Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster

Study Overview
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Brief Summary
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Distal radius fractures with dorsal dislocation among patients 70 years or older are randomized to conservative treatment with plaster or internal fixation with a volar plate. Thereafter they are followed at 2 weeks, 5 weeks, 3 months and 12 months with x-ray, functional scores and clinical examination. An additional follow up at three years with X-ray, functional scores and clinical outcome will be conducted after a new written consent of continued participation in the study. A health economy analysis will be preformed at 1, and 3 years for the participants with complete EQ5D.

Official Title
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Dorsally Displaced Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster - A Prospective Randomized Trial

Conditions
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Distal Radius Fracture

Intervention / Treatment
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* Procedure: Volar plate
* Device: Synthes TCP volar plate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dorsally displaced, 20 degrees or from a plane perpendicular do the diaphyseal axis, fracture. Low energy injury Patient 70 years old or older 72 hours or less since injury at time of diagnosis Patient registered in the Stockholm region Patient understands spoken and written swedish Exclusion Criteria: Intraarticular displacement in radiocarpal joint of more than 1 mm Ulna fractured proximal to the base of the styloid process of ulna Earlier unilateral functional impairment of hand/wrist Injury to tendon, nerve or skin besides the fracture Rheumatoid arthritis or other severe systemic joint disease Severe psychiatric disorder, ongoing drug abuse or dementia (Pfeiffer score 5 points or less) Besides the wrist fracture also other big injuries, for example fracture of hip, shoulder or ankle Medical illness that makes general anesthesia impossible

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| No Intervention: Plaster cast<br>The patient will be treated in a dorsal plaster cast for 4 weeks following the injury to the wrist | |
| Experimental: Volar plate<br>The patient will undergo surgery to the injured wrist with a Synthes Two-column plate (TCP) with a volar approach. Cast will be worn 2 weeks after surgery. | Procedure: Volar plate<br>* An anatomically countoured volar plate is implanted through a Henry's incision.<br>* Other names: Synthes TCP volar plate for distal radius;Device: Synthes TCP volar plate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient related wrist evaluation (PRWE) |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient related wrist evaluation (PRWE) |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Distal radius fracture, wrist fracture, volar plate, surgical treatment, plaster immobilisation