A Prospective Comparison of Rotating Platform Cruciate Substituting Total Knee Arthroplasty With Rotating Platform High-Flex Cruciate Substituting Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 主要终点
- Clinical Flexion
研究概览
简要总结
The goal of this study is to determine if the rotating platform high flex design provides improved flexion compared to the standard rotating platform TKA.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 to 75 years old
- •Primary diagnosis of osteoarthritis of the knee
- •Patients who, in the investigator's opinion, are appropriate candidates for a cemented, rotating platform TKA.
- •Patients who, in the investigator's opinion, are capable of participation in a clinical trial and reliable enough to return for follow-up appointments.
排除标准
- •Pregnant or lactating female subjects
- •Patients with post-traumatic or inflammatory arthritis
- •Patients with a fixed flexion contracture of greater than 20 degrees
- •Patients with advanced hip, spine, or ankle disease
- •Patients with a BMI greater than 40, where knee flexion may be limited by soft tissues
研究组 & 干预措施
Rotating Platform High-Flex Cruciate Substituting TKA
干预措施: Rotating Platform High-Flex Cruciate Substituting TKA (Device)
Rotating Platform Cruciate Substituting TKA
干预措施: Rotating Platform Cruciate Substituting TKA (Device)
结局指标
主要结局
Clinical Flexion
时间窗: 1 year
Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.
Clinical Flexion
时间窗: Preoperative, 4-6 weeks
Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.
Clinical Flexion
时间窗: 4-6 months
Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.
次要结局
- Oxford Knee Score(1 year)
- Radiographic Flexion(1 year)
- Knee Society Score (KSS)(1 year)
- Radiographic Flexion(preoperative, 4-6 weeks)
研究者
William G. Hamilton, MD
Principal Investigator
Anderson Orthopaedic Research Institute