So, this is the result of a randomized controlled trial prospective study looking at the idea of should we add hyaluronic acid to platelet-rich plasma. As a disclosure, this study was funded by a grant from the state of Florida. It was not industry-sponsored at all. I do receive educational research support as well as speaking fees and royalties from OrthoRx. Within sports medicine, orthobiologics has been a big part of the past 10 years and things that we are interested in. Unfortunately though, many times it gets treated like just throwing spaghetti at a wall instead of thinking about the whole translational medicine pyramid. How we develop these and bring them forward through our practices is really about the translational medicine process, thinking about things first at the benchtop level, then developing them through a staged approach before clinical application. Hyaluronic acid has been around for decades and has been through this process. Platelet-rich plasma has also been around for decades and has been through this process as well. Many times clinicians think, well, we should just then add those two together and they should be synergistic. And that has been performed and there are randomized controlled trials on that front. This study was just looking to add to that body of evidence. Our inclusion criteria were simple. Anybody who had diagnosis of osteoarthritis for over six weeks. Exclusion criteria involved steroid injections within the past three months, hyaluronic acid injections within the past six months. We used Kelgan-Lawrence grading for these individuals and we included all four Kelgan-Lawrence grades. This represented a population who was presenting to our offices requesting orthobiologics. We did exclude those with rheumatoid arthritis and gout. For our product, for platelet-rich plasma, it was a one-spin preparation autologous condition plasma that involves 15 cc's of whole blood in a soft spin. Provided through preclinical studies and clinical studies as a three-injection series. For the hyaluronic acid, it was a high molecular weight viscoelastic hyaluronan or hymovis. It is labeled as a 2-3ML injection series. It specifically was engineered to increase viscoelasticity and residence time within the joint. Our control group was a three-injection series of PRP. We blindfolded our control group as well for the first two injections. Our intervention group was a three-injection series of PRP, but they also received hyaluronic acid injection at the first two injections. It was not an additional needle stick. We just unswiveled the syringe of ACP and swiveled on the hymovis syringe. They were blindfolded for the first two injections. Outcome measures include the Womack, IKDC, and KOOS. We assessed 64 for eligibility. Because it was a pretty open inclusion-exclusion, we excluded none. So we randomized 64, and both were allocated to the intervention group or the control group. Our follow-up was similar in terms of what we would see with 91% at one month at the control group, down to about 66 at 24 months, which was very similar in our intervention group in terms of compliance. Our total observations for both were 224 when you think about all three outcome measures at the different time points, and we had similar compliance in terms of what was collected and analyzed for these observations. So Womack, KOOS, and IKDC both had significant improvements at one month, which plateaued at three months and sustained out to 24 months. Womack scores improved 11.3 points below baseline in the PRP group, 13.3 in the intervention group. Our KOOS scores improved 17.1 points in the control group from baseline, and in the intervention group, 14.7 points from baseline. These improvements exceeded what has previously been reported as clinically significant improvements changes for both the Womack and the KOOS-5. For IKDC, it's not quite as simple because it was validated around ACL reconstruction, and so when you look at those validation studies, what we saw in improvement has been deemed somewhat better in terms of patient reports. There was no differences between the PRP or the PRP and HA groups. In conclusion, both PRP and the addition of PRP with HA were effective for at least 24 months. PRP plus HA was not superior to PRP alone. Meta-analysis of this data with other sites will further clarify this clinical question. One of the differences of this study compared with those previously reported in the literature is those already reported are 12-month studies, and this was a 24-month study. And although we looked at these at the different time point, there was some trends at the six-month toward superiority with the addition of HA, but it did not sustain out to the 24-month time point. Thank you for your attention today. I have to thank my co-authors, Eric Branch and Ali Raza-Emami, our fellows helping us with the manuscript this year. Josh Cook and Jesse True are part of our research team at AREF. Ashcroft Cohen helps us with statistics, and Hilary Plummer helps us with the execution of this study. Thank you.

randomized controlled trial

prospective study

hyaluronic acid

platelet-rich plasma

osteoarthritis