Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT06723782

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

Led by TBF Genie Tissulaire · Updated on 2024-12-09

16

Participants Needed

1

Research Sites

128 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Man or woman aged 18 to 65 years old
  • Adhesion of a flexor and/or extensor tendon of the hand
  • Adhesion localized to a single finger
  • Adhesion present for at least 3 months following primary repair despite high-quality rehabilitation
  • Total passive range of motion of the proximal and distal interphalangeal joints of at least 150 degrees
  • Informed and consenting patient
  • Patient enrolled in a social security plan or a beneficiary of such a plan
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding woman or without effective contraception
  • Patient requiring tenolysis after tendon grafting for deep common flexor reconstruction or after reimplantation
  • Patient with amputated hand(s)
  • Patient with untreated fracture or non-union in the affected hand
  • Patient requiring multiple surgical interventions that could affect results
  • Patient unable to understand rehabilitation or follow the study protocol
  • Patient with contraindication to anesthesia
  • Person deprived of liberty by judicial or administrative decision
  • Adult subject to legal protection measures or incapable of expressing consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Institut Chirurgical de la Main et du Membre Supérieur

Lyon, France, 69006

Actively Recruiting

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Research Team

J

Justine BOSC, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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