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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Decellularized, freeze-dried and sterile allogeneic graft of artery or vein from umbilical cord use by the investigator as a nerve regeneration conduit
Clinique de la Main - Nantes Atlantique
Saint-Herblain, France
Institut Chirurgical de la Main et du Membre Supérieur
Villeurbanne, France
Recovery of sensory function
Recovery of sensitivity in the nerve section area evaluated using the static 2-Point Discrimination (s2PD)
Time frame: 12 months
Progressive recovery of sensory function
Improvement in the s2PD
Time frame: 15 days, 1 month, 3 months, 6 months, 12 months
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)
Time frame: 15 days, 1 month, 3 months, 6 months, 12 months
Improvement of the touch-pressure threshold of the hand
Touch-pressure of the hand in grammes determined using Semmes-Weinstein Monofilament (SWM) tests
Time frame: 15 days, 1 month, 3 months, 6 months, 12 months
Percentage of nerve regeneration
Nerve regeneration after surgical repair evaluated by Hoffman-Tinel sign
Time frame: 1 month, 3 months, 6 months, 12 months
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)
Time frame: 15 days, 1 month, 3 months, 6 months, 12 months
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
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Time frame: 15 days, 1 month, 3 months, 6 months, 12 months