Thumb-base joint replacement for osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.