NCT01950858Unknown1 期
Safety and Efficacy of Hyper Baric Oxygen Therapy (HBOT) in Patients Presenting With Spontaneous Osteonecrosis of the Knee
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Efficacy
研究概览
简要总结
safety and efficacy of Hyper Baric Oxygen (HBO) in patients presenting with spontaneous osteonecrosis of the knee
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
- 年龄范围
- 40 Months 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age40-85 years
- •Diagnosis of Spontaneous osteonecrosis of the knee (SONK)in last month, Stage 1 or 2 by MRI.
排除标准
- •Hyperbaric treatment (HBOT) in the last 2 years.
- •Any contraindication for HBOT
- •Pregnancy.
- •Inability to sign inform consent
- •Any contraindication for MRI
结局指标
主要结局
Efficacy
时间窗: 6 weeks
Pain Reduction
Safety
时间窗: end of HBOT
Number of Participants with Adverse Events during HBOT
次要结局
- Reduction In AVN size by MRI(6 weeks)
研究者
Assaf Harofeh MC
Yiftah Beer
Assaf-Harofeh Medical Center
研究点 (2)
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