erve reconstruction with NeuraGen® nerve conduits

Not Applicable

Completed

• Conditions: erve reconstruction; Injury, Occupational Diseases, Poisoning; Injury of nerves at wrist and hand level

• Registration Number: ISRCTN18539256
• Lead Sponsor: Technical University Munich (Germany)

Brief Summary

1. 2013 results in https://www.ncbi.nlm.nih.gov/pubmed/24338485 (added 29/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-06-04
• Study Completion: 2012-04-30
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
erve regeneration at first week post-operation and then 3, 6 and 12 months.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Patient satisfaction at 3, 6 and 12 months (questionnaire)<br> 2. Pain at first week post-operation and then 3, 6 and 12 months (questionnaire)<br> 3. Dysaesthesia at first week post-operation and then 3, 6 and 12 months<br>