About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
Previous surgery to thumb base or STT-joint
Ongoing chronic pain condition
Dementia or cognitive impairment
Trapezium height <7 mm on plain radiograph
Trial design
Treatments tested in this trial
- Implantation of trapeziometacarpal prosthesis
- Trapeziectomy with Capsuloplasty
Treatment groups
Sponsors and collaborators
Uppsala University
Lead sponsor
Uppsala County Council, Sweden
Collaborator
Örebro County Council
Collaborator