A Prospective, Single-center Study of the Utility of the ATEC IOA Imaging Platform Tool in Intraoperative Imaging for Patients Undergoing Adult Spinal Deformity Surgery.
NYU Langone Health
Summary
The purpose of this study is to conduct a prospective study which assesses the utility of the ATEC Intraoperative Alignment (IOA) Imaging Platform tool in intraoperative imaging for patients undergoing adult spinal deformity surgery. The study aims to compare the precision of the ATEC IOA Imaging Platform to current standard 36" cassette intraoperative x-rays, as well as compare intraoperative versus postoperative standing alignment.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Skeletally mature patients 2. Able to give informed consent 3. Sagittal Spinal Deformity patients as defined by any of the following radiographic criteria: * Coronal cobb angle \>20 degrees * Pelvic Tilt \>25degrees * Sagittal Vertical Axis \>50mm * Pelvic Incidence - Lordosis of \>10 degrees * Thoracic Kyphosis \>60 degrees 4. Or clinically indicated for spinal fusion T10-Pelvis or more levels fused 5. Or adult degenerative pathology requiring 2 or more levels fused Exclusion Criteria: 1. Under the age of 18 years old 2. Skeletally immature patients 3…
Interventions
- Diagnostic TestATEC IntraOperative Alignment (IOA) Imaging Platform
The IntraOp Alignment System is intended for use in applications where a mobile C-arm fluoroscope is incorporated to aid in diagnosis and treatment during spinal surgery. It is intended to assist healthcare professionals in viewing, storing and measuring spinal alignment assessment images at various time points during surgery as well as planning spinal surgical procedures.
- Diagnostic TestStandard 36" cassette imaging
Specialized radiographic technique using a single, long X-ray cassette-either traditional film or a computed radiography (CR) imaging plate-to capture a large area of the body in one exposure.
- Diagnostic TestEOS radiographs
EOS radiographs are a low-dose, weight-bearing 3D imaging technology designed for full-body, orthopedic assessment while the patient is standing or sitting.
Location
- NYU Langone HealthNew York, New York