ClinicalTrials.gg
CompletedNCT03418987Updated Feb 6, 2025

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

An observational study in Scoliosis, sponsored by Tamas Illes. Completed at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2025-02-06.

Sponsored by Tamas Illes · Observational

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,500
Sex
All
01

Study 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.

02

Conditions studied

  • Scoliosis

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Keywords

  • 3D imaging
  • vertebral vector
  • Scoliosis
03

In context

Scoliosis

660 studies on the registry are indexed under Scoliosis; 186 are open to participants now.

This study's enrollment of 1,500 is above the median of 84 across 256 observational studies indexed under Scoliosis.

Browse Scoliosis studies →

Lead sponsor

Tamas Illes is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

None

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,500 participants (actual)
Patient registry
No

Groups and cohorts

  • Deformities of the spinal column

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

    Other: Medical File data analysis

Interventions

  • OtherMedical File data analysis

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

06

What researchers measure

Primary outcomes

  1. x coordinate of the centroid pedicle

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

    Time frame: 5 years

  2. y coordinate of the centroid pedicle

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

    Time frame: 5 years

  3. z coordinate of the centroid pedicle

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

    Time frame: 5 years

  4. Coordinate of the 'A' point of the vector

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

    Time frame: 5 years

  5. Coordinate of the 'B' point of the vector

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

    Time frame: 5 years

07

Study locations

1 site
  • CHU Brugmann
    Brussels, 1020, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2018 to primary completion in Nov 2024, 79 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2018
First posted
Feb 1, 2018
StartActual
Mar 20, 2018
Primary completionActual
Nov 12, 2024
CompletionActual
Nov 12, 2024
Last update
Feb 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03418987
Lead sponsor
Tamas Illes
Responsible party
Tamas Illes (Head of clinic, Brugmann University Hospital) — Sponsor-investigator
First posted
Feb 1, 2018
Start date
Mar 20, 2018
Primary completion
Nov 12, 2024
Completion
Nov 12, 2024
Last update
Feb 6, 2025

Study contacts

Tamas ILLES, MD
principal investigator · CHU Brugmann

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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