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

Nerve Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05199155
• Other study ID #: NerVFIX-TBF2
• Secondary ID: 2019-A03050-57
• Status: Recruiting
• Phase: Phase 2
• Start date: December 8, 2020
• Est. completion date: December 2023

Study information

• Verified date: April 2023
• Source: TBF Genie Tissulaire
• Contact: Laurence BARNOUIN, MD
• Phone: 0472686909
• Email: laurence.barnouin[@]tbf-lab.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nerve Injury

Intervention

Biological:
• NerVFIX
Decellularized, freeze-dried and sterile allogeneic graft of artery or vein from umbilical cord use by the investigator as a nerve regeneration conduit

Locations

Country	Name	City	State
France	Clinique de la Main - Nantes Atlantique	Saint-Herblain
France	Institut Chirurgical de la Main et du Membre Supérieur	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
TBF Genie Tissulaire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery of sensory function	Recovery of sensitivity in the nerve section area evaluated using the static 2-Point Discrimination (s2PD)	12 months
Secondary	Progressive recovery of sensory function	Improvement in the s2PD	15 days, 1 month, 3 months, 6 months, 12 months
Secondary	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
Secondary	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
Secondary	Percentage of nerve regeneration	Nerve regeneration after surgical repair evaluated by Hoffman-Tinel sign	1 month, 3 months, 6 months, 12 months
Secondary	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
Secondary	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