A Phase 1 interventional study of synovial fluid biomarker concentrations in Osteoarthritis, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-05-29.
Sponsored by NYU Langone Health · Phase 1, Interventional, and Treatment
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 75 is close to the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
intra-articular injection of 1 mL of the 40 mg/ml strength (1 vial)
Biological: synovial fluid biomarker concentrations
Standard of care PRP treatment
Biological: synovial fluid biomarker concentrations
Standard of Care steroid treatment
Biological: synovial 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
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)
Time frame: 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)
Time frame: 3 Months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
NYU Langone Health