Name: Office Orthobiologics: Rationale and Outcomes
Uploaded: 2017-06-19T00:00:00Z
Channel: Arthrex

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English  - en

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VPT1-00807-EN | A | Office Orthobiologics: Rationale and Outcomes

Kristin Oliver

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Office Orthobiologics: Rationale and Outcomes

So let's start with rationale. And I'd like to lay down the base rationale with these two quotes. One is by William Pollard when he says learning and innovation go hand in hand. The arrogance of success is to think that what you did yesterday will be sufficient for tomorrow. And let's take that one step further with a more industry specific quote by Doug Jackson. Douglas Jackson. Early in my arthroscopic surgical development, I remember a surgeon opening the door and saying, into the room where I was scoping a knee, it makes no sense to look through a keyhole when you can open the door. So the reason I put these in here really, is to lay the basis of rationale that we know we're doing a disservice to our patients, to take the status quo as being the only option, and to not look for opportunities in innovations to further patient care. And one of those innovations is orthobiologics. You're going to layer on top of that as far as rationale, the changing health care climate. Our patients are more aware than ever. They use the internet. They all have their WebMD degrees to various to various degrees. And they demand alternatives. So they're out there looking at what's out, and they have questions for us. And so it's good for us to know what's out there as alternatives, even if we don't use them. Another layer is our aging patient population. It is straining healthcare economics. The growth of health care expense in this country outpaces outpaces the GDP by over 2%. Add to that. An example of that is the prevalence of Neo. And for example, if you look at this graphic, by the year 2030, it's projected that total knee arthroplasty is going to increase by 601% and total hip arthroplasty by 137%. So these are just some of the rationale behind why Innovation is needed. This innovation comes in many forms. It may be outpatient, total joint arthroplasty, high demand implants, or the idea of some non-operative models. So moving on to the data side of things, we know that anecdotal success is not enough. We know data is necessary and that we have to follow outcomes. It's vital in regards to improving patient care. We know now through studies and some of them I'll outline the evidence is mounting that biologics are safe and effective treatment options. But we need more studies. We need to know what disease, what injury response effectively and what which one, what disease and injury responds to which biologic. So in patients who have soft tissue injuries tendinosis partial thickness tears, it's going to be it's possible it's going to be different than what's more applicable in osteoarthritis or lumbar disc. So with the introduction of others such as amniotic and adipose there's a lot to learn. So just briefly for the sake of time, it is through studies, there's been three very studies that have really shown the efficacy of PRP and Neo. This is just a small systematic review that was done by Mayhew in 15. And then with the furthering of this by the, excuse me, the Excuse me. The systematic review of meta analysis done by Campbell in 2015, and then the piece de resistance by Pat Smith, where we now have level one evidence that the use of a leukocyte poor, platelet rich plasma is safe and effective in the use of osteoarthritis. So this is huge, huge for all of us. So I'm going to take it one step further. Some people might say okay well now we know ACP is successful. We can stop. We don't have to keep innovating. But that's wrong. We need to keep innovating. So I'm going to share a little bit of my SOS data on a couple of a couple of patients. So we've been using the SOS system since 2014. And one of the things we look at closely is knee osteoarthritis. Although we've looked at all willing patients. This is data on everybody. This is our whole data set. And it says grade one through four. In this slide we have one grade one. So most of them are two through four. We now have 591 patients enrolled in. Our compliance is about 87%. We have 274 patients out a year in 106. Patients out two years. So. Va's findings are pain scales show an overall significant improvement up to two years. You can see there's a big jump between baseline in three months and a year and two years. Then if you take our Womack data and you lay it on top of that, it's interesting. So this slide shows that all three Womack scores pain, stiffness and function are all improved statistically. Significantly improved by three months a little bit of improvement between 6 and 12. Not significant. But then there's this jump between 12 and 24. So this is leading us to try to figure out what's going on, what actually is happening between 0 and 3 months. Why the jump between 12 and 24 months? And we don't know that yet. We do know that we've looked at the subset of patients at two years, and that they haven't returned to our clinic for repeat treatment of any sort, repeat any type of biologic, repeat cortisone, hyaluronic, nothing. So nobody's come back in that period of time. We haven't had a chance yet to go and call these individuals on the phone and see if they have possibly sought treatment somewhere else. So we still have to find that out, and we're still paring this data down. Another very important thing to discuss in our findings with BMC is that we are finding statistically significant outcomes. They're similar between grade two, three and four. In other words, we don't see any difference between the outcomes and our grade two knees and our four knees. So we're having just as much success in grade four in EOA as we are in grade two. Nio using bone marrow concentrate Intra-articular. So we know it's an effective option. It's equally effective in stages two through four, and it's effective up to two years. But there are a lot of questions that remain. How does this dovetail with PRP and ACP? We know it's safe and effective. Is it possible that if those patients that were that were had no clinically significant differences at a year after a series of ACP, is it possible they're still good at two years? We haven't followed that data all the way out. Or if you did a second series of ACP at year two, would they be just as good? We have We have to take into consideration cost, the cost and invasiveness with BMC versus the ease and efficacy of ACP. So there's some questions here that we still need to answer. The good news is that it's all pointing in the right direction as being safe and efficacious. I did want to briefly bring up this study and for the sake of time, I don't have a lot, but this is a recent study done by Shapiro. It was a level one study on BMC, and he had 25 patients, and he used BMC in one knee. He used saline in the other, found there was a definite significant change in the BMC noted knee, but also in the saline noted knee and no difference between the saline group and the BMC. There were some faults to the study. Looking at it, you know, we can always pick apart studies, obviously, but the stage of the neo in the same patient wasn't the same. So they didn't have stage 3 in 1 knee and three in the other knee. In other words, they were different stages which could lead to some confounding. And also he chose Shane Shapiro chose a 15ml per knee intra-articular and I'm not sure why he chose that. I haven't had a chance to ask him, but it really is a huge volume for orthopedic for an ortho biologic Application, and I'm not certain whether or not that may have affected this or caused some confounding either. So I only have a little bit of time, but I want to just briefly bring up one other data set we have in regards to our SOS outcomes on partial thickness rotator cuff tears using PRP. So these are platelet rich plasma partial thickness rotator cuff tears 50% or less total thickness. It could either be the supra infra GAP or a combination thereof. We only have 67 patients in this so far, and we have a total of 34 out a year. But we are finding encouraging data that shows that there's definitely clinical improvement, significant improvement even by three months, which is advanced even further by a year. Same thing with our Vas findings. They follow that same tune where you're seeing a big jump in improvement at three months and then improving up to a year. And the same with the Sain scores. So the great thing about this is that we're showing that this is a percutaneous option that you can use for partial thickness rotator cuff tears in the office.

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