NCT06654349

Short-term Recovery After Trapeziectomy and TMC Prosthesis: a Diary Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Reinier Haga Orthopedisch Centrum · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Rationale: The trapeziometacarpal (TMC) joint is one of the most common areas in the hand and wrist to develop osteoarthritis (OA). Currently, the two most widely used procedures are the trapeziectomy and the TMC-joint arthroplasty, both with their own pros and cons. No studies have demonstrated superiority of TMC-joint arthroplasty over gold-standard trapeziectomy. And no clinical studies show short-term recovery and patient experience after trapeziectomy or TMC-joint arthroplasty. Objective: To gather insight in short-term recovery and patient experience after a trapeziectomy or TMC prosthesis regarding pain, pain medication, function and quality of life. Study design: A prospective observational cohort diary study. Study population: In total 200 subjects with TMC-joint osteoarthritis will participate: 100 subjects will have trapeziectomy and 100 subjects will have TMC-joint arthroplasty Main study parameters/endpoints: The main study parameters are the pain, function and quality of life during the first 8 weeks after surgery. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will have no direct benefit from participation in this study. Subjects will only complete a diary and questionnaires for this study. Therefore, we expect no risks from participation. The burden for subjects consists of approximately five minutes daily for the diary in the first eight weeks after surgery.

Conditions

• Arthrosis of First Carpometacarpal Joint

Timeline

• Start date: 2025-05-15
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2024-10-23
• Last updated: 2025-05-21

Locations

1 site across 1 country: Netherlands