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Not yet recruiting NCT07416565

Intraoperative Alignment in Adult Spinal Deformity Surgery

No phase Interventional Spinal Deformity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ATEC IntraOperative Alignment (IOA) Imaging Platform, Standard 36" cassette imaging, EOS radiographs.
Who it may be relevant to
Registry conditions: Spinal Deformity. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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.

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Change in Pelvic incidence (PI) [Time frame: Pre-operative, 6 weeks post-operative]
  • Change in Pelvic incidence (PI) [Time frame: Pre-operative, 3 months post-operative]
  • Change in Pelvic incidence (PI) [Time frame: Pre-operative, 6 months post-operative]
  • Change in Lumbar lordosis (LL) [Time frame: Pre-operative, Intra-operative (up to 1 hour)]
  • Change in PI-LL mismatch [Time frame: Pre-operative, Intra-operative (up to 1 hour)]
  • Change in sagittal Vertical Axis (SVA) [Time frame: Pre-operative, Intra-operative (up to 1 hour)]
  • Change in T1-Pelvic Angle (TPA) [Time frame: Pre-operative, Intra-operative (up to 1 hour)]
  • Change in T10-pelivc angle (PA) [Time frame: Pre-operative, Intra-operative (up to 1 hour)]
  • Change in L1-pelivc angle (PA) [Time frame: Pre-operative, Intra-operative (up to 1 hour)]
  • Intraclass correlation coefficient (ICC) [Time frame: End of study (up to 24 months)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT07416565 · 25-00419

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