Thumb-base joint replacement for osteoarthritis
TRACE - A Single Arm Trial of Thumb Base Replacement Arthroplasty for Osteoarthritis Compared to External Controls
This trial tries replacing the thumb-base (CMC-1) joint with a prosthesis to reduce pain and improve hand strength in people with thumb-base osteoarthritis who have not had enough relief from non-surgical care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT07178223 on ClinicalTrials.gov |
What this trial studies
This interventional trial offers total joint arthroplasty (prosthetic replacement) of the first carpometacarpal (CMC-1) joint as an alternative to non-implant surgeries for symptomatic thumb-base osteoarthritis. Eligible adults have radiographic Eaton class 1–3 disease and clinical pain on palpation or provocation, while patients with rheumatoid arthritis, active infection, gout/pseudogout, recent intra-articular steroid injection, Eaton class 4, or severe trapezium deformity preventing cup placement are excluded. Procedures are performed at the Hand Surgery Clinic, Södersjukhuset (Karolinska sponsor) and participants are followed with a postoperative protocol to record pain, function, recovery time, and complications. The trial aims to add comparative outcome and safety data to earlier reports suggesting quicker recovery and preserved strength after prosthetic arthroplasty.
Who should consider this trial
Good fit: Adults with symptomatic thumb-base (CMC-1) osteoarthritis Eaton class 1–3 who have pain on palpation or a positive grinding test and who are suitable for prosthetic cup placement are ideal candidates.
Not a fit: Patients with rheumatoid arthritis, active hand/wrist infection, gout or pseudogout in the hand, Eaton class 4 disease, severe trapezium deformity preventing cup placement, recent intra-articular steroid injection, chronic centralized pain, or inability to comply with follow-up are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, prosthetic thumb-base replacement could reduce pain during hand loading, improve grip strength, and speed functional recovery compared with current non-implant surgeries.
How similar studies have performed: Small early studies and case series have shown promising short-term pain relief and faster recovery with CMC-1 arthroplasty, but robust long-term comparative data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Osteoarthritis in the thumb base. Radiological Eaton class 1-3 (Ladd et al. 2015). * Clinical signs of thumb base osteoarthritis: pain at palpation of the CMC-1 joint and pain during provocation/grinding test. The inclusion criteria are identical to those of the control population. Exclusion Criteria: * Rheumatoid arthritis. * Ongoing infection in the hand or wrist. * History of gout or pseudogout in the hand. * Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction). * Chronic pain syndrome / centralized pain. * Intra-articular corticosteroid injection in the affected joint within 3 months. -Eaton Littler class 4 (symptomatic STT joint osteoarthritis). The previously described exclusion criteria are identical to those of the control population. In addition patients with severe deformation of the trapezium, to the extent that it is not possible to place a prosthetic cup, will be excluded.
Where this trial is running
Stockholm
- Handkirurgiska kliniken Södersjukhuset — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Maria Wilcke, Associate professor — Karolinska Institutet
- Study coordinator: Maria Wilcke, MD, Associate professor
- Email: maria.wilcke@ki.se
- Phone: +4681236022
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.