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Trapeziometacarpal Joint Arthroplasty Versus Trapeziectomy for Thumb Carpometacarpal Osteoarthritis

NCT07552831 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

  • Thumb Osteoarthritis

Interventions

PROCEDURE

trapeziometacarpal arthroplasty

Participants allocated to arthroplasty will undergo implantation of the Touch® CMC-1 prosthesis according to routine practice at the study site. Surgery will be performed by experienced hand surgeons. Postoperatively, the thumb will be immobilised in a thumb spica cast that leaves the interphalangeal joint free.

PROCEDURE

Trapeziectomy

Participants allocated to trapeziectomy will undergo surgical excision of the trapezium without tendon interposition according to routine practice at the study site. Postoperatively, the thumb will be immobilised in a thumb spica cast that leaves the interphalangeal joint free

Sponsors & Collaborators

  • Vastra Gotaland Region

    collaborator OTHER_GOV

  • Sahlgrenska University Hospital

    lead OTHER

Principal Investigators

  • Joakim Stromberg, MD, PhD · Sahlgrenska University Hospital, University of Gothenburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-12-31
Completion
2038-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07552831 on ClinicalTrials.gov