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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Institut Chirurgical de la Main et du Membre Supérieur
RECRUITING
Lyon
Contact Information
Primary
Justine BOSC, MSc
justine.bosc@tbf-lab.com
4 72 68 69 11
Time Frame
Start Date: 2024-02-15
Estimated Completion Date: 2026-08
Participants
Target number of participants: 16
Treatments
Experimental: AMTRIX-D
Surgical release of the tendon and wrapping of the released tendon with desiccated amniotic membrane (AMTRIX-D)
Related Therapeutic Areas
Sponsors
Leads: TBF Genie Tissulaire

This content was sourced from clinicaltrials.gov