DIAM™ Spinal Stabilization System Long Term Follow up Clinical Plan
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 175
- 主要终点
- Evaluate the safety associated with the use of the investigational implant during long term follow up
研究概览
简要总结
A hybrid prospective/retrospective, multicenter, single-arm, data collection study.
详细描述
Collect long-term follow-up data with x-rays and CT on subjects who received the DIAM™ Spinal Stabilization System through the original IDE protocol.
Data collected at one-time point from subjects with at least 5 years of follow-up data.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject randomized to the DIAM arm and treated with the DIAM™Spinal Stabilization System in the IDE study OR randomized to the Control arm and crossed over to receive treatment with the DIAM™ Spinal Stabilization System in the IDE study.
- •Willing and able to consent to study procedures
排除标准
- 未提供
结局指标
主要结局
Evaluate the safety associated with the use of the investigational implant during long term follow up
时间窗: 5-10 years after implantation
The DIAM device, specifically at long-term follow-up. A subject is considered to be a long-term success if they are free from serious device-related adverse events through final follow-up. Secondary surgical intervention for treatment failure (i.e. recurrence of pain or functional impairment) without other serious device-related adverse event is not considered to be a serious device-related adverse event for the purposes of the primary endpoint.
次要结局
- Back Pain evaluation(5-10 years after implantation)