NCT07435571 Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of Trapeziometacarpal Osteoarthritis

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 22 participants in total. It began in 2026-11 with a primary completion date of 2028-03.

Brief Summary

The objective of this clinical trial is to evaluate whether a human umbilical cord amniotic membrane allograft can serve as an interposition implant in the surgical treatment of trapeziometacarpal osteoarthritis. The main question this study aims to address is : \- Can interposition of a human umbilical cord amniotic membrane within the trapeziometacarpal joint reduces postoperative pain and improves thumb mobility, grip and pinch strength, and overall wrist function. Participant will: * Undergo surgical treatment of the trapeziometacarpal osteoarthritis with the interposition in articular joint of an amniotic membrane of umbilical cord allograft on Day 0 * Visit the center for a series of tests 1 month, 3 months, 6 months and 12 months after the surgical intervention.

Eligibility Criteria

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.

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