Distal Radius FractureNCT05818241
Satisfaction and Recovery After Distal Radius Fracture
An observational study of Distal Radius Fracture, run by Sahlgrenska University Hospital at 2 sites in Sweden.
Trial summary
Distal radius fracture is the most common fracture in Sweden, but little is known about the patient's experience of pain and hand function during the first three months after the injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Treatment of fracture by forearm cast and Surgical treatment of fracture
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 2 sitesSweden
- Study dates
- 12 Jan 2023to 1 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with a distal radius fracture with the inclusion criteria and without the exclusion criteria at the emergency ward are eligible .
Who may be able to join
- Unilateral distal radius fractures in patients without any other significant injuries regardless of ligament injuries and ulnar fractures.
- Signed written consent
Who cannot join
- Compound injuries
- Open fractures
- Patients with post traumatic function deficits at any level in the affected arm prior to the distal radius fracture.
- Patients with function deficits in the affected arm due to other medical conditions (e.g. Parkinsons disease, Rheumatoid Arthritis)
- Reduced mental capacity (e.g. dementia, substance abuse)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Not yet recruiting
Alingsås Lasarett/ District Hospital
Alingsås
Joakim Strömberg, joakim.stromberg@vgregion.se
- Recruiting
Sahlgrenska University Hospital, Department of Hand Therapy
Mölndal, Region Västra Götaland
Ingrid Andreasson, PhD, +46313421000, ingrid.andreasson@vgregion.se
About this study
Official title: Study on the Immediate Recovery and Satisfaction After Distal Radius Fracture During the First Three Months- a PROM Based Observational Study With Day-to-day Records
Distal radius fracture is the most common fracture in Sweden, but little is known about the patient's experience of pain and hand function during the first three months after the injury. This observational study will provide detailed information on a daily basis regarding pain, use of analgesic drugs, use of splints and hand function as measured weekly by a condition-specific questionnaire.
Read the detailed description
Two hundred patients who are treated conservatively in a cast and one hundred patients who have undergone surgery will be asked to complete a questionnaire with the following outcome measures for three months:
- Pain (day-by-day registration on a Likert scale, range 0-10)
- Analgesic used (day-by-day registration of specific drug, dose and number)
- PRWE (Patient Reported Wrist Evaluation form, week-by-week registration)
- Use of and evaluation of efficacy of prefabricated wrist splints (week-by-week registration)
- Details of sick leave and return to work at completion of the questionnaire at three months.
The study is entirely PROM-based and the patient will not require any additional appointments.
- Conditions
- Distal Radius Fracture
- Being tested
- Treatment of fracture by forearm cast, Surgical treatment of fracture
- Keywords
- wrist function, recovery
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of fracture by forearm castProcedure or surgery
Also called casting, conservative treatment
Patient that are not surgically treated for DRF
Surgical treatment of fractureProcedure or surgery
Patients that are surgically treated for DRF
| Study group | Role | What they receive |
|---|---|---|
| Cast | Patients that are conservatively treated (in a cast, either without or with reduction) Receives: Procedure: Surgical treatment of fracture | |
| Surgery | Patients that undergo surgical treatment (regardless of method) Receives: Procedure: Treatment of fracture by forearm cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported hand function
Patient Rated Wrist Evaluation (PRWE) questionnaire
Measured: Every week for three months
Secondary outcomes (3)
Day-by-day pain record
Patient reported pain as measured on a Likert scale 0-10 (0=no pain, 10= maximum pain)
Measured: Every day for three months
Analgesics
Daily record of use of analgesic drugs
Measured: Every day for three months
Wrist splint usage
Patient reported use of splint and evaluation of its efficacy
Measured: Every week for three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start12 Jan 2023
- Primary completion31 Jan 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region
- Responsible party
- Principal investigator, Joakim Stromberg, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818241
- Sponsor's protocol ID
- DRFx STAR
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2023
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Immediate Recovery and Satisfaction After Distal Radius Fracture During the First Three Months- a PROM Based Observational Study With Day-to-day Records
- ClinicalTrials.gov ID
- NCT05818241
- Acronym / sponsor ID
- DRFx STAR
- Conditions
- Distal Radius Fracture
- Keywords
- wrist function, recovery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 18 Apr 2023 (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 is the most common fracture in Sweden, but little is known about the patient's experience of pain and hand function during the first three months after the injury. This observational study will provide detailed information on a daily basis regarding pain, use of analgesic drugs, use of splints and hand function as measured weekly by a condition-specific questionnaire.
Detailed description
Two hundred patients who are treated conservatively in a cast and one hundred patients who have undergone surgery will be asked to complete a questionnaire with the following outcome measures for three months:
- Pain (day-by-day registration on a Likert scale, range 0-10)
- Analgesic used (day-by-day registration of specific drug, dose and number)
- PRWE (Patient Reported Wrist Evaluation form, week-by-week registration)
- Use of and evaluation of efficacy of prefabricated wrist splints (week-by-week registration)
- Details of sick leave and return to work at completion of the questionnaire at three months.
The study is entirely PROM-based and the patient will not require any additional appointments.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cast | – | Procedure: Surgical treatment of fracturePatients that are conservatively treated (in a cast, either without or with reduction) |
| Surgery | – | Procedure: Treatment of fracture by forearm castPatients that undergo surgical treatment (regardless of method) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a distal radius fracture with the inclusion criteria and without the exclusion criteria at the emergency ward are eligible .
Key inclusion criteria (2 listed)
- Unilateral distal radius fractures in patients without any other significant injuries regardless of ligament injuries and ulnar fractures.
- Signed written consent
Key exclusion criteria (5 listed)
- Compound injuries
- Open fractures
- Patients with post traumatic function deficits at any level in the affected arm prior to the distal radius fracture.
- Patients with function deficits in the affected arm due to other medical conditions (e.g. Parkinsons disease, Rheumatoid Arthritis)
- Reduced mental capacity (e.g. dementia, substance abuse)
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 |
|---|---|---|
| Treatment of fracture by forearm castAlso: casting, conservative treatmentPatient that are not surgically treated for DRF | Procedure or surgery | Surgery |
| Surgical treatment of fracturePatients that are surgically treated for DRF | Procedure or surgery | Cast |
Primary outcome
Patient-reported hand function
Time frame: Every week for three months
Patient Rated Wrist Evaluation (PRWE) questionnaire
3 secondary outcomes
Day-by-day pain record
Time frame: Every day for three months
Analgesics
Time frame: Every day for three months
Wrist splint usage
Time frame: Every week for three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Radius Fracture, run by Sahlgrenska University Hospital at 2 sites in Sweden.
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 2 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: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joakim Stromberg, MD, PhD (+46768341327, joakim.stromberg@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported hand function (time frame: Every week for three 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 24 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.