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

Radius Fracture Distal Clinical Trial

— SLA-Ver  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03468023
• Other study ID #: 1165CESC
• Secondary ID: 1166CESC
• Status: Completed
• Phase: N/A
• Start date: March 15, 2017
• Est. completion date: March 28, 2020

Study information

• Verified date: September 2020
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: March 28, 2020
• Est. primary completion date: February 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Radius Fracture Distal
• Radius Fractures

Intervention

Procedure:
• Short arm cast
Application of a below-elbow cast
• Long arm cast
Application of an above-elbow cast

Locations

Country	Name	City	State
Italy	Ospedale Civile Maggiore Borgo Trento	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Country where clinical trial is conducted

Italy, 

Outcome

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