Treatment of Stage 3 Osteonecrosis of the Femoral Head by Autologous Transplantation of Bone Marrow Cells: a Randomized, Controlled Double Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- reduction of total prosthesis
研究概览
简要总结
In stage 3 Osteonecrosis (ON) of the femoral head, a beneficial effect of bone marrow grafting was reported with a reduction of the functional evolution and the necessity of a total prosthesis placement in a non-controlled retrospective trial. Based on this experience, the investigators would like to start a randomized controlled double blind study on the effect of autologous implantation of autologous bone marrow cells into the necrotic lesion of stage 3 ON of the 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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who have a non traumatic ON of the femoral head
- •Stage 3 ON (subchondral fracture).
- •Age > 18 years
- •Be able and willing to participate in the study
排除标准
- •evidence of malignant disorder in the past five years
- •Patient unable to undergo a MRI.
- •Patient who is positive for an HIV, hepatitis B or C infection.
研究组 & 干预措施
Control
Core decompression
干预措施: core decompression of the femoral head (Procedure)
Bone marrow
core decompression plus autologous concentrated bone marrow
干预措施: core decompression with autologous bone marrow implantation (Procedure)
结局指标
主要结局
reduction of total prosthesis
时间窗: 24, 60 months
Need to undergo a surgical treatment total prosthesis
次要结局
- Pain reduction(24, 60 months)
- functional status(24, 60 months)
研究者
Jean-Philippe Hauzeur
Principal investigator
University of Liege