NCT03491761 · Endeavor Health
Intra-articular Platelet-Rich Plasma Compared With Viscosupplementation in the Treatment of Knee Osteoarthritis
What this study is about
This is a single-center, forward-looking, randomly assigned, single-blind, comparator therapy, parallel group study for symptomatic patients diagnosed with knee osteoarthritis. The aim is to demonstrate superior effectiveness of platelet-rich plasma (PRP) as compared to hyaluronic acid (HA) in treating knee osteoarthritis.
View original scientific description
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.
Interventions
BIOLOGICAL
PRP Treatment
PRP will be prepared using an Arthrex ACP® kit (a low-leukocyte Autologous Conditioned Plasma system). This is a single-spin system that concentrates platelets and separates red blood cells (RBCs) as well as white blood cells (WBCs) from the treatment product.
BIOLOGICAL
HA Treatment
Euflexxa will be used for treatment. It will be prepared according to the package insert.
Primary outcome measures
Cartilage Thickness on MRI
Time frame: 6 and 12 months
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Skokie, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 28, 2024 · Source of record for eligibility and locations