Image Fusion System for 3D Preoperative Planning in the Osteosynthesis and Osteotomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Implant choices
研究概览
简要总结
Utility of image fusion system for the fracture and fracture malunion management will be evaluated.
详细描述
The fracture and malunion patients need osteosynthesis or osteotomy will be recruited. Image fusion group utilizes 3D preoperative planning and image fusion system. Control group utilizes only 3D preoperative planning. The age, sex, and fracture types will be matched between groups. In both groups, 3D preoperative planning will be performed in order to determine reduction, placement and choices of implants. In the image fusion group, the outline of planned image will be displayed on the monitor overlapping with fluoroscopy image during surgery. Reductions, implant choices/positions, and clinical outcomes will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fracture paitents need osteosynthesis
排除标准
- •Fracture patients under 18 years old
结局指标
主要结局
Implant choices
时间窗: 1month after the surgery
Reproducibility of the implant choices will be evaluated.
Reduction accuracy
时间窗: 1month after the surgery
Reproducibility of the reduction shape will be measured.
Implant placement
时间窗: 1month after the surgery
Reproducibility of the implant placement will be evaluated.
次要结局
未报告次要终点
研究者
Yuichi Yoshii
Associate Professor, Department of Orthopaedic Surgery
Tokyo Medical University