Clinical trial NCT05199155: Use of a Nerve Regeneration Conduit (NerVFIX®) in the Treatment of Nerve Section of the Wrist
Official title: Phase II Study Evaluating the Safety and Efficacy of NerVFIX Treatment for Trauma or Accidental Nerve Section of the Wrist
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Nerve Injury
Nerve Lesion
Lead sponsor: TBF Genie Tissulaire
Sponsor class: INDUSTRY
First posted: 2022-01-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Recovery of sensory function
timeFrame: 12 months
Secondary outcomes:
measure: Progressive recovery of sensory function
timeFrame: 15 days, 1 month, 3 months, 6 months, 12 months
measure: Decrease of the score of symptoms related to nerve section
timeFrame: 15 days, 1 month, 3 months, 6 months, 12 months
measure: Improvement of the touch-pressure threshold of the hand
timeFrame: 15 days, 1 month, 3 months, 6 months, 12 months
measure: Percentage of nerve regeneration
timeFrame: 1 month, 3 months, 6 months, 12 months
measure: Improvement of health-related quality of life
timeFrame: 15 days, 1 month, 3 months, 6 months, 12 months
measure: Improvement of clinical motricity
timeFrame: 15 days, 1 month, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Saint-Herblain
country: France
facility: Clinique de la Main - Nantes Atlantique
city: Villeurbanne
country: France
facility: Institut Chirurgical de la Main et du Membre Supérieur
Study officials:
References: