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Satisfaction and Recovery After Distal Radius Fracture

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05818241
Enrollment
300
Registered
2023-04-18
Start date
2023-01-12
Completion date
2028-04-01
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Radius Fracture

Keywords

wrist function, recovery

Brief 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. 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: 1. Pain (day-by-day registration on a Likert scale, range 0-10) 2. Analgesic used (day-by-day registration of specific drug, dose and number) 3. PRWE (Patient Reported Wrist Evaluation form, week-by-week registration) 4. Use of and evaluation of efficacy of prefabricated wrist splints (week-by-week registration) 5. 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.

Interventions

PROCEDURETreatment of fracture by forearm cast

Patient that are not surgically treated for DRF

PROCEDURESurgical treatment of fracture

Patients that are surgically treated for DRF

Sponsors

Sahlgrenska University Hospital
Lead SponsorOTHER
Vastra Gotaland Region
CollaboratorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Unilateral distal radius fractures in patients without any other significant injuries regardless of ligament injuries and ulnar fractures. * Signed written consent

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Patient-reported hand functionEvery week for three monthsPatient Rated Wrist Evaluation (PRWE) questionnaire

Secondary

MeasureTime frameDescription
Day-by-day pain recordEvery day for three monthsPatient reported pain as measured on a Likert scale 0-10 (0=no pain, 10= maximum pain)
AnalgesicsEvery day for three monthsDaily record of use of analgesic drugs
Wrist splint usageEvery week for three monthsPatient reported use of splint and evaluation of its efficacy

Countries

Sweden

Contacts

CONTACTJoakim Stromberg, MD, PhD
joakim.stromberg@vgregion.se+46768341327
CONTACTIngrid Andreasson, PhD
ingrid.andreasson@vgregion.se+46313421000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026