The Kiva® System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 39
- 主要终点
- Proportion of Participants With Study Success
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the Kiva VCF Treatment system in comparison to balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures of the thoracic or lumbar spine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 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
Proportion of Participants With Study Success
时间窗: 12 Month Post-op
Patient success will be defined as: 1. Reduction in VCF fracture-related pain at 12 months by \>15 mm from baseline as measured by a 100 mm Visual Analog Scale (VAS), 2. Maintenance or improvement in function at 12 months from baseline as measured by the 100 point Oswestry Disability Index (ODI), and 3. Absence of device-related serious adverse events, defined as device-related adverse events requiring surgical reintervention or retreatment at the index level, including revision, removal, reoperation, and/or supplemental fixation
次要结局
未报告次要终点