Cast OFF Trial: One Versus Four-five Weeks of Plaster Cast Immobilization (Cast-OFF)
Primary Purpose
Distal Radius Fracture
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
One week of plaster cast
Four-Five weeks of plaster cast
Sponsored by
About this trial
This is an interventional treatment trial for Distal Radius Fracture focused on measuring Distal radius fracture, Conservative treatment, Patient rated outcome (PRO)
Eligibility Criteria
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
Sites / Locations
- Rijnstate hospital
- Ziekenhuis Gelderse Vallei
- Radboudumc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
One week of plaster cast
Control; four-five weeks of plaster cast
Arm Description
One week of plaster cast after a non-reduced distal radius fracture.
Four-five weeks of plaster cast after a non-reduced distal radius fracture, usual care.
Outcomes
Primary Outcome Measures
Change in patient-rated wrist evaluation (PRWE) questionnaire score
Patient rated wrist evaluation score
Secondary Outcome Measures
Change in disability of the Arm, Shoulder and Hand (DASH) questionnaire score
In addition to the PRWE questionnaire.
Change in Short-Form 36 questionnaire score
In addition to the PRWE questionnaire.
Complications
The number of participants who experienced treatment related complications scored with a checklist.
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".
Full Information
NCT ID
NCT03240471
First Posted
July 18, 2017
Last Updated
January 19, 2021
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03240471
Brief Title
Cast OFF Trial: One Versus Four-five Weeks of Plaster Cast Immobilization
Acronym
Cast-OFF
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
February 14, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture
Keywords
Distal radius fracture, Conservative treatment, Patient rated outcome (PRO)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
One week of plaster cast
Arm Type
Experimental
Arm Description
One week of plaster cast after a non-reduced distal radius fracture.
Arm Title
Control; four-five weeks of plaster cast
Arm Type
Other
Arm Description
Four-five weeks of plaster cast after a non-reduced distal radius fracture, usual care.
Intervention Type
Procedure
Intervention Name(s)
One week of plaster cast
Intervention Description
One week of plaster cast as treatment for a non-reduced distal radius fracture.
Intervention Type
Procedure
Intervention Name(s)
Four-Five weeks of plaster cast
Intervention Description
Four-Five weeks of plaster cast as treatment for a non-reduced distal radius fracture.
Primary Outcome Measure Information:
Title
Change in patient-rated wrist evaluation (PRWE) questionnaire score
Description
Patient rated wrist evaluation score
Time Frame
Week 6, month 3, month 6 and month 12
Secondary Outcome Measure Information:
Title
Change in disability of the Arm, Shoulder and Hand (DASH) questionnaire score
Description
In addition to the PRWE questionnaire.
Time Frame
Week 6, month 3, month 6 and month 12
Title
Change in Short-Form 36 questionnaire score
Description
In addition to the PRWE questionnaire.
Time Frame
Week 6, month 3, month 6 and month 12
Title
Complications
Description
The number of participants who experienced treatment related complications scored with a checklist.
Time Frame
Duration of study (12 months)
Title
Pain after DRF
Description
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".
Time Frame
Baseline, week 6, month 3, month 6, month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JP Frolke, Dr.
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rijnstate hospital
City
Arnhem
Country
Netherlands
Facility Name
Ziekenhuis Gelderse Vallei
City
Ede
Country
Netherlands
Facility Name
Radboudumc
City
Nijmegen
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
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Cast OFF Trial: One Versus Four-five Weeks of Plaster Cast Immobilization
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