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NOT YET 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

2026-03

Completion Date

2028-03

Last Updated

2026-02-27

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