Clinical trial NCT03209752: Prediction of 3D Effect of Brace in Idiopathic Scoliosis Treatment Using EOS Imaging System and "Anatomic Transfer".
Official title: Prediction of 3D Effect of Brace in Adolescent and Children Idiopathic Scoliosis Treatment Using EOS Imaging System and "Anatomic Transfer".
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Scoliosis
Keywords: 3D analysis
Brace
EOS imagind system
Anatomical transfer
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Demeure Orthopédie
name: Anatoscope
name: Clinical Investigation Centre for Innovative Technology Network
First posted: 2017-07-06
Enrollment: 31
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children or adolescent idiopathic scoliosis patient

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the accuracy of the brace effect by the new anatomical transfer method in the frontal plane.
timeFrame: 12 month
Secondary outcomes:
measure: Evaluation of the accuracy of the brace effect by the new anatomical transfer method on the spinal axial rotation.
timeFrame: 12 month
measure: Evaluation of the accuracy of brace effect by the new anatomical transfer method on the torsion index.
timeFrame: 12 month
measure: Evaluation of the accuracy of the brace effect by the new anatomical transfer method in the sagittal plane
timeFrame: 12 month
measure: Evaluation of the accuracy of ribs position of the patient under 3D digital model of brace with respect to the actual position under brace
timeFrame: 12 month
Other outcomes:
Locations:
city: Grenoble cedex 9
country: France
facility: Pediatric Orthopedic Department, University Hospital, Grenoble
Study officials:
affiliation: Pediatric Orthopedic department, University GrenobleHospital
name: Courvoisier Aurélien, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: