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A comprehensive approach to the evaluation of alignment in spinal surgery patients - through preoperative planning, intraoperative assessment, and postoperative confirmation - has not been well-studied. This study aims to assess the value of such planning through clinical and radiographic outcomes.
Preoperative planning using tools such as NuvaMapTM (NuVasive®, Inc., San Diego, CA) enable a surgeon to preoperatively evaluate these alignment parameters and simulate a patient-specific plan using a combination of procedures, techniques, and implants. Once in the operating room, realignment objectives can be verified from a lateral fluoroscopic image in real-time using NuvaMap O.R. (NuVasive, Inc.), a software application integrated with the NVM5® neuromonitoring platform (NuVasive, Inc.). This real-time verification allows for confirmation and subsequent changing of the plan as necessary. The objective of this study is to validate the utility and effectiveness of comprehensive surgical planning in restoring and preserving sagittal alignment through the collection of clinical and radiographic outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NuvaMap and NuvaMap OR in Thoracolumbar Spinal Fusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NuvaMap O.R. | Device | Clinical imaging software used to assess intraoperative spinal alignment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the utility of alignment planning using surgical planning software | The incidence of a change in plan (pre- or intraoperative) based on alignment measurement feedback, and the consequential achievement of postoperative (at 3 months) alignment relative to planned goals. | Postoperative (3 months) |
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Inclusion Criteria:
Exclusion Criteria:
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At least 300 patients will be enrolled in this multicenter observational study. The following eligibility criteria are designed to identify existing clinic patients for whom study under this protocol are considered appropriate. All subjects must meet the inclusion/exclusion criteria below in order to be considered for enrollment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinic Medical Group | La Jolla | California | 92037 | United States | ||
| Orthopaedic Specialty Institute (OSI) |
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| Label | URL |
|---|---|
| Related Info | View source |
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| NuvaMap | Device | Clinical imaging software used to assess spinal alignment |
|
| Orange |
| California |
| 92868 |
| United States |
| Neurosurgical Medical Clinic, Inc. | San Diego | California | 92123 | United States |
| Spine Colorado | Durango | Colorado | 81301 | United States |
| Foundation for Orthopaedic Research and Education | Tampa | Florida | 33637 | United States |
| Augusta Orthopedic & Sports Medicine Specialists | Augusta | Georgia | 30909 | United States |
| Rezin Orthopedics and Sports Medicine | Morris | Illinois | 60450 | United States |
| Dupage Medical Group Spine Institute | Naperville | Illinois | 60540 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| University Spine Center | Wayne | New Jersey | 07470 | United States |
| Jacobs Institute/UB Neurosurgery, Inc., | Amherst | New York | 14226 | United States |
| Spine Center at Great Neck | Great Neck | New York | 11021 | United States |
| Carolina Neurosurgery & Spine Associates (CNSA) | Charlotte | North Carolina | 28204 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Carilion Clinic (Roanoke) | Roanoke | Virginia | 24013 | United States |