NCT04300777进行中（未招募）不适用
Clinical Evaluation of the SeaSpine Non-Cervical Pedicle Screw Systems
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The primary outcome for the study is device performance.
研究概览
简要总结
To perform a clinical evaluation of safety and performance for the SeaSpine Non- Cervical Pedicle Screw Systems
详细描述
A multi-center, post-market, clinical evaluation for subjects implanted with the SeaSpine Non-Cervical Pedicle Screw Systems
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
- •Have undergone surgery
- •Have undergone at least 12-months of postoperative follow-up
排除标准
- •Any condition that the Investigator determines is unacceptable
结局指标
主要结局
The primary outcome for the study is device performance.
时间窗: 12 months post-operative
Device performance is defined as lack of component failure involving screw and/or rod fracture and/or screw loosening or disassociation.
次要结局
- Evaluation of unanticipated adverse device effects (UADE)(12-months)
研究者
研究点 (2)
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