Comprehensive Spinal Alignment Planning Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Multicenter Study Evaluating the Clinical and Radiographic Outcomes of Thoracolumbar Spine Surgery When Comprehensive Sagittal Alignment Surgical Planning is Used

Conditions
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Spine Surgery

Intervention / Treatment
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* Device: NuvaMap O.R.
* Device: NuvaMap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients who are at least 18 years of age; Patients with planned thoracolumbar (any number of levels between T1 and the pelvis) spine fusion surgery and available preoperative standing lateral radiographs, inclusive of the femoral head axis; Able to undergo surgery based on physical exam, medical history and surgeon judgment; Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the evaluation. Exclusion Criteria: Patient has a mental or physical condition that would limit the ability to comply with study requirements; Patient is a prisoner; Patient is participating in another clinical study that would confound study data.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NuvaMap and NuvaMap OR in Thoracolumbar Spinal Fusion<br> | Device: NuvaMap O.R.<br>* Clinical imaging software used to assess intraoperative spinal alignment<br>Device: NuvaMap<br>* Clinical imaging software used to assess spinal alignment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spine Surgery Patients