Comprehensive Spinal Alignment Planning Study

NuVasive306 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

306

Conditions

Spine Surgery

Interventions

NuvaMap O.R.DEVICE

Clinical imaging software used to assess intraoperative spinal alignment

NuvaMapDEVICE

Clinical imaging software used to assess spinal alignment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male and female patients who are at least 18 years of age; 2. 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; 3. Able to undergo surgery based on physical exam, medical history and surgeon judgment; 4. Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the evaluation. Exclusion Criteria: 1. Patient has a mental or physical condition that would limit the ability to comply with study requirements; 2. Patient is a prisoner; 3. Patient is participating in another clinical study that would confound study data.

Locations (15)

Scripps Clinic Medical Group

La Jolla, California, United States

Orthopaedic Specialty Institute (OSI)

Orange, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Postoperative (3 months)

Data from ClinicalTrials.gov

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