Satisfaction and Recovery After Distal Radius Fracture

NCT05818241 | Recruiting

• 1 other identifier: DRFx STAR
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Distal Radius Fracture

Keywords

wrist function; recovery

Outcome Measures

Primary Outcomes (1)

• Patient-reported hand function

  Patient Rated Wrist Evaluation (PRWE) questionnaire

  Every week for three months

Secondary Outcomes (3)

• Day-by-day pain record

  Every day for three months

• Analgesics

  Every day for three months

• Wrist splint usage

  Every week for three months

Study Arms (2)

Cast

Patients that are conservatively treated (in a cast, either without or with reduction)

Procedure: Surgical treatment of fracture

Surgery

Patients that undergo surgical treatment (regardless of method)

Procedure: Treatment of fracture by forearm cast

Interventions

Treatment of fracture by forearm cast PROCEDURE

Patient that are not surgically treated for DRF

Also known as: casting, conservative treatment

Surgery

Surgical treatment of fracture PROCEDURE

Patients that are surgically treated for DRF

Cast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with a distal radius fracture with the inclusion criteria and without the exclusion criteria at the emergency ward are eligible .

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Vastra Gotaland Region: collaborator

Study Sites (2)

Sahlgrenska University Hospital, Department of Hand Therapy

Mölndal, Region Västra Götaland, Sweden

RECRUITING

Alingsås Lasarett/ District Hospital

Alingsås, Sweden

NOT YET RECRUITING

MeSH Terms

Conditions

Wrist Fractures

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Joakim Stromberg, MD, PhD

CONTACT

+46768341327; joakim.stromberg@vgregion.se

Ingrid Andreasson, PhD

CONTACT

+46313421000; ingrid.andreasson@vgregion.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior consultant,

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 18, 2023
• Study Start: January 12, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

SE (2)