Actively Recruiting
Short-term Recovery After Trapeziectomy and TMC Prosthesis: a Diary Study
Led by Reinier Haga Orthopedisch Centrum · Updated on 2025-05-21
200
Participants Needed
1
Research Sites
293 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Short-term Recovery After Trapeziectomy and TMC Prosthesis: a Diary Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Mentally disabled patients
- Active infection
- Current malignancy
- Corticosteroid infiltration within the last 3 months
- For TMC-joint arthroplasty group: trapezium height less than 8 mm
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Reinier Haga Orthopedisch Centrum
Zoetermeer, South Holland, Netherlands, 2725NA
Actively Recruiting
Research Team
R
Rianne Oomen
CONTACT
N
Nina Mathijssen
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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