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

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

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.

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