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临床试验/NCT03656575
NCT03656575已完成1 期

Reduction of Pro-Inflammatory Synovial Fluid Biomarkers in Osteoarthritis of the Knee With Alpha-2 Macroglobulin: A Randomized Controlled Trial

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2017年11月1日最近更新:
适应症

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

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

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)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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