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Recruiting NCT05818241

Satisfaction and Recovery After Distal Radius Fracture

Observational Distal Radius Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Treatment of fracture by forearm cast, Surgical treatment of fracture.
Who it may be relevant to
Registry conditions: Distal Radius Fracture. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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

  • Procedure Treatment of fracture by forearm cast
    Patient that are not surgically treated for DRF
  • Procedure Surgical treatment of fracture
    Patients that are surgically treated for DRF

Primary outcome measures

  • Patient-reported hand function [Time frame: Every week for three months]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Sweden · 2 centers
  • Sahlgrenska University Hospital, Department of Hand Therapy — Mölndal
  • Alingsås Lasarett/ District Hospital — Alingsås

Identifiers

NCT: NCT05818241 · DRFx STAR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