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

NCT06723782 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-12-09

No results posted yet for this study

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.

Conditions

  • Tendon Adhesion
  • Tenolysis

Interventions

BIOLOGICAL

AMTRIX-D

Use of a decellularized, viro-inactivated, desiccated, and sterile allogeneic amniotic membrane graft to wrap a tendon after release of its adhesions.

Sponsors & Collaborators

  • TBF Genie Tissulaire

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-15
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06723782 on ClinicalTrials.gov