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 |
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, 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.
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
sites
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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