Okay, welcome guys. Well it's a small audience but we'll make the best out of what we have. We'll keep it a little bit more informal than what I'd originally thought of but welcome. Thanks for coming. I know there isn't DJ was just here but not anyone else from the academy here to accept my thanks. I did want to acknowledge and thank the academy for this honor which is the Passer Legacy Lecture which every musculoskeletal person in PM&R is something that you look towards and you aspire to have this award so I do appreciate that. What I've done in this talk is I kind of thought about how to frame it and I really made it about the different components of MSK and in some ways a little bit used some of my work but also then what is a vision for musculoskeletal medicine or sports medicine for PM&R. How do we grow it? So that's the context of my presentation and I have a lot of pictures here. You'll see a lot of pictures from my team and it's done on purpose which is I work as a team and I think that is a strength of us as a physiatrist and as anybody. I have a lot of collaborators, staff, faculty and that's really what makes it fun, that's what makes it possible. You'll see my team all over. These are some of my disclosures, none of which I believe should affect the content of my presentation. So there are different components of musculoskeletal care and physiatry and I say that with purpose. I know this lecture is more towards musculoskeletal medicine but I will acknowledge that there is PM&R in general as well which in my kind of broadly has your musculoskeletal component and then the neurorehab component. And this lecture is more focused on MSK just given the context of this presentation but the first thing I always say is kind of step back and think about what is PM&R, what is physiatry. By definition we are we enhance function. We don't really have a medical domain. We are doctors that enhance function and quality of life. And in my opinion that has both been a blessing and a curse for PM&R where you don't really own a disease area so you can't say you're a lung doctor, you can't say you're a heart doctor. You really are a broader scope, a function and you don't usually when it comes to recognizing medical specialties either in terms of reimbursement or from other specialties that's sometimes very hard to explain as to what do you do. Now it also lends you the opportunity where you're actually able to practice in all different medical specialties. So because you deal with function that function applies across the board be it medical or surgical specialty. So it's both a blessing and a curse in my opinion and it just depends on how you use it. Now because we are doctors that don't necessarily own an organ or a body system the key to our success is really collaboration. And I don't mean collaboration is a term that's very loosely used. We all think well we are physiatrists by nature, we are good natured, we are collaborative and those are all kind of a fluff to me. Those words don't mean a whole lot. I think you really have to know and define what you mean by that collaboration. That collaboration essentially means to a large degree what you do does depend on your other specialties. It depends on your colleagues in neurology, it depends on your colleagues in orthopedics, it depends on your colleagues in medicine, it depends on a lot of people. And you can both use that to your advantage and you can use that to your disadvantage based on both your perception of it and what the other person is willing to do. But that collaboration essentially means that you really have to be willing to give and take. There has to be a give and a take with other specialties. And I have, I would say that if PM and I are given that we are small specialties and small departments at institutions we become territorial and we become protective. That is really not helpful. That is what causes a department not to grow and remain small. It allows for us to in some ways hold ourselves into a corner and not allow us to realize our full potential. So that's truly what I mean by collaboration. You really have to be willing to collaborate with other specialties. Now that collaboration also means that it is your responsibility to show what you bring to the table. It really is upon you to carve out a niche for yourself. And that is a bit of a challenge in PM&R just given that you don't own a body part or a body area. And you'll see this theme a little bit throughout my presentation. Where a lot of this in some ways excellence comes from, be it in the clinical space, be it in education, it really comes from investigation. It really comes from us differentiating ourselves as physiatrists. It is not enough for us to say, well we are here and you need to kind of respect us or offer us what we want. We really have to show what we are worth. And I think that is where sometimes PM&R hasn't done that great of a job. And really it's up to the new generation to do that work and continue that work. So I say collaboration and that applies to having clinical excellence. It applies to, I put here, it applies to your research, investigation, sports medicine, education. So these are the different facets. I'll go over some of these facets and present some of my experiences in some of these facets and how they relate to this broader picture. I put here partnership with orthopedics in kind of big letters. And maybe that's a personal bias that I have. But I do think when it comes to musculoskeletal care there is no question that they do own the field to a large degree. It is in our benefit to work with them and collaborate with them. They are our best partners. And it is they can be hard to work with, but they are our best partners and they will be our best advocates. I can tell you probably the people who have supported me the most in addition to physiatrists are orthopedists. And that really does benefit. They can really help grow your program if you can show the value. So