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Comprehensive Spinal Alignment Planning Study

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ClinicalTrials.gov Identifier: NCT02606695
Recruitment Status : Active, not recruiting
First Posted : November 17, 2015
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
NuVasive

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.

Condition or disease
Spine Surgery

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
Actual Enrollment : 306 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Multicenter Study Evaluating the Clinical and Radiographic Outcomes of Thoracolumbar Spine Surgery When Comprehensive Sagittal Alignment Surgical Planning is Used
Study Start Date : November 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020



Primary Outcome Measures :
  1. Evaluate the utility of alignment planning using surgical planning software [ Time Frame: Postoperative (3 months) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02606695


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

Additional Information:
Responsible Party: NuVasive
ClinicalTrials.gov Identifier: NCT02606695     History of Changes
Other Study ID Numbers: NUVA.IGA1503
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Product Manufactured in and Exported from the U.S.: No

Keywords provided by NuVasive:
Spine Surgery Patients