Prediction of 3D Effect of Brace in Idiopathic Scoliosis Treatment Using EOS Imaging System and "Anatomic Transfer".
EOSTransfert
1 other identifier
observational
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 3, 2017
CompletedFirst Posted
Study publicly available on registry
July 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedSeptember 10, 2018
September 1, 2018
1 year
July 3, 2017
September 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Evaluation of the accuracy of the brace effect by the new anatomical transfer method on the spinal axial rotation.
12 month
Evaluation of the accuracy of brace effect by the new anatomical transfer method on the torsion index.
12 month
Evaluation of the accuracy of the brace effect by the new anatomical transfer method in the sagittal plane
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
12 month
Eligibility Criteria
Children or adolescent idiopathic scoliosis patient
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Grenoblelead
- Demeure Orthopédiecollaborator
- Anatoscopecollaborator
- Clinical Investigation Centre for Innovative Technology Networkcollaborator
Study Sites (1)
Pediatric Orthopedic Department, University Hospital, Grenoble
Grenoble, 38043, France
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Courvoisier Aurélien, MD, PhD
Pediatric Orthopedic department, University GrenobleHospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2017
First Posted
July 6, 2017
Study Start
May 1, 2016
Primary Completion
May 1, 2017
Study Completion
September 1, 2018
Last Updated
September 10, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share