Contact information
Type
Scientific
Primary contact
Dr Jörn A Lohmeyer
ORCID ID
Contact details
Technical University Munich
University Hospital rechts der Isar
Ismaninger Str. 22
Munich
81675
Germany
+49 89 4140 2171
lohmeyer@lrz.tum.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NEU-112-LOH-1923-J
Study information
Scientific title
Prospective cohort study to evaluate factors for the therapy results after nerve reconstruction with NeuraGen® nerve guide
Acronym
Study hypothesis
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
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)
Study design
Observational, prospective, multi-centre cohort study.
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Nerve reconstruction
Intervention
All participants will have nerve reconstruction by interpositional grafting of NeuraGen® nerve guides.
Intervention type
Other
Phase
Not Specified
Drug names
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 trial start date
01/03/2008
Overall trial end date
30/04/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
100
Participant 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
Recruitment start date
01/03/2008
Recruitment end date
30/04/2012
Locations
Countries of recruitment
France, Germany
Trial participating centre
Technical University Munich
Munich
81675
Germany
Sponsor information
Organisation
Technical University Munich (Germany)
Sponsor details
University Hospital rechts der Isar
Ismaninger Strasse 22
Munich
81675
Germany
+49 89 4140 2171
lohmeyer@lrz.tum.de
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Integra Neurosciences (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2013 results in https://www.ncbi.nlm.nih.gov/pubmed/24338485 (added 29/01/2019)