Intraoperative Alignment in Adult Spinal Deformity Surgery

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07416565
Status
Not Yet Recruiting

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Conditions

  • Spinal Deformity

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Feb 9, 2026
Status verified
Feb 2026
Primary completion
Feb 9, 2029
Completion
Aug 9, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • 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.

Primary Outcome Measure

Change in Pelvic incidence (PI) [ Time Frame: Pre-operative, 6 weeks post-operative ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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By research site
NYU Langone Health· New York, NY

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