Knee Osteoarthritis Clinical Trial
Official title:
Does Intra-articular Platelet-Rich Plasma Injection Provide Superior Outcomes Compared With Viscosupplementation in the Treatment of Knee Osteoarthritis?
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2027 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | NorthShore University HealthSystems | Skokie | Illinois |
Lead Sponsor | Collaborator |
---|---|
NorthShore University HealthSystem |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6 and 12 months | |
Secondary | 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. |
6 weeks, 12 weeks, 6 months, and 12 months |
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