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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Reproducibility of obtaining reliable responses and response thresholds monitored over the course of surgery. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Malone, MS | NuVasive | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durango Orthopaedics Associates/Spine Colorado | Durango | Colorado | 81301 | United States | ||
| Pinnacle Orthopaedics & Sports Medicine Specialists |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Correlation between observed changes in the response or response threshold and postoperative neural status. | 6 weeks postoperative |
| Marrietta |
| Georgia |
| 30060 |
| United States |