Systematic Reviews
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Orthop. Sep 18, 2022; 13(9): 825-836
Published online Sep 18, 2022. doi: 10.5312/wjo.v13.i9.825
Fragility of statistically significant findings from randomized clinical trials of surgical treatment of humeral shaft fractures: A systematic review
Stephen Craig Morris, Anirudh K Gowd, Avinesh Agarwalla, Wesley P Phipatanakul, Nirav H Amin, Joseph N Liu
Stephen Craig Morris, Wesley P Phipatanakul, Department of Orthopaedic Surgery, Loma Linda University, Loma Linda, CA 92354, United States
Anirudh K Gowd, Department of Orthopaedic Surgery, Wake Forest University Baptist Medical Center, Winston-Salem, NC 27157, United States
Avinesh Agarwalla, Department of Orthopaedic Surgery, Westchester Medical Center, Valhalla, NY 10595, United States
Nirav H Amin, Department of Orthopaedic Surgery, Premier Orthopaedic and Trauma Specialists, Pomona, CA 91767, United States
Joseph N Liu, Department of Orthopedic Surgery, USC Epstein Family Center for Sports Medicine, Los Angeles, CA 90089, United States
Author contributions: Morris SC is responsible for the data collection; Morris SC and Gowd AK analyze the data; Phipatanakul WP, Liu JN and Amin NH are responsible for the study conception; all authors participate in the manuscript preparation.
Conflict-of-interest statement: All authors report no relevant conflict of interest for this article.
PRISMA 2009 Checklist statement: The authors have read the PRISMA 2009 Checklist, and the manuscript was prepared and revised according to the PRISMA 2009 Checklist.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Joseph N Liu, MD, Assistant Professor, Department of Orthopedic Surgery, USC Epstein Family Center for Sports Medicine, 950 Downey Way, Los Angeles, CA 90089, United States. josephnliu@gmail.com
Received: October 26, 2021
Peer-review started: October 26, 2021
First decision: February 15, 2022
Revised: February 28, 2022
Accepted: August 12, 2022
Article in press: August 12, 2022
Published online: September 18, 2022
Processing time: 325 Days and 10.9 Hours
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.

Keywords: Humerus fracture; Open reduction internal fixation; Intramedullary nail; Fragility index; Complications; Fragility index

Core Tip: Humerus shaft fractures have been managed with intramedullary nail fixation and plate osteosynthesis. Multiple randomized control trials have been performed to compare outcomes, complications, reoperations, and union rates between both treatment modalities. Despite multiple randomized control trials, there remains a lack of consensus from the existing literature regarding surgical treatment of humeral shaft fractures. This manuscript aims to further assess the quality of the literature that guides treatment decisions by employing a new metric, the fragility index.