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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A03050-57 | Registry Identifier | IDRCB |
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Low accrual rate
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NerVFIX | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NerVFIX | Biological | Decellularized, freeze-dried and sterile allogeneic graft of artery or vein from umbilical cord use by the investigator as a nerve regeneration conduit |
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| Measure | Description | Time Frame |
|---|---|---|
| Recovery of sensory function | Recovery of sensitivity in the nerve section area evaluated using the static 2-Point Discrimination (s2PD) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progressive recovery of sensory function | Improvement in the s2PD | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de la Main - Nantes Atlantique | Saint-Herblain | 44800 | France | |||
| Institut Chirurgical de la Main et du Membre Supérieur |
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| 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 | 15 days, 1 month, 3 months, 6 months, 12 months |
| Percentage of nerve regeneration | Nerve regeneration after surgical repair evaluated by Hoffman-Tinel sign | 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) | 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 | 15 days, 1 month, 3 months, 6 months, 12 months |
| Villeurbanne |
| 69100 |
| France |