Post-Market Study: The Efficacy of the 3DKnee™ System vs. the MJS Knee System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- The survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System
研究概览
简要总结
The purpose of this study is to compare the survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System in a group of 600 patients for whom data collection is already under way.
详细描述
The purpose of this study is to compare the survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System in a group of 600 patients for whom data collection is already under way. Approximately 300 patients have already received the MJS™ knee system and data, as described below, has been collected for these patients over a period of two years. A second group of 300 patients will receive the Encore 3DKnee™ system over the next two years, and equivalent data will be collected for these individuals. A portion of the data has been collected over the past year, and now we would like to obtain permission from the patients to analyze these data as well as collect an additional year of data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •This must be a primary knee replacement on this knee.
- •Patient is over 18 years of age or older
- •Patients must have one of the following
- •rheumatoid or traumatic arthritis OR
- •joint disease secondary to osteoarthritis
- •Patient is likely to be available for evaluation for the duration of the study
- •Able and willing to sign the informed consent and follow study procedures
- •Patient is not pregnant
排除标准
- •Is younger than 18 years of age
- •If there has been a total knee replacement on this knee in the past (no revisions allowed in study)
- •Overt infection
- •Alcoholism or other addictions
- •Muscular, neurological or vascular deficiencies which compromise the affected extremity
- •Marked bone loss
- •Materials sensitivity
- •Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements
- •Patient is pregnant
结局指标
主要结局
The survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System
时间窗: 2 year
次要结局
未报告次要终点