Short vs Long Arm Cast for Distal Radius Fractures: the Verona Trial

Not Applicable

Completed

• Conditions: Radius Fracture Distal
• Interventions: Procedure: Long arm cast; Procedure: Short arm cast

• Registration Number: NCT03468023
• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

Brief Summary

This study prospectively compares the performance of an above-elbow cast (long arm cast) and a below-elbow cast (short arm cast) to maintain reduction in conservatively managed distal radius fractures.

Detailed Description

The choice of cast length in conservative management of distal radius fractures still represents a much debated controversy. Classic teaching was to immobilize the elbow to reduce risk of secondary displacement; however, short arm casts are felt to be equally effective with less complications and higher patient comfort. There is currently no conclusive evidence for or against immobilization of the elbow in patients treated with cast immobilization.

Study Timeline

• Study Start: 2017-03-15
• Study First Submitted: 2018-03-11
• Study First Submitted QC: 2018-03-15
• Study First Posted: 2018-03-16
• Primary Completion: 2020-02-13
• Study Completion: 2020-03-28
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-27
• Last Update Posted: 2020-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 353

Inclusion Criteria

• Diagnosis of distal radius fracture
• Indication to conservative treatment
• Need for manipulation to reduce fracture

Exclusion Criteria

• Open fractures
• Existence of any skin lesion or wound that would impair cast treatment
• Neurovascular deficits
• Bilateral fractures
• Association with any other fracture of the homolateral arm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long arm cast	Long arm cast	Patients treated with above-elbow cast
Short arm cast	Short arm cast	Patient treated with below-elbow cast

Primary Outcome Measures

Name	Time	Method
Secondary displacement ratio	35 days	Percentage of fractures that displace during treatment as subjectively assessed on radiographs by investigators.
Variation of radial length	35 days	Difference between radial length values as objectively measured on postreduction radiographs and endtreatment radiographs.
Variation of radial inclination	35 days	Difference between radial inclination values as objectively measured on postreduction radiographs and endtreatment radiographs.
Variation of volar tilt	35 days	Difference between volar tilt vaues as objectively measured on postreduction radiographs and endtreatment radiographs.

Secondary Outcome Measures

Name	Time	Method
Post-treatment elbow range of motion (ROM)	35 days	Degrees of extension, flexion, pronation and supination of the elbow measured at the end of the treatment.
SF-12	35 days	Short Form 12 health questionnaire administered at the end of the treatment relating to patient's quality of life during treatment.
DASH score	35 days	Disability of Arm, Shoulder and Hand score measured at the end of the treatment relating to patient's comfort during treatment.

Trial Locations

Locations (1)

Ospedale Civile Maggiore Borgo Trento; 🇮🇹 Verona, Italy