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RECRUITING
NCT07435571
PHASE2

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

Sponsor: TBF Genie Tissulaire

View on ClinicalTrials.gov

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.

Official title: Evaluation of the Treatment of Trapeziometacarpal Osteoarthritis (TMC OA) With a Treated, Devitalized and Sterile Amniotic Membrane of Umbilical Cord Placed in Joint Interposition

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2026-11

Completion Date

2028-03

Last Updated

2026-10-06

Healthy Volunteers

No

Interventions

PROCEDURE

with SclerFIX

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

Locations (4)

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