Reduction of Pro-Inflammatory Synovial Fluid Biomarkers in Osteoarthritis of the Knee With Alpha-2 Macroglobulin

Completed · Phase 1

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT03656575

Run by

NYU Langone Health

People needed

75

Starts

2017-11-01

Expected to finish

2019-04-20

Last updated by the study team

2020-05-29

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients osteoarthritis classified as Kellegren-Lawrence grade 2 or 3

You may not qualify if…

• 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

Where it is running

• New York University School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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