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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
40
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.
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.
NYU Langone Health
New York, New York, United States
Change in Pelvic incidence (PI)
Pelvic incidence (PI) is a fixed anatomical parameter measuring the sagittal orientation of the sacrum relative to the hip joints (femoral heads), calculated as the angle between a line perpendicular to the midpoint of the sacral plate and a line connecting that midpoint to the axis of the femoral heads. The average PI angle in adults is generally between 40° and 55°.
Time frame: Pre-operative, 6 weeks post-operative
Change in Pelvic incidence (PI)
Pelvic incidence (PI) is a fixed anatomical parameter measuring the sagittal orientation of the sacrum relative to the hip joints (femoral heads), calculated as the angle between a line perpendicular to the midpoint of the sacral plate and a line connecting that midpoint to the axis of the femoral heads. The average PI angle in adults is generally between 40° and 55°.
Time frame: Pre-operative, 3 months post-operative
Change in Pelvic incidence (PI)
Pelvic incidence (PI) is a fixed anatomical parameter measuring the sagittal orientation of the sacrum relative to the hip joints (femoral heads), calculated as the angle between a line perpendicular to the midpoint of the sacral plate and a line connecting that midpoint to the axis of the femoral heads. The average PI angle in adults is generally between 40° and 55°.
Time frame: Pre-operative, 6 months post-operative
Change in Lumbar lordosis (LL)
Lumbar lordosis (LL) measures the degree of inward, anteriorly convex curvature of the lower spine, usually quantified as an angle on lateral radiographs or imaging, often ranging between 30° and 80°
Time frame: Pre-operative, Intra-operative (up to 1 hour)
Change in PI-LL mismatch
Pelvic incidence-lumbar lordosis (PI-LL) mismatch measures the difference between a fixed pelvic parameter (PI) and the functional lumbar curve (LL). A mismatch \>10 degrees (specifically PI minus LL) signifies sagittal malalignment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
EOS radiographs are a low-dose, weight-bearing 3D imaging technology designed for full-body, orthopedic assessment while the patient is standing or sitting.
Time frame: Pre-operative, Intra-operative (up to 1 hour)
Change in sagittal Vertical Axis (SVA)
Distance from the C7 plumb line to the posterior-superior corner of S1; optimal is \< 5 cm.
Time frame: Pre-operative, Intra-operative (up to 1 hour)
Change in T1-Pelvic Angle (TPA)
Angle between the center of the T1 vertebral body, the femoral heads, and the sacral endplate, representing both SVA and pelvic tilt.
Time frame: Pre-operative, Intra-operative (up to 1 hour)
Change in T10-pelivc angle (PA)
The angle between the center of the T10 vertebra, the hip center, and the midpoint of the S1 upper endplate.
Time frame: Pre-operative, Intra-operative (up to 1 hour)
Change in L1-pelivc angle (PA)
The angle between a line from the L1 vertebra center to the femoral head axis, and a line from the S1 superior endplate to the femoral head axis.
Time frame: Pre-operative, Intra-operative (up to 1 hour)
Intraclass correlation coefficient (ICC)
ICCs will be used to assess for consistency and reproducibility of the radiographic measurements made by the various observers. ICCs will be assessed using the following ranges: excellent (0.75-1.0), good (0.60-0.74), fair (0.40-0.59), and poor (\< 0.40).
Time frame: End of study (up to 24 months)