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

NYU Langone Health

Status and phase: Completed; Phase 1

Conditions: Osteoarthritis

Treatments: Biological: synovial fluid biomarker concentrations

Study type: Interventional

Funder types: Other

Identifiers

NCT03656575

17-01551

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups

intra-articular alpha-2-macroglobulin

Active Comparator group

Description:

intra-articular injection of 1 mL of the 40 mg/ml strength (1 vial)

Treatment:

Biological: synovial fluid biomarker concentrations

intra-articular Platelet-rich Plasma (PRP) injection

Active Comparator group

Description:

Standard of care PRP treatment

Treatment:

Biological: synovial fluid biomarker concentrations

Intra-articular corticosteroid

Active Comparator group

Description:

Standard of Care steroid treatment

Treatment:

Biological: synovial fluid biomarker concentrations