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

Study Overview
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Brief Summary
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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.

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

Conditions
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Radius Fractures

Intervention / Treatment
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* Procedure: closed reduction and external fixation
* Procedure: Internal fixation with a volar locked plate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Volar locked plate<br>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<br>* Open reduction and fixation of a unstable dorsally displaced fracture of the distal radius with a volar locked plate<br>* Other names: Volar locked plate brand: Königsee by Swemac;|
| Other: External fixation<br>Fixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation | Procedure: closed reduction and external fixation<br>* Fixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation<br>* Other names: External fixation: Hoffman compact;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PRWE (patient rated wrist evaluation) score |  | 3,6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective function (range of movement and grip strength) |  | 3,6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Volar plate, Distal radius fractures, Fractures of the distal radius, External fixation