NCT02019433终止不适用
Post Market Clinical Follow-Up of Acetabular Titan-Augment Structan®
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Aesculap AG
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Implant Survival Rates
研究概览
简要总结
Implant Survival as well as clinical and radiological Follow-Up of acetabular Titan-Augment Structan®
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 hip arthroplasty with acetabular defects that need Allograft or titanium augment
- •Patient consent for study participation
- •Physical and mental willingness to participate in the follow-ups
排除标准
- •Patient not available for follow-up
- •Increased anesthetics risks for the patient according to the "American Society of Anesthesiology": ASA IV
- •Alcohol- or Drug abuse
- •Permanent cortisone therapy
- •Clinically relevant infection
- •(Planned) pregnancy
结局指标
主要结局
Implant Survival Rates
时间窗: 12 months
Implant survival is analysed at follow-up examinations at 3 and 12 months
次要结局
- Pain(3 and 12 months)
- Implant Position(3 and 12 months)
- Osteolysis(3 and 12 months)
- Ossifications(3 and 12 months)
- Clinical Outcome(3 and 12 months)
- Migration of Structan®(3 and 12 months)
研究者
研究点 (3)
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