CERAMENT™| Bone Void Filler Device Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 13
- 主要终点
- Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
研究概览
简要总结
A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.
详细描述
A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •18 years and over (on the day of surgery)
- •Receive CERAMENT BVF as a component of their treatment at a participating, contracted center or healthcare provider, in accordance with the IFU for the implanted product
- •In receipt of patient information leaflet and have signed appropriately designed informed consent
排除标准
- •Any exclusion criteria as per IFU for CERAMENT BVF
- •Any off-label use
结局指标
主要结局
Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
时间窗: 18 months
Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
时间窗: 18 months
Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
时间窗: 12 months
Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
adverse device events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
时间窗: 18 months
Adverse device events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
时间窗: 18 months
SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
次要结局
- EQ-5D-3L(6, 12, and 18 months)
- Radiological assessment at 6 and 12 months. Objective assessment of regeneration(12 Months)
- Pain VAS score(6, 12, and 18 Months)