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
1 other identifier
observational
306
1 country
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2016
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2015
CompletedFirst Posted
Study publicly available on registry
November 17, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedDecember 22, 2025
December 1, 2025
4.8 years
November 5, 2015
December 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (1)
NuvaMap and NuvaMap OR in Thoracolumbar Spinal Fusion
Interventions
Clinical imaging software used to assess intraoperative spinal alignment
Clinical imaging software used to assess spinal alignment
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NuVasivelead
Study Sites (15)
Scripps Clinic Medical Group
La Jolla, California, 92037, United States
Orthopaedic Specialty Institute (OSI)
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
Related Links
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2015
First Posted
November 17, 2015
Study Start
March 1, 2016
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
December 22, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share