Distal Radius FracturesDRPIPIIINCT06235957
Three Weeks of Cast Immobilisation Versus One Week of Brace Immobilisation in Distal Radius Fractures
A study testing Cast 3 weeks and Brace 1 week in people with Distal Radius Fractures and Fractures, Bone, run by Spaarne Gasthuis at 3 sites in Netherlands.
Trial summary
Three weeks of cast immobilisation versus one week of brace immobilisation in non- or minimally displaced distal radius fractures in adult patients <50 years of age treated non-operatively. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Distal Radius Fractures, Fractures, Bone
- What is being tested?
- Cast 3 weeks and Brace 1 week
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 3 sitesNetherlands
- Study dates
- 1 Jun 2024to 1 Jun 2026
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-50 years (to eliminate osteoporosis);
- Primary non- or minimally displaced DRF;
- Independent for activities of daily living.
Who cannot join
- Fracture of the contralateral wrist;
- Ipsilateral fractures, proximal of the DRF;
- Pre-existent abnormalities or functional deficits of the fractured wrist;
- Open fractures;
- Polytrauma patients
- Language disability to understand the Dutch patient information and questionnaires.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Amsterdam Umc
Amsterdam, North Holland, 1081HV
Suus GJ van Bruggen, MD, 020-5669111, s.vanbruggen@amsterdamumc.nl
Eva AK van Delft, MD
Spaarne Gasthuis
Haarlem, North Holland, 2035RC
Nico L Sosef, MD, 023-22400000, nsosef@spaarnegasthuis.nl
Maasstad Ziekenhuis
Rotterdam, South Holland, 3079DZ
Niels WL Schep, MD PhD, 010 291 1911, schepn@maasstadziekenhuis.nl
About this study
Official title: Non- or Minimally Displaced Distal Radius Fractures in Adult Patients <50 Years of Age Treated Non-operatively: Three Weeks of Cast Immobilisation Versus One Week of Brace Immobilisation a Multicenter Randomised Controlled Trial.
Three weeks of cast immobilisation versus one week of brace immobilisation in non- or minimally displaced distal radius fractures in adult patients <50 years of age treated non-operatively.
Read the detailed description
Background: Currently, non- or minimally displaced distal radius fractures are treated by three to five weeks of cast immobilisation. Many patients with a distal radius fracture suffer from long-term functional restrictions, which might be related to stiffness due to cast immobilisation. Current literature indicates that one week of immobilisation might be safe, however, no level one evidence is available. This trial aims to compare one week of brace immobilisation with three weeks of cast immobilisation in patients with distal radius fractures that do not need reduction.
Methods: The aim of this trial is to evaluate the non-inferiority of one week of brace immobilisation in patients with non- or minimally displaced distal radius fractures. A single blinded multicentre randomised clinical trial will be conducted in three hospitals. Adult patients, between 18-50 years old, independent for activities of daily living, with a non- or minimally displaced distal radius fracture can be included in this study. The intervention group is treated with one week of brace immobilisation, and the control group with three weeks of cast immobilisation. Primary outcome is the Patient-Related Wrist Evaluation-score at six months. Secondary outcomes are: Quick Disabilities of the Arm, Shoulder and Hand-score at six weeks and six months, PRWE at six weeks, range of motion, pain, radiological outcome, complications and cost effectiveness measured by the EuroQol 5 Dimension questionnaire, Medical Consumption Questionnaire and Productivity Cost Questionnaire.
Discussion: This study will provide evidence on the optimal period of immobilisation in non-operatively treated displaced and reduced distal radius fractures. Both treatment options are accepted treatment protocols and both treatment options have a low risk of complications. Follow-up will be according to the current treatment protocol. This study will provide level one evidence on the optimal period and way of immobilisation for non- or minimally displaced distal radius fractures in adult patients.
- Conditions
- Distal Radius Fractures, Fractures, Bone
- Being tested
- Cast 3 weeks, Brace 1 week
- Keywords
- Distal radial fractures, non-operative treatment, immobilisation period
- Medical subject headings
- Wrist Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cast 3 weeksOther
patients will be treated either in a cast or a brace, patients in group A are treated by cast immobilization for 3 weeks
Brace 1 weekOther
patients will be treated either in a cast or a brace, patients in group B are treated in a brace for 1 week
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Three weeks of cast immobilisation Receives: Other: Cast 3 weeks |
| Group B | Other | One week of brace immobilisation Receives: Other: Brace 1 week |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Related Wrist Evaluation
The primary outcome measure is the PRWE (Patient Related Wrist Evaluation) score after six months. Patients rate their outcome on a 0-10 scale on pain and functional outcome, and scores will be transformed to a 0-100 score. A higher score indicates greater disability.
