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

NCT03418987 | Completed

• 1 other identifier: CHUB - 3D spine
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis

Keywords

3D imaging; vertebral vector; Scoliosis

Outcome Measures

Primary Outcomes (5)

• x coordinate of the centroid pedicle

  Precise spatial localisation of the centroid pedicle, computed with the sterEOS and MATLAB softwares.

  5 years

• y coordinate of the centroid pedicle

  Precise spatial localisation of the centroid pedicle, computed with the sterEOS and MATLAB softwares.

  5 years

• z coordinate of the centroid pedicle

  Precise spatial localisation of the centroid pedicle, computed with the sterEOS and MATLAB softwares.

  5 years

• Coordinate of the 'A' point of the vector

  Spatial coordinate of the initial point of the vector, computed with the sterEOS and MATLAB softwares.

  5 years

• Coordinate of the 'B' point of the vector

  Spatial coordinate of the terminal point of the vector, computed with the sterEOS and MATLAB softwares.

  5 years

Study Arms (1)

Deformities of the spinal column

Patients with adolescent idiopathic scoliosis or adult degenerative scoliosis, treated or untreated.

Other: Medical File data analysis

Interventions

Medical File data analysis OTHER

Analysis of the 2D/3D spine images (performed with the sterEOS software and the MATLAB software)

Deformities of the spinal column

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Tamas Illes: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Tamas ILLES, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of clinic

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 1, 2018
• Study Start: March 20, 2018
• Primary Completion: November 12, 2024
• Study Completion: November 12, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)