Surgical release of hand tendons using amniotic membrane wrapping
Surgical Release of Hand Tendons with Wrapping of the Released Tendon Using an Amniotic Membrane
PHASE2 · TBF Genie Tissulaire · NCT06723782
This study is testing if wrapping an amniotic membrane around hand tendons after surgery can help prevent them from sticking together again and improve how well your hand works.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | TBF Genie Tissulaire (industry) |
| Locations | 1 site (Lyon) |
| Trial ID | NCT06723782 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of using an amniotic membrane as an anti-adhesive barrier following the surgical release of tendon adhesions in the hand. Participants will undergo surgery to release the adhesions and have the amniotic membrane wrapped around the released tendon. They will then attend follow-up visits at 15 days, 6 weeks, 3 months, and 6 months post-surgery to assess recovery and functionality. The study aims to determine if this approach can reduce the recurrence of adhesions and improve hand function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with localized tendon adhesions in a single finger that have persisted for at least 3 months despite rehabilitation.
Not a fit: Patients with amputated hands or those requiring tenolysis after tendon grafting will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance recovery and functionality for patients with tendon adhesions in the hand.
How similar studies have performed: While the use of amniotic membranes in surgical procedures is gaining interest, this specific approach to tendon adhesion treatment is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lyon
- Institut Chirurgical de la Main et du Membre Supérieur — Lyon, France (RECRUITING)
Study contacts
- Study coordinator: Justine BOSC, MSc
- Email: justine.bosc@tbf-lab.com
- Phone: 4 72 68 69 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tendon Adhesion, Tenolysis