NCT07569549 Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
| NCT ID | NCT07569549 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Uppsala University |
| Condition | Thumb Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2030-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2026-07-01 with a primary completion date of 2030-05.
⚠ 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
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
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)
Contact & Investigator
Nils Hailer, MD, PhD. Professor
STUDY DIRECTOR
Department of orthopaedics and hand surgery, Akademiska hospital, Uppsala, Sweden
Frequently Asked Questions
Who can join the NCT07569549 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Thumb Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07569549 currently recruiting?
Yes, NCT07569549 is actively recruiting participants. Contact the research team at eva.nordin@akademiska.se for enrollment information.
Where is the NCT07569549 trial being conducted?
This trial is being conducted at Örebro, Sweden, Uppsala, Sweden.
Who is sponsoring the NCT07569549 clinical trial?
NCT07569549 is sponsored by Uppsala University. The principal investigator is Nils Hailer, MD, PhD. Professor at Department of orthopaedics and hand surgery, Akademiska hospital, Uppsala, Sweden. The trial plans to enroll 84 participants.