NCT01756144Unknown不适用
rhBMP-2 vs Autologous Bone Grafting for the Treatment of Non-union of the Docking Site in Tibial Bone Transport
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Bone healing in the docking site
研究概览
简要总结
When there is a bone defect, bone transport is used to bridge the defect. Frequently, the bone in the docking site (where the transported bone comes together) doesn't heal.
The objective is to study the effectivity of rhBmp-2 (inductos) to stimulate bone healing, in order to find new techniques to treat non-union of long bones.
The method of the study is a randomized controlled trial, to compare rhBMP-2 and autologous bone grafting in stimulating bone healing in the docking site.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated with bone transport (Ilizarov technique) and have non-union of the docking site, which is characterized by absence of bridging callus after two months of compression in the docking site.
排除标准
- •Allergy for inductos
- •active growth,
- •malignancy
- •infection
- •pathological fracture
研究组 & 干预措施
Autologous bone grafting
Active Comparator
autologous bone of the iliac crest
干预措施: rhBMP-2 (Device)
rhBMP-2
Experimental
Inductos, recombinant human bone morphogenetic protein
干预措施: rhBMP-2 (Device)
结局指标
主要结局
Bone healing in the docking site
时间窗: up to 4 months
次要结局
- Infection(up to one year)
- Edema(up to one year)
- cancer(up to one year)
研究者
Dr Jan Vanderstappen
MD
Universitaire Ziekenhuizen KU Leuven
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