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.
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.
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.
Parallel
trapeziometacarpal arthroplasty
Procedure/SurgeryParticipants 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.
Trapeziectomy
Procedure/SurgeryParticipants 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
Pain level
Patient-reported pain at the thumb base, measured on a 0-10 numeric rating scale (0 = no pain, 10 = worst imaginable pain).
Analgesics used
Daily registration of analgesic consumption
Use of Orthosis
• Orthosis use and perceived importance recorded weekly after cast removal
Patient-reported thumb symptoms
measured with Nelson score (a disease specific questionnaire)
Patient-reported upper extremity function
measured with QuickDASH questionnaire
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Sahlgrenska University Hospital
Lead sponsor
Vastra Gotaland Region
Collaborator
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