Clinical Trial

Wrist and Carpal Arthrodeses. A 1-year Follow-up Study.

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Summary
This study at the Orthopedic Department, Drammen Hospital, examines the effectiveness and safety of various arthrodesis procedures in the wrist and carpus to relieve chronic pain and restore functional stability. Arthrodesis, which fuses two or more bones to eliminate joint mobility, is considered as a last resort when conservative treatments do not produce the desired results. The study includes patients with advanced degenerative changes, rheumatoid arthritis, or extensive injuries. Patients assessed preoperatively and postoperatively through measurements of range of motion, grip strength, and pain using various tools such as PRWHE, QuickDASH, EQ-5D-5L and NRS. The checks include X-rays and CT to evaluate healing. The data is analyzed to identify trends and factors that influence positively outcome. The follow-up takes place after 8 weeks, 3 months and 1 year postoperatively, with a focus on pain relief and functional improvement. The data are compared before and after surgery to assess the effectiveness of the intervention efficiency. The study has been applied for approval by REK, but rejected because it was assessed as a quality control project, and applied for the Data Protection Commissioner (PVO). The data is anonymised and stored on secure servers, with switch keys stored separately. The patients give informed consent and are insured through Norwegian Patient Injury Compensation. The study seeks to improve patient care by increasing understanding of the long-term effects of osteoarthritis, including complications and secondary osteoarthritis. The results will contribute to better clinical decisions and treatments.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-31.
Trial Details
NCT Number NCT06917235
Lead Sponsor Vestre Viken Hospital Trust
Conditions Arthrodesis, Arthrosis, Wrist Osteoarthritis
Enrollment 20 participants
Start Date 2024-09-01
Primary Completion 2028-08-15 (estimated)
Study Completion 2029-08-15 (estimated)
Updated on ClinicalTrials.gov 2025-04-13