Fragility of statistically significant findings from randomized clinical trials of surgical treatment of humeral shaft fractures: A systematic review

Abstract

BACKGROUND Despite recent meta-analyses of randomized controlled trials (RCTs), there remains no consensus regarding the preferred surgical treatment for humeral shaft fractures. The fragility index (FI) is an emerging tool used to evaluate the robustness of RCTs by quantifying the number of participants in a study group that would need to switch outcomes in order to reverse the study conclusions. AIM To investigate the fragility index of randomized control trials assessing outcomes of operative fixation in proximal humerus fractures. METHODS We completed a systematic review of RCTs evaluating the surgical treatment of humeral shaft fractures. Inclusion criteria included: articles published in English; patients randomized and allotted in 1:1 ratio to 2 parallel arms; and dichotomous outcome variables. The FI was calculated for total complications, each complication individually, and secondary surgeries using the Fisher exact test, as previously published. RESULTS Fifteen RCTs were included in the analysis comparing open reduction plate osteosynthesis with dynamic compression plate or locking compression plate, intramedullary nail, and minimally invasive plate osteosynthesis. The median FI was 0 for all parameters analyzed. Regarding individual outcomes, the FI was 0 for 81/91 (89%) of outcomes. The FI exceeded the number lost to follow up in only 2/91 (2%) outcomes. CONCLUSION The FI shows that data from RCTs regarding operative treatment of humeral shaft fractures are fragile and does not demonstrate superiority of any particular surgical technique