Use of a Nerve Regeneration Conduit (NerVFIX®) in the Treatment of Nerve Section of the Wrist

Study Overview
=================
Brief Summary
-----------------
The purpose of this open, multicenter trial is to assess the impact of a nerve regeneration conduit made of allogeneic artery or vein from umbilical cord lining on the regeneration of wrist nerve.

Official Title
-----------------
Phase II Study Evaluating the Safety and Efficacy of NerVFIX Treatment for Trauma or Accidental Nerve Section of the Wrist

Conditions
-----------------
Nerve Injury, Nerve Lesion

Intervention / Treatment
-----------------
* Biological: NerVFIX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women over 18 years of age and under 65 years of age One wrist nerve section ( medial, ulnar) with a minimum of 2 mm and maximum gap of 2 cm evaluated during the surgical procedure (Sunderland Grade V) Inclusion of direct suture with wrapping or nerve defect with NerVFIX for nerve junction Poor outcome on the Mackinnon-Dellon scale: < S3 Within 1 month of the injury or accident event and/or at the time of the injury (emergency procedure) Any damaged artery must be repaired Patient with no poor vascularization risk (no surgical treatment of vessel section) or no disease linked to poor vascularization. Patient who received the study information and provided consent Patients who are members or the beneficiary of a national health insurance plan Exclusion Criteria: Breast feeding women or women without effective contraception (if no effective contraception: a pregnancy test is mandatory) Digital nerve section Pregnant or breast feeding women: Women of childbearing age will be asked to undergo a pregnancy test before being enrolled into the study and to use an effective birth control method Patient who suffered amputation of the hand in question Surgical site infection or necrotic area; tendon and/or bone damage Underlying motor or sensory disorder that could compromise the evaluation; inflammatory arthritis causing pain Disease that compromises healing such as diabetes, alcoholism or skin disorder Vascular disease leading to reduced blood flow or altered microvascularisation such as Raynaud's disease Subjects who are unlikely to follow through with rehabilitation or who could be addicted to drugs or alcohol; heavy smokers will be asked to stop smoking voluntarily Persons confined by a judicial or administrative decision Adults subject to legal protection measures or who are unable to provide their consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NerVFIX<br>Biological regeneration nerve conduit of allogeneic artery or vein from umbilical cord used as a conduit for gap < 2 cm or as a wrap after peripheral nerve suture | Biological: NerVFIX<br>* Decellularized, freeze-dried and sterile allogeneic graft of artery or vein from umbilical cord use by the investigator as a nerve regeneration conduit<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of sensory function | Recovery of sensitivity in the nerve section area evaluated using the static 2-Point Discrimination (s2PD) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progressive recovery of sensory function | Improvement in the s2PD | 15 days, 1 month, 3 months, 6 months, 12 months | 
| Decrease of the score of symptoms related to nerve section | Score of cold sensitivity, hyperaesthesia and numbing (0 = no complication, 4 = major complication) and score of pain to the pressure (0 = no pain, 10 = worst imaginable pain) | 15 days, 1 month, 3 months, 6 months, 12 months | 
| Improvement of the touch-pressure threshold of the hand | Touch-pressure of the hand in grammes determined using Semmes-Weinstein Monofilament (SWM) tests | 15 days, 1 month, 3 months, 6 months, 12 months | 
| Percentage of nerve regeneration | Nerve regeneration after surgical repair evaluated by Hoffman-Tinel sign | 1 month, 3 months, 6 months, 12 months | 
| Improvement of health-related quality of life | Quality of life related to nerve section of the hand evaluated using Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire (0 = no disability, 100 = most severe disability) | 15 days, 1 month, 3 months, 6 months, 12 months | 
| Improvement of clinical motricity | Improvement of thumb opposition in case of median nerve section or of Froment's sign, abduction and adduction of the fingers and movement of the 4th and 5th digit in case of ulnar nerve section | 15 days, 1 month, 3 months, 6 months, 12 months |