Conserve Plus Total Hip Resurfacing System: A Non-Randomized, Multi-center, NewEnrollement Post Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- Clinical success at Month 120
研究概览
简要总结
The objective of this post-approval study is to provide scientifically valid and reliable evidence that supports claims of longer term safety and effectiveness with regard to Month 120 device survivorship rates.
详细描述
This study will evaluate the performance of CONSERVE Plus Hip Resurfacing System under actual conditions of use. Additionally, this study will evaluate the performance of the device in the post approval environment to see if there are any significant changes in device performance as compared to the pre-market IDE Study
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
- •Was previously enrolled in the CONSERVE® Plus IDE as part of the All Enrolled Audited Cohort (N=1366 procedures (1206 patients)) and received the "Original Shell".
- •Is willing and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.
排除标准
- •Patient is mentally incompetent.
- •Patient is a prisoner.
- •Patient is an alcohol and/or drug abuser
- •Patient has undergone device revision or removal
结局指标
主要结局
Clinical success at Month 120
时间窗: 10 years
Clinical success at Month 120 for each patient will be survivorship, defined as freedom from revision or removal for any aseptic reason and at least "good" function/pain relief defined as Harris Hip Score ≥ 80.
次要结局
- Radiographic outcomes(10 years)
- Metal Ion (serum)(24 months)
- Measurement of Patient Satisfaction(10 years)
- Assessment for Adverse Events(10 years)