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)
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
- 否
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
