NCT06010433招募中不适用
CERAMENT G Device Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Primary Outcomes
研究概览
简要总结
This is an Observational Device Registry Study of CERAMENT|G in normal use in accordance with the IFU. It will run for a period of three years from enrolment of the first patient into the Study at each Site, before being subject to review. A Device Registry is a form of observational study that concerns the performance of a device in normal use. It is intended to collect data that is reflective of 'real world' device performance.
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|G as a component of their treatment at a participating, contracted centre 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 form.
排除标准
- •Any exclusion criteria as per IFU for CERAMENT|G
- •Any off-label use
结局指标
主要结局
Primary Outcomes
时间窗: 12 months
• Device safety - any unexpected device performance, complaints, adverse events, adverse device effects, SAEs throughout study period.
次要结局
- Secondary Outcome(12 months)
研究者
研究点 (3)
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