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

April 26, 2011 updated by: American British Cowdray Medical Center

Accuracy of Lumbar Pedicle Screw Placement Assisted With Continuous Pulse-train Stimulation During Track Creation and Screw Insertion

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Pedicle screw instrumentation as part of spine surgery is a recurrent technique used for most of spine surgeons. Since its description by Boucher in 1959 and its popularization later by Roy-Camille, has been considered a technique that demands great anatomy knowledge and some grade of expertise. Even in experienced hands the misplacement of pedicle screws could have an incidence of 10-40% (average of 20%). Medially misplacements during track creation and screw insertion are the most feared complications, because the anatomic relationship between medial pedicle wall and neural structures. The first attempt to use continuous electrical stimulation during pedicle track creation and screw insertion was communicated in 1997 by Welch WC, et al. In that study they used the bone impedance as a direct measurement of pedicle wall integrity; unfortunately they used inhaled anesthetics and assessed the final screw position with plain X-rays. They reported a sensibility and specificity of 98% and 99% respectively. The great limitation for this study is its assessment of screw accuracy performed by plain X-rays, now a days the best way to do it is with computed tomography (CT).

After the Welch report, a couple of studies more have used similar techniques in the thoracic spine trying to avoid neurological injuries during pedicle screw insertion, but none described the use of continuous train pulses during screwing.

The present study pretends to evaluate the final accuracy and trans-operative usefulness of the pulse train stimulation during track creation and screw insertion using intra venous anesthetic agents and CT scans to assess the integrity of pedicle walls

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ernesto E Galvan Hernandez, MD, MsC
  • Phone Number: 4155 52 (55) 16647205
  • Email: egalh@yahoo.com

Study Locations

  • Mexico
    • Mexico DF
      • Mexico City, Mexico DF, Mexico, 05300
        • Recruiting
        • American British Cowdray Medical Center
        • Sub-Investigator:
          • Angel Romero, MD

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

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electrical stimulation
Only arm of the study, the experimental
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra operative neurophysiological monitoring (IONM) alert
Time Frame: Participants will be followed for the duration of surgical procedure, an expected average of 3-4 hours
- 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pedicle screw accuracy
Time Frame: On day 2 after surgery before patient discharge, a CT scan will be performed
On day 2 post surgery, a CT scan with sagittal, coronal and axial reconstructions will be obtained . The same day of the study, two independent observers will assess the accuracy of screws inside lumbar pedicles, recording in millimeters, any pedicle wall violation on sagittal, axial and coronal views for each screw placed. In that way we could have the accuracy of pedicle screws placed with the proposed technique, before patient discharge.
On day 2 after surgery before patient discharge, a CT scan will be performed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American British Cowdray Medical Center

Investigators

  • Principal Investigator: Ernesto E Galvan Hernandez, MD, MsC, American British Cowdray Medical Center, Neurological Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2011

Primary Completion (Anticipated)

April 1, 2012

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

April 20, 2011

First Submitted That Met QC Criteria

April 26, 2011

First Posted (Estimate)

April 27, 2011

Study Record Updates

Last Update Posted (Estimate)

April 27, 2011

Last Update Submitted That Met QC Criteria

April 26, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ABC-11-03

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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