Morris SC, Gowd AK, Agarwalla A, Phipatanakul WP, Amin NH, Liu JN. Fragility of statistically significant findings from randomized clinical trials of surgical treatment of humeral shaft fractures: A systematic review. World J Orthop 2022; 13(9): 825-836 [PMID: 36189338 DOI: 10.5312/wjo.v13.i9.825]
Corresponding Author of This Article
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
Research Domain of This Article
Orthopedics
Article-Type of This Article
Systematic Reviews
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (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: http://creativecommons.org/licenses/by-nc/4.0/
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
ARTICLE HIGHLIGHTS
Research background
Humeral shaft fractures are a common injury which could be managed non-operatively or operatively. There is a lack of clear evidence to support open reduction internal fixation vs intramedullary nail fixation.
Research motivation
Identify the fragility index, which identifies the number of patients have a change in outcome from a significant to non-significant. This is important as higher level studies guide management in orthopedics.
Research objectives
Applying the fragility index to humeral shaft fractures will aid in clinical decision making on treatment of humeral shaft fractures.
Research methods
A systematic review of randomized controlled trials (RCTs) evaluating the surgical treatment of humeral shaft fractures was conducted. The fragility index (FI) was calculated for total complications, each complication individually, and secondary surgeries using the Fisher exact test, as previously published.
Research 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.
Research conclusions
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.
Research perspectives
Further research is needed to delineate whether open reduction internal fixation or intramedullary nail fixation is superior in the management of humeral shaft fractures.
