NL-OMON47294已完成3 期
A randomised sham controlled trial of vertebroplasty for painful chronic osteoporotic vertebral fractures - VERTOS V
Sint Elisabeth Ziekenhuis0 个研究点目标入组 80 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •VCF on X-ray of the spine (minimal 15% loss of height)
- •level of VCF Th5 or lower
- •back pain <= 6 weeks at time of X-ray
- •>= 50 years of age
- •bone edema on MRI of the fractured vertebral body
- •focal tenderness on VCF level
- •decreased bone density T-scores <= -1
排除标准
- •severe cardio-pulmonary condition
- •untreatable coagulopathy
- •systemic or local infection of the spine (osteomyelitis, spondylodiscitis)
- •suspected alternative underlying disease (malignancy)
- •radicular and/or cauda compression syndrome
- •contra-indication for MRI
研究者
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