The purpose of this study is to evaluate the affect that platelet rich plasma has on the
molecular an cellular functioning of the knee joint.
In this study 18 subjects with mild to moderate symptomatic knee osteoarthritis will be
recruited per an IRB approved protocol with explicit inclusion and exclusion criteria.
Subjects who are enrolled and meet all criteria will be blinded and randomized (2:1) to
receive Platelet Rich Plasma or normal saline "control". Prior to the intervention, a
synovial fluid aspiration will occur. At follow up number one (approximately 10 days from
baseline) a repeat aspiration will occur and a differential analysis of the molecular and
biochemical effects will be undertaken; this data will serve as the primary outcome measures.
This data will be correlated to clinical and imaging outcome measures which will be secondary
outcome measures completed at baseline and intermittently throughout the study. The duration
of the study is one year.
1. Early/Mild to Moderate Stage knee osteoarthritis (KOA), as determined by
Kellgren-Lawrence Grade 2 to 3 on PA standing radiograph within the past three months;
- A prospective subject who has a diagnosis of non-end stage KOA (i.e., a potential
study candidate) and expresses interest in participating but has no XRAY within
the specified time-period will be sent for a fresh XRAY. This XRAY will be read
by a radiologist & be paid for by the study.
2. >=40 years of age;
3. Average 100-point VAS score of >50, on average, within the past 3 months*, with KOA
felt to be the primary contributor to pain.
- Alternate 10-point scales with pain scores averaging >5 may be considered if the
prospective subject also completes a VAS with score >50 at screening.
4. Exam consistent with KOA being primary etiology of pain;
5. No signs of inflammatory arthropathy in medical record, history or physical
6. A >3 millimeter intra-articular (IA) effusion present on ultrasound evaluation.
7. [If a chronic liver or renal disease patient, evidence of stable disease over/within
the past six months, else exclusion.]
8. Veteran receiving care at McGuire VAMC.
1. Morbid obesity (BMI >40);
2. Poorly controlled diabetes (hemoglobin A1C > 7.5 or fasting blood glucose of >200) in
last 6 months;
3. Ipsilateral knee surgery, trauma within last 6 months, or corticosteroid injection
within 3 months.
4. 4. History of inflammatory arthropathy (RA, SLE or crystalline arthritis of the
5. Any rheumatoid arthritis or gout diagnosis is exclusionary.
6. Current infection of the affected joint or any other uncontrolled or untreated active
7. Moderate to severe anemia (hemoglobin < 11 g/dl) or thrombocytopenia (platelet count <
100,000); Hemoglobin >17 g/dl or <11 g/dl and/or platelet counts >500,000 or <100,000
- [CBC obtained within 6 months will be required, even if obtained at initial
8. Individuals on dialysis, with liver failure, or uncontrolled renal or liver disease
- In those with chronic renal or liver disease, documentation of stable disease
within the most recent 6 months will be required.
9. Individuals on a therapeutic anticoagulant (e.g., Warfarin, Dabigatran, Enoxaparin)
and those with a history of coagulopathy are excluded.
- Per standard clinical practice, subjects on anti-platelet therapy are not
10. Pregnancy or breast-feeding;
- Female subjects of child-bearing potential must have a negative pregnancy screen
prior to enrollment.
- Female subjects of child-bearing potential must confirm they are not actively
breast-feeding prior to enrollment.
11. Current illicit drug abuse / active alcohol abuse (i.e, Current substance abuse);
12. Uncontrolled psychiatric disorder;
13. Lack of transportation (i.e., to get to/from appointments at VAMC) and/or willingness
to attend study appointments (screening/consent, Intervention, Day10-follow-up,
Month-6 follow-up, and then visits over-the-phone / in-person / or via Telehealth for
Month-3 and Month-12;
14. Advanced or currently active cancer.
15. Blood disorders (such as Sickle Cell Anemia, TTP, others)
16. Vulnerable populations: Individuals incapable of making informed decisions will not be
enrolled, nor will those under some form of incarceration.