Postmarket Registry for Evaluation of the Superion® Spacer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,674
- 试验地点
- 65
- 主要终点
- Vertiflex® Patient Satisfaction Survey
研究概览
简要总结
To gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the Superion® Indirect Decompression System (IDS).
详细描述
To gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the Superion® IDS in patients ≥45 years of age suffering from symptoms of neurogenic intermittent claudication secondary to a confirmed diagnosis of moderate degenerative lumbar spinal stenosis at one or two contiguous levels from L1 to L5.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female patients ≥45 years of age
- •symptoms of neurogenic intermittent claudication and a confirmed diagnosis of moderate degenerative lumbar stenosis at one or two contiguous levels from L1 to L5
- •meeting the labeled indications for use of the Superion® Indirect Decompression System (IDS)
排除标准
- •not contraindicated as described in the labeled indications for use
结局指标
主要结局
Vertiflex® Patient Satisfaction Survey
时间窗: 12 Month Follow-Up Visit
Percentage of patients reporting satisfied or somewhat satisfied with treatment during study follow up was calculated. Patients chose one of the following options to describe their overall satisfaction with their treatment (1) Satisfied (2) Somewhat Satisfied (3) Somewhat Dissatisfied (4) Dissatisfied. The percentage of patients who reported (1) Satisfied or (2) Somewhat satisfied were included and calculated in the analysis. Maximum is 100% of patients reported being satisfied and minimum is 0%.
次要结局
未报告次要终点