NCT07416565

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.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2026-02-09
• Primary completion: 2029-02-09
• Completion: 2029-08-09
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study