Intra-articular Platelet-Rich Plasma Compared With Viscosupplementation in the Treatment of Knee Osteoarthritis
Recruiting · NCT03491761 · Interventional (participants receive a specific treatment) · Lead sponsor: Endeavor Health
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
1 location listed across 1 US state.
- NorthShore University HealthSystems - Skokie, Illinois, United States