Muscle-in-vein Conduits for Digital Nerve Reconstruction
October 5, 2013 updated by: Dr. Theodora Manoli, BG Trauma Center Tuebingen
Evaluation of Sensory Recovery After Reconstruction of Digital Nerves of the Hand Using Muscle-in-vein Conduits in Comparison to Nerve Suture or Nerve Transplantation
The actual study should provide a first direct comparison between results after reconstruction of sensory nerves of the hand using muscle-in-vein conduits to the standard methods of nerve transplantation and direct nerve suture.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
77
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tuebingen, Germany, 72076
- BG Trauma Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
primary care clinic
Description
Inclusion Criteria:
complete digital nerve injuries, nerve reconstruction in the first 6 months post trauma
Exclusion Criteria:
total or subtotal amputations
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
N
nerve suture
|
|
|
NT
nerve transplantation
|
|
|
VM
vein-in-muscle conduit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Semmes-Weinstein-Monofilament test
Time Frame: The earliest 6 months post-OP
|
The earliest 6 months post-OP
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Two-point-discrimination
Time Frame: The earliest 6 months post-OP
|
The earliest 6 months post-OP
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
October 5, 2013
First Submitted That Met QC Criteria
October 5, 2013
First Posted (Estimate)
October 9, 2013
Study Record Updates
Last Update Posted (Estimate)
October 9, 2013
Last Update Submitted That Met QC Criteria
October 5, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 117/2012BO2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.