The Combined Effect of Mesenchymal Stem Cell, HA-CaSO4,BMP-2, and Implant in Inducing The Healing of Critical-Sized Bone Defect
试验速览
- 阶段
- 1 期
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- RADIOGRAPHIC UNION SCALE (RUST Score) as a measure of bone union
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects with critical size defect of bone
排除标准
- •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.
研究组 & 干预措施
Stemcell
Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant
干预措施: Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant (Drug)
结局指标
主要结局
RADIOGRAPHIC UNION SCALE (RUST Score) as a measure of bone union
时间窗: Before surgery, after surgery, week 4 , 8, 12, 16, 20, 24 up to 1.5 years
plain radiograps will be taken to determine whether the bone has healed.
次要结局
- Visual analog scale as the measure of clinical union(Before surgery, after surgery, week 4 , 8, 12, 16, 20, 24 up to 1.5 years)
研究者
Ismail Hadisoebroto Dilogo
PhD
Indonesia University