Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly

Study Overview
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Brief Summary
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The purpose of this study is to examine whether operation and fixation with a metal plate gives better result from the patient's perspective than plaster treatment in elderly patients with a displaced wrist fracture.

Detailed Description
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We will perform a prospective randomized clinical trial comparing open reduction and internal fixation with a volar plate with closed reduction and plaster treatment in elderly patients with a displaced Colles' fracture in order to test the null hypothesis that the patient-perceived result is equal after conservative or operative treatment. Secondary outcomes are objective physical measurements.

Official Title
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Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly. A Randomized Comparison Between Operative Fixation and Plaster Cast Treatment.

Conditions
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Fracture of the Distal Radius, Wrist Fracture

Intervention / Treatment
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* Procedure: open reduction and internal fixation with a volar plate
* Procedure: closed reduction and plaster treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral unstable dislocated dorsally angulated fracture of the distal radius (radial shortening ≥4 mm and/or dorsal angulation ≥20°). Exclusion Criteria: Previous displaced fracture of the distal radius. Additional fractures of the upper extremities, an open fracture, terminal disease, patient not fit for surgery, unwilling or unable to co-operate with follow-up (advanced dementia (SPMSQ<5), psychiatric illness, alcohol abuse).

Ages Eligible for Study
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Minimum Age: 75 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 |
| --- | --- |
| Active Comparator: ORIF<br>Open reduction and internal fixation with a volar plate | Procedure: open reduction and internal fixation with a volar plate<br>* flexor carpi radialis approach, open reduction, fixed-angle volar plate, plaster cast 2 weeks at the surgeon's discretion<br>* Other names: plate: Königsee or Aculoc from Swemac, Sweden;|
| Active Comparator: plaster treatment<br>Closed reduction and plaster treatment | Procedure: closed reduction and plaster treatment<br>* closed reduction, below elbow plaster cast, semicircular for 5 week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient-perceived disability measured by the PRWE and DASH questionnaires |  | one year after wrist fracture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impairments (grip strength and range of motion compared with the uninjured wrist) |  | one year after wrist fracture | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elderly, wrist fracture, fracture of the distal radius, volar plate, plaster cast