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

Not Applicable

Completed

• Conditions: Distal Radius Fracture
• Interventions: Procedure: Four-Five weeks of plaster cast; Procedure: One week of plaster cast

• Registration Number: NCT03240471
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-07
• Study Start: 2017-10-01
• Primary Completion: 2020-02-14
• Study Completion: 2020-07-01
• Status Verified: 2020-10
• Last Update Submitted: 2021-01-19
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control; four-five weeks of plaster cast	Four-Five weeks of plaster cast	Four-five weeks of plaster cast after a non-reduced distal radius fracture, usual care.
One week of plaster cast	One week of plaster cast	One week of plaster cast after a non-reduced distal radius fracture.

Primary Outcome Measures

Name	Time	Method
Change in patient-rated wrist evaluation (PRWE) questionnaire score	Week 6, month 3, month 6 and month 12	Patient rated wrist evaluation score

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Rijnstate hospital; 🇳🇱 Arnhem, Netherlands

Ziekenhuis Gelderse Vallei; 🇳🇱 Ede, Netherlands

Radboudumc; 🇳🇱 Nijmegen, Netherlands