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Compares treatment options for Knee Osteoarthritis
Official title Intra-articular Platelet-Rich Plasma Compared With Viscosupplementation in the Treatment of Knee Osteoarthritis
ClinicalTrials.gov ID: NCT03491761
What this study is testing
What is PRP Treatment?
PRP Treatment is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for knee osteoarthritis.
Also referred to as Platelet-Rich Plasma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
- Minimum score of 40 out of possible 100 on the VAS (Visual Analog Scale) for pain
- Age 18 to 75 years old
You likely can't join 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Skokie, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Skokie, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.