Prediction of 3D Effect of Brace in Adolescent and Children Idiopathic Scoliosis Treatment Using EOS Imaging System and "Anatomic Transfer".
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Evaluation of the accuracy of the brace effect by the new anatomical transfer method in the frontal plane.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 9 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Evaluation of the accuracy of the brace effect by the new anatomical transfer method in the frontal plane.
时间窗: 12 month
Difference measurement in degrees between the digital Cobb angle after simulation and the actual Cobb angle under brace after EOS radiography.
次要结局
- 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 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)
- Evaluation of the accuracy of brace effect by the new anatomical transfer method on the torsion index.(12 month)