This is a single-center, prospective, randomized, single-blind, comparator therapy, parallel group study for symptomatic patients diagnosed with knee osteoarthritis. The aim is to demonstrate superior efficacy of platelet-rich plasma (PRP) as compared to hyaluronic acid (HA) in treating knee osteoarthritis. This aim will be objectively measured by endpoint consisting of changes in cartilage thickness from baseline in the MRI. The Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire will be used to calculate The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score. It will measure changes in pain and function from baseline. Approximately 100 subjects will be treated at NorthShore University HealthSystem (NorthShore) as part of this study. This study has the potential to improve outcomes in a very common chronic degenerative disease, osteoarthritis, which can have a significant effect on individuals' quality of life.
Ability to provide informed consent
Chronic pain (>3 months)
Grade 2 -3 according to Kellgren- Lawrence (K-L) classification system (using bilateral anteroposterior radiograph image acquired while the patient is weight-bearing with both knees in full extension)
Minimum score of 40 out of possible 100 on the VAS (Visual Analog Scale) for pain
Presence of major axial deformity (>5° valgus or varus deviation)
Surgery on target knee within 12 months prior to scheduled treatment
Autoimmune disorder
Active infections
Parallel
PRP Treatment
Biological/VaccinePRP will be prepared using an Arthrex ACP® kit (a low-leukocyte Autologous Conditioned Plasma system). This is a single-spin system that concentrates platelets and separates red blood cells (RBCs) as well as white blood cells (WBCs) from the treatment product.
HA Treatment
Biological/VaccineEuflexxa will be used for treatment. It will be prepared according to the package insert.
Cartilage Thickness on MRI
Evaluation of changes from baseline in central medial femorotibial compartment cartilage thickness measurements (via ordered value method) using quantitative T1 and cartilage compositional changes using T2 MRI at 6 and 12 months.
3. A secondary outcome will be measuring changes in the KOOS Jr (Knee injury and Osteoarthritis Outcome Score)
The KOOS is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score will be calculated using KOOS Questionnaire. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). The total WOMAC score is created by summing the items for all three subscales, with higher scores reflecting worse pain, stiffness, and physical function. Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. This objective will be measured in WOMAC total score from baseline to 6 weeks, 12 weeks, 6 months, and 12 months in 100 subjects.
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