NCT06465940已完成不适用
Observational Ambispective Study on HYPE Cups Associated With HIPER Liner
Societe dEtude, de Recherche et de Fabrication1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2020年7月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Functional score
研究概览
简要总结
This study intend to collect data on total hip arthroplasty performed with HYPE cups used with conventional polyethylene liner (HIPER).
Medical Device Regulation 2017/745 regulation required proper clinical data to support claims. This study is therefore intended to provide data on HYPE devices to comply with Medical Device Regulation2047/745 regulation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient was an adult at surgery,
- •Patient implanted with HYPE® acetabular cup and HIPER liner,
- •Patient was followed-up at least once on retrospective part of the study,
- •Patient's current social security affiliation is valid.
排除标准
- •Patient refuses the use of his/her personal data,
- •Patient is unable to follow surgeon's instruction or unavailable for follow-up,
- •Patient with contraindication to x-rays,
- •Patient not implanted with HYPE® acetabular cup and HIPER liner.
结局指标
主要结局
Functional score
时间窗: per operative period to at least 2 year
The information will be collected through questionnaires to compare preoperatively situation to last follow-up situation
次要结局
- Patient satisfaction(per operative period to at least 2 year)
- Safety adverse event(per operative period to at least 2 year)
- Survival rate(per operative period to at least 2 year)
研究者
研究点 (1)
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