Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Recruiting · NCT07569549 · Interventional (participants receive a specific treatment) · Lead sponsor: Uppsala University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this clinical trial is to learn if the surgical method with total joint arthroplasty, (TOUCH joint prosthesis), is as good as or better than the traditional surgical method, trapezectomy, to treat thumb base joint osteoarthritis. The main questions it aims to answer are: Does surgery with total joint arthroplasty provide better power grip and pinch grip strength compared to traditional surgery? What is the long-term risk of complications for both methods? Which method is more cost-effective for the healthcare system? Researchers will compare total joint arthroplasty (TOUCH) to trapezectomy (a procedure where a bone in the thumb base is removed) to see which method provides the best results for the patient. Participants will: Be randomized to undergo either an operation with total joint arthroplasty or a trapezectomy. Undergo an initial evaluation and a health economic cost analysis after one year. Attend follow-up checkups at 2, 5, and 10 years post-surgery to evaluate long-term function and the durability of the prosthesis.
Who can take part
Inclusion criteria
- Age 40-80 years at inclusion
- CMC-joint osteoarthritis grade 1-3 (Eaton-Littler classification)
- Rest pain or pain reducing hand function with indication for surgery
- Insufficient relief from non-operative treatment for ≥3 months (orthosis, OTC analgesics, cortisone injection)
- Eligible for both prosthesis and trapezectomy per including surgeon
- Non-smoker or complete smoking cessation ≥6 weeks prior to surgery
Exclusion criteria
- Previous surgery to thumb base or STT-joint
- Ongoing chronic pain condition
- Dementia or cognitive impairment
- Trapezium height \<7 mm on plain radiograph
- Active smoker
- Osteoarthritis grade 4 (Eaton-Littler)
Where it is running
2 locations listed.
- Department of Handsurgery, Uppsala University Hospital - Uppsala, Sweden
- Örebro university hospital - Örebro, Sweden