Intraoperative Alignment in Adult Spinal Deformity Surgery

NCT07416565 | Not Yet Recruiting FDA Device

• 1 other identifier: 25-00419
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Deformity

Keywords

Spinal; Spinal Fusion

Outcome Measures

Primary Outcomes (10)

• 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°.

  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°.

  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°.

  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°

  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.

  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.

  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.

  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.

  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.

  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).

  End of study (up to 24 months)

Study Arms (1)

Spinal Deformity

EXPERIMENTAL

Patients will receive preoperative standing electronic optical scan (EOS) radiographs, and first-erect postoperative standing EOS radiographs. Intraoperatively, patients will receive standard 36" cassette imaging as well as imaging with the ATEC IOA Imaging Platform.

Diagnostic Test: ATEC IntraOperative Alignment (IOA) Imaging Platform; Diagnostic Test: Standard 36" cassette imaging; Diagnostic Test: EOS radiographs

Interventions

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.

Spinal Deformity

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.

Spinal Deformity

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.

Also known as: IntraOp Alignment System

Spinal Deformity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Study Officials

• Themistocles Protopsaltis, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Themistocles Protopsaltis, MD

CONTACT

646-501-7200; Themistocles.Protopsaltis@nyulangone.org

Korine Pagulayan

CONTACT

646-794-8643; Korine.Pagulayan@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 18, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): February 9, 2029
• Study Completion (Estimated): August 9, 2029
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)