NCT00289575Unknown2 期
Evaluation of Safety and Performance of Macroporous Biphasic Calcium Phosphate Granules Combined With Cellulosic-Derived Gel, in Filling Bones Gap After Aseptic Osteonecrosis Biopsy of Femur Head.
适应症
试验速览
- 阶段
- 2 期
- 发起方
- Biomatlante
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Infection and inflammation of the drilled area (blood and clinical assessment).
研究概览
简要总结
The aim of this pilot study is to evaluate MBCP performance in bone regeneration after osteonecrosis biopsy of the femur head. This technic may prevent the neck of the femur bone weakness following the healthy area drilling, thanks to a bone reconstruction at the expense of the biomaterial.
详细描述
Twelve patients will be enrolled in this study and evaluation of infection and inflammation of the drilled area, pain and hip function will be assessed during a one year follow up. Bone reconstruction will be evaluated with scanner and radiography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •femur head osteonecrosis (1 to 2 level in ARCO scale)
- •signed informed consent
排除标准
- •primary bone infection
- •femur head sphericity loss
- •cancer, diabetes, tuberculosis previous history
- •HIV, Hepatitis B, Hepatitis C infection
- •drepanocytosis
- •current corticotherapy
- •current immunosuppressive therapy
- •innate or acquired immune deficience
- •pregnancy or lack of efficient contraception
- •current participation in an other study
结局指标
主要结局
Infection and inflammation of the drilled area (blood and clinical assessment).
Adverse events.
次要结局
- Pain (Analogic Visual Scale)
- Hip function
- Bone reconstruction evaluation through scanner and radiography
研究者
研究点 (2)
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