NCT00285974已完成不适用
Dosage of Metal Ions in the Blood of Different Metal-on-metal Prostheses, in Correlation With Physical Activity
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Concentration of metal ions in the blood
研究概览
简要总结
Prospective study including 6 groups of 20 patients with a total hip prosthesis. Five different types of metal-on-metal prostheses are studied, and 1 group with ceramic-on-ceramic prostheses acts as control group. Patients undergo a clinical evaluation and blood sampling preoperatively, and 3, 6, 12 and 24 months postoperatively.
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hip osteoarthritis
排除标准
- 未提供
研究组 & 干预措施
hip prosthesis
Experimental
干预措施: metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis (Device)
结局指标
主要结局
Concentration of metal ions in the blood
时间窗: preoperatively, and 3, 6, 12 and 24 months postoperatively.
次要结局
未报告次要终点
研究者
研究点 (1)
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