Fusion With the Neo Pedicle Screw and Cage Systems: A Post Market Clinical Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in patient´s function from baseline to 12 months
研究概览
简要总结
The objectives of this clinical observational study is to evaluate the safety and efficacy (performance) of the Neo Pedicle Screw System™ and the Neo Cage System™ interbody fusion device. To demonstrate non-inferiority of safety and function to an historical control from the published medical literature on competitive devices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in patient´s function from baseline to 12 months
时间窗: 12 months
Clinical outcome in function as measured by the 100 point Oswestry Disability Index (ODI). Zero is equated with no disability and 100 is the maximum disability possible.
The rate of pedicle screw loosening in screw only and cage-plus-screw systems.
时间窗: 12 months and 24 months post operatively
A radiolucent zone, \>1mm, surrounding the pedicle screw seen in radiograhs
The rate of cage migration in cage-plus-screw systems.
时间窗: 12 months and 24 months post operatively
Defined as posterior movement of the cage past the posterior wall of the vertebral body.
次要结局
未报告次要终点