NCT04255966进行中（未招募）不适用
Prospective, Multi-centric, Comparative, Long-term Clinical Follow-Up Study for the Evidence of Safety and Performance Indicators of the Plasmafit® Revision Structan® Hip Endoprosthesis Cup
适应症
干预措施
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
- 60
- 试验地点
- 8
- 主要终点
- Harris Hip Score (Functional results of the operated hip) over time
研究概览
简要总结
The aim of this observational study is to collect clinical and radiological results of the new Plasmafit® Revision Structan® Hip Endoprosthesis Cup in a standard patient population and when used in routine clinical practice.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Plasmafit® Revision Structan®
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
干预措施: Plasmafit® Revision Structan® (Device)
结局指标
主要结局
Harris Hip Score (Functional results of the operated hip) over time
时间窗: up to five years postoperatively
The functional results of the operated hip will be assessed with the Harris Hip Score (HHS) and evaluated over time
次要结局
- Radiological Assessment: Osseointegration of the cup over time(at 3 months, 24 months, 5 years follow-up)
- Impingement(Intraoperative)
- Complications(up to 5 years postoperatively)
- Technical problems during surgery(Intraoperative)
- Quality of Life over time(up to five years postoperatively)
- Radiological assessment: Radiographic loosening of the cup over time(at 3 months, 24 months, 5 years follow-up)
- General handling of instruments / containers(Intraoperative)
- Survival of the implant(up to five years postoperatively)
研究者
研究点 (8)
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