Intraoperative Alignment in Adult Spinal Deformity Surgery
This study is looking at a new imaging tool called the ATEC IntraOperative Alignment (IOA) Imaging Platform. It's designed to help doctors see and measure spinal alignment during surgery for adults with spinal deformity (when the spine has an abnormal curve). The study will compare how well the ATEC IOA Imaging Platform works compared to standard 36-inch X-rays during surgery. It will also compare how the spine looks during surgery versus after surgery. You may be able to join if you are an adult with a spinal deformity and meet specific X-ray criteria. The study aims to see if the ATEC IOA system can accurately measure changes in your pelvic incidence (a measurement of your pelvis's tilt) before and after surgery, up to 6 months later. The current status of this study is unclear.
- Study design
- This is an interventional study planning to enroll 40 participants. It compares the ATEC IntraOperative Alignment (IOA) Imaging Platform to standard 36" cassette imaging and EOS radiographs.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for changes in Pelvic incidence (PI) at 6 weeks, 3 months, and 6 months after surgery.
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Intraoperative Alignment in Adult Spinal Deformity Surgery
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Themistocles Protopsaltis, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Change in Pelvic incidence (PI)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)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)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)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 mismatchPre-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)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)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)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)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)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).