NCT02846636暂停不适用
Prospective, Multicentric, Non-controlled, Non-randomized Clinical Survey to Evaluate Mpact Cup Performance After Total Hip Arthroplasty
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- implant survival trough Kaplan-Meier curve
研究概览
简要总结
The main objective of this study is to evaluate the 10 year performances of Mpact cup in total hip arthroplasty.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •patients requiring a total hip replacement who meets the standard indications for use for Medacta implants
- •patients who accept to participate in the study
- •patients who signed the consent form for the treatment of personal data
排除标准
- •patients presenting conditions identified as contraindication for Medacta implants
- •revision surgeries
结局指标
主要结局
implant survival trough Kaplan-Meier curve
时间窗: 10 years
次要结局
- implant stability trough assessment of presence of radiolucencies(3/6 months, 1, 3, 5, 7, 10 years)
- record of adverse events(intraop, 3/6 months, 1, 3, 5, 7, 10 years)
- hip function with Harris Hip Score(preop, 3/6 months, 1, 3, 5, 7, 10 years)
研究者
研究点 (1)
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