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临床试验/NCT00180206
NCT00180206Unknown4 期

Prospective, Non-Randomised, Non-Comparative Multicentric Investigation of the Functional and Radiological Result and Subjective Patient Outcome After Implantation of a Hip Resurfacing Endoprosthesis (Birmingham Hip Resurfacing)

Technische Universität Dresden2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2005年1月最近更新:
适应症

试验速览

阶段
4 期
入组人数
300
试验地点
2
主要终点
Functional result

研究概览

简要总结

The purpose of this study is the investigation of the functional and radiological results and subjective patient outcome after the implantation of a hip resurfacing endoprosthesis (Birmingham hip resurfacing).

详细描述

High volumetric wear of polyethylene was the main factor in periprosthetic bone resorption and failure of historic hip resurfacing prosthesis. Metal-on-metal devices reduce the wear substantially and may solve this problem. The purpose of this study is the investigation of the functional and radiological result and subjective patient outcome after implantation of a hip resurfacing endoprosthesis (Birmingham Hip Resurfacing) during the first two years after surgery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical and radiological signs of coxarthritis
  • Implantation of a total hip replacement indicated
  • Informed consent

排除标准

  • Osteoporosis
  • Acute infection
  • Higher grade congenital dysplasia of the hip
  • Pregnancy

结局指标

主要结局

Functional result

Radiological result

Subjective patient outcome

次要结局

  • Perioperative and postoperative complication rate
  • Revision rate

研究者

申办方类型
Other

研究点 (2)

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