Reduction of Pro-Inflammatory Synovial Fluid Biomarkers in Osteoarthritis of the Knee With Alpha-2 Macroglobulin: A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Measure of synovial fluid biomarker levels
研究概览
简要总结
The purpose of the current study is to assess the ability of alpha-2-macroglobulin treatment to reduce the level of pro-inflammatory synovial fluid biomarkers in patients with osteoarthritis of the knee.
This is a double-blinded rationalized control trial with prospective data collection. The study will collect and analyze the synovial fluid, serum, and urine of patients presenting with knee osteoarthritis in Kellegren-Lawrence grade 2 or 3. It will compare synovial fluid biomarker levels between patients receiving an intra-articular alpha-macroglobulin, intra-articular PR injection and intra-articular corticosteroid serving as a control. Pre-injection pain and function will be assessed. Post-injection pain, function and outcomes will be assessed after six weeks and three months.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients osteoarthritis classified as Kellegren-Lawrence grade 2 or 3
排除标准
- •Mentally impaired (e.g, Alzheimer's subjects, dementia, etc.)
- •Younger than 18 years of age
- •Greater than 90 years of age
- •Patients with underlying inflammatory arthropathies
研究组 & 干预措施
intra-articular Platelet-rich Plasma (PRP) injection
Standard of care PRP treatment
干预措施: synovial fluid biomarker concentrations (Biological)
intra-articular alpha-2-macroglobulin
intra-articular injection of 1 mL of the 40 mg/ml strength (1 vial)
干预措施: synovial fluid biomarker concentrations (Biological)
Intra-articular corticosteroid
Standard of Care steroid treatment
干预措施: synovial fluid biomarker concentrations (Biological)
结局指标
主要结局
Measure of synovial fluid biomarker levels
时间窗: 3 Months
synovial fluid will be aspirated and analyzed for the presence of 20 biomarkers using bead assay (Milliplex®, Millipore, Billerica MA)
Measure of synovial fluid biomarker levels
时间窗: 6 Weeks
synovial fluid will be aspirated and analyzed for the presence of 20 biomarkers using bead assay (Milliplex®, Millipore, Billerica MA)
次要结局
未报告次要终点