CTRI/2020/08/027343尚未招募不适用
Prospective evaluation of percutaneous vertebroplasty in osteoporotic vertebral compression fracture patients.
DrShivani Rastogi1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2020年8月26日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- pain relief following percutaneous vertebroplasty.
研究概览
简要总结
osteoporotic vertebral compression fracture is a leading cause of disability and morbidity in the elderly. percutaneous vertebroplasty is a minimally invasive procedure providing better pain relief and avoid major surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1-3 painful OVCF at any levels with a physical examination and radiographic findings -patients with chronic back pain ( > 12 weeks )not responding to primary treatment.
- •coagulation test should be normal.
排除标准
- •pedicle fracture -cord compression -patients refusal to give consent -local or systemic infection -concomitant hip fractures -osteoporotic vertebral collapse > 90 % -previous vertebroplasty -posterior vertebral body breach -significant compromise of spinal canal by retropulsed bone fragment or tumor -pregnant patients -vertebral compression fracturea patients with multiple myeloma and metstatic tumors.
- •patient with known coagulopathy.
结局指标
主要结局
pain relief following percutaneous vertebroplasty.
时间窗: follow up at 1 week , 1 month, 6th month
次要结局
- improvement in vertebral height, wedge angle, corelation of pain relief with percentage of correction(follow up at 1 week , 1 month, 6th month)
研究者
研究点 (1)
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Effectiveness of percutaneous vertebroplasty in patients with osteoporotic vertebral compression fracture.CTRI/2020/08/027343DrShivani Rastogi