NCT04171544已完成不适用
Streamline Occipito-Cervico-Thoracic System Post-Market Clinical Follow-up (OCT PMCF)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- RTI Surgical
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Evaluate time to demonstration of fusion.
研究概览
简要总结
This is a multi-center, post-market, retrospective study design to collect safety and performance data for patients implanted with the Streamline OCT System.
详细描述
This is a multi-center, post-market, retrospective study design to collect safety and performance data for patients implanted with the Streamline OCT System. The study will include a minimum of 58 patients at a minimum of 3 sites in the United States. The study will enroll at a minimum of 5 subjects implanted with the occipital plate.
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
- •Subject must have had an implant of the OCT System.
排除标准
- •No exclusion criteria.
结局指标
主要结局
Evaluate time to demonstration of fusion.
时间窗: 12 months
Evaluate time to demonstration of fusion.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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