Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius?

Not Applicable

Completed

• Conditions: Radius Fractures
• Interventions: Procedure: Internal fixation with a volar locked plate; Procedure: closed reduction and external fixation

• Registration Number: NCT00989222
• Lead Sponsor: Danderyd Hospital

Brief Summary

Promising results have been reported after volar locked plating of unstable dorsally displaced fractures of the distal radius. It offers stable fixation and early mobilization. The investigators' aim is to test if volar locked plating results in better patient-perceived, objective functional and radiological outcomes compared to the less invasive external fixation that has been the standard operation for decades.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2009-10
• Study First Submitted: 2009-10-02
• Study First Submitted QC: 2009-10-02
• Last Update Submitted: 2009-10-02
• Study First Posted: 2009-10-05
• Last Update Posted: 2009-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• An acute unilateral Colles' fracture (AO class A and C1) with a dorsal angulation of more than 20 degrees or radial shortening of 4 mm or more, AND
• Patient aged 20-70 years with no previous fracture of either wrist.

Exclusion Criteria

• Bilateral fractures,
• Other current injury to the upper extremities,
• Dementia, OR
• Severe comminution or too small distal fragment to allow plating.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Volar locked plate	Internal fixation with a volar locked plate	Open reduction and fixation of a unstable dorsally displaced fracture of the distal radius with a volar locked plate
External fixation	closed reduction and external fixation	Fixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation

Primary Outcome Measures

Name	Time	Method
PRWE (patient rated wrist evaluation) score	3,6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Objective function (range of movement and grip strength)	3,6 and 12 months

Trial Locations

Locations (1)

Division of Orthopaedics, Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital; 🇸🇪 Stockholm, Sweden