Cast OFF Trial: One Versus Four-five Weeks of Plaster Cast Immobilization

Study Overview
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Brief Summary
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Distal radius fracture (DRF) is a common fracture of which the incidence appears to be increasing worldwide. On average, a total of 17% of all diagnosed fractures are DRF's. In the Dutch guideline for DRF the treatment advice for DRF, without reduction, is treatment with plaster cast or brace for one-three weeks. Despite the advice in the guideline and despite several studies from the 90's showing that plaster cast treatment of a stable DRF for one week is safe, the usual length of plaster cast treatment for stable DRF is four-six weeks. In addition, recent studies have also shown that a long period of immobilization can lead to more post traumatic pain by increasing disuse and kinesiophobia. This evidence suggests that the usual duration (4-6 weeks) of plaster cast treatment for DRF is unnecessary. The aim of this feasibility study is to define whether one week of plaster cast treatment is possible and can lead to better functional results, with at least the same patient satisfaction and complications. In addition, this feasibility study will be used to define the sample size of the future RCT.

Official Title
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Cast OFF Trial: One Versus Four-five Weeks of Plaster Cast Immobilization for Non-reduced Distal Radius Fractures: A Randomized Clinical Trial - A Feasibility Trial

Conditions
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Distal Radius Fracture

Intervention / Treatment
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* Procedure: One week of plaster cast
* Procedure: Four-Five weeks of plaster cast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 75 years Isolated acute distal radius fracture Closed reduction is not performed Non-operative treatment with cast immobilisation Understanding of Dutch language Exclusion Criteria: Under the age of 18 or older than 75 years Multiple injured patient Reduction is indicated/performed Operative treatment Not understanding of Dutch language

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum 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
Interventional Model Description: Randomized clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One week of plaster cast<br>One week of plaster cast after a non-reduced distal radius fracture. | Procedure: One week of plaster cast<br>* One week of plaster cast as treatment for a non-reduced distal radius fracture.<br>|
| Other: Control; four-five weeks of plaster cast<br>Four-five weeks of plaster cast after a non-reduced distal radius fracture, usual care. | Procedure: Four-Five weeks of plaster cast<br>* Four-Five weeks of plaster cast as treatment for a non-reduced distal radius fracture.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient-rated wrist evaluation (PRWE) questionnaire score | Patient rated wrist evaluation score | Week 6, month 3, month 6 and month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in disability of the Arm, Shoulder and Hand (DASH) questionnaire score | In addition to the PRWE questionnaire. | Week 6, month 3, month 6 and month 12 | 
| Change in Short-Form 36 questionnaire score | In addition to the PRWE questionnaire. | Week 6, month 3, month 6 and month 12 | 
| Complications | The number of participants who experienced treatment related complications scored with a checklist. | Duration of study (12 months) | 
| Pain after DRF | 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. | Baseline, week 6, month 3, month 6, month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Distal radius fracture, Conservative treatment, Patient rated outcome (PRO)