Total Knee Replacement Using Standard Knee Cutting Guides vs Otismed MRI Generated Cutting Guide
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Patient scores on Oxford, Womac, and Knee Society scores
研究概览
简要总结
Patients are referred to the VA orthopedic surgical clinic because of osteoarthritis and are requesting consideration for a total knee replacement. Those who qualify for the knee replacement are informed about the study. Those who consent to participate are randomly assigned to either the standard cutting guide or to the new method which is a MRI generated cutting guide called Otismed. All patients have an MRI so both groups will be unaware of which surgical technique is used. All patients receive the usual pre-op care and same type of replacement knee. Follow-up research visits are scheduled at 4 weeks, 3 and 6 months, and 1 and 2 years. Patients will be informed of which surgical technique they were randomized to at the conclusion of the study.
详细描述
Objective(s):
Primary:
Compare the surgical and clinical outcomes between patients receiving total knee replacement after random assignment to one of two groups:
- surgical procedure with the standard knee cutting guide and
- surgical procedure with the Otismed MRI generated cutting guide
Secondary:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All Veterans that are referred to orthopedics surgical clinic for a total knee replacement for osteoarthritis and meet study criteria will be invited to participate.
排除标准
- •Patients who have undergone osteotomy, had previous healed tibia or femur fractures, previous joint replacement surgery or cannot have an MRI will be excluded.
结局指标
主要结局
Patient scores on Oxford, Womac, and Knee Society scores
时间窗: 4 week, 3 mo. 6 mo. 1 yr. 2 yr.
次要结局
- Leg alignment based on Long Leg CT scans(Post-op)