Comprehensive Spinal Alignment Planning Study



Status:Active, not recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:12/13/2018
Start Date:November 2015
End Date:October 2020

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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

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.

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.
We found this trial at
15
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280 South Main Street
Orange, California 92868
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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875 Ellicott Street
Amherst, New York 14226
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Augusta, GA
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225 Baldwin Avenue
Charlotte, North Carolina 28204
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Charlotte, NC
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Durango, Colorado 81301
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611 Northern Boulevard
Great Neck, New York 11021
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La Jolla, California 92037
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Morris, Illinois 60450
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Naperville, Illinois 60540
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Roanoke, Virginia 24013
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8010 Frost Street
San Diego, California 92123
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Tampa, FL
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Wayne, New Jersey 07470
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Wayne, NJ
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