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Completed

NCT Number: NCT03209752

Prediction of 3D Effect of Brace in Idiopathic Scoliosis Treatment Using EOS Imaging System and "Anatomic Transfer".

In this study, the accuracy of a new numerical method is evaluated for predicting the 3D effect of brace on idiopathic scoliosis. This method results from the combination of several innovative technologies: the EOS imaging system and the anatomical transfer developed by Anatoscope. This is an essential step in validating a digital tool that can be used in routine clinical practice.

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Key information

Conditions

Idiopathic Scoliosis

Age range

9 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pediatric Orthopedic Department, University Hospital, Grenoble

Grenoble, 38043, France

About this study

The whole process of brace production remains unchanged. In this study, the simulation software will not be used to influence the medical decision or the manufacture of the brace. In parallel with conventional production, anatomical transfer will be used in the deformed digital model of the trunk to simulate the effect of conventional brace on the spine. This modeling will be used to compare the correction of the conventional brace observed on the spine with EOS imaging system, with that simulated by the software.

EOS Tranfert study is a observationnal, prospective, monocentric, unrandomized and controlled study. This research doesn't modify care of the patient

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients aged 9 to 15 years;
  • with idiopathic scoliosis (left lumbar and / or right chest);
  • with moderate scoliosis: Cobb angle evaluated between 15 ° and 35 °;
  • requiring brace placement or renewal;
  • having signed a non-objection form
  • affiliated with, or receiving, social security

Exclusion criteria

  • patient/parents who refuse to sign a non-objectiont form
  • with unstable medical condition
  • person deprived of liberty by judicial or administrative decision
  • person under legal protection or unable to express their consent
  • person hospitalized for psychiatric care

Treatment and study plan

Primary outcomes

  1. Evaluation of the accuracy of the brace effect by the new anatomical transfer method in the frontal plane.

    Time frame: 12 month

    Difference measurement in degrees between the digital Cobb angle after simulation and the actual Cobb angle under brace after EOS radiography.

Secondary outcomes

  1. Evaluation of the accuracy of the brace effect by the new anatomical transfer method on the spinal axial rotation.

    Time frame: 12 month

    Difference measurement in degrees between apical axial vertebral rotation angle (AVR) after simulation and the actual AVR under brace after EOS radiography.

  2. Evaluation of the accuracy of brace effect by the new anatomical transfer method on the torsion index.

    Time frame: 12 month

    Difference measurement in degrees between the numerical torsion index after simulation and the actual torsion index under brace after EOS radiography.

  3. Evaluation of the accuracy of the brace effect by the new anatomical transfer method in the sagittal plane

    Time frame: 12 month

    Difference measurement in degrees between kyphosis angle, digital lordosis after simulation and kyphosis angle, real lordosis under brace after EOS radiography.

  4. Evaluation of the accuracy of ribs position of the patient under 3D digital model of brace with respect to the actual position under brace

    Time frame: 12 month

    Point-to-point distance between the average rib line after simulation and under brace after EOS radiography

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Anatoscope
  • Clinical Investigation Centre for Innovative Technology Network
  • Demeure Orthopédie

Registry information

Official study title

Prediction of 3D Effect of Brace in Adolescent and Children Idiopathic Scoliosis Treatment Using EOS Imaging System and "Anatomic Transfer".

Acronym: EOSTransfert

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 6, 2017
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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