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Intra-articular Platelet-Rich Plasma Compared With Viscosupplementation in the Treatment of Knee Osteoarthritis

RecruitingPhase 2Ages 18 Years - 75 YearsAllEndeavor Health
NCT03491761 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, osteoarthriti

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * Age 18 to 75 years old * Physical exam and medical history * Complete Blood Count to include platelets and differential (CBC with Diff) within normal limits * C-Reactive Protein (CRP) within normal limits * Sed Rate (ESR) within normal limits * Survey of current medications Exclusion Criteria: * 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 * Immuno-suppression (e.g., AIDS, etc.) * Anti-coagulant therapy * Use of NSAIDs 5 days prior to blood draw or up to 7 days after last PRP / HA treatment * Hemoglobin (Hg) \<12 g/dL * Platelet counts (PLT) \<150,000 /mm3 * Previous infiltrative treatment within 3 weeks prior to scheduled treatment * Pregnancy/Breastfeeding * Hypersensitivity to HA * Inability to complete an MRI due to metal implants or claustrophobia * Diabetes * Active treatment for a malignancy * Active wound in the knee * Recent history of knee trauma * Vasovagal history * An injection of hyaluronic acid (HA) or platelet-rich plasma (PRP) to the affected knee within the last two years. * In the judgment of the investigator, the patient is unable to perform and/or complete all of the study visits or treatments required.
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What it tests

  • PRP Treatment
  • HA Treatment
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Where

1 site
NorthShore University HealthSystems
Skokie, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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