Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prothesis System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 185
- 试验地点
- 12
- 主要终点
- Survivorship
研究概览
简要总结
This study is intended to gather medium (0-5 years) and long-term (6-10 years) information regarding the performance and safety of the commercially available Ceramax™ Ceramic on Ceramic Total Hip System. This is a two-phased study consisting of a clinical follow-up phase and a clinical outcomes phase.
In Phase One (0-5 years), diagnostic, demographic and operative information will be gathered for each subject enrolled in this study. In addition, Harris Hip Evaluations, subjective evaluations and radiographs will be completed annually.
In Phase Two (6 - 10 years), a subjective outcomes questionnaire and a SF-12 Health Survey will be mailed to subjects annually.
详细描述
This is a prospective, non-randomized study of the 28mm Ceramic on Ceramic (COC) device. This study will follow each subject through 10 years postoperatively and will consist of:
- a clinical follow-up phase and
- a clinical outcomes phase.
Radiographic and clinical follow-up exams will take place at six-weeks, six-months and then annually through year 5 for each subject. For years 6 - 10, a communication will be sent to each subject in order to collect survivorship and general health information. This communication will ask whether the COC device is still in vivo and, if not, when the revision surgery took place, why, and which components were removed, if applicable. In addition, subjects will be asked to complete a SF-12 Health Survey at each 6 to 10-year follow-up interval. A self-addressed, stamped envelope will be provided to facilitate information return and privacy.
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 who were previously enrolled in the COC28 IDE study, or
- •Newly recruited individuals who are qualified based on the approved labeling of the device, and;
- •Individuals who are willing and able to provide informed patient consent for participation in the study;
- •Individuals who are willing and able to return for follow-up as specified by the study protocol; and
- •Individuals who are willing and able to complete the Hip Outcomes questionnaire and SF-12 Health Survey as specified by the study protocol
排除标准
- •In the opinion of the Investigator, the individual does not qualify based upon approved labeling requirements.
结局指标
主要结局
Survivorship
时间窗: 10 years
The primary outcome measure is that the 10-year Kaplan-Meier survivorship estimate of the COC 28mm implanted hips will be a minimum of 90% (as recommended by National Institute of Clinical Excellence \[NICE\]). Based on an anticipated margin of error (ie. one-half the width of the confidence interval) of 7%, the lower 95% confidence interval will be no worse than 83%.
次要结局
- Harris Hip Score(5 years)
- Radiographic(5 years)
- Survivorship(5 years)