Condition category
Injury, Occupational Diseases, Poisoning
Date applied
27/02/2008
Date assigned
04/06/2008
Last edited
05/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.med.tu-muenchen.de

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes