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The purpose of this research study is to gather information about the NeuroVision System (which is FDA cleared for this indication) during the placement of pedicle screws. NeuroVision is a machine that monitors nerve activity during surgery and will alert the surgeon if there are any nerve-related issues during screw placement. The use of nerve monitoring is standard of care at most centers during spine surgery. The standard monitoring for screws placed is performed after the screw is placed, to ensure it is well positioned in the bone (if it is not, the screw may be removed and/or repositioned). The NeuroVision System has a novel feature called "Dynamic Screw Test" that allows for that monitoring to be performed as the screw is placed, rather than after the fact. This study is being done to determine if this real-time monitoring of screw placement provides beneficial additional information to the operating surgeon to prevent misplacement of screws before it happens.
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivities/specificities of NeuroVision Basic and Dynamic Screw Test monitoring modalities to predict (1) pedicle breach and (2) neural injury | 6 weeks postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| The change in subject self-reported pain ratings (Visual Analog Scales, leg and back pain) from the preoperative period through postoperative follow-up. | 6 weeks postoperative | |
| Intraoperative time (in minutes) taken to place Basic vs Dynamically tested screws. |
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Inclusion Criteria:
Exclusion Criteria:
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Surgical candidates for posterior instrumented lumbar fusion surgery
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States | ||
| Northwest Orthopaedic Specialists, PS |
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| Intraoperative |
| Intraoperative fluoroscopy (in minutes) used to place Basic vs Dynamically tested screws. | Intraoperative |
| Spokane |
| Washington |
| 99208 |
| United States |
| Aurora BayCare Medical Center | Green Bay | Wisconsin | 54308 | United States |