The statistical fragility of outcomes in calcaneus fractures: A systematic review of randomized controlled trials.

The purpose of this study was to utilize the fragility index to assess the robustness of randomized controlled trials (RCTs) evaluating the management of calcaneus fractures. We hypothesize that the dichotomous outcomes in calcaneus fracture literature will be statistically fragile and comparable to other orthopedic specialties. We performed a PubMed search for calcaneus fracture RCTs from 2000 to 2022 using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The fragility index (FI) of each outcome was calculated through the reversal of a single outcome event until significance was reversed. The fragility quotient (FQ) was calculated by dividing each fragility index by study sample size. The interquartile range (IQR) was also calculated for the FI and FQ. Of the 3003 studies screened, 97 met the search criteria, with 19 RCTs evaluating calcaneus fractures included in the analysis. Seventy-nine dichotomous outcomes with 30 significant (P < 0.05) outcomes and 49 with nonsignificant (P> 0.05) outcomes were identified. The overall FI and FQ of all outcomes were 6 (IQR 3-8) and 0.067 (IQR 0.032-0.100), respectively. The literature surrounding calcaneus fractures may not be as statistically stable as previously thought. The sole reliance on the P value may depict misleading results. We, therefore, recommend reporting the P value in conjunction with the FI and FQ to give a robust contextualization of clinical findings in the calcaneus fracture literature.

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Declaration of Competing Interest The authors did not receive support from any organization for the submitted work. Michael Megafu MPH, Hassan Mian MBA, Emmanuel Megafu BA, Sulabh Singhal BS, Katrina Nietsch MS, Avanish Yendluri BS, have no relevant financial or non-financial interests to disclose. Robert L. Parisien, MD has received grant support, hospitality, financial or material support from Anthrex Inc. Robert Parisien services committee roles and editorial roles on the following boards: American Orthopaedic Society for Sports Medicine, American Orthopaedic Society for Sports Medicine, Arthroscopy Association of North America, Arthroscopy Association of North America, Society of Military Orthopaedic Surgeons, Journal of Cartilage & Joint Preservation, Arthroscopy, Arthroscopy, Sports Medicine and Rehabilitation and Journal of Sport Rehabilitation. Paul Tornetta III, MD has received publishing royalties, financial and material from Wolters Kluwer Health – Lippincott Williams & Wilkins. Paul Tornetta III, MD also receives royalties from Smith & Nephew. Paul Tornetta III, MD is currently on the editorial and governing board for the Journal of Orthopedic Trauma. No animals or humans were used in this study and the Institutional Review Board was not notified due to the nature of the article.