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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date April 2023
Source Sahlgrenska University Hospital, Sweden
Contact Joakim Stromberg, MD, PhD
Phone +46768341327
Email joakim.stromberg@vgregion.se
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Sweden Alingsås Lasarett/ District Hospital Alingsås
Sweden Sahlgrenska University Hospital, Department of Hand Therapy Mölndal Region Västra Götaland

Sponsors (2)

Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

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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