Comparison of Preoperative 3D Spine Reconstruction With the EOS System and Peroperative 3D Spine Reconstruction With SURGIVISIO
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Comparison between the shape of of the spine in supine position in the OR with the Surgivisio system and the 3D shape with the 3D pre-operative planning with the EOS
研究概览
简要总结
The objective is to collect data from a per-operative navigation system called SURGIVISIO during scoliosis surgeries. A research program is in progress in order super-impose pre-operative 3D reconstructions of the spine performed with the EOS system on the per-operative 3D reconstructions performed with the SURGIVISIO system.
The purpose of the study is to collect the pre and per operatives data in order to perform the research and development program.
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
- 12 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged between 12 and 20
- •Adolescent idiopathic scoliosis
- •Fusion surgery planned
排除标准
- •Patient under "tutelle" or privation of liberty
- •Opposition of parents or patient
结局指标
主要结局
Comparison between the shape of of the spine in supine position in the OR with the Surgivisio system and the 3D shape with the 3D pre-operative planning with the EOS
时间窗: 1 day
Comparison in degrees of the pre-operative Cobb angle with the EOS system and the per-operative spine reconstruction with the Surgivisio System.
次要结局
- Evaluation of angular measurements between preop and perop images(1 year)
- Vertebrae automatic segmentation in 3D and 2D(1 year)
- Evaluation of the "recalage" accuracy between preop planning and CBCT perop.(1 year)
- Automatic identification of the vertebrae(1 year)
- Evaluation of respiratory movements on image quality(1 year)
- Evaluation of angular measurements between preop and postop images(1 year)
- Evaluation of angular measurements between 1st erect postop Xrays and + 6 months postop Xrays.(1 year)
- Evaluation angular measurements between 1st erect postop Xrays and the preop planning(1 year)