Outcomes of Rotating Platform Versus Mobile Bearing Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Change in Overall Health Status over time
研究概览
简要总结
Patients were randomly assigned to a fixed bearing or rotating platform of two prostheses. A subsequent study (the one retrospectively registering the original study) asked these patients a series of questions from published questionnaires to assess long term outcomes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis
- •Rheumatoid or other inflammatory arthritis
- •Post-traumatic arthritis
- •Juvenile rheumatoid arthritis
- •Avascular necrosis
排除标准
- •History of recent/active joint sepsis
- •Charcot neuropathy
- •Psycho-social disorders that would limit rehabilitation
- •Metabolic disorders of calcified tissues, such as Paget's disease
- •Joint replacement due to autoimmune disorders
- •Skeletal immaturity
- •Ligamentous laxity requiring a constrained prosthesis
结局指标
主要结局
Change in Overall Health Status over time
时间窗: Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20.
Medical Outcomes Study Short Form -36 Health Survey (SF-36)- A 36 item questionnaire to assess overall health.
Change in Functional Status over time
时间窗: Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20.
Knee Society Clinical Rating Scale
Change in Osteoarthritis Status over time
时间窗: Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20.
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)- A 24 item questionnaire to assess pain, stiffness, and physical function in patients with hip or knee osteoarthritis divided into 3 subscales: Pain (5 items), Stiffness (2 items), Physical function (17 items)
次要结局
- Change in Satisfaction of Knee over time(Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20.)
研究者
William Hopkinson
Professor, Vice Chairman of Orthopaedic Surgery and Rehabilitation
Loyola University