Investigation of Biomarkers in an Exploratory Study in Patients With Osteoarthritis of the Knee Undergoing Total Knee Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Proportion of patients with upregulation of IL-6 or the IL-6 signalling pathway in the knee.
研究概览
简要总结
The main purpose of the study is to better understand how specific proteins/markers in blood, urine, synovial fluid (a lubricating fluid secreted by the membrane lining the joints), and joint tissue are involved in osteoarthritis of the knee. The aim is to investigate if there is a correlation between x-ray results, specific proteins/markers and different types of pain in patients with osteoarthritis of the knee. The study consists of 3 visits over 3-20 days and the last visit will be the day of surgery.
详细描述
Investigation of Biomarkers in an Exploratory Study in Patients with Osteoarthritis of the Knee Undergoing Total Knee Replacement Surgery
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who will undergo a total knee replacement due to osteoarthritis.
- •Symptoms of the knee for at least 6 months prior to study start.
排除标准
- •Key-hole surgery performed on target knee within 3 months prior to study start.
- •History of disorders in which part of the immune system is missing or defective.
结局指标
主要结局
Proportion of patients with upregulation of IL-6 or the IL-6 signalling pathway in the knee.
时间窗: 3-20 days prior to day 1 (surgery) and day 1 (surgery) .
次要结局
- Biomarkers by Magnetic Resonance Imaging (MRI).(1-5 days prior to day 1 (surgery).)
- Polymorphisms in 10 specific genes.(3-20 days prior to day 1 (surgery) or at any time in the study.)
- Biomarkers in synovial fluid, synovial membrane, and cartilage.(Day 1 (surgery).)
- Biomarkers in blood and urine.(3-20 days prior to day 1 (surgery) and day 1 (surgery).)
- WOMAC (Western Ontario and McMaster Osteoarthritis Index) variables and NPQ (Neuropathic Pain Questionnaire) variables.(3-20 days prior to day 1 (surgery) and 1-5 days prior to day 1 (surgery).)