Function, Pain, and Alignment Following Knee Replacement for the Treatment of Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 261
- 试验地点
- 2
- 主要终点
- Function
研究概览
简要总结
There are many factors that can influence patient satisfaction and patient related outcomes following total knee replacement including the surgical alignment of the joint components. Historically, total knee replacements have been performed with an aim aiming to achieve neutral alignment or a mechanical weight axis in the lower extremity . However, only 0.1 % of the population have a pre-surgical anatomical neutral alignment, and therefore the constitutional anatomy of the patient is neglected. There is a growing trend to return patients back their anatomical constitutional alignment after a knee replacement, referred to as Kinematic Alignment using robotics. The aim of this randomized controlled trial is to examine how mechanical alignment and kinematic alignment impacts function, pain, mood and fatigue following TKR for the treatment of osteoarthritis. Outcomes will be measured at 6 week, 6 months, 1 year and 2 years after surgery.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing unilateral TKR for the treatment of osteoarthritis
- •between the age of 18 and 85 years of age
- •able to read, speak and understand English, have a telephone
- •are able to provide consent
排除标准
- •enrolled in another study, are
- •undergoing revision surgery or bilateral surgery, and are
- •over the age of 85 years. Patients will also be excluded if they
- •have a cognitive impairment (as indicated in the medical record) affecting their ability to comprehend the questions being asked
结局指标
主要结局
Function
时间窗: post-operatively 1 year
Oxford knee score
次要结局
- Function(post-operatively at 2 years)
- Pain intensity and effectiveness of analgesics(Post-operatively at 2 years)
- Quality of Life following knee surgery(post-operatively at 1 year)
- Satisfaction with knee surgery(Post-operatively at 2 years)
研究者
Mary Rahmat
Clinical Trials Manager
North York General Hospital