A Clinical Evaluation of Metal Ion Release From Metal-on-Metal Cementless Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- concentration of Cobalt, Chromium and Molybdenum ions in urine
研究概览
简要总结
A clinical Evaluation to determine metal ion release from 4th generation metal-on-metal hip articulating surfaces in cementless total hip arthroplasty.
详细描述
This evaluation is being conducted to investigate the extent of metal ion release and its incorporation into the surrounding tissue resulting from metal on metal articulating surfaces in cementless total hip arthroplasty.
The amount of metallic ions released post operatively will be assessed by the concentration of Cobalt, Chromium and Molybdenum present in urine and analysed by I.C.P.M.S. (Inductive Coupled Plasma Mass Spectroscopy). The amounts of metallic ions released will be related to the hip function and range of motion measured pre-operatively and post-operatively. Secondary performance of the metal-on-metal articulation will be determined by radiographic evaluation and incidence of complications / revision rates.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects selected for this Evaluation will be grouped by initial diagnosis into one of the following diagnostic groups:
- •Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and traumatic arthritis.
- •Rheumatoid arthritis.
- •Selection of subjects for this Evaluation should include the following considerations:
- •Patients under 70 years of age.
- •Willing to return for follow-up evaluations.
- •No bias to sex.
排除标准
- 未提供
结局指标
主要结局
concentration of Cobalt, Chromium and Molybdenum ions in urine
时间窗: various follow-up visits
次要结局
- harris Hip Score, oxford hip, WOMAC and SF-12(various follow-up visits)