Nerve reconstruction Injury, Occupational Diseases, Poisoning Injury of nerves at wrist and hand level
Conditions
Interventions
All participants will have nerve reconstruction by interpositional grafting of NeuraGen® nerve guides.
Sponsors
Technical University Munich (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females, age 6+ 2. Existence of a complete nerve transsection of a sensitive nerve of the hand that cannot be overcome by tensionless nerve coaptation 3. Informed consent to the procedure and the inclusion into the study given by the patient and the parents in case of underage 4. Time interval between primary nerve damage and reconstruction less than 12 months 5. Nerve gap equals or is shorter than 30 mm
Exclusion criteria
Exclusion criteria: 1. Polyneuropathia 2. Pre-existing damage to the injured nerve (e.g., trauma or chronic compression disease) - injury at different levels of the nerve 3. Acute local infection 4. The reconstructed nerve cannot be covered with soft tissue 5. Life expectancy <1 year due to malignancy or other systemic diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nerve regeneration at first week post-operation and then 3, 6 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient satisfaction at 3, 6 and 12 months (questionnaire) 2. Pain at first week post-operation and then 3, 6 and 12 months (questionnaire) 3. Dysaesthesia at first week post-operation and then 3, 6 and 12 months | — |
Countries
France, Germany
Outcome results
None listed