A Prospective, Multicenter Observational Study Evaluating the Long Term Safety in Terms of Explantation Rate and Number of Infections of the Custom-made Bioceramic Implant CustomBone™
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 18
- 主要终点
- Explantation rate after 2 years of follow-up
研究概览
简要总结
A Prospective, Multicenter Observational Study Evaluating the Long Term Safety in Terms of Explantation Rate and Number of Infections of the Custom-made Bioceramic Implant CustomBone™
The patients will be included as soon as they are implanted and follow-up for 2 years. It is observational so no specific exam is planned.
The explantation rate will be measured, that is to say the number of patients whose prosthesis will be removed (with or without any relationship with the implant or the procedure).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient planning to have a cranioplasty and be implanted with the Custombone™ medical device
- •Patient who agrees to take part in the study, or agreement of a representative of the patient in case of patient inability, after being informed by the investigator and having received an information letter
- •Exclusion criteria:
- •Patient who does not accept to take part in the study after being informed
排除标准
- 未提供
结局指标
主要结局
Explantation rate after 2 years of follow-up
时间窗: 24 months after implantation
The main objective of the study is to measure the explantation rate after the implantation of a Custombone TM prosthesis. We will measure the number of patients whose prosthesis has an been removed, with or without any relationship with the implant or the procedure
次要结局
未报告次要终点