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

NCT06723782 | Recruiting Phase 2

• 2 other identifiers: AMTRIX-Tenolyse-TBF2023-A01189-36
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in the finger total active range of motion

  Total active range of motion of the finger evaluated according to Strickland's classification: (TAM/175) × 100, where TAM = flexion of the proximal interphalangeal joint + flexion of the distal interphalangeal joint - extension deficit. Total active range of motion scores are expressed as percentages and classified into four categories: poor if \< 25%, moderate from 25% to 49%, good from 50% to 74%, and excellent if \> 75%. The primary objective of the study will be achieved if the total active range of motion is good or excellent (\>50%) at 6 months.

  6 months

Secondary Outcomes (4)

• Change in the daily functionality of the finger

  15 days, 6 weeks, 3 months, 6 months

• Change in finger pain

  15 days, 6 weeks, 3 months, 6 months

• Change in hand grip strength

  6 weeks, 3 months, 6 months

• Frequency of occurrence of post-surgical complications

  15 days, 6 weeks, 3 months, 6 months

Study Arms (1)

AMTRIX-D

EXPERIMENTAL

Surgical release of the tendon and wrapping of the released tendon with desiccated amniotic membrane (AMTRIX-D)

Biological: AMTRIX-D

Interventions

AMTRIX-D BIOLOGICAL

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

AMTRIX-D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TBF Genie Tissulaire: lead

Study Sites (1)

Institut Chirurgical de la Main et du Membre Supérieur

Lyon, 69006, France

RECRUITING

Central Study Contacts

Justine BOSC, MSc

CONTACT

4 72 68 69 11; justine.bosc@tbf-lab.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: February 15, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)