This trial is active, not recruiting.

Condition knee osteoarthritis
Treatments platelet rich plasma, normal saline
Phase phase 0
Sponsor Hunter Holmes Mcguire Veteran Affairs Medical Center
Collaborator Foundation for Physical Medicine and Rehabilitation
Start date September 2014
End date November 2015
Trial size 18 participants
Trial identifier NCT02468492, IRB #01979/FDA IDE#15944


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacodynamics study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose basic science
Approximately 5mL of intraarticular PRP once at baseline
platelet rich plasma Platelet Concentrate
Platelet rich plasma injection into knee versus placebo (saline) injection.
Approximately 5mL of intraarticular normal saline once at baseline
normal saline
Platelet rich plasma injection into knee versus placebo (saline) injection.

Primary Outcomes

Biochemical Molecular Outcomes
time frame: Baseline and 10 day follow up

Secondary Outcomes

Clinical Outcomes
time frame: 1 year
Imaging Outcomes
time frame: 6 months

Eligibility Criteria

Male or female participants at least 40 years old.

Inclusion Criteria: 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 examination; 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. Exclusion Criteria: 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 knee)**; 5. Any rheumatoid arthritis or gout diagnosis is exclusionary. 6. Current infection of the affected joint or any other uncontrolled or untreated active infection. 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 platelets/μl. - [CBC obtained within 6 months will be required, even if obtained at initial screening visit.] 8. Individuals on dialysis, with liver failure, or uncontrolled renal or liver disease are excluded. - 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 excluded. 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.

Additional Information

Official title Synovial Fluid Biomarker and Mesenchymal Stem Cell Response to PRP in Knee Osteoarthritis With Clinical and Imaging Outcome Correlation: Proof of Concept Study
Principal investigator Lance L Goetz, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Hunter Holmes Mcguire Veteran Affairs Medical Center.