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

  • Germany
      • Tuebingen, Germany, 72076
        • BG Trauma Center

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
Procedure: Nerve reconstruction
NT
nerve transplantation
Procedure: Nerve reconstruction
VM
vein-in-muscle conduit
Procedure: Nerve reconstruction

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

BG Trauma Center Tuebingen

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.

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