RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: TBF Genie Tissulaire • ClinicalTrials.gov ID: NCT07435571

Registry updated: 2026-10-06

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Description

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.

Interventions

with SclerFIX (Procedure)
Use of the treated umbilical cord amniotic membrane allograft SclerFIX as an interposition implant in the TMC joint

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.

Conditions

Trapeziometacarpal Osteoarthritis

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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