Spinal DeformityNCT07416565
Intraoperative Alignment in Adult Spinal Deformity Surgery
A study testing ATEC IntraOperative Alignment (IOA) Imaging Platform, Standard 36" cassette imaging and EOS radiographs in people with Spinal Deformity, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Deformity
- What is being tested?
- ATEC IntraOperative Alignment (IOA) Imaging Platform, Standard 36" cassette imaging and EOS radiographs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2026to 9 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
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
- Being tested
- ATEC IntraOperative Alignment (IOA) Imaging Platform, Standard 36" cassette imaging, EOS radiographs
- Keywords
- Spinal, Spinal Fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATEC IntraOperative Alignment (IOA) Imaging PlatformDiagnostic test
Also called IntraOp Alignment System
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 imagingDiagnostic 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 radiographsDiagnostic 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 group | Role | What they receive |
|---|---|---|
| Spinal Deformity | Experimental | 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. Receives: Diagnostic Test: ATEC IntraOperative Alignment (IOA) Imaging Platform; Diagnostic Test: Standard 36" cassette imaging; Diagnostic Test: EOS radiographs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pelvic incidence (PI)
Pelvic incidence (PI) is a fixed anatomical parameter measuring the sagittal orientation of the sacrum relative to the hip joints (femoral heads), calculated as the angle between a line perpendicular to the midpoint of the sacral plate and a line connecting that midpoint to the axis of the femoral heads. The average PI angle in adults is generally between 40° and 55°.
Measured: Pre-operative, 6 weeks post-operative
Change in Pelvic incidence (PI)
Pelvic incidence (PI) is a fixed anatomical parameter measuring the sagittal orientation of the sacrum relative to the hip joints (femoral heads), calculated as the angle between a line perpendicular to the midpoint of the sacral plate and a line connecting that midpoint to the axis of the femoral heads. The average PI angle in adults is generally between 40° and 55°.
Measured: Pre-operative, 3 months post-operative
Change in Pelvic incidence (PI)
Pelvic incidence (PI) is a fixed anatomical parameter measuring the sagittal orientation of the sacrum relative to the hip joints (femoral heads), calculated as the angle between a line perpendicular to the midpoint of the sacral plate and a line connecting that midpoint to the axis of the femoral heads. The average PI angle in adults is generally between 40° and 55°.
Measured: Pre-operative, 6 months post-operative
Change in Lumbar lordosis (LL)
Lumbar lordosis (LL) measures the degree of inward, anteriorly convex curvature of the lower spine, usually quantified as an angle on lateral radiographs or imaging, often ranging between 30° and 80°
Measured: Pre-operative, Intra-operative (up to 1 hour)
Change in PI-LL mismatch
Pelvic incidence-lumbar lordosis (PI-LL) mismatch measures the difference between a fixed pelvic parameter (PI) and the functional lumbar curve (LL). A mismatch >10 degrees (specifically PI minus LL) signifies sagittal malalignment.
Measured: Pre-operative, Intra-operative (up to 1 hour)
Change in sagittal Vertical Axis (SVA)
Distance from the C7 plumb line to the posterior-superior corner of S1; optimal is < 5 cm.
Measured: Pre-operative, Intra-operative (up to 1 hour)
Change in T1-Pelvic Angle (TPA)
Angle between the center of the T1 vertebral body, the femoral heads, and the sacral endplate, representing both SVA and pelvic tilt.
Measured: Pre-operative, Intra-operative (up to 1 hour)
Change in T10-pelivc angle (PA)
The angle between the center of the T10 vertebra, the hip center, and the midpoint of the S1 upper endplate.
Measured: Pre-operative, Intra-operative (up to 1 hour)
Change in L1-pelivc angle (PA)
The angle between a line from the L1 vertebra center to the femoral head axis, and a line from the S1 superior endplate to the femoral head axis.
Measured: Pre-operative, Intra-operative (up to 1 hour)
Intraclass correlation coefficient (ICC)
ICCs will be used to assess for consistency and reproducibility of the radiographic measurements made by the various observers. ICCs will be assessed using the following ranges: excellent (0.75-1.0), good (0.60-0.74), fair (0.40-0.59), and poor (< 0.40).
