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

NCT ID: NCT03209752

Last Updated: 2018-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Idiopathic Scoliosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Demeure Orthopédie

UNKNOWN

Sponsor Role collaborator

Anatoscope

UNKNOWN

Sponsor Role collaborator

Clinical Investigation Centre for Innovative Technology Network

NETWORK

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Courvoisier Aurélien, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pediatric Orthopedic department, University GrenobleHospital

Locations

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Pediatric Orthopedic Department, University Hospital, Grenoble

Grenoble, , France

Site Status

Countries

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France

Related Links

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http://www.cic-it.fr/cic-it-grenoble.php

Clinical Investigation Centre for Innovative Technology Network website

Other Identifiers

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DCIC15-01

Identifier Type: -

Identifier Source: org_study_id

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