- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03418987
The Vertebral Vector in a Horizontal Plane. A Simple Way to See in 3D.
The diagnosis and classification of scoliosis are almost exclusively based on frontal and lateral radiographs. Current classifications of adolescent or adult idiopathic degenerative scoliosis are based only on the 2D approach. The classifications consider only the lateral deviation and the sagittal alignment and completely ignore all the changes (the axial vertebral rotation and the lateral translation etc ...) in the horizontal plane.
The demand for an accurate assessment of the vertebral rotation in scoliosis is not new. Biplane x-ray images provide insufficient quantitative or qualitative information on the anatomical landmarks needed to determine axial rotation. Several measurement methods have been published, all of which are based on the evaluation of the relative positions of various posterior vertebral elements. The Perdriolle torsiometer is currently the most accepted method in clinical practice, but its reproducibility is very limited and can not be quantified accurately.The horizontal plane deviations are more accurately evaluated by the CT scan, but the systematic use of this method is limited because of its relatively high cost and excessive radiation dose. Expert opinion is also divided on the veracity and reproducibility of CT scan for such measurements.
Given the absence of a definitive and reproducible measurement method for 3D characterization of the vertebral columnar deformities, the investigators introduced the concept and system of vertebral vectors.The vertebral vector technique is currently the only technique in the world that allows the visualization of vertebral column deformities by analyzing each vertebral body and defining characteristic mathematical and geometric parameters that uniquely characterize each vertebrae. A new digital radioimaging technique based on a low dose X-ray detection technology simultaneously creates frontal and lateral whole body radiographic images captured in a standing position, which is the basis of visualization of the vertebral vector.
To examine the two phenotypes of scoliosis, it is necessary to collect the radiological data specific to the disease. After generating the vertebral vectors and obtaining the three-dimensional coordinates, an analysis and an exact mathematical description will be performed. The projections of the curves in the three planes will also be analyzed, with particular attention to the projections in the horizontal planes. Based on the mathematical models and the axial projection of the curves, a new three-dimensional classification can be imagined for the first time not only for adolescent scoliosis, but also for adult degenerative scoliosis.
The main objective of this study is to develop new evidence-based treatments based on the unambiguous understanding of 3D features of vertebral columnar deformities.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Brussels, Belgium, 1020
- CHU Brugmann
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients with adolescent idiopathic scoliosis or adult degenerative scoliosis, treated or untreated, radiographed with the EOS system
Exclusion Criteria:
None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Deformities of the spinal column
Patients with adolescent idiopathic scoliosis or adult degenerative scoliosis, treated or untreated.
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Analysis of the 2D/3D spine images (performed with the sterEOS software and the MATLAB software)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
x coordinate of the centroid pedicle
Time Frame: 5 years
|
Precise spatial localisation of the centroid pedicle, computed with the sterEOS and MATLAB softwares.
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5 years
|
|
y coordinate of the centroid pedicle
Time Frame: 5 years
|
Precise spatial localisation of the centroid pedicle, computed with the sterEOS and MATLAB softwares.
|
5 years
|
|
z coordinate of the centroid pedicle
Time Frame: 5 years
|
Precise spatial localisation of the centroid pedicle, computed with the sterEOS and MATLAB softwares.
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5 years
|
|
Coordinate of the 'A' point of the vector
Time Frame: 5 years
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Spatial coordinate of the initial point of the vector, computed with the sterEOS and MATLAB softwares.
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5 years
|
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Coordinate of the 'B' point of the vector
Time Frame: 5 years
|
Spatial coordinate of the terminal point of the vector, computed with the sterEOS and MATLAB softwares.
|
5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tamas ILLES, MD, CHU Brugmann
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUB - 3D spine
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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