NCT00939406已完成2 期
A Multi-center Prospective Randomized Phase II Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy
AO Clinical Investigation and Publishing Documentation5 个研究点 分布在 3 个国家目标入组 45 人开始时间: 2009年11月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 5
- 主要终点
- Rate of adverse events
研究概览
简要总结
The aim of this Phase II trial is to evaluate safety and efficacy of Hyalospine in patients undergoing lumbar laminectomy or laminotomy for degenerative spinal stenosis or disk herniation. The device is used as an adjunct in lumbar spine surgery to prevent post- surgical fibrosis and adhesions, and improve patient outcomes.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for elective single- or two-level lumbar laminectomy or laminotomy procedure for treatment of spinal stenosis and/or disk herniation.
- •Subjects who have failed conservative care for at least 6 weeks.
排除标准
- •Contraindication to MRI
- •Instrumented fusion
结局指标
主要结局
Rate of adverse events
时间窗: 6 months
Extent of epidural fibrosis
时间窗: 12 months
次要结局
- differences in pain, neurological status, neurological symptoms, function, quality of life, patient satisfaction, immunologic and clinical laboratory results(12 months)
研究者
研究点 (5)
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