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临床试验/NCT03026868
NCT03026868Unknown不适用

Randomized Trails of Different Fixations for Acetabular Fracture Involving Quadrilateral Surface

Hebei Medical University Third Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
fracture healing time

研究概览

简要总结

The novel plate could be used to manage acetabular fractures involving quadrilateral surface and posterior column, which may lower the intraoperative blood loss and reduce complication rate.

详细描述

Stoppa approach was more minimally invasive than ilioinguinal approach for pelvic and acetabular fractures. Then, Stoppa approach was widely used clinically. For the fragments involving quadrilateral surface, the Kocher-Langenbeck approach was added because the fixation of posterior fragments could not be obtained with reconstruction plate through single Stoppa approach. Novel quadrilateral surface plate was used in this study to examine its fixed role for posterior fragments. Functional outcome and complication were recorded to compare with the results treated with reconstruction plate. If good results were obtained for the patients fixed with quadrilateral surface plate, it was meaningful to popularize the fixed method.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 18 years old
  • Fracture involving quadrilateral surface
  • Operation was conducted within 14 days
  • Fixed with quadrilateral surface plate through Stoppa approach

排除标准

  • Presented with a pathologic acetabular fracture
  • Neuropathic arthropathy,dementia and other disease processes which made postoperative compliance unreliable
  • Refused to participate
  • Follow-up insufficient 12 months

研究组 & 干预措施

quadrilateral surface plate

Experimental

The fragments of the acetabulum were fixed with novel quadrilateral surface plate through Stoppa approach.

干预措施: quadrilateral surface plate (Procedure)

结局指标

主要结局

fracture healing time

时间窗: 4 months

fracture line disappeared in the radiograph

次要结局

  • complication(1 month)

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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