Cast vs. Splints for Minimally Displaced Distal Radius Fractures in the Elderly

Study Overview
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Brief Summary
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The purpose of this prospective randomized study is to add to the body of knowledge on the treatment of minimally displaced distal radius fractures in patients over 60 years of age. The investigators believe that treating minimally displaced distal radius fractures in people over 60 with a removable splint and early range of motion will provide greater patient satisfaction, fewer complications, and earlier functional returns to pre-injury for these patients compared to those treated with a short arm cast which immobilizes the limb for at least four weeks, and has been shown to lead to longer recovery and possible residual stiffness. The investigators hope to provide sufficient evidence in directing treatment that will give the most efficacious and the most satisfactory return of prior function to patients. Since distal radius fractures in the elderly are common because of poorer bone quality, the elderly proportion of the population is increasing, and controlling health costs is of current concern, answering the question of which treatment produces the best results for all these concerns is of increasing importance now.

Official Title
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Use of Cast Versus Removable Splints for Minimally Displaced Distal Radius Fractures in Elderly Patients: A Prospective, Randomized Trial

Conditions
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Radius; Fracture, Lower or Distal End

Intervention / Treatment
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* Device: Cast made of generic plaster or fiberglass cast material
* Device: Generic off the shelf removable splint


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Colles' Fracture - Distal radius fracture with dorsal angulation, apex volar (satisfies non-operative radiographic criteria before or after reduction Isolated upper limb injury No previous wrist fracture Available for follow-up Between 60 and 100 years of age Exclusion Criteria: Less than 60 years of age Fractures that do not meet non-operative criteria or are deemed unstable by surgeon, subsequently requiring surgery after first clinic visit.

Ages Eligible for Study
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Minimum Age: 60 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: Generic plaster or fiberglass cast group<br>Patients will be randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks. | Device: Cast made of generic plaster or fiberglass cast material<br>* Patients will randomly receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture.<br>* Other names: No brand name applicable.;|
| Active Comparator: Generic off the shelf removable splint group<br>Subjects will be randomized and receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks. | Device: Generic off the shelf removable splint<br>* Patients will be randomized to receive a generic off the shelf removable splint for treatment of a non-displaced distal radius fracture.<br>* Other names: No brand name applicable;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Wrist Range of Motion (ROM) | Wrist ROM will be assessed by a goniometer exam. | Baseline, Month 3 | 
| Mean Mayo Wrist Score | The Mayo Wrist Score is a clinician-completed scoring system used to evaluate the level of functionality in the wrist, assessing pain, functional status (able to work), range of motion and grip strength. Total scores for functionality range from 0-100 and are categorized as follows: 90-100 indicates excellent, 80-90 indicates good, 60-80 indicates satisfactory, below 60 indicates poor. The assessment was completed at all study visits. | Baseline, Week 2, Week 6, Week 12 | 
| Change in Grip Strength | Grip strength will be assessed by bilateral dynamometer testing. | Baseline, Month 3 | 
| Complication Rate | The number of participants who experienced treatment related complications including the need for manipulation in the case of lost reduction. | Duration of Study (Up to 3 Months) | 
| Mean Pain Score | Pain will be assessed by a visual analog scale (VAS). Participants rate their pain level in a scale from 0 to 10; 0 representing no pain and 10 representing the worst pain imaginable. The assessment was completed at all study visits. | Baseline, Week 2, Week 6, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Disabilities of the Arm and Shoulder (DASH) Questionnaire Score | The DASH questionnaire asks about symptoms as well as ability to perform certain activities. Scores range on a 0-100 scale. A higher score indicates greater disability. | Baseline, Week 2, Week 6, Week 12 | 
| Change in SF-12 QOL | The SF-12 QOL is a self-administered measure asking views about participant's health and how well they are able to perform usual activities. | Baseline, Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wrist fracture, Radius fracture, Elderly, Splint, Cast