) checklist provides authors with a framework for reporting harms in randomized controlled trials (RCTs). Objectives: The purpose of this study was to measure harms reporting among RCTs cited as supporting evidence for the AAOS CPG on the treatment of clavicle fractures. This study also sought to determine whether these reporting rates changed over time. Methods: Adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we used the AAOS CPG for clavicle fractures and conducted a linear regression analysis to model the relationship between the year of publication and the total CONSORT checklist percentage adherence over time. Results: There were 28 RCTs cited as supporting evidence for the clavicle fractures CPG included in the final sample. The average number of the 18 CONSORT Extension for Harms items appropriately reported across all included RCTs was 9.32 (51.8%). Nine checklist items had more than 50% compliance (50%), 3 items had between 20% and 50% compliance (16.7%), and 6 items had less than 20% compliance (33.3%). The linear regression model demonstrated no significant improvement in CONSORT Harms reporting over time. Conclusions: Adverse events are inadequately reported in RCTs cited as supporting evidence for the AAOS Treatment of Clavicle Fractures CPGs. We recommend the utilization of standardized adverse event reporting tools specific to orthopedic trauma literature to facilitate ease in adverse event reporting among RCTs. [ABSTRACT FROM AUTHOR]

Background: Complete blood cell count-based ratios (CBRs), including the neutrophil-lymphocyte ratio (NLR) and monocyte-lymphocyte ratio (MLR), are inflammatory markers associated with postoperative morbidity. Given the link between the surgical stress response and complications after total joint arthroplasty (TJA), this study aimed to evaluate whether higher preoperative CBR values predict greater postoperative benefits associated with dexamethasone utilization. Methods: The Premier Healthcare Database was queried for adult patients who underwent primary, elective total hip or knee arthroplasty (THA or TKA). Multivariable logistic regression models using dexamethasone exposure and CBRs as independent variables assessed primary end points of 90-day postoperative complications and length of stay (LOS) of ≥3 days. The probability difference between the dexamethasone and non-dexamethasone groups for each primary end point was determined across all values of each CBR. Probability differences were compared across CBR quartiles. Results: A total of 32,849 primary, elective TJAs (12,788 THAs [38.93%], 20,061 TKAs [61.07%]) performed between 2016 and 2021 were identified, and 22,282 (67.83%) of the patients received perioperative dexamethasone. Among patients with an NLR value of >1.00, those receiving dexamethasone had a lower probability of postoperative complications (all p < 0.05). Dexamethasone was associated with lower odds of an LOS of ≥3 days among patients in the highest NLR quartile (≥4.67) compared with the lowest quartile (NLR <1.84) (p = 0.002). Among patients with an MLR value of ≥0.36, those receiving dexamethasone had significantly lower odds of postoperative complications. Dexamethasone was associated with lower odds of an LOS of ≥3 days among patients with an MLR of ≥0.33 (the 2 highest quartiles) compared with an MLR of <0.24 (the lowest quartile) (p = 0.039). Conclusions: Higher NLR and MLR values were associated with greater marginal benefit from perioperative dexamethasone treatment, establishing a modifiable link between adverse outcomes and perioperative inflammation in TJA. Level of Evidence: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

Ex vivo regional gene therapy is a promising tissue-engineering strategy for bone regeneration: osteogenic mesenchymal stem cells (MSCs) can be genetically modified to express an osteoinductive stimulus (e.g., bone morphogenetic protein-2), seeded onto an osteoconductive scaffold, and then implanted into a bone defect to exert a therapeutic effect. Compared to recombinant human BMP-2 (rhBMP-2), which is approved for clinical use, regional gene therapy may have unique benefits related to the addition of MSCs and the sustained release of BMP-2. However, the cellular and transcriptional mechanisms regulating the response to these two strategies for BMP-2 mediated bone regeneration are largely unknown. Here, for the first time, we performed single-cell RNA sequencing (10x Genomics) of hematoma tissue in six rats with critical-sized femoral defects that were treated with either regional gene therapy or rhBMP-2. Our unbiased bioinformatic analysis of 2393 filtered cells in each group revealed treatment-specific differences in their cellular composition, transcriptional profiles, and cellular communication patterns. Gene therapy treatment induced a more robust chondrogenic response, as well as a decrease in the proportion of fibroblasts and the expression of profibrotic pathways. Additionally, gene therapy was associated with an anti-inflammatory microenvironment; macrophages expressing canonical anti-inflammatory markers were more common in the gene therapy group. In contrast, pro-inflammatory markers were more highly expressed in the rhBMP-2 group. Collectively, the results of our study may offer insights into the unique pathways through which ex vivo regional gene therapy can augment bone regeneration compared to rhBMP-2. Furthermore, an improved understanding of the cellular pathways involved in segmental bone defect healing may allow for the further optimization of regional gene therapy or other bone repair strategies. [ABSTRACT FROM AUTHOR]

