Dib G, Maluta T, Cengarle M, Bernasconi A, Marconato G, Corain M, Magnan B. Short arm cast is as effective as long arm cast in maintaining distal radius fracture reduction: Results of the SLA-VER noninferiority trial. World J Orthop 2022; 13(9): 802-811 [PMID: 36189333 DOI: 10.5312/wjo.v13.i9.802]
Corresponding Author of This Article
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
Research Domain of This Article
Orthopedics
Article-Type of This Article
Clinical Trials Study
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): 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 Processing time: 200 Days and 22.7 Hours
Abstract
BACKGROUND
Distal radius fractures (DRFs) are a common challenge in orthopaedic trauma care, yet for those fractures that are treated nonoperatively, strong evidence to guide cast treatment is still lacking.
AIM
To compare the efficacy of below elbow cast (BEC) and above elbow cast (AEC) in maintaining reduction of manipulated DRFs.
METHODS
We conducted a prospective, monocentric, randomized, parallel-group, open label, blinded, noninferiority trial comparing the efficacy of BEC and AEC in the nonoperative treatment of DRFs. Two hundred and eighty patients > 18 years of age diagnosed with DRFs were successfully randomized and included for analysis over a 3-year period. Noninferiority thresholds were defined as a 2 mm difference for radial length (RL), a 3° difference for radial inclination (RI), and volar tilt (VT). The trial is registered at Clinicaltrials.gov (NCT03468023).
RESULTS
One hundred and forty-three patients were treated with BEC, and 137 were treated with AEC. The mean time of immobilization was 33 d. The mean loss of RL, RI, and VT was 1.59 mm, 2.83°, and 4.11° for BEC and 1.63 mm, 2.54°, and 3.52° for AEC, respectively. The end treatment differences between BEC and AEC in RL, RI, and VT loss were respectively 0.04 mm (95%CI: -0.36-0.44), -0.29° (95%CI: -1.03-0.45), and 0.59° (95%CI: -1.39-2.57), and they were all below the prefixed noninferiority thresholds. The rate of loss of reduction was similar.
CONCLUSION
BEC performs as well as AEC in maintaining the reduction of a manipulated DRF. Being more comfortable to patients, BEC may be preferable for nonoperative treatment of DRFs.
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.
