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

Radius Fractures Clinical Trial

Official title:

Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius? A Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989222
• Other study ID #: 2005/4:8
• Status: Completed
• Phase: N/A
• First received: October 2, 2009
• Last updated: October 2, 2009
• Start date: January 2006
• Est. completion date: June 2009

Study information

• Verified date: October 2009
• Source: Danderyd Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Radius Fractures

Intervention

Procedure:
• closed reduction and external fixation
Fixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation
• 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

Locations

Country	Name	City	State
Sweden	Division of Orthopaedics, Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Danderyd Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PRWE (patient rated wrist evaluation) score		3,6 and 12 months	No
Secondary	Objective function (range of movement and grip strength)		3,6 and 12 months	No