Induced Membrane Properties in Children and Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Measure of the BMP2 concentration of the induced membrane by immunodetection
研究概览
简要总结
Bone reconstruction in critical sized defect (CSD) remains a real challenge in orthopedic surgery in children and adults. The Masquelet technique is an innovative therapeutic technique, which offers a bone reconstruction in two steps, by the formation of an induced membrane (IM) around a polymethylmethacrylate (PMMA) spacer placed into the bone defect. After, PMMA removal, the cavity is filled with corticocancellous graft allowing bone healing. Up to date, all angiogenesis and osteogenic properties of IM remain unknown. The purpose of this study is to characterize angiogenesis and osteogenic properties of IM in children and adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 9 Months 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients treated at CHU Amiens-Picardie for bone critical sized defect treated using the induced membrane reconstruction technique.
- •patients from 9 months to 60 years old
排除标准
- •Patients managed by another reconstruction technique for critical sized defect
- •Patients under guardianship, curators or deprived of liberty.
- •Pregnant and nursing women.
- •Patients who refused to participate in the study and to sign informed consent.
结局指标
主要结局
Measure of the BMP2 concentration of the induced membrane by immunodetection
时间窗: one year (one year from day of surgery)
Measure of the osteogenic property of the induced membrane will be made after harvesting the induced membrane
次要结局
- BMP2 concentration of the induced membrane implanted in adults measured by immunodetection(one year (one year from day of surgery))
- BMP2 concentration of the induced membrane implanted in children measured by immunodetection(one year (one year from day of surgery))