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

Phase 2

Terminated

• Conditions: Nerve Injury; Nerve Lesion
• Interventions: Biological: NerVFIX

• Registration Number: NCT05199155
• Lead Sponsor: TBF Genie Tissulaire

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-08
• Study First Submitted: 2021-12-30
• Study First Submitted QC: 2022-01-14
• Study First Posted: 2022-01-20
• Primary Completion: 2024-08-13
• Study Completion: 2024-08-13
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NerVFIX	NerVFIX	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

Primary Outcome Measures

Name	Time	Method
Recovery of sensory function	12 months	Recovery of sensitivity in the nerve section area evaluated using the static 2-Point Discrimination (s2PD)

Secondary Outcome Measures

Name	Time	Method
Progressive recovery of sensory function	15 days, 1 month, 3 months, 6 months, 12 months	Improvement in the s2PD
Decrease of the score of symptoms related to nerve section	15 days, 1 month, 3 months, 6 months, 12 months	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)
Improvement of the touch-pressure threshold of the hand	15 days, 1 month, 3 months, 6 months, 12 months	Touch-pressure of the hand in grammes determined using Semmes-Weinstein Monofilament (SWM) tests
Percentage of nerve regeneration	1 month, 3 months, 6 months, 12 months	Nerve regeneration after surgical repair evaluated by Hoffman-Tinel sign
Improvement of health-related quality of life	15 days, 1 month, 3 months, 6 months, 12 months	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)
Improvement of clinical motricity	15 days, 1 month, 3 months, 6 months, 12 months	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

Trial Locations

Locations (2)

Clinique de la Main - Nantes Atlantique; 🇫🇷 Saint-Herblain, France

Institut Chirurgical de la Main et du Membre Supérieur; 🇫🇷 Villeurbanne, France