NCT02683590已完成不适用
STernectOmy Repair Efficiency of a Ceramic Implant
University Hospital, Limoges4 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2016年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 4
- 主要终点
- vital capacity
研究概览
简要总结
For the replacement of the sternum, there is no consensus regarding the most appropriate and most effective physiologically material. The use of ceramic implant offers significant operational time saving and biocompatibility coupled with the strength of the material allow us to realize a more natural operation, limiting the risk of infection and rejection.
Main objective: to evaluate the efficiency of the replacement of the sternum by a ceramic implant on the respiratory capacity at 3 months post surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patient major
- •Having a replacement indicating the sternum (or a part of the sternum)
- •With an expected life of over one year, estimated by the principal investigator
- •Written consent of the patient
排除标准
- •People under safeguard justice,
- •Patient under guardianship,
- •Patient pregnant or breastfeeding,
- •Topic attending another search including a period of exclusion still going to run-in
- •Contraindication to general anesthesia
- •Of alumina allergy antecedent
- •Recent infectious disease unsupported
研究组 & 干预措施
sternum by a ceramic implant
Experimental
The replacement of the sternum by a ceramic implant
干预措施: Ceramic Implant (Device)
结局指标
主要结局
vital capacity
时间窗: 1 day
Slow Vital Capacity (liters), forced vital capacity (liters)
次要结局
未报告次要终点
研究者
研究点 (4)
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