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NCT Number: NCT07416565

Intraoperative Alignment in Adult Spinal Deformity Surgery

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Skeletally mature patients
  • Able to give informed consent
  • 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
  • Or clinically indicated for spinal fusion T10-Pelvis or more levels fused
  • Or adult degenerative pathology requiring 2 or more levels fused

Exclusion criteria

  • Under the age of 18 years old
  • Skeletally immature patients
  • Active infection
  • Presence of inflammatory spinal disease (e.g. ankylosing spondylitis, Diffuse Idiopathic Skeletal Hyperostosis (DISH), Rheumatoid Arthritis)
  • Concurrent Spinal or pelvic fracture
  • Vulnerable patient (pregnant, prisoner, inability to consent)

Treatment and study plan

ATEC IntraOperative Alignment (IOA) Imaging Platform

Diagnostic Test

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

Standard 36" cassette imaging

Diagnostic Test

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

Diagnostic Test

EOS radiographs are a low-dose, weight-bearing 3D imaging technology designed for full-body, orthopedic assessment while the patient is standing or sitting.

Primary outcomes

  1. Change in Pelvic incidence (PI)

    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°.

  2. Change in Pelvic incidence (PI)

    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°.

  3. Change in Pelvic incidence (PI)

    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°.

  4. Change in Lumbar lordosis (LL)

    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°

  5. Change in PI-LL mismatch

    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.

  6. Change in sagittal Vertical Axis (SVA)

    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.

  7. Change in T1-Pelvic Angle (TPA)

    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.

  8. Change in T10-pelivc angle (PA)

    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.

  9. Change in L1-pelivc angle (PA)

    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.

  10. Intraclass correlation coefficient (ICC)

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Korine Pagulayan

CONTACT

[email protected]

646-794-8643

Themistocles Protopsaltis, MD

CONTACT

[email protected]

646-501-7200

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 18, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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