Not Yet RecruitingNot Applicable

Intraoperative Alignment in Adult Spinal Deformity Surgery

United States40 participantsStarted 2026-02-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Skeletally mature patients
. Able to give informed consent
. Sagittal Spinal Deformity patients as defined by any of the following radiographic criteria:
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Pelvic incidence (PI)

Timeframe: Pre-operative, 6 weeks post-operative

Change in Pelvic incidence (PI)

Timeframe: Pre-operative, 3 months post-operative

Change in Pelvic incidence (PI)

Timeframe: Pre-operative, 6 months post-operative

Change in Lumbar lordosis (LL)

Timeframe: Pre-operative, Intra-operative (up to 1 hour)

Change in PI-LL mismatch

Timeframe: Pre-operative, Intra-operative (up to 1 hour)

Change in sagittal Vertical Axis (SVA)

Timeframe: Pre-operative, Intra-operative (up to 1 hour)

Change in T1-Pelvic Angle (TPA)

Timeframe: Pre-operative, Intra-operative (up to 1 hour)

Trial details

NCT IDNCT07416565

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-02-09

Contact for this trial

Themistocles Protopsaltis, MD

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

View on ClinicalTrials.gov More Spinal Deformity trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Skeletally mature patients
. Able to give informed consent
. Sagittal Spinal Deformity patients as defined by any of the following radiographic criteria:
. 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

What they're measuring

Change in Pelvic incidence (PI)

Timeframe: Pre-operative, 6 weeks post-operative

Change in Pelvic incidence (PI)

Timeframe: Pre-operative, 3 months post-operative

Change in Pelvic incidence (PI)

Timeframe: Pre-operative, 6 months post-operative

Change in Lumbar lordosis (LL)

Timeframe: Pre-operative, Intra-operative (up to 1 hour)

Change in PI-LL mismatch

Timeframe: Pre-operative, Intra-operative (up to 1 hour)

Change in sagittal Vertical Axis (SVA)

Timeframe: Pre-operative, Intra-operative (up to 1 hour)

Change in T1-Pelvic Angle (TPA)

Timeframe: Pre-operative, Intra-operative (up to 1 hour)