Randomized, Double Blind Trial of Study of PLGA-Mg Material in Clinical Orthopedics
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- fracture union time
研究概览
简要总结
The different proportion samples of PLGA-Mg were made in this study. Then, they would be placed in the femoral condyle of the New Zealand rabbits. The appropriate proportion of PLGA-Mg is obtained after the experiment, which will be used to make the plate or screw to fix the fragments. Then, the clinical role for bone will be assessed.
详细描述
The deposition of calcium could be facilitated by the increase of magnesium, which played an important role in fracture union. However, its degradation may be completed before the fracture line was disappeared. In addition, the hydrogen may be released during degradation. Thus, its clinical popularization was limited.
As a new polymer material, poly lactic-co-glycolic acid (PLGA) has been widely used clinically. The hydrolytic production of PLGA was acidic, which could neutralize the alkalinity of production degraded from magnesium. In addition, it was a long time before the total accomplishment of degradation of PLGA, which may postpone the degradation of magnesium.
The different proportion samples of PLGA-Mg were made in this study. Their physical and chemical properties were analyzed to estimate its safety of implantation. Then, they would be placed in the femoral condyle of the New Zealand rabbits. The osteogenesis and complication of samples are examined to select an appropriate proportion of PLGA-Mg is obtained. Then, the PLGA-Mg material will be used to fix the fracture of human as a fixation. The review of the patients will be conducted to assess its clinical role.
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
- 是
入选标准
- •18-65 years old
- •Closed fracture
- •Sign the agreement of the experiment
排除标准
- •Pathologic fracture
- •Open fracture
- •Refused to participate
- •Follow-up insufficient 12 months
研究组 & 干预措施
PLGA-Mg material
The fixation of fragments of study group was accomplished with PLGA-Mg material.
干预措施: PLGA-Mg material (Biological)
titanium alloy
The fixation of fragments of control group was accomplished with titanium alloy material.
干预措施: titanium alloy (Biological)
结局指标
主要结局
fracture union time
时间窗: 4 months
次要结局
- complication(1 months)
