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Accuracy of Lumbar Pedicle Screw Placement Assisted With Continuous Pulse-train Stimulation

NCT01342588 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-04-27

No results posted yet for this study

Summary

The purpose of this study is to establish the accuracy of pedicle positioning using continuous electrical pulse during screwing. Additionally, the investigators evaluate if this maneuver can prevent neurological injury during track creation and screwing in lumbar and thoracic spine instrumentation surgery

Conditions

  • Spine Pedicle Screw Placement

Interventions

PROCEDURE

Electric pulse train stimulation

Electric pulse train stimulation of regular probes and screw drivers used in track creation and screw placement Using a standard neurophysiological work station, a series of square wave pulses will be delivered through standard probes and screw drivers using an alligator clip during pedicle probing and screw insertion (4 Hz for 50-200 μsec at 10-30 μAmp)

Sponsors & Collaborators

  • American British Cowdray Medical Center

    lead OTHER

Principal Investigators

  • Ernesto E Galvan Hernandez, MD, MsC · American British Cowdray Medical Center, Neurological Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-04-30
Completion
2012-05-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01342588 on ClinicalTrials.gov