Measured: 6 months
Secondary outcomes (9)
Patient Related Wrist Evaluation
The primary outcome measure is the PRWE (Patient Related Wrist Evaluation) score after six weeks The primary outcome measure is the PRWE (Patient Related Wrist Evaluation) score after six months. Patients rate their outcome on a 0-10 scale on pain and functional outcome, and scores will be transformed to a 0-100 score. A higher score indicates greater disability.
Measured: 6 weeks
Quick Disabilities of the Arm, Shoulder and Hand
shortened version of the DASH Outcome Measure, using 11 items instead of 30 (scored 1-5) to measure pain and functional outcome. At least 10 of the 11 items must be completed to calculate a score. The scores will be transformed to a 0-100. A higher score indicates greater disability.
Measured: 6 weeks, 6 months
Range of motion
Range of motion measured by goniometer
Measured: 6 weeks, 6 months
Pain/Visual analogue scale score
Pain measured by VAS score VAS-score is a widely used method for pain assessments. Patients score their pain on a scale of 1-10. A higher score indicated a higher level of pain.
Measured: at emergency department (day 0-1), one week, 6 weeks, 6 months
Radiological outcome
Analysis of X-rays, dorsal and volar tilt in degrees, radial height in millimetres and ulnar variance in millimetres will be calculated
Measured: 6 weeks, 6 months
Complications
Complications secondary displacement (radial shortening >3mm, dorsal tilt >10° or intra-articular step-off >2mm), delayed/non-union, re-interventions, complex regional pain syndrome (CRPS), tendon injuries (ruptures and tendinitis), nerve injuries (carpal tunnel syndrome and lesions), and distal radial ulnar joint disability.
Measured: 6 weeks, 6 months
Cost-effectiveness
Cost-effectiveness measured by iMCQ (Medical Consumption questionnaires) Only the applicable items are included in this study. To create baseline data patients will be asked to complete those questionnaires at the ED at the day of trauma (t = 0). Patients will also be asked to complete these questionnaires at 6 weeks and 6 months
Measured: 6 weeks, 6 months
Cost-effectiveness
Cost-effectiveness measured by iPCQ (Productivity Cost Questionnaire) Only the applicable items are included in this study. To create baseline data patients will be asked to complete those questionnaires at the ED at the day of trauma (t = 0). Patients will also be asked to complete these questionnaires at 6 weeks and 6 months
Measured: 6 weeks, 6 months
Cost-effectiveness
Cost-effectiveness measured by EuoQol 5D (Euroquol quality of life score) Only the applicable items are included in this study. To create baseline data patients will be asked to complete those questionnaires at the ED at the day of trauma (t = 0). Patients will also be asked to complete these questionnaires at 6 weeks and 6 months
Measured: 6 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- 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
- This study will be conducted as a single-blinded multicentre randomised clinical trial in three hospitals. In this study, three weeks of cast immobilisation is compared to one week of brace immobilisation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaarne Gasthuis
- Sponsor type
- University, hospital or other
- Collaborators
- Maasstad Hospital, Amsterdam UMC
- Responsible party
- Sponsor
- Investigators
- Frank W Bloemers, Prof, Study chair, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235957
- Sponsor's protocol ID
- ABR 81638 | NL81638.029.22
- Acronym
- DRPIPIII
- Status last verified
- Jan 2024
- First submitted
- 23 Nov 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non- or Minimally Displaced Distal Radius Fractures in Adult Patients <50 Years of Age Treated Non-operatively: Three Weeks of Cast Immobilisation Versus One Week of Brace Immobilisation a Multicenter Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT06235957
- Acronym / sponsor ID
- DRPIPIII / ABR 81638 | NL81638.029.22
- Conditions
- Distal Radius Fractures, Fractures, Bone
- Keywords
- Distal radial fractures, non-operative treatment, immobilisation period
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Spaarne GasthuisUniversity, hospital or other
- Collaborators
- Maasstad Hospital, Amsterdam UMC
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 1 Feb 2024 (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.
