Short-term Recovery After Trapeziectomy and TMC Prosthesis: a Diary Study
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- Who runs it
- Reinier Haga Orthopedisch Centrum
- Trial code
- NCT06654349
- Record updated
- 21 May 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: Failed conservative treatment for osteoarthritis; Planned for trapeziectomy or TMC-joint arthroplasty; Age 18-75 years; Willing and able to comply with the postoperative functional assessment and to participate in a rehabilitation schedule.
Exclusion: Active infection; Current malignancy; Mentally disabled patients; Infiltration (corticoids < 3 months); The following criteria is specific for the TMC-joint arthroplasty group and is an addition to the criteria mentioned above:; Trapezium height < 8 mm.