Trapeziometacarpal Joint Arthroplasty Versus Trapeziectomy for Thumb Carpometacarpal Osteoarthritis RCT
ClinicalTrials.gov Studies
Summary
Sahlgrenska University Hospital in Gothenburg, Sweden has registered a single-centre, blinded randomized controlled trial comparing trapeziometacarpal prosthetic arthroplasty versus trapeziectomy for symptomatic thumb carpometacarpal osteoarthritis in adults aged 18-69 years with Eaton grade 2-3 disease refractory to 3 months of non-operative treatment. The target enrollment is 64 participants randomized 1:1, with primary outcome of day-by-day pain measured on a numeric rating scale (NRS 0-10) and follow-up extending to 10 years.
“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.”
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What changed
A randomized controlled trial registration was added to ClinicalTrials.gov for a single-centre study at Sahlgrenska University Hospital, Gothenburg, Sweden. The trial will enroll 64 adults aged 18-69 with symptomatic thumb carpometacarpal osteoarthritis (Eaton grade 2-3) refractory to at least 3 months of non-operative treatment, randomized 1:1 to either trapeziometacarpal prosthetic arthroplasty or trapeziectomy.
This trial registration provides notice of an upcoming clinical investigation comparing two surgical approaches for thumb arthritis. The 10-year follow-up period and comprehensive outcome measures including pain, function, and imaging make this a long-term comparative effectiveness study. No compliance obligations are created by this registration.
Archived snapshot
Apr 28, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Trapeziometacarpal Joint Arthroplasty Versus Trapeziectomy for Thumb Carpometacarpal Osteoarthritis
N/A NCT07552831 Kind: NA Apr 27, 2026
Abstract
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.
Conditions: Thumb Osteoarthritis
Interventions: trapeziometacarpal arthroplasty, Trapeziectomy
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