Three weeks of cast immobilisation versus one week of brace immobilisation in non- or minimally displaced distal radius fractures in adult patients <50 years of age treated non-operatively.
Detailed description
Background: Currently, non- or minimally displaced distal radius fractures are treated by three to five weeks of cast immobilisation. Many patients with a distal radius fracture suffer from long-term functional restrictions, which might be related to stiffness due to cast immobilisation. Current literature indicates that one week of immobilisation might be safe, however, no level one evidence is available. This trial aims to compare one week of brace immobilisation with three weeks of cast immobilisation in patients with distal radius fractures that do not need reduction.
Methods: The aim of this trial is to evaluate the non-inferiority of one week of brace immobilisation in patients with non- or minimally displaced distal radius fractures. A single blinded multicentre randomised clinical trial will be conducted in three hospitals. Adult patients, between 18-50 years old, independent for activities of daily living, with a non- or minimally displaced distal radius fracture can be included in this study. The intervention group is treated with one week of brace immobilisation, and the control group with three weeks of cast immobilisation. Primary outcome is the Patient-Related Wrist Evaluation-score at six months. Secondary outcomes are: Quick Disabilities of the Arm, Shoulder and Hand-score at six weeks and six months, PRWE at six weeks, range of motion, pain, radiological outcome, complications and cost effectiveness measured by the EuroQol 5 Dimension questionnaire, Medical Consumption Questionnaire and Productivity Cost Questionnaire.
Discussion: This study will provide evidence on the optimal period of immobilisation in non-operatively treated displaced and reduced distal radius fractures. Both treatment options are accepted treatment protocols and both treatment options have a low risk of complications. Follow-up will be according to the current treatment protocol. This study will provide level one evidence on the optimal period and way of immobilisation for non- or minimally displaced distal radius fractures in adult patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study will be conducted as a single-blinded multicentre randomised clinical trial in three hospitals. In this study, three weeks of cast immobilisation is compared to one week of brace immobilisation.
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Other: Cast 3 weeksThree weeks of cast immobilisation |
| Group B | Other | Other: Brace 1 weekOne week of brace immobilisation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-50 years (to eliminate osteoporosis);
- Primary non- or minimally displaced DRF;
- Independent for activities of daily living.
Key exclusion criteria (6 listed)
- Fracture of the contralateral wrist;
- Ipsilateral fractures, proximal of the DRF;
- Pre-existent abnormalities or functional deficits of the fractured wrist;
- Open fractures;
- Polytrauma patients
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 |
|---|---|---|
| Cast 3 weekspatients will be treated either in a cast or a brace, patients in group A are treated by cast immobilization for 3 weeks | Other | Group A |
| Brace 1 weekpatients will be treated either in a cast or a brace, patients in group B are treated in a brace for 1 week | Other | Group B |
Primary outcome
Patient Related Wrist Evaluation
Time frame: 6 months
The primary outcome measure is the PRWE (Patient Related Wrist Evaluation) score after six months. Patients rate their outcome on a 0-10 scale on pain and functional outcome, and scores will be transformed to a 0-100 score. A higher score indicates greater disability.
9 secondary outcomes
Patient Related Wrist Evaluation
Time frame: 6 weeks
Quick Disabilities of the Arm, Shoulder and Hand
Time frame: 6 weeks, 6 months
Range of motion
Time frame: 6 weeks, 6 months
Pain/Visual analogue scale score
Time frame: at emergency department (day 0-1), one week, 6 weeks, 6 months
Radiological outcome
Time frame: 6 weeks, 6 months
Complications
Time frame: 6 weeks, 6 months
Cost-effectiveness
Time frame: 6 weeks, 6 months
Cost-effectiveness
Time frame: 6 weeks, 6 months
Cost-effectiveness
Time frame: 6 weeks, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- 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.
Frank W Bloemers, Prof study chair
Amsterdam UMC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cast 3 weeks and Brace 1 week in people with Distal Radius Fractures and Fractures, Bone, run by Spaarne Gasthuis 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 1 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva van Delft, MD (020 - 566 3111, e.vandelft@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Related Wrist Evaluation (time frame: 6 months). 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 1 Feb 2024.