Short vs Long Arm Cast for Distal Radius Fractures: the Verona Trial (SLA-Ver)

Short vs Long Arm Cast for Distal Radius Fractures: the Verona Trial. Randomized Clinical Trial to Assess the Efficacy of Short Arm Cast Versus Long Arm Cast in Conservative Management of Distal Radius Fractures

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.

Study Overview

• Status: Completed
• Conditions: Radius Fracture Distal
• Intervention / Treatment: Procedure: Short arm cast; Procedure: Long arm cast

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 Type: Interventional
• Enrollment (Actual): 353
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy, 37126
    • Ospedale Civile Maggiore Borgo Trento

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short arm cast; Patient treated with below-elbow cast	Procedure: Short arm cast; Application of a below-elbow cast; Other Names: below-elbow cast; antebrachio-metacarpal cast
Active Comparator: Long arm cast; Patients treated with above-elbow cast	Procedure: Long arm cast; Application of an above-elbow cast; Other Names: above-elbow cast; brachio-metacarpal cast

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona
• Investigators: Study Director: Tommaso Maluta, MD, Azienda Ospedaliera Universitaria Integrata Verona; Principal Investigator: Giovanni Dib, MD, Azienda Ospedaliera Universitaria Integrata Verona; Principal Investigator: Matteo Cengarle, MD, Azienda Ospedaliera Universitaria Integrata Verona; Principal Investigator: Alice Bernasconi, DR, Azienda Ospedaliera Universitaria Integrata Verona; Principal Investigator: Franco Lavini, MD, Azienda Ospedaliera Universitaria Integrata Verona; Study Chair: Andrea Scalvi, MD, Azienda Ospedaliera Universitaria Integrata Verona; Study Chair: Bruno Magnan, MD, Azienda Ospedaliera Universitaria Integrata Verona

Publications and helpful links

General Publications

• 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 Sep 18;13(9):802-811. doi: 10.5312/wjo.v13.i9.802. eCollection 2022 Sep 18.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2017
• Primary Completion (Actual): February 13, 2020
• Study Completion (Actual): March 28, 2020

Study Registration Dates

• First Submitted: March 11, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (Actual): March 16, 2018

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 27, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Cast treatment; above-elbow cast; below-elbow cast; long arm cast; short arm cast
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Cysteine Proteinase Inhibitors; Calpastatin
• Other Study ID Numbers: 1165CESC; 1166CESC (Registry Identifier: Comitato Etico per la sperimentazione clinica delle province di Verona e Rovigo)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No