Prediction of Outcomes Following Total Knee Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Brief Pain Inventory (BPI)
研究概览
简要总结
This is an observational study (not a treatment study) of pain and physical functioning after total knee replacement. The study includes 5 visits, 1 before surgery and 4 after surgery. You may be eligible if you are 50 or older,will soon be undergoing knee replacement surgery, do not have a serious heart condition or certain other medical conditions, and are not taking certain types of medications. The study includes evaluation of peoples' pain, physical functioning, medication use, and physiological responses to sensory stimuli such as heat and cold.
详细描述
This is an observational study (not a treatment study) of pain and physical functioning after total knee replacement. The study includes 5 visits, 1 before surgery and 4 after surgery. The last visit will be about 1 year after surgery. You may be eligible if you are 50 or older, will soon be undergoing knee replacement surgery, do not have a serious heart condition or certain other medical conditions, and are not taking certain types of medications. The study includes evaluation of peoples' pain, physical functioning, medication use, and physiological responses to sensory stimuli such as heat and cold.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 or older
- •Meet the American College of Rheumatology criteria for knee osteoarthritis
- •Scheduled to undergo total knee arthroplasty
- •Facility with the English language that is adequate to complete study procedures
排除标准
- •Cognitive impairment preventing completion of study assessment procedures
- •Myocardial infarction within the past 12 months
- •Severe raynaud's or severe neuropathy
- •Active vasculitis or severe peripheral vascular disease
- •Current infection
- •Use of oral steroids
- •Recent history of substance abuse or dependence
- •Confirmed diagnosis of periodic limb movement disorder or restless legs syndrome
- •Systemic inflammatory or autoimmune disorders such as rheumatoid arthritis, lupus, etc.
- •Known anemia
结局指标
主要结局
Brief Pain Inventory (BPI)
时间窗: 6 months
A widely-used measure of pain severity and pain interference. Pain severity and pain interference scores range from 0-10 (0= no pain / no pain interference and 10= severe pain / pain interference).
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: 6 months
A widely-used, OA-specific measure of pain, function, and stiffness. WOMAC Pain scores range from 0-50, with 0= no pain and 50= severe pain.
次要结局
未报告次要终点
研究者
Robert Edwards
Principal Investigator
Brigham and Women's Hospital