NCT02049892已完成不适用
A Comparison of Large Diameter Metal Heads vs. Small Diameter Metal Heads vs/ Dual Mobility Total Hip Replacements
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Metal Ion levels
研究概览
简要总结
Does having a large diameter metal on polyethylene total hip replacement increase metal ion release. Larger metal heads are thought to have increased torsional forces on the trunion which would like release more metal ions. Increased metal ion levels have been associated with adverse local tissue reactions. Are there any differences comparing these groups to a dual mobility type total hip replacement.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One total hip replacement, either a large metal head (>40) or a small metal head (<30) on a polyethylene bearing surface.
- •2 to 5 years s/p surgery minimum. No symptoms
排除标准
- •Any other bearing surface besides metal on poly, no other joint replacements, symptomatic
结局指标
主要结局
Metal Ion levels
时间窗: 2 years
We would like to determine a difference in metal ion levels on metal on polyethylene total hip replacement
次要结局
未报告次要终点
研究者
研究点 (1)
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