Surgical Release of Hand Tendons with Wrapping of the Released Tendon Using an Amniotic Membrane (NCT06723782) | Clinical Trial Compass
RecruitingPhase 2
Surgical Release of Hand Tendons with Wrapping of the Released Tendon Using an Amniotic Membrane
France16 participantsStarted 2024-02-15
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.