Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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