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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
AMTRIX-D
Biological/VaccineUse of a decellularized, viro-inactivated, desiccated, and sterile allogeneic amniotic membrane graft to wrap a tendon after release of its adhesions.
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: AMTRIX-DExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
6 monthsSecondary outcomes
1
Change in the daily functionality of the finger
Daily functionality of the finger evaluated using Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire (0 = no disability, 100 = most severe disability).
Time frame
15 days, 6 weeks, 3 months, 6 months2
Change in finger pain
Pain evaluated from 0 (no pain) to 10 (worst imaginable pain) on a visual analog scale (VAS).
Time frame
15 days, 6 weeks, 3 months, 6 months3
Change in hand grip strength
Grip strength measured in kg by grip strength test using a hand dynamometer.
Time frame
6 weeks, 3 months, 6 months4
Frequency of occurrence of post-surgical complications
Evaluation of the frequency of occurrence of post-surgical complications and in particular rupture of the deep common flexor tendon, phlegmon, wound dehiscence.
Time frame
15 days, 6 weeks, 3 months, 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov