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RECRUITING
NCT06723782
PHASE2

Surgical Release of Hand Tendons with Wrapping of the Released Tendon Using an Amniotic Membrane

Sponsor: TBF Genie Tissulaire

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate whether an amniotic membrane can function as an effective anti-adhesive barrier following surgical release of tendon adhesions. The main question the clinical trial aims to answer is: \- Can wrapping an amniotic membrane around a surgically released tendon help reduce recurrence of adhesions and promote recovery of hand functionality? Participants will: * Undergo surgical treatment (surgical release of the tendon adhesions and wrapping of the amniotic membrane around the release tendon) on Day 0. * Visit the center for a series of tests 15 days, 6 weeks, 3 months, 6 months after the surgical intervention.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2024-02-15

Completion Date

2026-08

Last Updated

2024-12-09

Healthy Volunteers

No

Interventions

BIOLOGICAL

AMTRIX-D

Use of a decellularized, viro-inactivated, desiccated, and sterile allogeneic amniotic membrane graft to wrap a tendon after release of its adhesions.

Locations (1)

Institut Chirurgical de la Main et du Membre Supérieur

Lyon, France