Trapeziometacarpal Joint Arthroplasty Versus Trapeziectomy for Thumb Carpometacarpal Osteoarthritis (NCT07552831) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Trapeziometacarpal Joint Arthroplasty Versus Trapeziectomy for Thumb Carpometacarpal Osteoarthritis
64 participantsStarted 2026-09-01
Plain-language summary
Thumb carpometacarpal osteoarthritis is common and may cause severe pain and functional limitation. Trapeziectomy is widely used, whereas prosthetic arthroplasty may offer faster early recovery. However, detailed information on early postoperative and long-term radiological outcomes remains limited.
This is a single-centre, blinded randomised controlled trial at Sahlgrenska University Hospital, Gothenburg, Sweden. Adults aged 18-69 years with symptomatic thumb carpometacarpal osteoarthritis (Eaton grade 2-3) refractory to at least 3 months of non-operative treatment will be randomised 1:1 to trapeziometacarpal prosthetic arthroplasty or trapeziectomy. The primary outcome is day-by-day pain (registration on a numeric rating scale NRS, 0-10). Secondary outcomes include day-by-day analgesic consumption for 90 days, orthosis use after cast removal, patient-reported function (HQ-8, QuickDASH, and Nelson score) at 30, 45, 60, 75 and 90 days, assessor-measured range of motion and strength at 45 and 90 days, and long-term clinical follow-up at 6 months and 1, 2, 5 and 10 years. Cone beam computed tomography will be obtained in the arthroplasty group at 1 week postoperatively as reference and at 6 months and 1, 2, 5 and 10 years to assess implant position, migration and loosening. The target sample size is 64 participants (32 per group), providing 95% power to detect a 1-point between-group difference on the pain scale. Analyses will follow the intention-to-treat principle.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pain at the base of the thumb affecting activities of daily living and insufficient response to at least 3 months of non-operative treatment (orthosis, non-steroidal anti-inflammatory drugs, and/or corticosteroid injections).
* Radiographic thumb carpometacarpal osteoarthritis, Eaton grade 2-3.
* For Eaton grade 2, age ≥50 years.
* Age 18-69 years.
* Provision of written informed consent.
Exclusion Criteria:
* Symptomatic osteoarthritis of adjacent joints (e.g., scaphotrapeziotrapezoid joint, STT-joint).
* Need for concurrent surgery in the metacarpophalangeal joint (e.g. arthrodesis or capsulodesis).
* Post-traumatic thumb carpometacarpal osteoarthritis.
* Previous surgery for thumb carpometacarpal osteoarthritis in the contralateral hand.
* Inflammatory arthritis (e.g., rheumatoid arthritis or systemic lupus erythematosus).
* Osteoporosis/osteopenia of such severity that secure cup placement in the trapezium is not possible (for arthroplasty).
* Ongoing systemic corticosteroid treatment.
* Other hand surgical condition in the same hand that could confound outcomes (e.g., carpal tunnel syndrome or de Quervain tenosynovitis).
* Cognitive impairment preventing reliable participation.
* Ongoing, or suspected ongoing, alcohol or drug misuse.
* Insufficient Swedish language proficiency to complete the questionnaires.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.