NCT02188095进行中（未招募）不适用
Post Market Clinical Follow-Up Study of Excia T® Hip Prosthesis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Aesculap AG
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Survival Rate of the Implant
研究概览
简要总结
Clinical and radiological 10 year results of Excia T® Hip Stem
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient gave written informed consent
- •age ≥ 18 years
排除标准
- •pregnancy
结局指标
主要结局
Survival Rate of the Implant
时间窗: 10 years
Kaplan-Meier Survival Rate up to 10 years
次要结局
- Change of functional outcome over follow-up period (Harris Hip Score (HHS))(at discharge, after 3 and 12 months 3, 5 and 10 years)
- Hip disability and Osteoarthritis Outcome Score (HOOS)(preoperatively, intraoperatively + discharge, after 3 and 12 months 3, 5 and 10 years)
- Stress Shielding(10 years)
- Pain Assessment(at 6 examinations during follow-up (discharge, after 3 and 12 months and 3, 5, and 10 years))
- Hypertrophies(10 years)
- Shaftposition ap and lateral(10 years)
研究者
研究点 (2)
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