Evaluation of Locomotor Activity Before and After Total Hip Replacement in Patients With Hip Osteoarthritis. Use of Ganglion and Neural Network Techniques to Identify Objective Criteria for the Success of Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Degree of patient statisfaction
研究概览
简要总结
The investigators believe that the application of non-linear methods of analysis using the ganglion and neural network technique will make it possible to analyse all of the complex data obtained in patients with hip osteoarthritis before and then after total hip replacement, and should allow us to identify a combination of objective variables to classify the surgery as " successful " or " unsuccessful ".
To this end, the study will take place as follows:
Step 1: Screening, and inclusion. Step 2: Evaluation of the hip osteoarthritis and analysis of locomotor activity Step 3: Total hip replacement Step 4: Clinical evaluation of locomotor activity carried out between 6 months and 1 year after the THR Step 5: Data analysis
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Control group:
- •Subjects who have provided written informed consent
- •Subjects covered by the national health insurance scheme
- •Men or women aged between 25 and 85 years
- •able to understand simple instructions and packaging instructions and able to give informed consent
- •Patients group:
- •Patients who have provided written informed consent
- •Patients covered by the national health insurance scheme
- •Men or women aged between 25 and 85 years
- •able to understand simple instructions and packaging instructions and to give their informed consent
- •Suffering from hip osteoarthritis defined according to ACR criteria
- •Most recent radiography examination less than 6 months earlier
- •Radiological stage II, III or IV hip osteoarthritis according to the Kellgren and Lawrence classification
- •Presenting with an indication for total hip replacement, according to the surgeon's usual criteria
排除标准
- •Control group:
- •Hip osteoarthritis or other arthrosis in the lower limbs
- •Pregnant or breast-feeding women
- •Disorders that may interfere with gait analysis
- •Disorder that may be destabilized by gait analysis
- •Neurological disease and/or motor neuron disease
- •Patients group:
- •Contra-indication for total hip replacement
- •Repeat surgery for total hip replacement
- •Impossibility to use a standard implant
- •Pregnant or breast-feeding women
- •Inflammatory flare of the hip osteoarthritis
- •Disorder that may interfere with gait analysis
- •Disorder that may be destabilized by gait analysis
- •Rapidly destructive hip osteoarthritis
- •Neurological disease and/or motor neuron disease
- •Hip dysplasia requiring THR to be completed using a graft
结局指标
主要结局
Degree of patient statisfaction
时间窗: Before and between 6 months and 1 year after total hip replacement
次要结局
未报告次要终点