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Clinical Trials in France / NCT06038331
Recruiting Phase 2

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

NCT06038331 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2024-05-28
Last updated
2025-09-30

Condition(s) studied

Osteoarthritis Hand

Investigational drug(s) / intervention(s)

SclerFIX-IP →

SclerFIX-IP: Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of amniotic membrane of umbilical cord used as an interposition implant in the STT joint

Study summary

The aim of this open, prospective, multicenter trial is to evaluate the use of a sterile, devitalized, processed umbilical cord amniotic membrane implant placed in joint interposition in the treatment of STT osteoarthritis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Male or female; age between 18 and 75 years. * Patient with symptomatic STT OA. * Patient treated medically for functional signs for more than 3 months, without improvement, justifying a surgical intervention. * Patient with a QuickDash score \> 33 points (converted to 50%). * Patient with wrist pain in front of the STT joint at rest = or \> 4/10 on VAS. * Patient who received the study information and provided consent. * Member or beneficiary of a national health insurance plan. Exclusion Criteria: * Pregnant or breastfeeding woman; woman without effective contraception. * Patient with functional rhizarthrosis that has not been stabilized or treated medically or surgically. * Patient with signs of neuropathy with functional disorders such as hyperesthesia. * Patient with uncontrolled epilepsy or neuropathy that contraindicates locoregional anesthesia. * Person confined by a judicial or administrative decision. * Adult subjected to legal protection measures or unable to provide his/her consent.

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
CHU de Besançon Besançon France Recruiting
Institut Chirurgical de la Main et du Membre Supérieur (ICMMS) Lyon France Recruiting
Centre de la Main - Clinique Jules Verne Nantes France Recruiting
Hôpitaux Universitaires de Strasbourg Strasbourg France Recruiting

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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 NCT06038331 on ClinicalTrials.gov ↗ ← All trials in France