NCT01342588

Brief 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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

April 27, 2011

Status Verified

April 1, 2011

Enrollment Period

1.2 years

First QC Date

April 20, 2011

Last Update Submit

April 26, 2011

Conditions

Spine Pedicle Screw Placement

Keywords

Pedicle screwssafety

Outcome Measures

Primary Outcomes (1)

  • Intra operative neurophysiological monitoring (IONM) alert

    \- Continuous electrical stimulation delivered by a wire connected to the surgical instruments only during pedicle track creation and screw placement combined with neurophysiological monitoring will let us identify any IONM alert, defined as nerve irritation or a decrease in voltage and/or amplitude response. This is a single and immediate measurement obtained at surgery during spinal screw placement.

    Participants will be followed for the duration of surgical procedure, an expected average of 3-4 hours

Secondary Outcomes (1)

  • Pedicle screw accuracy

    On day 2 after surgery before patient discharge, a CT scan will be performed

Study Arms (1)

Electrical stimulation

EXPERIMENTAL

Only arm of the study, the experimental

Procedure: Electric pulse train stimulation

Interventions

Electric pulse train stimulationPROCEDURE

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)

Electrical stimulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient who needs pedicle screw placement for any spine condition

You may not qualify if:

  • Previous spine surgery
  • Pedicle fracture documented before or during surgery.
  • Preoperative identified neurological deficit of the nerve roots close to the instrumented levels

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American British Cowdray Medical Center

Mexico City, Mexico DF, 05300, Mexico

RECRUITING

Related Publications (4)

  • Roy-Camille R, Saillant G, Mazel C. Internal fixation of the lumbar spine with pedicle screw plating. Clin Orthop Relat Res. 1986 Feb;(203):7-17.

    PMID: 3955999BACKGROUND

  • Donohue ML, Murtagh-Schaffer C, Basta J, Moquin RR, Bashir A, Calancie B. Pulse-train stimulation for detecting medial malpositioning of thoracic pedicle screws. Spine (Phila Pa 1976). 2008 May 20;33(12):E378-85. doi: 10.1097/BRS.0b013e31817343c1.

    PMID: 18496333BACKGROUND

  • Welch WC, Rose RD, Balzer JR, Jacobs GB. Evaluation with evoked and spontaneous electromyography during lumbar instrumentation: a prospective study. J Neurosurg. 1997 Sep;87(3):397-402. doi: 10.3171/jns.1997.87.3.0397.

    PMID: 9285605BACKGROUND

  • Collado-Corona MA, de Leo-Vargas R, Sandoval-Sanchez V, Diaz-Hernandez A, Gutierrez-Sougarret BJ, Shkurovich-Bialik P. Neurophysiological monitoring in spinal cord surgery. Cir Cir. 2009 Sep-Oct;77(5):385-90.

    PMID: 19944028BACKGROUND

Study Officials

  • Ernesto E Galvan Hernandez, MD, MsC

    American British Cowdray Medical Center, Neurological Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ernesto E Galvan Hernandez, MD, MsC

CONTACT

52 (55) 16647205egalh@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 20, 2011

First Posted

April 27, 2011

Study Start

January 1, 2011

Primary Completion

April 1, 2012

Study Completion

May 1, 2012

Last Updated

April 27, 2011

Record last verified: 2011-04

Locations

ME(1)