NCT02019849已完成不适用
Post Market Clinical Follow-Up of Plasmafit® Cup
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Implant Survival Rates
研究概览
简要总结
Twelve months follow-up of implant survival and clinical and radiological follow-up of Plasmafit® Cup.
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
- •Minimum age 18 years
- •Indication for cementless total hip arthroplasty
- •Patient consent for study participation
- •Physical and mental willingness to participate at clinical and radiological follow-up
排除标准
- •Patient not available for follow-up
- •Increased anesthetics risks according to the "American Society of Anesthesiology": ASA IV
- •Alcohol or drug abuse
- •Permanent cortisone therapy
- •Clinically relevant infection
- •Pregnancy or planned pregnancy
- •Prior interventions like osteotomy, fracture treatment or prior THA at the concerned hip
- •Acute fracture at the concerned hip
- •Patients needing a cemented hip arthroplasty
结局指标
主要结局
Implant Survival Rates
时间窗: 10 years
Implant survival is analysed at follow-up examinations at 3 months, 12 months, 5 years and 10 years
次要结局
- Implant Position(3 months, 12 months, 5 years, 10 years)
- Migration of Plasmafit®(3 months, 12 months, 5 years, 10 years)
- Clinical Outcome(3 months, 12 months, 5 years, 10 years)
- Osteolysis(3 months, 12 months, 5 years, 10 years)
- Ossifications(3 months, 12 months, 5 years, 10 years)
研究者
研究点 (2)
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