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

NCT ID: NCT00989222

Last Updated: 2009-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2009-06-30

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.

Conditions

Radius Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Volar locked plate

Open reduction and fixation of a unstable dorsally displaced fracture of the distal radius with a volar locked plate

Group Type: OTHER

Internal fixation with a volar locked plate

Intervention Type: PROCEDURE

Open reduction and fixation of a unstable dorsally displaced fracture of the distal radius with a volar locked plate

External fixation

Fixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation

Group Type: OTHER

closed reduction and external fixation

Intervention Type: PROCEDURE

Fixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation

Interventions

closed reduction and external fixation

Fixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Other Intervention Names

External fixation: Hoffman compact; Volar locked plate brand: Königsee by Swemac

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danderyd Hospital

OTHER

Sponsor Role: lead

Responsible Party

Division of Orthopaedics, Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden.

Principal Investigators

Gustaf Neander, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Division of Orthopaedics, Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

2005/4:8

Identifier Type: -

Identifier Source: org_study_id