The iO-Flex® Study: Evaluation of the Baxano iO-Flex® System for Decompressive Lumbar Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 18
- 主要终点
- Change in Visual Analog Scale (VAS) for leg pain related to lumbar spinal stenosis at the treatment level from baseline to 6 months post-procedure quantified as a percentage of subjects with an improvement of at least 30%
研究概览
简要总结
The purpose of this study is to evaluate the clinical performance of the iO-Flex® System in reducing pain and symptom severity in patients with one or two level lumbar spinal stenosis that requires surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 Visual Analog Scale (VAS) for leg pain related to lumbar spinal stenosis at the treatment level from baseline to 6 months post-procedure quantified as a percentage of subjects with an improvement of at least 30%
时间窗: 6 months
Re-operation at the treatment level(s) at one year post-procedure
时间窗: One year
Acute safety outcomes will be determined by evaluating the type, frequency, severity, and relatedness of adverse events through discharge visits for all subjects
时间窗: Hospital discharge
Change in the Symptom Severity domain of the Zurich Claudication Questionnaire (ZCQ) from baseline to 6 months post-procedure quantified as a percentage of subjects with an improvement of at least 0.5 points
时间窗: 6 months
次要结局
- Long term safety outcomes that occur after discharge through 2 years post-procedure will be determined by evaluating adverse events involving the musculoskeletal or neurological systems(Through 2 years)
- Changes in Visual Analog Scale scores compared to baseline(6 weeks, 3 months, 6 months, 12 months, 24 months)
- Changes in Zurich Claudication Questionnaire scores compared to baseline(6 weeks, 3, 6, 12, and 24 months)
- Changes in Oswestry Disability Index scores compared to baseline(6 weeks, 3, 6, 12, and 24 months)
- Flexion/extension lumbar spine plain film radiographs will be collected and assessed for presence/absence of instability at baseline, 6-month, 12-month, and 24-months(6, 12, and 24 months)