Surgical Release of Hand Tendons with Wrapping of the Released Tendon Using an Amniotic Membrane
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTBF Genie Tissulaire
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- AMTRIX-D
Treatment groups
16 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov