NCT00867256终止不适用
Large Diameter Metal-on-Metal Total Hip System IDE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Corin
- 入组人数
- 195
- 主要终点
- Composite clinical criterion
研究概览
简要总结
To demonstrate the safety and efficacy of the Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System using a composite clinical success (CCS) primary endpoint.
详细描述
The results from the Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System cohort will be compared to the historical results from a ceramic on ceramic (CoC) hip system cohort. The primary endpoint clinical composite success (CCS) criterion at 24 months postoperative is based on a Harris Hip Score ≥ 80 and the absence of any revision,replacement, or modification of any study component.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •is skeletally mature
- •is mentally capable of completing follow-up forms
- •will be available for follow-up out to 2 years
- •has a preoperative Harris Hip Score <70 points
- •has been deemed a candidate for hip replacement by diagnosis of the investigator.
排除标准
- •has active joint infection
- •has had previous hip arthrodesis (fusion)
- •has had above knee amputation of either extremity
- •has active neoplastic disease
- •has a need for a structural bone graft in the operative side
- •has an ipsilateral hemi or total arthroplasty of any kind
- •has a nonunion or malunion of any part of the femur on operative side
- •has severe osteoporosis of the pelvis and/or femur as noted on standard radiograph
- •is a prisoner
- •is pregnant
- •is known to be allergic to implant materials
- •is morbidly obese.
结局指标
主要结局
Composite clinical criterion
时间窗: 24-months postoperative
Based on Harris Hip Score ≥ 80, and absence of any revision, replacement, or modification of any study component
次要结局
未报告次要终点
研究者
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