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The Vertebral Vector in a Horizontal Plane. A Simple Way to See in 3D.

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ClinicalTrials.gov Identifier: NCT03418987
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Tamas Illes, Brugmann University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment
Scoliosis Other: Medical File data analysis

Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Vertebral Vector in a Horizontal Plane. A Simple Way to See in 3D.
Actual Study Start Date : March 20, 2018
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Group/Cohort Intervention/treatment
Deformities of the spinal column
Patients with adolescent idiopathic scoliosis or adult degenerative scoliosis, treated or untreated.
Other: Medical File data analysis
Analysis of the 2D/3D spine images (performed with the sterEOS software and the MATLAB software)




Primary Outcome Measures :
  1. x coordinate of the centroid pedicle [ Time Frame: 5 years ]
    Precise spatial localisation of the centroid pedicle, computed with the sterEOS and MATLAB softwares.

  2. y coordinate of the centroid pedicle [ Time Frame: 5 years ]
    Precise spatial localisation of the centroid pedicle, computed with the sterEOS and MATLAB softwares.

  3. z coordinate of the centroid pedicle [ Time Frame: 5 years ]
    Precise spatial localisation of the centroid pedicle, computed with the sterEOS and MATLAB softwares.

  4. Coordinate of the 'A' point of the vector [ Time Frame: 5 years ]
    Spatial coordinate of the initial point of the vector, computed with the sterEOS and MATLAB softwares.

  5. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with adolescent idiopathic scoliosis or adult degenerative scoliosis, treated or untreated, radiographed with the EOS system
Criteria

Inclusion Criteria:

Patients with adolescent idiopathic scoliosis or adult degenerative scoliosis, treated or untreated, radiographed with the EOS system

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418987


Contacts
Contact: Tamas ILLES, MD 3224773080 Tamas.ILLES@chu-brugmann.be

Locations
Belgium
CHU Brugmann Recruiting
Brussels, Belgium, 1020
Contact: Tamas Illes, MD    3224773080    Tamas.ILLES@chu-brugmann.be   
Principal Investigator: Tamas Illes, MD         
Sponsors and Collaborators
Tamas Illes
Investigators
Principal Investigator: Tamas ILLES, MD CHU Brugmann

Responsible Party: Tamas Illes, Head of clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT03418987     History of Changes
Other Study ID Numbers: CHUB - 3D spine
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tamas Illes, Brugmann University Hospital:
3D imaging
vertebral vector
Scoliosis

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases