Treatment of Distal Radius Fractures in Elderly Patients

Study Overview
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Brief Summary
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The purpose of this study is to create and test a treatment algorithm to guide the treatment of distal radius fractures in patients 65 and older and to obtain level-one evidence to determine the best method of treating distal radius fractures in this growing population demographic.

Detailed Description
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Distal radius fractures with borderline alignment will be randomized to surgical intervention or conservative treatment. Patients will fill out subjective questionnaires at 0, 6weeks, 3months, 6 months, and 1 year. Patients will perform objective strength tests, dexterity tests and have their range of motion tested at 12 weeks, 6 months and 12 months.

Official Title
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Treatment of Distal Radius Fractures in Elderly Patients, a Randomized Controlled Trial

Conditions
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Distal Radius Fractures

Intervention / Treatment
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* Procedure: Distal Radius Fracture Reduction
* Other: Conservative Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Distal Radius Fracture Between 10 and 20 degrees of dorsal angulation Between 3 and 5mm of Ulnar positive variance Between 1 and 2mm intra Articular Step deformity Age 65 and older Exclusion Criteria: Pre-Morbid medical conditions which preclude surgical intervention Patients who do not live independently. Patients with an open fracture Associated soft tissue or skeletal injury to the same limb. Pre-existing wrist arthrosis or disability

Ages Eligible for Study
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Minimum Age: 65 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: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Surgery<br>Surgical intervention to reduce Distal Radius Fracture | Procedure: Distal Radius Fracture Reduction<br>* Surgical Intervention to Reduce Distal Radius Fracture<br>* Other names: Distal Radius Reduction;|
| Other: Conservative Treatment<br>Conservative treatment of Distal Radius Fractures | Other: Conservative Management<br>* Conservative management of Distal Radius Fractures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary: Patient pain and disability. Will be quantified with Disabilities of the Arm and Shoulder (DASH) and Patient Rated Wrist Evaluation (PRWE). |  | 0-1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary: To determine if other baseline factors influence outcome. For example, baseline activity levels (RAPA), home supports, hand dominance, and general mental health will be analyzed. |  | over 1 year | 
| Secondary: To stratify results by age. (65-75, 77-80, and >80) |  | 0-1 year | 
| Grip strength, Range of Motion and Dexterity testing of wrists |  | 3 months to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Distal Radius Fracture, Elderly, Prospective randomized trial, Outcomes, Pain and Function, Surgical Vs. conservative management, Fractures with borderline alignment