NCT00279877已完成3 期
Cost Effectiveness and Efficacy of Kypho and Vertebro Plasty Trial
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Back specific functional status(Roland)
研究概览
简要总结
Randomized trial comparing cost effectiveness and efficacy of kyphoplasty vs vertebroplasty for the treatment of painful, osteoporotic vertebral compression fractures.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> or = 50 years of age
- •Compression fracture (T4-L5)within previous 12 mo.
- •Pain from compression fracture
- •No malignant tumor
- •No back surgery
排除标准
- 未提供
研究组 & 干预措施
vertebroplasty
Active Comparator
vertebroplasty
干预措施: Kyphoplasty (Procedure)
kyphoplasty
Active Comparator
kyphoplasty
干预措施: Kyphoplasty (Procedure)
结局指标
主要结局
Back specific functional status(Roland)
时间窗: 12 mo
Pain
时间窗: 12 mo
次要结局
- Health status outcome measure(SF-36)(12 mo)
研究者
Avery Evans, MD
MD
University of Virginia
研究点 (1)
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