Nerve reconstruction with NeuraGen® nerve conduits
| ISRCTN | ISRCTN18539256 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18539256 |
| Protocol serial number | NEU-112-LOH-1923-J |
| Sponsor | Technical University Munich (Germany) |
| Funder | Integra Neurosciences (USA) |
- Submission date
- 27/02/2008
- Registration date
- 04/06/2008
- Last edited
- 29/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jörn A Lohmeyer
Scientific
Scientific
Technical University Munich
University Hospital rechts der Isar
Ismaninger Str. 22
Munich
81675
Germany
| Phone | +49 89 4140 2171 |
|---|---|
| lohmeyer@lrz.tum.de |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational, prospective, multi-centre cohort study. |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Prospective cohort study to evaluate factors for the therapy results after nerve reconstruction with NeuraGen® nerve guide |
| Study objectives | The objective of the clinical study is the evaluation of the nerve regeneration after nerve reconstruction of the sensible nerves of the digits with the NeuraGen® nerve guide. The main clinical objective will be the return of sensibility which will be assessed after different time-points. The general purpose is to specify the perspective of successful nerve regeneration after nerve reconstruction with the NeuraGen® nerve guide in a large population to support former findings in smaller populations. There is no control group within this study. The results of this study will be compared with data found in published material. Also, the influence of different parameters on the clinical outcome (e.g. age, gender, concomitant injuries) will be examined. As of 05/01/2012, the anticipated end date was changed from 28/02/2011 to 30/04/2012. |
| Ethics approval(s) | 1. Institutional Review Board of the University Medical Centre Schleswig-Holstein. Date of approval: 10/02/2007 (ref: 07-112) 2. Institutional Review Board of the University Hospital rechts der Isar, Technical University Munich. Date of approval: 12/12/2007 (ref: 1923) |
| Health condition(s) or problem(s) studied | Nerve reconstruction |
| Intervention | All participants will have nerve reconstruction by interpositional grafting of NeuraGen® nerve guides. |
| Intervention type | Other |
| Primary outcome measure(s) |
Nerve regeneration at first week post-operation and then 3, 6 and 12 months. |
| Key secondary outcome measure(s) |
1. Patient satisfaction at 3, 6 and 12 months (questionnaire) |
| Completion date | 30/04/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2008 |
| Date of final enrolment | 30/04/2012 |
Locations
Countries of recruitment
- France
- Germany
Study participating centre
Technical University Munich
Munich
81675
Germany
81675
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2014 | 29/01/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
29/01/2019: Publication reference added
