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ISRCTN
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ISRCTN18539256
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ClinicalTrials.gov identifier
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Public title
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Nerve reconstruction with NeuraGen® nerve conduits
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Scientific title
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Prospective cohort study to evaluate factors for the therapy results after nerve reconstruction with NeuraGen® nerve guide
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Acronym
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N/A
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Serial number at source
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NEU-112-LOH-1923-J
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Study hypothesis
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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.
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Ethics approval
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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)
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Study design
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Observational, prospective, multi-centre cohort study.
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Countries of recruitment
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France, Germany
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Disease/condition/study domain
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Nerve reconstruction
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/03/2008
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Anticipated end date
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28/02/2011
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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100
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Interventions
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All participants will have nerve reconstruction by interpositional grafting of NeuraGen® nerve guides.
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Primary outcome measure(s)
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Nerve regeneration at first week post-operation and then 3, 6 and 12 months.
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Secondary outcome measure(s)
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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
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Sources of funding
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Integra Neurosciences (USA)
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Trial website
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Publications
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Contact name
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Dr
Jörn A
Lohmeyer
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Address
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Technical University Munich
University Hospital rechts der Isar
Ismaninger Str. 22
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City/town
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Munich
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Zip/Postcode
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81675
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Country
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Germany
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Tel
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+49 89 4140 2171
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Fax
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+49 89 41404869
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Email
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lohmeyer@lrz.tum.de
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Sponsor
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Technical University Munich (Germany)
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Address
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University Hospital rechts der Isar
Ismaninger Strasse 22
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City/town
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Munich
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Zip/Postcode
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81675
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Country
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Germany
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Tel
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+49 89 4140 2171
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Fax
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+49 89 4140 4869
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Email
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lohmeyer@lrz.tum.de
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Sponsor website:
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http://www.med.tu-muenchen.de
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Date applied
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27/02/2008
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Last edited
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04/06/2008
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Date ISRCTN assigned
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04/06/2008
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