Study of PLGA-Mg Material in Clinical Orthopedics
Randomized, Double Blind Trial of Study of PLGA-Mg Material in Clinical Orthopedics
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Hebei
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Shijiazhuang、Hebei、中国、050051
- 招聘中
- Hebei Medical University Third Hospital
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接触:
- Yingze Zhang, M.D
- 电话号码:+8613313012888
- 邮箱:yzzhangdr@126.com
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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:
- 18-65 years old
- Closed fracture
- Sign the agreement of the experiment
Exclusion Criteria:
- Pathologic fracture
- Open fracture
- Refused to participate
- Follow-up insufficient 12 months
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较:PLGA-Mg material
The fixation of fragments of study group was accomplished with PLGA-Mg material.
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The PLGA-Mg material was used to accomplish the fixation of fragments.
Then, the clinical outcome was assessed.
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安慰剂比较:titanium alloy
The fixation of fragments of control group was accomplished with titanium alloy material.
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Traditional fixation was titanium alloy.
the clinical outcome was assessed.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
fracture union time
大体时间:4 months
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4 months
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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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complication
大体时间:1 months
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nonunion, toxicity
|
1 months
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合作者和调查者
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 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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