Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Gait Stride Length
研究概览
简要总结
The goal of this study is to provide gait parameters as a new objective method to assess total knee arthroplasty outcome between patients with fixed- and mobile-bearing, using an ambulatory device with minimal sensor configuration.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from a primary unilateral knee osteoarthritis and requiring a knee replacement
- •Informed consent
排除标准
- 未提供
结局指标
主要结局
Gait Stride Length
时间窗: 5years
distance in meters of gait stride lenght measured by a data logger with five inertial sensors
EuroQoL Quality of Life Scale (EQ-5D)
时间窗: 5years
The EQ-5D is a measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Part I of the scale consists of 5 single-item dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a 3 point response scale designed to indicate the level of the problem. Part II uses a vertical graduated VAS (thermometer) to measure health status, ranging from worst imaginable health state to best imaginable health state. T. Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Part II is scored from 0 (worst health state imaginable) to 100 (best health state imaginable). The score from Part II can be used to track changes in health, on an individual or group level, over time.
次要结局
- Semi-objective Evaluation Knee Sciety Score (KSS) Clinical Outcome Measures(5years)
- Number of Participants With Dislocation(5years)
研究者
Brigitte Jolles, MD
Prof
University of Lausanne Hospitals