Published online Sep 18, 2022. doi: 10.5312/wjo.v13.i9.802
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
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.
To compare the efficacy of below elbow cast (BEC) and above elbow cast (AEC) in maintaining reduction of manipulated DRFs.
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).
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.
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.