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临床试验/NCT03060655
NCT03060655Unknown2 期

Randomized, Double Blind Trial of Study of PLGA-Mg Material in Clinical Orthopedics

Hebei Medical University Third Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年8月1日最近更新:
适应症
干预措施

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

Placebo Comparator

The fixation of fragments of study group was accomplished with PLGA-Mg material.

干预措施: PLGA-Mg material (Biological)

titanium alloy

Placebo Comparator

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)

研究者

发起方
Hebei Medical University Third Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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