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

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.

Study Overview

• Status: Recruiting
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Procedure: Surgical treatment of fracture; Procedure: Treatment of fracture by forearm cast

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Joakim Stromberg, MD, PhD; Phone Number: +46768341327; Email: joakim.stromberg@vgregion.se
• Study Contact Backup: Name: Ingrid Andreasson, PhD; Phone Number: +46313421000; Email: ingrid.andreasson@vgregion.se

Study Locations

• Sweden
  • Alingsås, Sweden
    • Not yet recruiting
    • Alingsås Lasarett/ District Hospital
    • Contact: Joakim Strömberg; Email: joakim.stromberg@vgregion.se
  • Region Västra Götaland
    • Mölndal, Region Västra Götaland, Sweden
      • Recruiting
      • Sahlgrenska University Hospital, Department of Hand Therapy
      • Contact: Ingrid Andreasson, PhD; Phone Number: +46313421000; Email: ingrid.andreasson@vgregion.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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 .

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cast; Patients that are conservatively treated (in a cast, either without or with reduction)	Procedure: Surgical treatment of fracture; Patients that are surgically treated for DRF
Surgery; Patients that undergo surgical treatment (regardless of method)	Procedure: Treatment of fracture by forearm cast; Patient that are not surgically treated for DRF; Other Names: casting, conservative treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported hand function	Patient Rated Wrist Evaluation (PRWE) questionnaire	Every week for three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Day-by-day pain record	Patient reported pain as measured on a Likert scale 0-10 (0=no pain, 10= maximum pain)	Every day for three months
Analgesics	Daily record of use of analgesic drugs	Every day for three months
Wrist splint usage	Patient reported use of splint and evaluation of its efficacy	Every week for three months

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital
• Collaborators: Vastra Gotaland Region

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: recovery; wrist function
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Arm Injuries; Wrist Injuries; Wrist Fractures; Therapeutics; Conservative Treatment
• Other Study ID Numbers: DRFx STAR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No