Thumb Base Joint OA: Using a treated umbilical cord membrane as an interposed implant

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 is a Phase 2 interventional study evaluating an interposition implant made from a treated umbilical cord amniotic membrane in trapeziometacarpal (thumb-base) joint surgery. Participants undergo standard surgical treatment with the membrane interposition on day 0, followed by visits at 1, 3, 6, and 12 months to assess pain, function, and mobility. The study aims to determine if the implant can reduce postoperative pain and improve grip, pinch strength, and overall wrist function. Eligible adults have symptomatic TMC OA, limited response to non-surgical care, and radiographic stage I-II OA.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient presenting with symptomatic osteoarthritis of the trapeziometacarpal joint, with wrist pain ≥ 40/100 according to the PRWE pain subscale (scaled to 100).
* Patient who has received medical treatment for functional symptoms for more than 3 months without improvement, and for whom surgical intervention is indicated.
* Patient with radiographic stage I-II trapeziometacarpal joint osteoarthritis according to the Eaton-Glickel classification.
* Patient able to understand, date, and sign the informed consent form.
* Patient affiliated with a social security system or beneficiary of such a system.

Exclusion Criteria:

* Pregnant or breastfeeding woman ; woman without effective contraception.
* Patient with scaphotrapeziotrapezoid (STT) joint osteoarthritis requiring prosthetic surgical treatment.
* Patient with thumb osteoarthritis secondary to a systemic inflammatory disease (e.g., rheumatoid arthritis).
* Patient with osteoarthritis experiencing an acute inflammatory flare, characterized by a warm, painful, and swollen joint at the time of enrollment.
* Patient with amputated hand(s).
* Patient presenting signs of neuropathy with functional impairment such as hyperesthesia. Neuropathy may be peripheral (nerve injury) or systemic (caused by diabetes or excessive alcohol consumption).
* Patient lacking capacity to participate in rehabilitation or to comply with study follow-up.
* Patient with a contraindication to anesthesia (poorly controlled epilepsy, neuropathy, etc.).
* Person deprived of liberty by a judicial or administrative decision.
* Adult subject under legal protection or unable to provide informed consent.

Where it's running

• Institut Chirurgical de la Main et du Membre Supérieur (ICMMS)
  Lyon, France Recruiting
• Lyon Ortho Clinic - Centre de la Main - Clinqiue de la Sauvegarde
  Lyon, France Recruiting
• Centre de la Main - Clinique Jules Verne
  Nantes, France Recruiting
• ORTHOSUD Clinique Saint Jean Sud de France
  Saint-Jean-de-Védas, France Recruiting

Study contacts

• Study coordinator: Laurence BARNOUIN
• Email: laurence.barnouin@tbf-lab.com
• Phone: 4 72 68 69 09

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This trial will try an isolated double‑mobility thumb‑base joint replacement to see if it improves pain and hand function in adults with trapeziometacarpal osteoarthritis who need surgery.

  Recruiting Clinique Saint Jean, France · Montpellier · NCT07169474

• Treatment of thumb base osteoarthritis using a collagen-based medical device

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• Corticosteroid versus saline injections for thumb osteoarthritis

  This study will test whether saline injections work better than corticosteroid (triamcinolone) injections to reduce pain and improve hand function in adults with thumb (trapeziometacarpal) osteoarthritis.

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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.