So, I'm going to give you an overview that will hopefully resonate with those of you that aren't currently using orthobiologics, but are just starting to stick your toe in the water. I always date these talks because things are changing that rapidly, and so this is the 7-2021 Practical Orthobiologics Talk. It may change next month. These are my disclosures. I am involved in quite a few orthobiologic things, including courses. None of these will have me standing up here telling you untruths. So I want to try and get two things across in this talk, which is that there are gaps in orthopedics where the natural healing process and any surgical solution are imperfect in terms of time to heal, ultimate outcome, ultimate dysfunction. If there's an effective, safe alternative, it may be an attractive treatment option, especially if it's minimally invasive and done at the point of care in the office. So why choose orthobiologics to fill that gap? Well, these are several, but not all, of the reasons that I choose orthobiologics. To enhance the natural healing process without surgery or steroids. To enhance the healing process with surgery, I do some surgical procedures and use orthobiologics as an adjunct. To minimize pain and dysfunction without steroids or opiates. We all know that we have an opioid crisis, and we have a steroid crisis also, in my opinion. And finally, this would be the holy grail, to delay, prevent, or maybe one day even have the right recipe to reverse degenerative MSK conditions. Let's jump right in and talk about platelet-rich plasma. This is a practical talk, so what would happen, what would you have to do Monday, tomorrow, to start using PRP in your office? You're going to have to figure out who's going to draw blood. Is it going to be you, or is it going to be your nurse, your PA, or are you going to hire a phlebotomist? You have to pick a kit. Ideally, you would want to pick a kit that gives you maximum flexibility to make granulocyte-rich or granulocyte-poor platelet-rich plasma. There may be clinical indications for both. Or you're going to do it yourself. If you choose that route, it's a little bit more time-intensive to learn up front, but you may save 95 to 99% of the cost of a kit. You have to learn about MSK ultrasound. Many of these procedures require pinpoint placement of the orthobiologic. And there really is no other imaging modality where we can see soft tissue in real time in the office. So whether or not you're doing orthobiologics, I think MSK ultrasound is a tremendous asset to all of our practices. I'm a little biased. I teach a course on it. You have to use a registry. This is not something that I was taught 20 years ago, 25 years ago, coming up as a baby orthopedist. But nowadays, I think we're all tuned in that registries are how we collect data. They're how we collaborate. They're how we get to faster answers, get answers faster. If you're going to really go wholeheartedly into orthobiologics, I think it behooves you to get a hematology analyzer. We have to be able to do a CBC. We have to be able to quantify the PRP. Ultimately, it would be wonderful to be able to create a dose response curve like any other drug. In order to do that, all of us in this room have to be able to tell what the platelet dose was. We have to know the platelet concentration and the amount that we inject for that particular patient, and then track that patient in the registry to see how they did. Can't do that without a hematology analyzer. We can't just depend on white papers from the companies saying that this is 5 to 9x. That's not good enough anymore for publications. That's not good anymore as a clinical practice, in my opinion. We have to have a way, if you don't already in your practice, to manage cash-pay patients. These are primarily cash-pay procedures. In my opinion, hopefully they stay that way. I think the decision-making on cost should be left in the hands of the clinician who knows the patient the best. Let's see, we're not advancing. There we go. Okay. So the next autologous orthobiologic, and you'll note in this talk, I'm going to try and stay on the regulatory safe side, and we'll get to that in a minute. But if you're going to incorporate bone marrow or bone marrow aspirate concentrate into your practice, you're going to have to answer many of the same questions that you do with PRP. Who's going to draw the marrow? In my practice, that's me. Where is the marrow going to come from? I think there's really only one answer for that question, and that's the iliac crest. You can choose anterior or posterior. I always choose posterior because it's the safest, least painful way to do it. It gets the patient's face away from mine, gets them on their stomach, and that's where the highest concentration of mesenchymal stem cells is located. You still need to have MSK ultrasound in your office. We use a registry. Quantifying