Trapeziometacarpal Joint Arthroplasty Versus Trapeziectomy for Thumb Carpometacarpal Osteoarthritis

NCT07552831 | Not Yet Recruiting

• 1 other identifier: The T3 Study
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pain level

  Patient-reported pain at the thumb base, measured on a 0-10 numeric rating scale (0 = no pain, 10 = worst imaginable pain).

  daily for three months

Secondary Outcomes (8)

• Analgesics used

  daily for three months

• Use of Orthosis

  Daily for three months

• Patient-reported thumb symptoms

  at 30, 45, 60, 75 and 90 postoperative days

• Patient-reported upper extremity function

  at 30, 45, 60, 75 and 90 postoperative days

• Patient-reported hand function

  at 30, 45, 60, 75 and 90 postoperative days

Study Arms (2)

Trapeziometacarpal joint arthroplasty

EXPERIMENTAL

Implantation of the Touch® CMC-1 prosthesis

Procedure: trapeziometacarpal arthroplasty

Trapeziectomy

ACTIVE COMPARATOR

Surgical excision of the trapezium

Procedure: trapeziometacarpal arthroplasty; Procedure: Trapeziectomy

Interventions

trapeziometacarpal arthroplasty PROCEDURE

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.

Trapeziectomy; Trapeziometacarpal joint arthroplasty

Trapeziectomy PROCEDURE

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

Trapeziectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Vastra Gotaland Region: collaborator

Study Officials

• Joakim Stromberg, MD, PhD

  Sahlgrenska University Hospital, University of Gothenburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joakim Stromberg, Md,PhD

CONTACT

+46768341327; joakim.stromberg@vgregion.se

Victoria Wängberg, MD

CONTACT

+46739804631; victoria.wangberg@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: After either intervention, patients will be masked to the hand therapist
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomised controlled study

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2038
• Last Updated: May 1, 2026

Record last verified: 2026-04