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

Launched by TBF GENIE TISSULAIRE · Dec 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether wrapping a special type of membrane, called an amniotic membrane, around a tendon that has been surgically released can help prevent the tendon from sticking to surrounding tissues again. The main goal is to see if this method can reduce the chance of adhesions (which are like internal scar tissues) forming again and help patients regain better use of their hands after surgery.

To be eligible for the trial, participants should be between 18 and 65 years old and have had problems with a tendon in one finger for at least three months, even after receiving treatment. They will have surgery to release the tendon and wrap it with the membrane, followed by follow-up visits at 15 days, 6 weeks, 3 months, and 6 months after the surgery to monitor their recovery. This study is currently looking for participants of all genders who meet these criteria. It's a chance to receive cutting-edge treatment while helping researchers learn more about improving recovery for hand injuries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 that has been present for at least 3 months following primary repair, despite high-quality rehabilitation. Primary repair is defined as the repair of a tendon injury, fracture, crush injury of the finger, infection, etc., leading to the adhesion of the tendon to surrounding tissue.
• • Patient with a total passive range of motion of the proximal and distal interphalangeal joints of at least 150°.
• • Informed and consenting patient.
• • Patient enrolled in a social security plan or a beneficiary of such a plan.
• Exclusion Criteria:
• • Pregnant or breastfeeding woman, or without an effective method of contraception.
• • Patient requiring tenolysis after tendon grafting for the reconstruction of a deep common flexor or after reimplantation.
• • Patient with amputated hand(s).
• • Patient with an untreated fracture or non-union in the affected hand.
• • Patient requiring multiple surgical interventions that may be potential confounding factors, particularly those involving additional incisions.
• • Patient unable to understand rehabilitation or follow the study protocol.
• • Patient with a contraindication to anesthesia.
• • Person deprived of liberty by judicial or administrative decision.
• • Adult subject to legal protection measures or incapable of expressing consent.