Evaluation of the Fortilink IBF System With TETRAfuse Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- RTI Surgical
- 入组人数
- 119
- 试验地点
- 5
- 主要终点
- Safety outcomes associated with use of the Fortlink System
研究概览
简要总结
This is a multi-center, post-market, retrospective study to collect safety and performance data for patients implanted with the Fortilink IBF System.
详细描述
This is a multi-center, post-market, retrospective study to collect safety and performance data for patients implanted with the Fortilink IBF System.
The study will include up to 110 patients at up to 8 US sites. All patients implanted with the Fortilink System at a site will be included in the data collection. The goal is to collect data for at least 100 subjects, but the sample size will be capped at 110 to ensure that all patients at a given site are included in the analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have had an attempted implant of the Fortilink IBF System
排除标准
- •There are no exclusion criteria
结局指标
主要结局
Safety outcomes associated with use of the Fortlink System
时间窗: Up to 1 year
Safety assessment includes evaluation of all adverse events or complications related to the procedure and post-operative adverse events.
次要结局
未报告次要终点