NCT01176292已完成不适用
A Prospective Comparison of Rotating Platform Cruciate Substituting Total Knee Arthroplasty With Rotating Platform High-Flex Cruciate Substituting Total Knee Arthroplasty
适应症
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
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.
次要结局
- Oxford Knee Score(1 year)
- Radiographic Flexion(1 year)
- Knee Society Score (KSS)(1 year)
研究者
William G. Hamilton, MD
Principal Investigator
Anderson Orthopaedic Research Institute
相似试验
已完成
不适用
Vanguard Complete Knee Versus Vanguard High Flex Rotating Platform (RP) Knee StudyTraumatic ArthritisRheumatoid ArthritisOsteoarthritisNCT01010269Zimmer Biomet300
已完成
不适用
Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKAPost-traumatic ArthritisRheumatoid ArthritisOsteoarthritisAvascular Necrosis of BoneJuvenile Rheumatoid ArthritisNCT00289094DePuy Orthopaedics99
已完成
不适用
Randomized Fixed Bearing vs Mobile Bearing Cruciate Substituting TKAOther Inflammatory ArthritisRheumatoid ArthritisOsteoarthritisJuvenile Rheumatoid ArthritisPost-Traumatic ArthritisAvascular NecrosisNCT00289107DePuy Orthopaedics149
已完成
不适用
Anteroposterior glide versus rotating platform low contact stress knee arthroplastyMusculoskeletal DiseasesArthitisOsteoarthritisISRCTN52943804niversity Hospital of North Staffordshire NHS Trust (UK)50
Unknown
不适用
Outcomes of Rotating Platform Versus Mobile Bearing Total Knee ArthroplastyTotal Knee ArthroplastyNCT03731676William Hopkinson250