Ceramic on Metal Total Hip System, CoMplete™ Acetabular Hip System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 58
- 试验地点
- 8
- 主要终点
- Survivorship
研究概览
简要总结
The primary objective of this investigation is to evaluate survivorship at ten years. For this post approval study (PAS), a maximum acceptable hazard of revision is assumed to be a constant 1% per year.
详细描述
This is a retrospective and prospective, non-randomized study of the Ceramic on Metal(CoM) device. This study will follow each subject through 10 years postoperatively. A total of 250 subjects will be enrolled in the investigation comprised of approximately 150 new PAS subjects and approximately 100 subjects recruited from the investigational device exemption study to the PAS.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •If the subject:
- •Was previously enrolled in the CoM IDE study with the Ceramic-on- Metal device, or
- •Qualifies based on the approved labeling for the device; and
- •Is willing and able to provide informed patient consent for participation in the PAS study; and
- •Is willing and able to return for follow-up as specified by the PAS study protocol; and
- •Is willing and able to complete the hip outcomes questionnaire as specified by the PAS study protocol. A patient will be considered a "Valid Study Subject" when he/she has
- •consented to participate,
- •authorized release of Personal Health Information (PHI),
- •met all eligibility criteria through the operative stage, and
- •received the implant as noted in this protocol.
排除标准
- •Subjects will be excluded if, in the opinion of the investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion criteria.
结局指标
主要结局
Survivorship
时间窗: 10 years
Subjects will be seen each year through year 5 postoperatively for radiographic and clinical follow-up, and then at 8 and 10 years postoperatively for radiographic and clinical follow-up. Survivorship means the removal of either or both of the components (ceramic head or metal liner).
次要结局
- Metal Ion Levels(5 years, 8 years, and 10 years postoperatively)