NCT06654349 Short-term Recovery After Trapeziectomy and TMC Prosthesis: a Diary Study
| NCT ID | NCT06654349 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Reinier Haga Orthopedisch Centrum |
| Condition | Arthrosis of First Carpometacarpal Joint |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-05-15 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-05-15 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Mentally disabled patients * Active infection * Current malignancy * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06654349 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Arthrosis of First Carpometacarpal Joint. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06654349 currently recruiting?
Yes, NCT06654349 is actively recruiting participants. Contact the research team at Onderzoek@rhoc.nl for enrollment information.
Where is the NCT06654349 trial being conducted?
This trial is being conducted at Zoetermeer, Netherlands.
Who is sponsoring the NCT06654349 clinical trial?
NCT06654349 is sponsored by Reinier Haga Orthopedisch Centrum. The trial plans to enroll 200 participants.