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Recruiting Phase 2

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

NCT07435571 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2026-11
Last updated
2026-10-06

Condition(s) studied

Trapeziometacarpal Osteoarthritis

Investigational drug(s) / intervention(s)

with SclerFIX

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

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in thumb osteoarthritis-related pain between the baseline and the the 12-month end-of-study visit. — Enrollment, 12 months
    Thumb osteoarthritis-related pain will be assessed using the PRWE (Patient-Rated Wrist Evaluation) pain subscale and expressed as a percentage. The use of oral analgesics for hand pain will also be recorded at each follow-up visit, based on the preceding 7 days.

Trial sites (4)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07435571 on ClinicalTrials.gov ↗ ← All trials in France