NCT01958632

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
Last Updated

October 9, 2013

Status Verified

October 1, 2013

Enrollment Period

1.3 years

First QC Date

October 5, 2013

Last Update Submit

October 5, 2013

Conditions

Sensory Recovery

Outcome Measures

Primary Outcomes (1)

  • Semmes-Weinstein-Monofilament test

    The earliest 6 months post-OP

Secondary Outcomes (1)

  • Two-point-discrimination

    The earliest 6 months post-OP

Study Arms (3)

N

nerve suture

Procedure: Nerve reconstruction

NT

nerve transplantation

Procedure: Nerve reconstruction

VM

vein-in-muscle conduit

Procedure: Nerve reconstruction

Interventions

Nerve reconstructionPROCEDURE
NNTVM

Eligibility Criteria

Age10 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic

You may qualify if:

  • complete digital nerve injuries, nerve reconstruction in the first 6 months post trauma

You may not qualify if:

  • total or subtotal amputations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BG Trauma Center

Tübingen, 72076, Germany

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Plastic Surgeon

Study Record Dates

First Submitted

October 5, 2013

First Posted

October 9, 2013

Study Start

February 1, 2012

Primary Completion

June 1, 2013

Last Updated

October 9, 2013

Record last verified: 2013-10

Locations

DE(1)