Clinical Trials Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Orthop. Sep 18, 2022; 13(9): 802-811
Published online Sep 18, 2022. doi: 10.5312/wjo.v13.i9.802
Short arm cast is as effective as long arm cast in maintaining distal radius fracture reduction: Results of the SLA-VER noninferiority trial
Giovanni Dib, Tommaso Maluta, Matteo Cengarle, Alice Bernasconi, Giulia Marconato, Massimo Corain, Bruno Magnan
Giovanni Dib, Tommaso Maluta, Matteo Cengarle, Giulia Marconato, Bruno Magnan, Department of Orthopaedics and Trauma Surgery, University of Verona Medical School, AOUI Borgo Trento, Verona 37126, Italy
Alice Bernasconi, MsC Biostatistics, Evaluative Epidemiology Unit, Department of Research, National Cancer Institute Foundation IRCSS, Milano 20133, Italy
Massimo Corain, Department of Hand Surgery, University of Verona Medical School, AOUI Borgo Roma, Verona 37134, Italy
Author contributions: Dib G and Cengarle M equally conceptualized and designated the research work; Maluta T contributed to organizing and performing the research; Marconato G performed the research and was actively involved together with Dib G and Cengarle M in reviewing patients' X-ray; Bernasconi A analyzed the data; Dib G drafted the manuscript; Magnan B and Corain M revised the manuscript.
Institutional review board statement: This study was approved by the local Institutional Review Board (CE1165CESC).
Clinical trial registration statement: This study was registered on ClinicalTrials.org (NCT03468023).
Informed consent statement: All study participants provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Each author certifies that he or she has no conflict of interest in connection with the submitted article.
Data sharing statement: Dataset and statistical code is available from the corresponding author on request.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
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: Giovanni Dib, MD, Surgeon, Department of Orthopaedics and Trauma Surgery, University of Verona Medical School, AOUI Borgo Trento, Piazzale Aristide Stefani 1, Verona 37126, Italy. dib.giovanni@gmail.com
Received: February 27, 2022
Peer-review started: February 27, 2022
First decision: May 31, 2022
Revised: June 15, 2022
Accepted: August 7, 2022
Article in press: August 7, 2022
Published online: September 18, 2022
Core Tip

Core Tip: Currently, there is no general agreement on how best to immobilize a distal radius fracture (DRF) although classic teaching was that immobilization of the elbow would ensure better control of fracture instability. This has been recently challenged by a number of new randomized controlled trials (RCTs) but no one was designed as a non-inferiority RCT, which is the most appropriate way to evaluate the hypothesis that blocking the elbow is unnecessary. We devised a large population noninferiority RCT to give statistical evidence that short arm cast is as effective as long arm cast to treat DRFs using predetermined noninferiority thresholds.