Osteoarthritis
Conditions
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.
Interventions
BIOLOGICALsynovial fluid biomarker concentrations
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
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of synovial fluid biomarker levels | 6 Weeks | synovial fluid will be aspirated and analyzed for the presence of 20 biomarkers using bead assay (Milliplex®, Millipore, Billerica MA) |
Countries
United States
Outcome results
None listed