- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03240471
Cast OFF Trial: One Versus Four-five Weeks of Plaster Cast Immobilization (Cast-OFF)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Arnhem, Netherlands
- Rijnstate Hospital
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Ede, Netherlands
- Ziekenhuis Gelderse Vallei
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Nijmegen, Netherlands
- Radboudumc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: One week of plaster cast
One week of plaster cast after a non-reduced distal radius fracture.
|
One week of plaster cast as treatment for a non-reduced distal radius fracture.
|
Other: Control; four-five weeks of plaster cast
Four-five weeks of plaster cast after a non-reduced distal radius fracture, usual care.
|
Four-Five weeks of plaster cast as treatment for a non-reduced distal radius fracture.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in patient-rated wrist evaluation (PRWE) questionnaire score
Time Frame: Week 6, month 3, month 6 and month 12
|
Patient rated wrist evaluation score
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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
Time Frame: Week 6, month 3, month 6 and month 12
|
In addition to the PRWE questionnaire.
|
Week 6, month 3, month 6 and month 12
|
Change in Short-Form 36 questionnaire score
Time Frame: Week 6, month 3, month 6 and month 12
|
In addition to the PRWE questionnaire.
|
Week 6, month 3, month 6 and month 12
|
Complications
Time Frame: Duration of study (12 months)
|
The number of participants who experienced treatment related complications scored with a checklist.
|
Duration of study (12 months)
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Pain after DRF
Time Frame: 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".
|
Baseline, week 6, month 3, month 6, month 12
|
Collaborators and Investigators
Investigators
- Principal Investigator: JP Frolke, Dr., Radboud University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL 59217.091.17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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