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

Phase 1

Completed

• Conditions: Osteoarthritis
• Interventions: Biological: synovial fluid biomarker concentrations

• Registration Number: NCT03656575
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2018-08-29
• Study First Submitted QC: 2018-08-31
• Study First Posted: 2018-09-04
• Primary Completion: 2019-04-20
• Study Completion: 2019-04-20
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-27
• Last Update Posted: 2020-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intra-articular Platelet-rich Plasma (PRP) injection	synovial fluid biomarker concentrations	Standard of care PRP treatment
Intra-articular corticosteroid	synovial fluid biomarker concentrations	Standard of Care steroid treatment
intra-articular alpha-2-macroglobulin	synovial fluid biomarker concentrations	intra-articular injection of 1 mL of the 40 mg/ml strength (1 vial)

Primary Outcome Measures

Name	Time	Method
Measure of synovial fluid biomarker levels	3 Months	synovial fluid will be aspirated and analyzed for the presence of 20 biomarkers using bead assay (Milliplex®, Millipore, Billerica MA)

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States