Observational Study to Collect Safety Data and Patient-reported Outcomes Measures (PROMs) on Retrospective Primary Total Hip Arthroplasty Surgeries With Trinity Cup and Meije Duo Cementless Hip Stem
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Corin
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Evaluation of hip functional performance
研究概览
简要总结
This observational study is designed to collect safety data and PROMs on retrospective primary total hipa arthroplasty surgeries with Trinity cup and Meije Duo cementless hip system
详细描述
The major goal of this study is to collect safety and patient-reported outcomes measures (PROMs) data on Trinity cup in combination with Meije Duo cementless hip stem when used in primary total hip arthroplasty (THA).
Data collected from this study will be fed into the Post-Market Surveillance (PMS) and Clinical Evaluation processes of the devices under assessment annually and support presentations at orthopaedic congresses and/or peer-reviewed publication(s) on mid- and long-term safety and clinical performance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Both genders.
- •Adult subjects.
- •Subjects who received a primary THR with Trinity cup and Meije Duo cementless femoral stem.
- •The subject is willing to comply with the required follow-up visits as per protocol.
- •The subject has signed a Patient Informed Consent Form (PICF), specific to this study, and approved by the local EC.
排除标准
- •Subjects under guardianship.
- •Subjects in the opinion of the Investigator/ investigative team who will be unable to comply with study procedures (Examples: recent psychotic or mania disorders, alcohol, drug or substance abusers) and/or those unable for any medical or other reason to comply with study procedures/visits.
结局指标
主要结局
Evaluation of hip functional performance
时间窗: 2 years
Improvement of Oxford Hip Score (OHS)
次要结局
- Evaluation of outcome after hip arthroplasty(2 years)
- Evaluation of clinical outcomes(2 years)
- Assessment of health-related quality of life(2 years)
- Assessment of patient's satisfaction(2 years)
- Confirmation of safety of the study devices(2 years)