Intraoperative Alignment in Adult Spinal Deformity Surgery

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Spinal Deformity
• Intervention / Treatment: Diagnostic test: ATEC IntraOperative Alignment (IOA) Imaging Platform; Diagnostic test: Standard 36" cassette imaging; Diagnostic test: EOS radiographs

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Themistocles Protopsaltis, MD; Phone Number: 646-501-7200; Email: Themistocles.Protopsaltis@nyulangone.org
• Study Contact Backup: Name: Korine Pagulayan; Phone Number: 646-794-8643; Email: Korine.Pagulayan@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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. Active infection
4. Presence of inflammatory spinal disease (e.g. ankylosing spondylitis, Diffuse Idiopathic Skeletal Hyperostosis (DISH), Rheumatoid Arthritis)
5. Concurrent Spinal or pelvic fracture
6. Vulnerable patient (pregnant, prisoner, inability to consent)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Spinal Deformity; 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; 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; Diagnostic test: Standard 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 test: EOS 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Themistocles Protopsaltis, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): February 9, 2026
• Primary Completion (Estimated): February 9, 2029
• Study Completion (Estimated): August 9, 2029

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Spinal; Spinal Fusion
• Other Study ID Numbers: 25-00419

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only statistical aggregate data of de-identified collected data will be available. The investigator who proposed to use the data will be granted access to this data upon reasonable request. Requests should be directed to Themistocles.Protopsaltis@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes