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This is a prospective, non-randomized multi-center study to evaluate intraoperative neuromonitoring results in subjects who undergo eXtreme Lateral Interbody Fusion (XLIF) surgery at any number of levels inclusive of L4-5.
Subjects will present with degenerative conditions in the lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will undergo neuromonitoring during the XLIF operation, as per standard care. They will then be re-evaluated immediately after surgery and at the first standard postoperative follow-up visit (6 weeks) to assess for presence of new neural deficit. If a new neural deficit is identified, the patient will be followed per the Investigator's standard follow-up schedule until symptoms have resolved (or are deemed permanent).
A total of 300 subjects will be enrolled in this study from multiple centers. The subjects will have degenerative conditions of the lumbar spine with planned treatment including XLIF surgery. 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NV in XLIF | This group will have the XLIF procedure done using NV. |
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| Measure | Description | Time Frame |
|---|---|---|
| The sensitivity and specificity of EMG and SSEP (if available) testing in identifying neural injury. | For evaluation of the primary endpoint and additional assessments, descriptive statistics including mean, standard deviation, minimum, median, and maximum for continuous variables and frequency distribution for categorical variables will be provided, as well as tabular listings. All complications will be itemized including incidence, duration, and relationship to devices used and/or procedures performed. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Study population will consist of patients from participating site locations.
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| Name | Affiliation | Role |
|---|---|---|
| Kelli Howell, MS | NuVasive | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shiley Center for Orthopaedic Research | La Jolla | California | 92037 | United States | ||
| UC Irvine Medical Center |
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| Orange |
| California |
| 92868 |
| United States |
| Durango Orthopaedics | Durango | Colorado | 81301 | United States |
| USF Neurology and Neurosurgery | Tampa | Florida | 33606 | United States |
| West Augusta Spine Specialists | Augusta | Georgia | 30909 | United States |
| Georgia Spine and Neurosurgery Center | Decatur | Georgia | 30033 | United States |
| Pinnacle Orthopaedics and Sports Medicine | Marietta | Georgia | 30060 | United States |
| McLean Country Orthopedics | Bloomington | Illinois | 61704 | United States |
| Illinois Neurological Institute | Peoria | Illinois | 61605 | United States |
| Columbia Orthopaedic Group | Columbia | Missouri | 65205 | United States |
| Spine Midwest, Inc. | Jefferson City | Missouri | 65101 | United States |
| Western Regional Center for Brain and Spine Surgery | Las Vegas | Nevada | 89109 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| South Oregon Spine Care | Medford | Oregon | 97504 | United States |
| Univerisity of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Coastal Orthopaedic Associates | Conway | South Carolina | 29526 | United States |
| Spine Pain Be Gone Clinic | San Antonio | Texas | 78229 | United States |
| Caribbean Orthopaedic and Spine Institute | San Juan | PR | 00901 | Puerto Rico |
| Kantonsspital St. Gallen | Sankt Gallen | 9007 | Switzerland |