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

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status

Completed

Conditions

Idiopathic Scoliosis

Study type

Observational

Funder types

Other
NETWORK

Identifiers

NCT03209752
DCIC15-01

Details and patient eligibility

About

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.

Full description

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

Enrollment

31 patients

Sex

All

Ages

9 to 15 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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