Background: Total shoulder arthroplasty (TSA), which includes anatomic total shoulder arthroplasty (aTSA) and reverse total shoulder arthroplasty (rTSA), is a technically demanding procedure and limited data exist on the relationship between case volume and complications. We sought to identify volume thresholds for TSA, aTSA, and rTSA at which risk of a major surgical complication decreased and to compare complications of patients treated by high-volume surgeons with those of patients treated by low-volume surgeons. Materials and Methods: Primary, elective TSAs (aTSA and rTSA) from January 1, 2016, to December 31, 2019, were identified in the Premier Healthcare Database. Multivariable logistic regression with restricted cubic splines modeled the relationship between annual TSA, aTSA, and rTSA surgeon volume and 90-day risk of major surgical complications. The 90-day complications of patients treated by high- and low-volume surgeons were compared. Results: From 2016 to 2019, 3177 surgeons performed 78,639 TSAs. Increasing annual volume was associated with decreasing major surgical complication risk (thresholds: 50 TSAs, 25 aTSAs, and 36 rTSAs). High- and low-volume surgeons performed 24,595 and 54,044 TSAs, respectively. Patients of high-volume surgeons had lower risk of major surgical complications (adjusted odds ratio [aOR], 0.69; 95% CI, 0.56–0.84), myocardial infarction (aOR, 0.59; 95% CI, 0.36–0.97), and readmission (aOR, 0.71; 95% CI, 0.62–0.81). Importantly, 74.9% of high-volume and 93.0% of low-volume surgeon-year units had major surgical complication rates below the mean of all recorded surgeons. Conclusion: While most high- and low-volume surgeons had major surgical complication rates below the cohort average, increasing TSA volume was associated with a decreased risk of complications. [Orthopedics. 2025;48(1):e15–e21.] [ABSTRACT FROM AUTHOR]

Background/Objectives: Artri King is an over-the-counter supplement previously marketed to treat joint pain and arthritis. In 2022, the Food and Drug Administration (FDA) issued a product warning after it discovered Artri King contained hidden ingredients including dexamethasone, diclofenac, and methocarbamol. Given the risk of adrenal insufficiency in the context of long-term dexamethasone use, we sought to report on adverse endocrinologic outcomes observed among patients endorsing the use of these supplements who presented to an orthopedic surgery clinic at a county safety net hospital. Methods: Preoperative patients presenting from November 2023 to June 2024 were screened for supplement use. Data were collected including patient demographics and comorbidities. Serum cortisol, adrenocorticotropic hormone (ACTH), and C-reactive protein (CRP) were obtained to assess adrenal function. Recommendations from Endocrinology regarding perioperative stress dose corticosteroids were also recorded. Standard descriptive statistics were employed to report our results. Results: In total, 13 patients (6 female and 7 male) were identified with a mean age of 62.8 years (range of 47–79 years) and an average BMI of 32.03 kg/m2 (range of 22.93–45.81 kg/m2). The average duration of use was 10.2 months (range of 1–36 months). One patient developed new-onset diabetes mellitus while taking supplements. Nine patients had low cortisol levels (<6.7 mcg/dL), necessitating referral to Endocrinology, and two were found to have concomitantly low ACTH levels (<5 pg/mL). Endocrinology recommended perioperative stress dose corticosteroids for all nine patients with low cortisol. Conclusions: Artri King and similar supplements may lead to severe endocrinological consequences. We recommend routine screening and continued management of patients who endorse supplement use. [ABSTRACT FROM AUTHOR]