The Combined Effect of Mesenchymal Stem Cell, HA-CaSO4,BMP-2, and Implant in Inducing The Healing of Critical-Sized Bone Defect
This research is aimed to evaluate the combination of mesenchymal stem cell, HA-CaSO4, BMP-2, and implant in treating critical-sized bone defect.
In the presence of critical-sized bone defect whose defect size is more than 2.5 cm, bone will suffer a healing disturbance. In treating these conditions, the conventional method were vascularised bone grafting and bone transport. But the existing methods of treatment have many weaknesses Vascularized bone graft is a procedure with a high level of difficulty. Hence not every orthopaedic surgeon were able to perform it. It also takes more operating time and its failure rate is also quite high.
Meanwhile, external fixation which is applied with bone transport, was being often complained by the patient in terms of cosmetic and psychologically.
According to diamond concept of bone healing, there are four main factors that influence the bone healing. These factors are osteogenic factor (mesenchymal stem cell), osteconductive factor (HA-CaSO4), osteoinductive factor (bone morphogenetic protein-2) and mechanical component (implant). The potency of each component in fracture healing with/out bone defect has been proved in many studies. The combined effect of these components is often studied as well, but not in critical-sized bone defect.
研究概览
研究类型
注册 (预期的)
阶段
- 阶段1
联系人和位置
学习地点
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Indonesia, Singapore
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Jakarta, Singapore、Indonesia, Singapore、印度尼西亚、14430
- University of Indonesia, National University of Singapore
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- subjects with critical size defect of bone
Exclusion Criteria:
- subjects with patological fracture caused by primary or secondary bone malignancy, imunological deficit, active hepatitis or those who's under immunosuppresant therapy or other therapeutic modality that can interferes with bone healing.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Stemcell
Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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RADIOGRAPHIC UNION SCALE (RUST Score) as a measure of bone union
大体时间:Before surgery, after surgery, week 4 , 8, 12, 16, 20, 24 up to 1.5 years
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plain radiograps will be taken to determine whether the bone has healed.
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Before surgery, after surgery, week 4 , 8, 12, 16, 20, 24 up to 1.5 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Visual analog scale as the measure of clinical union
大体时间:Before surgery, after surgery, week 4 , 8, 12, 16, 20, 24 up to 1.5 years
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We will measure VAS (grade 0-10) to determine the clinical union
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Before surgery, after surgery, week 4 , 8, 12, 16, 20, 24 up to 1.5 years
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- SCNONUNION12
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