BMC, unlike PRP, is still an evolving concept. There are total nucleated cell count machines that we can have in our office. They're not overly expensive. The problem is they don't always correlate with the mesenchymal stem cell count, but it is the best thing we can do at the point of care is to get a TNC count on this particular orthobiologic. And, again, these are cash pay patients. Microfat or nanofat, again, very similar questions that we have to answer as clinicians. Who's going to do the aspiration or the liposuction? You have to pick a kit. You've still got to place it in the human body, so you need a way to see that. You need ultrasound. You still need a registry to manage and track your outcomes. Quantifying adipose is not really a thing at the point of care, as far as I know, so we don't really have to worry about a hematology analyzer for that particular injectate. And these are cash pay patients. So just one slide. I know Lou's going to talk a little bit about the business aspect of this, but these are national averages. This is, I guess, level five data. I send out polls often to my network, and for PRP, the national average for orthopedic surgeons ranges from $250 all the way up to $2,500 in one practice for a single joint. Bone marrow concentrate ranges from $1,500 up to $8,000 for a single joint, and adipose or mfat or nanofat is from $3,000 to $8,000. In Texas, I know a guy, and without being able to name names, we can assume hypothetically that he might charge $650 for one knee for PRP and $1,000 for two. BMC is at $2,800, and for two knees, it's $5,000. One of the things I noticed early on in incorporating this modality into my practice was the farther a specialist got away from orthopedic surgery, the higher these prices tended to be, and the less legit the inject date was, the higher the price tended to be. So if you have, now I have tons of friends that are chiropractors, but if you have a chiropractor injecting something out of a bottle for one cc, that price might be $20,000, and there's people that would pay it. So I think all of us in the room know our fee schedules. We know what we get if you do a knee replacement. That price structure never sat right with me. I couldn't sleep. And so I do what I think is fair given our time and given the costs that go into doing this for the patient. In my experience, 80% of the orthobiologic practice is with platelet-rich plasma. 20% is with bone marrow concentrate. And the question is why, and the answer is because that's where the evidence is. In terms of level of evidence, we've looked at that. This was a nice COVID pandemic study. We looked at 13 months of articles in the six of the top 10 orthopedic journals. We looked at over 1,400 articles, and the average level of evidence in orthopedic surgery is three. And that was in every article, in every edition, in every journal, at every time point. This is just an example of some of the data that's out there for PRP. There are over 30 level one studies published showing that PRP is better than placebo, steroid, and visco-supplementation for knee osteoarthritis, with an average length of benefit of 9 to 12 months. The data's there. Elbow tendinopathy, Alan Mishra kind of lit the flame in 2013 with that landmark study that showed that PRP was better than steroid and better than dry needling for lateral epicondylitis. All of our patients that have ulnar collateral ligament pathology deserve one or two PRP injections before we even talk about surgery, in my opinion. We can keep 72% of them out of surgery. Bone marrow concentrate is safe. We have publications that have 30-year follow-up. It does not increase cancer risk. If you're a newbie, even your first 101 cases do not show any increased risk over a steroid injection. I won't go through this too much, but I'll leave a thought with you, which is that we talk about MSCs when we're talking about bone marrow, really the player may be the HSC, the hematopoietic stem cell, and I say that because there's millions, hundreds of millions more HSCs in our injectate than MSCs. These slides we can talk off the podium, but this is just to illustrate and to show you that there is plenty of data in the last two or three years showing that allograft, I'm sorry, autograft sources have data. Last slide. The allograft market is in flux right now because of the FDA. Everything listed on the left side is considered a drug. We cannot use drugs unless they are approved by the FDA, and not one of these products has an approval. Once a drug has an approval, as doctors, we can use them off-label. We do that with gabapentin, for example, but none of these drugs have an on-label approval yet so we can't use them. And I'll leave you with the same thought we started with. Thank you very much. Thank you.

orthobiologics

platelet-rich plasma

bone marrow concentrate

MSK ultrasound

regulatory challenges