having said that, I'm going to move on to the investigation. So I've had the privilege of being involved in some investigations. And I will present some of these to you. And in some ways it goes back to the theme of how do these relate to the overall field of musculoskeletal care eventually. So we have three large studies. We have a cohort study that's called RHO, which is the Rotator Cuff Outcomes Workgroup. We have a randomized clinical trial called ARC. And then we have a genetic study called CuffGen. So first I will go over ARC, which stands for the Orthoscopic Rotator Cuff Trial. This is a, some of you may be familiar with the SPORT trial or with some of the knee arthroscopy trials that came out in the 2014-13 time where they compared knee arthroscopy versus shame arthroscopy versus CNS physical therapy. And there was a lot of emphasis or questions being asked by various academies. This was the American Academy of Orthopedic Surgeons as well as CMS, the Agency for Healthcare Research and Quality. There were questions about how efficacious or what is the comparative effectiveness of arthroscopic rotator cuff surgery versus physical therapy or non-operative treatment. And the reason for it was because if you look at shoulder arthroscopy or if you look at rotator cuff, it's one of the top ten procedures for which CMS actually pays. It's one of the top ten in their list essentially. It's one of the highest in terms of their volume and how much the CMS has to pay out. So they are very interested in knowing if this really works and are we paying for something that offers value and offers good patient outcomes. So these questions that come about, to give you a sense, we do about probably the last more reliable numbers are about 300,000. We probably now do about half a million of these just for rotator cuff tears. And then if you look at other shoulder arthroscopies, probably about 700 to 800,000 a year. So it is a very high volume procedure for which we still don't know what its comparative effectiveness is as compared to either non-operative treatment or even weight and watch. And so that was the emphasis or that was the driving force behind the clinical trial. So we had proposed a clinical trial and the goal was to compare pain and function for operative versus non-operative treatment at 12 months for rotator cuff tears and atraumatic cuff tears. So it's a very actually simple clinical trial design. It's a very straightforward head-to-head comparison between two treatments, two arms. Our primary outcome was shoulder pain and function that's measured by CT. And we also measure a composite medical shoulder elbow surgeon score. So essentially it is depending on the scale you look at, it's anywhere from 10 to 13 questions that inquire about the patient's pain with different activities as well as their function. And that gives a composite score. We also had a secondary aim where we were looking at the heterogeneity of treatment effects by tear size and age. Those are two variables that are important to patients. And so we looked at, we powered the study for that as well. This has been a long journey. This has been probably one of the most difficult things I've done in my life. It's been a very, very long journey. Initially we kind of formed a, there's a consortium, there's a loose consortium which essentially works towards multi-center studies in musculoskeletal health. Most of the collaborators there are orthopedic surgeons or almost all of them are. We proposed a preparation grant. You have to prepare for something of this scale to the NIH that which was funded. And eventually this study was funded for the actual clinical trial by what we call the Patient-Centered Outcomes Research Institute. It stands for PCORI. It actually came out of the Affordable Care Act. It still exists. Their emphasis is essentially on patient-centered outcomes. So they will only fund research that directly impacts clinical care or directly impacts patients. Now one of their mandates actually is that you engage stakeholders during the process of the study. And this was a learning experience, but you know, one that I've enjoyed quite a bit, but learned from as well, where every few months I present to the stakeholders. That includes patients, that includes caregivers, that includes payers, that includes the industry, and obviously providers. So all of them form stakeholders. And we present it in a way that they are members of the team and they provide input. So we update them on the progress of the study. They provide input. And the patients have actually provided a lot of valuable input, especially when it came to stuff like informed consent forms, how do you approach patients for the clinical trial? How do we, in the future I can imagine, how do you disseminate the results? How do you make them acceptable to patients? So it's been a very good experience in terms of learning how to incorporate this information in a way that a layperson can understand. And how do you have them contribute in a way that they feel valued as well? So we send out actually quarterly surveys to them as to how do they feel about their engagement and different times of the trial. We've had a fairly high level of engagement. Different parts of the trial we do have some ups and downs. So this is, as I mentioned, a fairly large clinical trial. This trial was actually attempted before. This was attempted in the UK in their national health system. It was tried across about over 50 hospitals. That trial actually failed. I think part of it was because of the nuances with the health care system in England. It was also tried in Europe. And it was unsuccessful. And so we have up to now, we have about 19 actually different institutions that have contributed towards the clinical trial. So 19 sites have participated. Some of these sites are kind of shown here. To give you a sense of how difficult this trial has been to enroll, we have screened about 15,000 patients, of whom we found about 2,000 patients were eligible. And eventually we recruited and randomized 184 patients to date. So it's a huge population that we have screened. But even amongst eligible, it's about an 8% uptake rate. So these eligible means these patients actually have MRI evidence of a tear. The patient fills out the form. They are eligible by all means. And they still, most of them still refuse. 