Distal Radius FractureCast-OFFNCT03240471
Cast OFF Trial: One Versus Four-five Weeks of Plaster Cast Immobilization
A study testing One week of plaster cast and Four-Five weeks of plaster cast in people with Distal Radius Fracture, run by Radboud University Medical Center at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- One week of plaster cast and Four-Five weeks of plaster cast
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesNetherlands
- Study dates
- 1 Oct 2017to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Under the age of 18 or older than 75 years
- Multiple injured patient
- Reduction is indicated/performed
- Operative treatment
- Not understanding of Dutch language
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Rijnstate hospital
Arnhem
Ziekenhuis Gelderse Vallei
Ede
Radboudumc
Nijmegen
About this study
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
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.
Read more
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.
- Conditions
- Distal Radius Fracture
- Being tested
- One week of plaster cast, Four-Five weeks of plaster cast
- Keywords
- Distal radius fracture, Conservative treatment, Patient rated outcome (PRO)
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One week of plaster castProcedure or surgery
One week of plaster cast as treatment for a non-reduced distal radius fracture.
Four-Five weeks of plaster castProcedure or surgery
Four-Five weeks of plaster cast as treatment for a non-reduced distal radius fracture.
| Study group | Role | What they receive |
|---|---|---|
| One week of plaster cast | Experimental | One week of plaster cast after a non-reduced distal radius fracture. Receives: Procedure: One week of plaster cast |
| Control; four-five weeks of plaster cast | Other | Four-five weeks of plaster cast after a non-reduced distal radius fracture, usual care. Receives: Procedure: Four-Five weeks of plaster cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient-rated wrist evaluation (PRWE) questionnaire score
Patient rated wrist evaluation score
Measured: Week 6, month 3, month 6 and month 12
Secondary outcomes (4)
Change in disability of the Arm, Shoulder and Hand (DASH) questionnaire score
In addition to the PRWE questionnaire.
Measured: Week 6, month 3, month 6 and month 12
Change in Short-Form 36 questionnaire score
In addition to the PRWE questionnaire.
Measured: Week 6, month 3, month 6 and month 12
Complications
The number of participants who experienced treatment related complications scored with a checklist.
Measured: 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".
Measured: Baseline, week 6, month 3, month 6, month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start1 Oct 2017
- Primary completion14 Feb 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JP Frolke, Dr., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240471
- Sponsor's protocol ID
- NL 59217.091.17
- Acronym
- Cast-OFF
- Status last verified
- Oct 2020
- First submitted
- 18 Jul 2017
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03240471
- Acronym / sponsor ID
- Cast-OFF / NL 59217.091.17
- Conditions
- Distal Radius Fracture
- Keywords
- Distal radius fracture, Conservative treatment, Patient rated outcome (PRO)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 7 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| One week of plaster cast | Experimental | Procedure: One week of plaster castOne week of plaster cast after a non-reduced distal radius fracture. |
| Control; four-five weeks of plaster cast | Other | Procedure: Four-Five weeks of plaster castFour-five weeks of plaster cast after a non-reduced distal radius fracture, usual care. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Under the age of 18 or older than 75 years
- Multiple injured patient
- Reduction is indicated/performed
- Operative treatment
- Not understanding of Dutch language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One week of plaster castOne week of plaster cast as treatment for a non-reduced distal radius fracture. | Procedure or surgery | One week of plaster cast |
| Four-Five weeks of plaster castFour-Five weeks of plaster cast as treatment for a non-reduced distal radius fracture. | Procedure or surgery | Control; four-five weeks of plaster cast |
Primary outcome
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
4 secondary outcomes
Change in disability of the Arm, Shoulder and Hand (DASH) questionnaire score
Time frame: 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
Complications
Time frame: Duration of study (12 months)
Pain after DRF
Time frame: Baseline, week 6, month 3, month 6, month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JP Frolke, Dr. principal investigator
Radboud University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One week of plaster cast and Four-Five weeks of plaster cast in people with Distal Radius Fracture, run by Radboud University Medical Center at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient-rated wrist evaluation (PRWE) questionnaire score (time frame: Week 6, month 3, month 6 and month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.