NCT00203554已完成不适用
Percutaneous Vertebroplasty Versus Conservative Treatment of Pain: A Prospective, Randomized Controlled Study of Osteoporotic Fractures in the Spine
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Level of pain
研究概览
简要总结
The purpose of this study is to compare the effect of vertebroplasty with that of traditional medical treatment in the treatment of painful vertebral fractures in osteoporotic patients.
详细描述
In vertebroplasty a bone cement is injected in one or more fractured vertebra. The indication is pain that needs high doses of analgesics.
The cement is a well known product called poly methyl metacrylate (PMMA) normally used fixate joint prosthesis.
Vertebroplasty is done in local anaesthesia. The treatment was introduced in 1984 in France and today thousands of patients have been treated worldwide, but so far no randomized controlled trials have been published.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •new pain in spine (within 6 months)
- •x-ray verified low energy spinal fracture(s)
排除标准
- •less than 20% or more than 90% reduction of the vertebral height
- •lack of pain at fracture level
- •no need for continuous analgesic treatment
- •patient no able to communicate
- •general anaesthesia contraindicated
- •MRI not possible
- •coagulopathy (not adjustable)
- •spondylitis
- •spinal metastasis
结局指标
主要结局
Level of pain
时间窗: before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months.
次要结局
- Needs for analgetics, number of days at hospital, level of ADL(before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months.)
研究者
研究点 (2)
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