- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01342588
Accuracy of Lumbar Pedicle Screw Placement Assisted With Continuous Pulse-train Stimulation
Accuracy of Lumbar Pedicle Screw Placement Assisted With Continuous Pulse-train Stimulation During Track Creation and Screw Insertion
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ernesto E Galvan Hernandez, MD, MsC
- Phone Number: 4155 52 (55) 16647205
- Email: egalh@yahoo.com
Study Locations
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Mexico DF
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Mexico City, Mexico DF, Mexico, 05300
- Recruiting
- American British Cowdray Medical Center
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Sub-Investigator:
- Angel Romero, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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)
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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.
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Participants will be followed for the duration of surgical procedure, an expected average of 3-4 hours
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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.
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On day 2 after surgery before patient discharge, a CT scan will be performed
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Collaborators and Investigators
Investigators
- Principal Investigator: Ernesto E Galvan Hernandez, MD, MsC, American British Cowdray Medical Center, Neurological Center
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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