NCT02648152已完成不适用
Multicenter Clinical Observation Using the Cementless Version of the POLARSTEM
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 3
- 主要终点
- Long term survivorship of Polarstem
研究概览
简要总结
Multicenter observational study to validate that the POLARSTEM™ is a state-of-the-art implant in terms of radiographic, clinical performance and long-term survivorship.
详细描述
The goal of this multicenter clinical observation is to validate short-, mid-, and long-term outcome (efficacy and safety) of the POLARSTEM™.
Efficacy evaluations:
- Evaluation of function, range of motion (ROM) and pain as assessed by Harris Hip Score, Hip disability and osteoarthritis outcome score (HOOS) [7, 8], an extension of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
- Radiographic changes as defined by radiolucent lines, osteolysis, hypo- and hypertrophy, implant loosening or migration
Safety evaluations:
- Intra- and perioperative device-related adverse events (AE) and complications up to discharge
- Postoperative AE up to 10 years
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has no general medical contraindication to surgery
- •Informed consent to participate in the MCO signed by the patient
- •Routine radiographic assessment is possible
- •Patient is likely to comply with study follow-up requirements
- •Primary total hip replacement (THR) to the affected side, unilateral or bilateral
排除标准
- •Previously failed endoprosthesis and /or THR components in relevant hip
- •History of infection in the affected joint; systemic infections
- •Grossly insufficient femoral or acetabular bone stock in the involved hip
- •Charcot joint disease or other severe neurosensory deficit
- •Severe spinal disorders
- •Age of patient at date of surgery > 75 years
- •High comorbidity
- •Cemented acetabular cup
结局指标
主要结局
Long term survivorship of Polarstem
时间窗: 10 years Follow Up after surgery
Long-term survivorship will be calculated according to Kaplan-Meier with stem revision due to any reason as endpoint
次要结局
未报告次要终点
研究者
研究点 (3)
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