Comprehensive Spinal Alignment Planning Study
- Conditions
- Spine Surgery
- Interventions
- Device: NuvaMap O.R.Device: NuvaMap
- Registration Number
- NCT02606695
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 306
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description NuvaMap and NuvaMap OR in Thoracolumbar Spinal Fusion NuvaMap O.R. - NuvaMap and NuvaMap OR in Thoracolumbar Spinal Fusion NuvaMap -
- Primary Outcome Measures
Name Time Method Evaluate the utility of alignment planning using surgical planning software 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Augusta Orthopedic & Sports Medicine Specialists
🇺🇸Augusta, Georgia, United States
Neurosurgical Medical Clinic, Inc.
🇺🇸San Diego, California, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Rezin Orthopedics and Sports Medicine
🇺🇸Morris, Illinois, United States
University Spine Center
🇺🇸Wayne, New Jersey, United States
Orthopaedic Specialty Institute (OSI)
🇺🇸Orange, California, United States
Spine Colorado
🇺🇸Durango, Colorado, United States
Carolina Neurosurgery & Spine Associates (CNSA)
🇺🇸Charlotte, North Carolina, United States
Carilion Clinic (Roanoke)
🇺🇸Roanoke, Virginia, United States
Jacobs Institute/UB Neurosurgery, Inc.,
🇺🇸Amherst, New York, United States
Spine Center at Great Neck
🇺🇸Great Neck, New York, United States
Duke University
🇺🇸Durham, North Carolina, United States
Dupage Medical Group Spine Institute
🇺🇸Naperville, Illinois, United States
Scripps Clinic Medical Group
🇺🇸La Jolla, California, United States
Foundation for Orthopaedic Research and Education
🇺🇸Tampa, Florida, United States