Postmarket Outcomes Study for Evaluation of the Superion™ Spacer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 23
- 主要终点
- Low Back Pain Responder Rate
研究概览
简要总结
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
详细描述
The purpose of this outcomes study is to compile real-world outcomes for the commercially approved Indirect Decompression Systems (IDS) in routine clinical practice when used according to the applicable Instructions for Use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to receive or previously received a commercially approved Boston Scientific Indirect Decompression Systems, per local Instructions for Use (IFU)
- •Signed a valid, IRB approved informed consent form
排除标准
- •Meets any contraindication in BSC Indirect Decompression Systems local IFU
结局指标
主要结局
Low Back Pain Responder Rate
时间窗: Up to 3 years post-procedure
Proportion of subjects with an improvement of 20 mm during the last 7 days for low back pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)
Left Leg Pain Responder Rate
时间窗: Up to 3 years post-procedure
Proportion of subjects with an improvement of 20 mm during the last 7 days for left leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)
Right Leg Pain Responder Rate
时间窗: Up to 3 years post-procedure
Proportion of subjects with an improvement of 20 mm during last 7 days for left leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)
次要结局
未报告次要终点