Intraoperative Alignment in Adult Spinal Deformity Surgery
ConditionSpinal Deformity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Skeletally mature patients
Able to give informed consent
Coronal cobb angle >20 degrees
Pelvic Tilt >25degrees
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
ATEC IntraOperative Alignment (IOA) Imaging Platform
Diagnostic testThe 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 imaging
Diagnostic testSpecialized 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 radiographs
Diagnostic testEOS radiographs are a low-dose, weight-bearing 3D imaging technology designed for full-body, orthopedic assessment while the patient is standing or sitting.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Spinal DeformityExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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°.
Time frame
Pre-operative, 6 weeks post-operative2
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°.
Time frame
Pre-operative, 3 months post-operative3
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°.
Time frame
Pre-operative, 6 months post-operative4
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°
Time frame
Pre-operative, Intra-operative (up to 1 hour)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: