EOSTransfert: Prediction of 3D Effect of Brace in Idiopathic Scoliosis Treatment Using EOS Imaging System and "Anatomic Transfer".
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
- Evaluation of the accuracy of the brace effect by the new anatomical transfer method in the frontal plane. [12 month]
Difference measurement in degrees between the digital Cobb angle after simulation and the actual Cobb angle under brace after EOS radiography.
Secondary Outcome Measures
- Evaluation of the accuracy of the brace effect by the new anatomical transfer method on the spinal axial rotation. [12 month]
Difference measurement in degrees between apical axial vertebral rotation angle (AVR) after simulation and the actual AVR under brace after EOS radiography.
- Evaluation of the accuracy of brace effect by the new anatomical transfer method on the torsion index. [12 month]
Difference measurement in degrees between the numerical torsion index after simulation and the actual torsion index under brace after EOS radiography.
- Evaluation of the accuracy of the brace effect by the new anatomical transfer method in the sagittal plane [12 month]
Difference measurement in degrees between kyphosis angle, digital lordosis after simulation and kyphosis angle, real lordosis under brace after EOS radiography.
- 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]
Point-to-point distance between the average rib line after simulation and under brace after EOS radiography
Eligibility Criteria
Criteria
Inclusion Criteria:
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patients aged 9 to 15 years;
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with idiopathic scoliosis (left lumbar and / or right chest);
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with moderate scoliosis: Cobb angle evaluated between 15 ° and 35 °;
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requiring brace placement or renewal;
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having signed a non-objection form
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affiliated with, or receiving, social security
Exclusion Criteria:
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patient/parents who refuse to sign a non-objectiont form
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with unstable medical condition
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person deprived of liberty by judicial or administrative decision
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person under legal protection or unable to express their consent
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person hospitalized for psychiatric care
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pediatric Orthopedic Department, University Hospital, Grenoble | Grenoble cedex 9 | France | 38043 |
Sponsors and Collaborators
- University Hospital, Grenoble
- Demeure Orthopédie
- Anatoscope
- Clinical Investigation Centre for Innovative Technology Network
Investigators
- Principal Investigator: Courvoisier Aurélien, MD, PhD, Pediatric Orthopedic department, University GrenobleHospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- DCIC15-01