Distal Radius FractureNCT05370365
Four or Six Weeks of Immobilization in the Conservative Treatment of Distal Radius Fractures in Elderly Population?
A study testing Below elbow cast in people with Distal Radius Fracture, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
The purpose of this study is to compare if there are differences in wrist function and pain after a distal radius fracture treated conservatively with immobilization for 4 or 6 weeks in elderly patients after six months of follow-up. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Below elbow cast
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteSpain
- Study dates
- 20 Apr 2021to 3 Nov 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients older than 65 years with a low energy distal radius fracture
- Intra or extraarticular distal radius fracture (A2, A3, C1, C2)
- Acceptable primary reduction (dorsal inclination <10º, radial shortening <3mm, articular gap <2mm)
Who cannot join
- History of ipsilateral fracture
- Bilateral fracture
- Open fracture
- Other concomitant fracture (except ulnar styloid fracture)
- Fracture AO B
- Previous surgeries in this area
- Dementia
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare if there are differences in wrist function and pain after a distal radius fracture treated conservatively with immobilization for 4 or 6 weeks in elderly patients after six months of follow-up.
- Conditions
- Distal Radius Fracture
- Being tested
- Below elbow cast
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Below elbow castProcedure or surgery
Patients will be stay with a below elbow cast for 4 or 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 4 week cast | Experimental | Patients over 65 years old with a distal radius fracture will be treated conservatively with a cast for 4 weeks. Once the immobilization will be removed, the standard rehabilitation protocol of our center used in these fractures will be carried out. The usual clinical and radiological follow-up will be performed at 3, 6 and 12 months. Receives: Procedure: Below elbow cast |
| 6 week cast | Experimental | Patients over 65 years old with a distal radius fracture will be treated conservatively with a cast for 6 weeks. Once the immobilization will be removed, the standard rehabilitation protocol of our center used in these fractures will be carried out. The usual clinical and radiological follow-up will be performed at 3, 6 and 12 months. Receives: Procedure: Below elbow cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Rated Wrist Evaluation (PRWE)
The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living.
Measured: 3 months
Patient Rated Wrist Evaluation (PRWE)
The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living.
Measured: 6 months
Patient Rated Wrist Evaluation (PRWE)
The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living.
Measured: 1 year
Secondary outcomes (10)
Quick Disability of Arm and Shoulder (QuickDASH)
It is a questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.
Measured: 3 months
Quick Disability of Arm and Shoulder (QuickDASH)
It is a questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.
Measured: 6 months
Quick Disability of Arm and Shoulder (QuickDASH)
It is a questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.
Measured: 1 year
Visual Analogue Scale (VAS)
is a measuring instrument that tries to measure the amount of pain a patient feels, which is supposed to be a value that oscillates in a continuous between no pain and an extreme amount of pain.
Measured: 3 months
Visual Analogue Scale (VAS)
is a measuring instrument that tries to measure the amount of pain a patient feels, which is supposed to be a value that oscillates in a continuous between no pain and an extreme amount of pain.
Measured: 6 months
Visual Analogue Scale (VAS)
is a measuring instrument that tries to measure the amount of pain a patient feels, which is supposed to be a value that oscillates in a continuous between no pain and an extreme amount of pain.
Measured: 1 year
Range Of Movement (ROM)
Flexion, Extension, radial and ulnar deviation
Measured: 3 months
Range Of Movement (ROM)
Flexion, Extension, radial and ulnar deviation
Measured: 6 months
Range Of Movement (ROM)
Flexion, Extension, radial and ulnar deviation
Measured: 1 year
Complications
Stiffness, delayed and non-union and complex regional pain syndrome (CRPS).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start20 Apr 2021
- Primary completion6 Nov 2022
- Study completion3 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FractureStudies 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
- Prospective single-blinded randomised clinical trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370365
- Sponsor's protocol ID
- 4/6
- Status last verified
- Nov 2024
- First submitted
- 6 May 2022
- Last updated
- 3 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sala-Pujals A, Portes Chiva A, Chillon Soria J, Valverde Vilamala D, Dominguez Font E, Pardo Pol A. Immobilization Time for Conservative Treatment of Distal Radial Fractures in Elderly Patients: A Randomized Controlled Trial. J Bone Joint Surg Am. 2025 Jun 5;107(14):1628-1635. doi: 10.2106/JBJS.24.01480.
