Comprehensive Spinal Alignment Planning Study

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

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.

Study Overview

• Status: Completed
• Conditions: Spine Surgery
• Intervention / Treatment: Device: NuvaMap O.R.; Device: NuvaMap

Detailed Description

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 (Actual): 306

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Scripps Clinic Medical Group
    • Orange, California, United States, 92868
      • Orthopaedic Specialty Institute (OSI)
    • San Diego, California, United States, 92123
      • Neurosurgical Medical Clinic, Inc.
  • Colorado
    • Durango, Colorado, United States, 81301
      • Spine Colorado
  • Florida
    • Tampa, Florida, United States, 33637
      • Foundation for Orthopaedic Research and Education
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Augusta Orthopedic & Sports Medicine Specialists
  • Illinois
    • Morris, Illinois, United States, 60450
      • Rezin Orthopedics and Sports Medicine
    • Naperville, Illinois, United States, 60540
      • Dupage Medical Group Spine Institute
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • New Jersey
    • Wayne, New Jersey, United States, 07470
      • University Spine Center
  • New York
    • Amherst, New York, United States, 14226
      • Jacobs Institute/UB Neurosurgery, Inc.,
    • Great Neck, New York, United States, 11021
      • Spine Center at Great Neck
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolina Neurosurgery & Spine Associates (CNSA)
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Virginia
    • Roanoke, Virginia, United States, 24013
      • Carilion Clinic (Roanoke)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NuvaMap and NuvaMap OR in Thoracolumbar Spinal Fusion	Device: NuvaMap O.R.; Clinical imaging software used to assess intraoperative spinal alignment; Device: NuvaMap; Clinical imaging software used to assess spinal alignment

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: NuVasive

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: November 5, 2015
• First Submitted That Met QC Criteria: November 13, 2015
• First Posted (Estimate): November 17, 2015

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 16, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Spine Surgery Patients
• Other Study ID Numbers: NUVA.IGA1503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No