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

September 7, 2018 updated by: University Hospital, Grenoble

Prediction of 3D Effect of Brace in Adolescent and Children 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.

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble cedex 9, France, 38043
        • Pediatric Orthopedic Department, University Hospital, Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children or adolescent idiopathic scoliosis patient

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 month
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.
12 month
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.
12 month
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
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Clinical Investigation Centre for Innovative Technology Network
Demeure Orthopédie
Anatoscope

Investigators

  • Principal Investigator: Courvoisier Aurélien, MD, PhD, Pediatric Orthopedic department, University GrenobleHospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

July 3, 2017

First Submitted That Met QC Criteria

July 3, 2017

First Posted (Actual)

July 6, 2017

Study Record Updates

Last Update Posted (Actual)

September 10, 2018

Last Update Submitted That Met QC Criteria

September 7, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC15-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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