Distal Radius Fracture Clinical Trial
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
NCT number | NCT05818241 |
Other study ID # | DRFx STAR |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 12, 2023 |
Est. completion date | April 1, 2024 |
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | April 1, 2024 |
Est. primary completion date | January 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Sweden | Alingsås Lasarett/ District Hospital | Alingsås | |
Sweden | Sahlgrenska University Hospital, Department of Hand Therapy | Mölndal | Region Västra Götaland |
Lead Sponsor | Collaborator |
---|---|
Sahlgrenska University Hospital, Sweden | Vastra Gotaland Region |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient-reported hand function | Patient Rated Wrist Evaluation (PRWE) questionnaire | Every week for three months | |
Secondary | 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 | |
Secondary | Analgesics | Daily record of use of analgesic drugs | Every day for three months | |
Secondary | Wrist splint usage | Patient reported use of splint and evaluation of its efficacy | Every week for three months |
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