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

Study Overview
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Brief Summary
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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.

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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Biological: synovial fluid biomarker concentrations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients osteoarthritis classified as Kellegren-Lawrence grade 2 or 3 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intra-articular alpha-2-macroglobulin<br>intra-articular injection of 1 mL of the 40 mg/ml strength (1 vial) | Biological: synovial fluid biomarker concentrations<br>* Synovial fluid samples will be obtained pre-injection, Post Injection 3 Weeks, Post Injection 6 Weeks, Post Injection 9 Weeks, Post Injection 3 Months, Post Injection 6 Months, Post Injection phone call at 1 Year<br>|
| Active Comparator: intra-articular Platelet-rich Plasma (PRP) injection<br>Standard of care PRP treatment | Biological: synovial fluid biomarker concentrations<br>* Synovial fluid samples will be obtained pre-injection, Post Injection 3 Weeks, Post Injection 6 Weeks, Post Injection 9 Weeks, Post Injection 3 Months, Post Injection 6 Months, Post Injection phone call at 1 Year<br>|
| Active Comparator: Intra-articular corticosteroid<br>Standard of Care steroid treatment | Biological: synovial fluid biomarker concentrations<br>* Synovial fluid samples will be obtained pre-injection, Post Injection 3 Weeks, Post Injection 6 Weeks, Post Injection 9 Weeks, Post Injection 3 Months, Post Injection 6 Months, Post Injection phone call at 1 Year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of synovial fluid biomarker levels | synovial fluid will be aspirated and analyzed for the presence of 20 biomarkers using bead assay (Milliplex®, Millipore, Billerica MA) | 6 Weeks | 
| Measure of synovial fluid biomarker levels | synovial fluid will be aspirated and analyzed for the presence of 20 biomarkers using bead assay (Milliplex®, Millipore, Billerica MA) | 3 Months |