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.
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)
Previous surgery to thumb base or STT-joint
Ongoing general chronic pain condition or other pain in the same hand predominant over the thumb base pain.
Dementia or cognitive impairment
Trapezium height <7 mm on plain radiograph
Parallel
Implantation of trapeziometacarpal prosthesis
DeviceSurgical implantation of the TOUCH trapeziometacarpal total joint prosthesis (Kerimedical). The prosthesis consists of an uncemented stainless steel stem inserted into the first metacarpal and a dual cup mobility system with a polyethylene ball articulating against a metal cup fixed in the trapezium. The stem is available in straight or 15-degree angled neck configurations. Postoperative management consists of a stable soft dressing for 3 weeks to allow early controlled mobilization, followed by a standardized hand therapy rehabilitation protocol.
Trapeziectomy with Capsuloplasty
Procedure/SurgerySurgical excision of the trapezium bone (trapeziectomy) followed by capsuloplasty using a distally based dorsal capsular flap, without tendon interposition. The capsular flap is sutured to stabilize the base of the first metacarpal. No implant or tendon graft is used. Postoperatively, a cast immobilizing the thumb in functional position is applied for 3 weeks, followed by a standardized hand therapy rehabilitation protocol.
Hand grip strength
Hand grip strength (JAMAR dynamometer) at 12 months post operatively
Key-pinch grip strength
Key-pinch strength measured by pinch-gauge in kilograms
Pinch grip strength
3-finger pinch strength measured by pinch gauge in kilograms
Postoperative Pain Intensity on a Numeric Rating Scale (NRS)
Pain measured with the Numerical Rating Scale (NRS) at rest and load, where 0 is "no pain" and 10 is "worst imaginable pain"
Range of movement
Range of movement of thumb measured by physiotherapist. Extension, flexion, volar abduction, radial abduction. In degrees.
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Uppsala University
Lead sponsor
Uppsala County Council, Sweden
Collaborator
