NCT02367417进行中（未招募）不适用
Prospective Clinical 5-year Follow-up of the LINK® Endo-Model® SL® Rotational and Hinge Knee Prosthesis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 61
- 试验地点
- 3
- 主要终点
- KOOS
研究概览
简要总结
The objective of this study is to collect outcome information on patients requiring Total Knee Replacement (TKR) in primary or revision cases and therefore receiving the LINK® Endo-Model® SL® under routine conditions.
详细描述
Post Market Clinical Follow-ups (PMCF) through observational investigations are an important tool to detect infrequent complications or problems, events specific to defined patient populations and long term performance issues under routine condition. Against this background a prospective multi-center study with the LINK® Endo-Model® SL® will be conducted.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
KOOS
时间窗: 1 yr, 3 yrs and 5 yrs
Knee Injury and Osteoarthritis Outcome Score
次要结局
- KSS(at 3 months, 1 year and 5 years)
- Prosthetic Survival Rate(up to 5 years)
- Complications(At each Follow-up, up to 5 years)
- Rate of subsequent surgical interventions(At each Follow-up, up to 5 years)
研究者
研究点 (3)
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