Nerve reconstruction with NeuraGen® nerve conduits

ISRCTN	ISRCTN18539256
DOI	https://doi.org/10.1186/ISRCTN18539256
Secondary identifying numbers	NEU-112-LOH-1923-J

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

Technical University Munich
University Hospital rechts der Isar
Ismaninger Str. 22
Munich
81675
Germany

Phone	+49 89 4140 2171
Email	lohmeyer@lrz.tum.de

Study information

Study design	Observational, prospective, multi-centre cohort study.
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	Nerve regeneration at first week post-operation and then 3, 6 and 12 months.
Secondary outcome measures	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
Overall study start date	01/03/2008
Completion date	30/04/2012

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	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

Sponsor information

Technical University Munich (Germany)
University/education

University Hospital rechts der Isar
Ismaninger Strasse 22
Munich
81675
Germany

Phone	+49 89 4140 2171
Email	lohmeyer@lrz.tum.de
Website	http://www.med.tu-muenchen.de
"ROR"	https://ror.org/02kkvpp62

Funders

Funder type

Industry

Integra Neurosciences (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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

Editorial Notes

29/01/2019: Publication reference added