Study of the Wear of a Highly Cross-linked Polyethylene Acetabular Doped With Vitamin E and Coated With Titanium in Total Hip Replacement
试验速览
- 阶段
- 不适用
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- penetration of the metal femoral head in acetabular
研究概览
简要总结
The total hip replacement, with over 120,000 cases per year in France, provides short term, excellent functional results and a significant improvement in quality of life, in almost all cases. However, the observation has shown that the lifetime of the implants is limited due to aseptic loosening. One of the factors associated with these failures is a peri-prosthetic osteolysis wherein the polyethylene wear debris (PE) have been implicated. Several solutions have been proposed: change the friction torque (hard-hard pairs using ceramic or metal on the two components of the couple) or improving quality polyethylene. Improving the resistance of polyethylene wear is the primary objective evaluated in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged men and women 18 to 75 years
- •with a primary or secondary osteoarthritis or osteonecrosis
- •having a functional disorder requiring the installation of a total hip prosthesis of primary
排除标准
- •patients aged 76 years or more
- •pregnant or desiring to be for the duration of the study
- •minors or adults protected
- •repeated hip replacement
- •cephalic prosthesis recovery or intermediate
- •repeated cupules
- •primary or secondary malignant tumor of the hip
结局指标
主要结局
penetration of the metal femoral head in acetabular
时间窗: 2 years
head penetration in milimeters
次要结局
未报告次要终点