Measured: End of study (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start9 Feb 2026 (estimated)
- Primary completion9 Feb 2029 (estimated)
- Study completion9 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DeformityStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Themistocles Protopsaltis, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416565
- Sponsor's protocol ID
- 25-00419
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Only statistical aggregate data of de-identified collected data will be available. The investigator who proposed to use the data will be granted access to this data upon reasonable request. Requests should be directed to Themistocles.Protopsaltis@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07416565
- Acronym / sponsor ID
- 25-00419
- Conditions
- Spinal Deformity
- Keywords
- Spinal, Spinal Fusion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 9 Feb 2026 (estimated)
- Primary completion
- 9 Feb 2029 (estimated)
- Study completion
- 9 Aug 2029 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Deformity | Experimental | Diagnostic Test: ATEC IntraOperative Alignment (IOA) Imaging Platform, Diagnostic Test: Standard 36" cassette imaging, Diagnostic Test: EOS radiographsPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATEC IntraOperative Alignment (IOA) Imaging PlatformAlso: IntraOp Alignment SystemThe 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 | Spinal Deformity |
| Standard 36" cassette imagingSpecialized 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 | Spinal Deformity |
| EOS radiographsEOS radiographs are a low-dose, weight-bearing 3D imaging technology designed for full-body, orthopedic assessment while the patient is standing or sitting. | Diagnostic test | Spinal Deformity |
Primary outcome
Change in Pelvic incidence (PI)
Time frame: Pre-operative, 6 weeks post-operative
Pelvic incidence (PI) is a fixed anatomical parameter measuring the sagittal orientation of the sacrum relative to the hip joints (femoral heads), calculated as the angle between a line perpendicular to the midpoint of the sacral plate and a line connecting that midpoint to the axis of the femoral heads. The average PI angle in adults is generally between 40° and 55°.
Change in Pelvic incidence (PI)
Time frame: Pre-operative, 3 months post-operative
Pelvic incidence (PI) is a fixed anatomical parameter measuring the sagittal orientation of the sacrum relative to the hip joints (femoral heads), calculated as the angle between a line perpendicular to the midpoint of the sacral plate and a line connecting that midpoint to the axis of the femoral heads. The average PI angle in adults is generally between 40° and 55°.
Change in Pelvic incidence (PI)
Time frame: Pre-operative, 6 months post-operative
Pelvic incidence (PI) is a fixed anatomical parameter measuring the sagittal orientation of the sacrum relative to the hip joints (femoral heads), calculated as the angle between a line perpendicular to the midpoint of the sacral plate and a line connecting that midpoint to the axis of the femoral heads. The average PI angle in adults is generally between 40° and 55°.
Change in Lumbar lordosis (LL)
Time frame: Pre-operative, Intra-operative (up to 1 hour)
Lumbar lordosis (LL) measures the degree of inward, anteriorly convex curvature of the lower spine, usually quantified as an angle on lateral radiographs or imaging, often ranging between 30° and 80°
Change in PI-LL mismatch
Time frame: Pre-operative, Intra-operative (up to 1 hour)
Pelvic incidence-lumbar lordosis (PI-LL) mismatch measures the difference between a fixed pelvic parameter (PI) and the functional lumbar curve (LL). A mismatch >10 degrees (specifically PI minus LL) signifies sagittal malalignment.
Change in sagittal Vertical Axis (SVA)
Time frame: Pre-operative, Intra-operative (up to 1 hour)
Distance from the C7 plumb line to the posterior-superior corner of S1; optimal is < 5 cm.
Change in T1-Pelvic Angle (TPA)
Time frame: Pre-operative, Intra-operative (up to 1 hour)
Angle between the center of the T1 vertebral body, the femoral heads, and the sacral endplate, representing both SVA and pelvic tilt.
Change in T10-pelivc angle (PA)
Time frame: Pre-operative, Intra-operative (up to 1 hour)
The angle between the center of the T10 vertebra, the hip center, and the midpoint of the S1 upper endplate.
Change in L1-pelivc angle (PA)
Time frame: Pre-operative, Intra-operative (up to 1 hour)
The angle between a line from the L1 vertebra center to the femoral head axis, and a line from the S1 superior endplate to the femoral head axis.
Intraclass correlation coefficient (ICC)
Time frame: End of study (up to 24 months)
ICCs will be used to assess for consistency and reproducibility of the radiographic measurements made by the various observers. ICCs will be assessed using the following ranges: excellent (0.75-1.0), good (0.60-0.74), fair (0.40-0.59), and poor (< 0.40).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No. Only statistical aggregate data of de-identified collected data will be available. The investigator who proposed to use the data will be granted access to this data upon reasonable request. Requests should be directed to Themistocles.Protopsaltis@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Themistocles Protopsaltis, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATEC IntraOperative Alignment (IOA) Imaging Platform, Standard 36" cassette imaging and EOS radiographs in people with Spinal Deformity, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Themistocles Protopsaltis, MD (646-501-7200, Themistocles.Protopsaltis@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pelvic incidence (PI) (time frame: Pre-operative, 6 weeks post-operative). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.