A Single Time-Point Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System Versus Off-the-Shelf Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 873
- 试验地点
- 16
- 主要终点
- Functional Outcome time differences between the two groups
研究概览
简要总结
It has been noted that patients "dramatically overestimate their functional ability early after surgery." Despite use of assistive devices increasing and functional testing scores decreasing post-surgery, the patient reported outcome scores fail to show worsening. Outcome questionnaires will be administered and functional testing will be conducted on all patients to capture these changes.
详细描述
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 that the patients are familiar with.
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 at least 6 months post-op and doing well
- •Patient has had a total CR knee implant
- •> 18 years of age
排除标准
- •Simultaneous bilateral procedure occurred
- •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 Outcome time differences between the two groups
时间窗: at least 6 months post-op
The study primary endpoint is to compare functional testing time between patients implanted with the iTotal implant verses the off-the-shelf implants
次要结局
- Outcomes questionnaire- Knee Society Score(At least 6 months post op)
- Outcomes questionnaire- KOOS(At least 6 months post op)
- Outcomes questionnaire- Forgotten Joint Score(At least 6 months post op)