PubMed 40472139
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Four or Six Weeks of Immobilization in the Conservative Treatment of Distal Radius Fractures in Elderly Population?
- ClinicalTrials.gov ID
- NCT05370365
- Acronym / sponsor ID
- 4/6
- Conditions
- Distal Radius Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 6 Nov 2022 (actual)
- Study completion
- 3 Nov 2024 (actual)
- First posted
- 11 May 2022 (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.
The purpose of this study is to compare if there are differences in wrist function and pain after a distal radius fracture treated conservatively with immobilization for 4 or 6 weeks in elderly patients after six months of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective single-blinded randomised clinical trial
| Arm | Type | Receives |
|---|---|---|
| 4 week cast | Experimental | Procedure: Below elbow castPatients over 65 years old with a distal radius fracture will be treated conservatively with a cast for 4 weeks. Once the immobilization will be removed, the standard rehabilitation protocol of our center used in these fractures will be carried out. The usual clinical and radiological follow-up will be performed at 3, 6 and 12 months. |
| 6 week cast | Experimental | Procedure: Below elbow castPatients over 65 years old with a distal radius fracture will be treated conservatively with a cast for 6 weeks. Once the immobilization will be removed, the standard rehabilitation protocol of our center used in these fractures will be carried out. The usual clinical and radiological follow-up will be performed at 3, 6 and 12 months. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients older than 65 years with a low energy distal radius fracture
- Intra or extraarticular distal radius fracture (A2, A3, C1, C2)
- Acceptable primary reduction (dorsal inclination <10º, radial shortening <3mm, articular gap <2mm)
Key exclusion criteria (7 listed)
- History of ipsilateral fracture
- Bilateral fracture
- Open fracture
- Other concomitant fracture (except ulnar styloid fracture)
- Fracture AO B
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 |
|---|---|---|
| Below elbow castPatients will be stay with a below elbow cast for 4 or 6 weeks | Procedure or surgery | 4 week cast, 6 week cast |
Primary outcome
Patient Rated Wrist Evaluation (PRWE)
Time frame: 3 months
The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living.
Patient Rated Wrist Evaluation (PRWE)
Time frame: 6 months
The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living.
Patient Rated Wrist Evaluation (PRWE)
Time frame: 1 year
The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living.
10 secondary outcomes
Quick Disability of Arm and Shoulder (QuickDASH)
Time frame: 3 months
Quick Disability of Arm and Shoulder (QuickDASH)
Time frame: 6 months
Quick Disability of Arm and Shoulder (QuickDASH)
Time frame: 1 year
Visual Analogue Scale (VAS)
Time frame: 3 months
Visual Analogue Scale (VAS)
Time frame: 6 months
Visual Analogue Scale (VAS)
Time frame: 1 year
Range Of Movement (ROM)
Time frame: 3 months
Range Of Movement (ROM)
Time frame: 6 months
Range Of Movement (ROM)
Time frame: 1 year
Complications
Time frame: 1 year
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 3 Jun 2025.
- Derived from this study: PubMed 40472139Sala-Pujals A, Portes Chiva A, Chillon Soria J, Valverde Vilamala D, Dominguez Font E, Pardo Pol A. Immobilization Time for Conservative Treatment of Distal Radial Fractures in Elderly Patients: A Randomized Controlled Trial. J Bone Joint Surg Am. 2025 Jun 5;107(14):1628-1635. doi: 10.2106/JBJS.24.01480.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Below elbow cast in people with Distal Radius Fracture, run by Parc de Salut Mar at 1 site in Spain.
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 7 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 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Patient Rated Wrist Evaluation (PRWE) (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05370365, which also lists 1 linked publication.
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 3 Jun 2025.