Control Study of Implantation of Enriched Bone Marrow Cells for the Treatment of Avascular Necrosis of Femoral Head
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 主要终点
- change of Visual Analogue Scale
研究概览
简要总结
The purpose of this study is to compare the efficacy of autologous enriched bone marrow cell implantation combined with core decompression to single core decompression for the treatment of avascular necrosis of femoral head.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •femoral head necrosis patients
- •stage I/II/III (Ficat)
- •age from 18 to 55 years
- •stop steroid treatment for minimal 6 months
排除标准
- •age younger than 18 or older than 55
- •any hemopathy
- •femoral head/neck fracture
研究组 & 干预措施
control group:core decompression
single core decompression
干预措施: core decompression (Procedure)
Treatment group: BMCs+core decompression
Enriched bone marrow cells combined with core decompression
干预措施: Enriched BMCs implantation combined with core decompression (Procedure)
结局指标
主要结局
change of Visual Analogue Scale
时间窗: before invention and 24 months after invention
Change from baseline in 24 months
change of lequensne algofunctional index
时间窗: before invention and 24 months after invention
change from baseline in 24 months
change of WOMAC index
时间窗: before invention and 24 months after invention
change from baseline in 24 months
次要结局
未报告次要终点
研究者
Qiujiang Zheng
Director of Orthopaedic Surgery
Guangdong Provincial People's Hospital