Intra-articular Platelet-Rich Plasma Compared With Viscosupplementation in the Treatment of Knee Osteoarthritis
Eligible age
18–75 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Endeavor Health
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Skokie
Source: ClinicalTrials.gov · NCT03491761 · last updated 2024-02-28