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

Idiopathic Scoliosis Clinical Trial

— EOSTransfert  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03209752
• Other study ID #: DCIC15-01
• Status: Completed
• Start date: May 2016
• Est. completion date: September 2018

Study information

• Verified date: September 2018
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Scoliosis
• Scoliosis

Locations

Country	Name	City	State
France	Pediatric Orthopedic Department, University Hospital, Grenoble	Grenoble cedex 9

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Anatoscope, Clinical Investigation Centre for Innovative Technology Network, Demeure Orthopédie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the accuracy of the brace effect by the new anatomical transfer method in the frontal plane.	Difference measurement in degrees between the digital Cobb angle after simulation and the actual Cobb angle under brace after EOS radiography.	12 month
Secondary	Evaluation of the accuracy of the brace effect by the new anatomical transfer method on the spinal axial rotation.	Difference measurement in degrees between apical axial vertebral rotation angle (AVR) after simulation and the actual AVR under brace after EOS radiography.	12 month
Secondary	Evaluation of the accuracy of brace effect by the new anatomical transfer method on the torsion index.	Difference measurement in degrees between the numerical torsion index after simulation and the actual torsion index under brace after EOS radiography.	12 month
Secondary	Evaluation of the accuracy of the brace effect by the new anatomical transfer method in the sagittal plane	Difference measurement in degrees between kyphosis angle, digital lordosis after simulation and kyphosis angle, real lordosis under brace after EOS radiography.	12 month
Secondary	Evaluation of the accuracy of ribs position of the patient under 3D digital model of brace with respect to the actual position under brace	Point-to-point distance between the average rib line after simulation and under brace after EOS radiography	12 month

External Links

•   Clinical Investigation Centre for Innovative Technology Network website