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Fragility of statistically significant findings from randomized clinical trials of surgical treatment of humeral shaft fractures: A systematic review.
Morris, Stephen Craig; Gowd, Anirudh K; Agarwalla, Avinesh; Phipatanakul, Wesley P; Amin, Nirav H; Liu, Joseph N.
Affiliation
  • Morris SC; Department of Orthopaedic Surgery, Loma Linda University, Loma Linda, CA 92354, United States.
  • Gowd AK; Department of Orthopaedic Surgery, Wake Forest University Baptist Medical Center, Winston-Salem, NC 27157, United States.
  • Agarwalla A; Department of Orthopaedic Surgery, Westchester Medical Center, Valhalla, NY 10595, United States.
  • Phipatanakul WP; Department of Orthopaedic Surgery, Loma Linda University, Loma Linda, CA 92354, United States.
  • Amin NH; Department of Orthopaedic Surgery, Premier Orthopaedic and Trauma Specialists, Pomona, CA 91767, United States.
  • Liu JN; Department of Orthopedic Surgery, USC Epstein Family Center for Sports Medicine, Los Angeles, CA 90089, United States. josephnliu@gmail.com.
World J Orthop ; 13(9): 825-836, 2022 Sep 18.
Article in En | MEDLINE | ID: mdl-36189338
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.
Key words

Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Clinical_trials / Diagnostic_studies / Systematic_reviews Language: En Journal: World J Orthop Year: 2022 Document type: Article Affiliation country: United States Country of publication: United States

Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Clinical_trials / Diagnostic_studies / Systematic_reviews Language: En Journal: World J Orthop Year: 2022 Document type: Article Affiliation country: United States Country of publication: United States