Reduction of Pro-Inflammatory Synovial Fluid Biomarkers in Osteoarthritis of the Knee With Alpha-2 Macroglobulin: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Measure of synovial fluid biomarker levels
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
intra-articular Platelet-rich Plasma (PRP) injection
Standard of care PRP treatment
Intervention: synovial fluid biomarker concentrations (Biological)
intra-articular alpha-2-macroglobulin
intra-articular injection of 1 mL of the 40 mg/ml strength (1 vial)
Intervention: synovial fluid biomarker concentrations (Biological)
Intra-articular corticosteroid
Standard of Care steroid treatment
Intervention: synovial fluid biomarker concentrations (Biological)
Outcomes
Primary Outcomes
Measure of synovial fluid biomarker levels
Time Frame: 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
Time Frame: 6 Weeks
synovial fluid will be aspirated and analyzed for the presence of 20 biomarkers using bead assay (Milliplex®, Millipore, Billerica MA)
Secondary Outcomes
No secondary outcomes reported