Longterm Clinical Outcome Study of the Femoral Cementless Ti/HA Polarstem - A Multicenter Retrospective 10-years Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 502
- 试验地点
- 5
- 主要终点
- Femoral stem revision rate at 10 years for any reason
研究概览
简要总结
The primary purpose of this study is to demonstrate the POLARSTEM™ Ti/HA cumulative femoral stem revision rate at 10 years.
The secondary purpose of this study is to provide 10 years of safety and effectiveness data of POLARSTEM™ Ti/HA in terms of radiographic and clinical performance
详细描述
This is a multicenter retrospective longterm clinical outcome study conducted in up to 6 hospitals in France. 502 subjects who have undergone THA with POLARSTEM™ from 2002 to 2005 will be enrolled in this study and clinical and radiographically followed up for at least 10 years. Subjects who have not reached the 10-year post surgery timepoint will be invited to a 10-year post-operative follow-up visit to obtain the clinical and radiographic outcome measures.
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
- •Subject required and received primary total hip arthroplasty between 2002 and
- •Subject received the POLARSTEM™ Ti/HA unilateral or bilateral, due to severe hip joint damage resulting from arthrosis, degenerative disease, traumatic events, inflammatory or rheumatoid processes.
- •Subject received the non-cemented POLARSYSTEM (POLARSTEM™ Ti/HA in combination with POLARCUP™).
- •Subject was aged between 18 and 75 at time of surgery.
- •Signed Informed Consent (ICF).
排除标准
- •Subject received the cemented POLARSTEM™.
- •Previously failed endoprosthesis and/or THR components in relevant hip.
- •Medical or mental health conditions which could impair the stubject's ability or willingness to comply with the study.
结局指标
主要结局
Femoral stem revision rate at 10 years for any reason
时间窗: since surgery until 10 years Follow Up
Long term cumulative femoral stem revision rate of Polarstem will be evaluated in 502 subjects
次要结局
- Number of subjects with revision of any components for any reason(date of surgery until 10 years Follow Up)
- Adverse Events(through study completion, an average of 10 years)
- Standard radiographic assessment at least at 10 years(date of surgery and at 10 years Follow Up)
- Merle D'Aubigné and Postel (MAP) at least at 10-year assessment(pre-operative and at 10 years Follow Up)
- Hip Disability and Osteoarthritis Outcome Score (HOOS) at least at 10-year assessment as patient reported outcome (PRO(at 10 years Follow Up)