NCT02192112|Completed
Advanced XLIF Monitoring Pilot Study
Evaluation of Transcutaneous Stimulation of Lumbosacral Nerve Roots: A Pilot Study
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Evaluation of Transcutaneous Stimulation of Lumbosacral Nerve Roots: A Pilot Study
Sponsor study identifier
observational
57
1 country
2
Study Start
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 8, 2018
Actual (reported)Study Completion
May 8, 2018
Actual (reported)Though the utility of NVM5 neuromonitoring by stimulating within the surgical site during XLIF has been demonstrated, it is hypothesized that more information may be gathered if a greater section of the motor neural pathway was monitored (i.e., stimulation above the surgical site and recording the subsequent muscle response in the lower limbs). Currently, there has not been demonstrated a practical method of stimulating the lumbosacral nerve roots locally, but well-above the surgical site in this fashion. This protocol is intended to evaluate the feasibility and reproducibility of using surface stimulation and return (anode) electrodes to stimulate the lumbosacral nerve roots, and record responses from the relevant innervated muscle groups of the lower limbs.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 8, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
July 1, 2014
Actual (reported)July 16, 2014
Actual (reported)May 8, 2018
Actual (reported)May 8, 2018
Actual (reported)Reproducibility of obtaining reliable responses and response thresholds monitored over the course of surgery.
Intraoperative
Correlation of any observed changes in the response or response thresholds with surgical events.
Intraoperative
Correlation between patient characteristics and the ability to generate and reliably record responses and response thresholds.
Intraoperative
Correlation between observed changes in the response or response threshold and postoperative neural status.
6 weeks postoperative
At least 20 subjects will be consecutively enrolled in this prospective pilot study from up to three (3) participating centers. Patients who, in the surgeon investigator's opinion, require lateral approach spinal fusion surgery at spinal level L4-5 (though may include any number of levels from L2 through L5), and have consented to XLIF surgery for their condition will be included. The following eligibility criteria are designed to identify existing clinic patients for whom study under this protocol is considered appropriate. All subjects must meet the inclusion/exclusion criteria below in order to be considered for enrollment.
Durango Orthopaedics Associates/Spine Colorado
Durango, Colorado, 81301, United States
Pinnacle Orthopaedics & Sports Medicine Specialists
Marrietta, Georgia, 30060, United States
Kyle Malone, MS
NuVasive
57 participants (actual enrollment reported by the registry).
First Submitted
July 1, 2014
First Posted
July 16, 2014
Study Start
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
May 8, 2018
Actual (reported)Study Completion
May 8, 2018
Actual (reported)Last Updated
December 22, 2025
Record last verified: 2025-12
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Source: ClinicalTrials.gov.
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