Clinical Outcomes Following Total Joint Replacement With Corin Prostheses : Trinity™ Cup and MetaFix™ Collared Stem
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Corin
- 入组人数
- 51
- 主要终点
- Post operative survivorship of MetaFix Collared Stem at 3-year follow-up
研究概览
简要总结
Assessment of the clinical performance and survivorship of the Corin Total Hip System with Trinity™ cup MetaFix™ Collared stem in a prospective study. The primary endpoint of the study is to evaluate the 3-year survivorship and clinical performance of the Corin Total Hip System using Trinity™ cup and MetaFix™ Collared stem. Additionally, the study follow up will continue until 10 years for subjects who consent to do.
详细描述
The primary objective is the 3-year survivorship of the study devices.
The Secondary Objectives include:
-
The improvement of clinical outcomes:
-
Oxford Hip Score (OHS) up to 10-year follow-up
-
Harris Hip Score (HHS) up to 10-year follow-up
-
Hip disability and Osteoarthritis Outcome Score (HOOS) up to 10-year follow-up
-
Safety performance monitoring including hip- and device-related AEs and the revision rate up to 10-year follow-up
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring a THR
排除标准
- 未提供
结局指标
主要结局
Post operative survivorship of MetaFix Collared Stem at 3-year follow-up
时间窗: 3 years
Survivorship measured via Kaplan-Meier (KM) curve.
次要结局
- Harris Hip Score (HHS) up to 10-year follow-up(Baseline to 10 years)
- Hip- and device-related adverse events up to 10-year follow-up(Baseline to 10 years)
- Oxford Hip Score (OHS) up to 10-year follow-up(Baseline to 10 years)
- Hip disability and Osteoarthritis Outcome Score (HOOS) up to 10-year follow-up(Baseline to 10 years)
- Post operative survivorship of MetaFix Collared Stem at 10-year follow-up(Baseline to 10 years)
- MetaFix Collared Stem radiographic performance up to 10-years(Baseline to 10 years)