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

• Sponsor: Danderyd Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00989222
• Collaborator: (none)
• Enrollment: 63
• Location: 1
• Arms: 2
• Duration (Months): 41
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Radius Fractures	Procedure: closed reduction and external fixation; Procedure: Internal fixation with a volar locked plate	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius? A Prospective Randomized Study
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: Volar locked plate Open reduction and fixation of a unstable dorsally displaced fracture of the distal radius with a volar locked plate	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; Other Names: Volar locked plate brand: Königsee by Swemac
Other: External fixation Fixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation	Procedure: closed reduction and external fixation; Fixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation; Other Names: External fixation: Hoffman compact

Outcome Measures

Primary Outcome Measures

1. PRWE (patient rated wrist evaluation) score [3,6 and 12 months]

Secondary Outcome Measures

1. Objective function (range of movement and grip strength) [3,6 and 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Orthopaedics, Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital	Stockholm		Sweden	S-18288

Sponsors and Collaborators

• Danderyd Hospital

Investigators

• Principal Investigator: Gustaf Neander, MD, PhD, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00989222
• Other Study ID Numbers: 2005/4:8
• First Posted: Oct 5, 2009
• Last Update Posted: Oct 5, 2009
• Last Verified: Oct 1, 2009

• Keywords provided by , ,: Distal radius fractures; Fractures of the distal radius; Volar plate; External fixation
• Additional relevant MeSH terms: Fractures, Bone; Radius Fractures

Study Results

No Results Posted as of Oct 5, 2009