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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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°. | 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°. | 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°. | 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° | 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. |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Themistocles Protopsaltis, MD | Contact | 646-501-7200 | Themistocles.Protopsaltis@nyulangone.org | |
| Korine Pagulayan | Contact | 646-794-8643 | Korine.Pagulayan@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Themistocles Protopsaltis, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
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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| 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. |
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| 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. |
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| 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. | 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. | 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. | 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. | 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). | End of study (up to 24 months) |