NYU Langone Health
New York, 10016, United States
NCT Number: NCT07416565
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
New York, 10016, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: IntraOp Alignment System
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.
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, 6 weeks post-operative
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
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
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, Intra-operative (up to 1 hour)
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)
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.
Time frame: Pre-operative, Intra-operative (up to 1 hour)
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)
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)
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)
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: End of study (up to 24 months)
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).
Contact information is provided by the study sponsor or research team.
Korine Pagulayan
CONTACT
Themistocles Protopsaltis, MD
CONTACT
NYU Langone Health
Other
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.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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