Clinical Trial

Trapeziometacarpal Joint Arthroplasty Versus Trapeziectomy for Thumb Carpometacarpal Osteoarthritis

Study acronym: T3
Not Yet Recruiting
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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.
Protocol Amendment History 2 changes
notable Primary completion moved earlier: 2030-12-31 -> 2028-12-31 2026-05-02
minor Completion pushed: 2030-12-31 -> 2038-12-31 2026-05-02
Trial Details
NCT Number NCT07552831
Lead Sponsor Sahlgrenska University Hospital
Collaborators: Vastra Gotaland Region
Conditions Thumb Osteoarthritis
Enrollment 64 participants
Start Date 2026-09-01
Primary Completion 2028-12-31 (estimated)
Study Completion 2038-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-01