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 range18 Years

SexALL

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
✕. 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)

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)

Change in T10-pelivc angle (PA)

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 range18 Years

SexALL

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
✕. 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)

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)

Change in T10-pelivc angle (PA)

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