Phase
Condition
Nerve Injury
Treatment
NerVFIX
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 2cm evaluated during the surgical procedure (Sunderland Grade V)
Inclusion of direct suture with wrapping or nerve defect with NerVFIX for nervejunction
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
Exclusion Criteria:
Breast feeding women or women without effective contraception (if no effectivecontraception: a pregnancy test is mandatory)
Digital nerve section
Pregnant or breast feeding women: Women of childbearing age will be asked to undergoa pregnancy test before being enrolled into the study and to use an effective birthcontrol 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 suchas Raynaud's disease
Subjects who are unlikely to follow through with rehabilitation or who could beaddicted to drugs or alcohol; heavy smokers will be asked to stop smokingvoluntarily
Persons confined by a judicial or administrative decision
Adults subject to legal protection measures or who are unable to provide theirconsent
Study Design
Connect with a study center
Clinique de la Main - Nantes Atlantique
Saint-Herblain, 44800
FranceSite Not Available
Institut Chirurgical de la Main et du Membre Supérieur
Villeurbanne, 69100
FranceSite Not Available

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