Analysis of a Customized Percutaneous External Guidance System for Scaphoid Fracture Fixation Using 3D Printing
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Screw Position
研究概览
简要总结
The investigators want to analyse the advantages of using a 3D constructed prototype from a previous CT Scan to model an external customised guide por percutaneous Scaphoid fixation.
The investigators hypothesise that the usage of this device will shorten surgery time, radiation for the surgery team and optimise the percutaneous screw trajectory inside of the scaphoid bone.
详细描述
To carry out this analysis the investigators will recruit 10 patients who present with an acute fracture of the Scaphoid bone type B1 and B2 (Herbert Classification).
A CT Scan will be performed and a 3D exoesqueleton model printed, previously deciding the position of the fixation screw inside of the bone and adding a cannulated sleeve in the volar aspect of the exoesqueleton to insert the initial positional guide wire for surgery.
Surgery time, surgery radiation exposure and screw positioning will be recorded and compared to 10 control patients operated following standard procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Acute scaphoid fracture (Herbert B1 B2)
排除标准
- •Concomitant fractures
结局指标
主要结局
Screw Position
时间窗: 1st day Xray
Correct position of screw inside of the scaphoid
次要结局
- Surgery time(1st day)
- xray exposure(1st day)
研究者
Francesc A. Marcano-Fernández
MD
Corporacion Parc Tauli