Comparing Platelet-Rich Plasma and Hyaluronic Acid for Knee Osteoarthritis Treatment
Does Intra-articular Platelet-Rich Plasma Injection Provide Superior Outcomes Compared With Viscosupplementation in the Treatment of Knee Osteoarthritis?
This study is testing whether platelet-rich plasma or hyaluronic acid works better to relieve pain and improve function in people with knee osteoarthritis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Endeavor Health Academic / other |
| Locations | 1 site (Skokie, Illinois) |
| Trial ID | NCT03491761 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a single-center, prospective, randomized, single-blind study aimed at evaluating the efficacy of platelet-rich plasma (PRP) compared to hyaluronic acid (HA) in treating knee osteoarthritis. The study will involve approximately 100 symptomatic patients diagnosed with knee osteoarthritis, who will be randomly assigned to receive either PRP or HA treatment. The primary endpoint will be measured through MRI-based cartilage thickness, while secondary outcomes will be assessed using the WOMAC total score to evaluate changes in pain and function. The trial will last approximately 13 months, with data collection concluding at month 12 post-treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with chronic knee pain and a Kellgren-Lawrence grade of 2 or 3.
Not a fit: Patients with major knee deformities, recent knee surgeries, autoimmune disorders, or those on anticoagulant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from knee osteoarthritis, potentially improving their quality of life.
How similar studies have performed: Other studies have shown promising results with PRP in treating knee osteoarthritis, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Skokie, Illinois
- NorthShore University HealthSystems — Skokie, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Jason L Koh, MD, MBA — Clinical Chairman, Dept. of Orthopaedics
- Study coordinator: Jason L Koh, MD, MBA
- Email: jkoh@northshore.org
- Phone: 224-251-3481
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.