A Single Time-Point Study to Evaluate the ConforMIS iTotal® (PS) Knee Replacement System Versus Off-the-Shelf Knee Replacement Systems
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Functional testing differences
研究概览
简要总结
This study is designed to compare outcome data for patients who have recently undergone surgery with the iTotal® Posterior Stabilizing (PS) Knee Replacement System (hereafter referred to as the "iTotal") versus those who have undergone surgery with Off-the-Shelf (OTS) systems.
详细描述
This is a prospective, single-time point study that will be conducted in the US.To compare outcomes of these two study groups, this study will include routine office questionnaires such as the Knee Society Score (KSS) and the Knee Injury and Osteoarthritis Outcome Score (KOOS).The functional testing used in this study consists of tests that physical therapists use daily as objective methods to assess patients' functional status. The testing is designed to closely mimic daily activities with which the subjects are familiar.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
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
- •Implant must be a minimum of 6 months post-op and doing well in the opinion of site staff
- •Subject has had a knee replacement utilizing a fixed bearing PS (Posterior Stabilized) implant design
- •> 18 years of age
- •Willingness to participate in the clinical study, to give informed consent, and to perform all evaluations
排除标准
- •Simultaneous or staged bilateral procedure
- •BMI > 40
- •Other physical disability that requires an aid for walking or disability affecting the hips, spine, contralateral knee or other joint that limits function
- •Participation in another clinical study which would confound results
- •Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons
结局指标
主要结局
Functional testing differences
时间窗: At least 6 months post-surgery
Physical therapy functional testing between the iTotal PS and off-the-shelf PS implants
次要结局
- Knee Society Clinical Rating Score(At least 6 months post-surgery)
- The Knee Injury and Osteoarthritis Outcome Score (KOOS)(At least 6 months post-surgery)