NCT00721994已完成不适用
Cormet Resurfacing Hip System Post PMA Approval Study (PMA #P050016)Pre-market (IDE) Study Group 10 Year Follow-Up With Metal Ion and Renal Function Data Collection Clinical Investigation Plan
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Corin
- 入组人数
- 231
- 试验地点
- 5
- 主要终点
- to monitor the clinical performance of the Cormet implant system for a period of up to 10 years postoperative in order to confirm that there are no unexpected reductions in device performance following PMA approval
研究概览
简要总结
primary endpoint of this Study is maintenance of "at least good clinical status" for a period of 10 years following initial implantation among Cormet procedures enrolled inthe pre-market IDE.
详细描述
Maintaining "at least good clinical status" will be determined based upon the composite clinical success (CCS) criterion which includes no revision, removal, or replacement of any device component and a Harris Hip Total score of greater or equal to 80 points.
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
- •subjects enrolled in the Cormet IDE study at the 5 identified clinical sites
- •Individuals who agree to participate in the study by signing the informed patient consent form
排除标准
- 未提供
结局指标
主要结局
to monitor the clinical performance of the Cormet implant system for a period of up to 10 years postoperative in order to confirm that there are no unexpected reductions in device performance following PMA approval
时间窗: 10 years
次要结局
- device survival(10 years)
- device related adverse events(10 years)
- radiographic evaluation including radiolucencies, component migration, and femoral subsidence and tilt(10 years)
- Harris Hip Score components including total score, pain, function and range of motion(10 years)
- whole blood trace metals and renal function(10 years)
研究者
研究点 (5)
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