92% of those patients still refuse to participate. The number one reason they refuse to participate is because this is a randomized clinical trial. They do not want, they wish, they prefer that their provider or they themselves decide their treatment. They do not want that treatment to be decided by the flip of a coin or by a computer. And so that is what makes it, they come with their own biases about what treatment they think works well for them. And quite frankly, I think even if they don't have a bias, just the idea of randomly picking a treatment makes them uncomfortable. They'd rather just have their provider tell them, this is what you need. And they'd be more comfortable. So we go at lens to explain the trial to the patient so that they understand what they're getting into. We make sure that we make them understand that, do you understand that your doctor nor you will choose your treatment? And we give them a questionnaire as to how, whether they understood that or not. And if, for example, they say, I have a very strong preference for surgery. We will go back to them and say, hey, you have indicated that you have a very strong preference for surgery, but you're still saying that you want to participate. Are you sure? So that's part of the reason why we randomized, why we also have such a low rate. But in general, these trials are extremely difficult to recruit for. As you can see, we have variability in how successful each one of the centers is. We've probably had over a hundred surgeons recruit for this trial. The bulk of the recruitment, though, comes from some champion, who I call clinical champions. So they have been more successful than many. But there have been a lot of folks who have participated. Now, one of the reasons why this trial, we had this study designed where patients were recruited from surgical clinics was because it would be difficult, it would kind of reduce its feasibility if we try to recruit from non-operative clinics or from primary care. And the reason is one of the arms of the trial is surgery. So they could either get surgery or they could get a standardized physical therapy. So this is not your mom and pop physical therapy. We've gone at length to standardize this. This was published before our standardized physical therapy program. It was compiled by, there were 18 physical therapists. All of the MDs, we agreed to a protocol that we follow. I have been extremely impressed as to how the fidelity with which that protocol has been followed. We asked the physical therapists at three months, six months, nine months, as to, you know, are they following the protocol? If there are deviations, we ask the patients. So we have all of that data. And I've been very impressed with how they have really responded to our call for standardized physical therapy program. Each of the sites has a lead site PT. They reach out. So these are not just physical therapists in academic centers. These are physical therapists out in the community. Because the patients could go anywhere for physical therapy. So our lead site physical therapists reach out to their counterpart in small clinics and villages sometimes. And they tell them that they are part of a trial. And each one of them has filled out a survey for us. So it's been very impressive how they have felt valued when they have participated in this research and clinical trial. But it's been incredibly difficult to compute for this. But I'm happy to say that our target end was 178 for AIM-1. So we have surpassed that end. So we do have the requisite sample size to address AIM-1, which is a head-to-head comparison between the two treatments. Now for AIM2, which was more of a stratification, in other words, of the analysis by age and tear size, that usually requires a very large sample size. So we had to make a little bit of a compromise there where we would have needed about 500 patients for that if we had to really address that question with full confidence. So we made a compromise there where there's a, I guess, something called the MCID which some of you may be familiar with, which is the minimally clinically important difference, is if you compare two treatments, what is the difference on a scale of zero to 100 that is meaningful to the patient, right? That's what it simply means. And you need to detect at least that much of a difference. So if the MCID is 10 points, if let's say the MCID is 10 points, it takes at least a 10 point reduction in that score, in that Spady score, for the patient to feel some clinical benefit from the treatment. That's essentially what it means. And so we had to compromise on that. The smaller MCID you need to detect, the bigger sample size you need. So we sort of went with a little bit more what you call liberal estimate where there is a range of it from 10 to 25, so we picked 20, and that helped us reduce our sample size. So we can still answer question two, but with less of a, with a greater MCID. So it's not as robust, I would say. So again, as I said, this work is really a teamwork with MDs, physical therapists, staff, data management. You know, all of them have come together to make this happen. Our next study is a NIH-funded study, which, you know, really kind of goes to why, to the why. The first study is a treatment-based study which kind of comes across as very cool. You'll have immediate results, not immediate, but results after the clinical trial to give you an answer about which treatment actually works better in what patient. One of the things we don't understand is why do we actually have these rotator cuff tears? Why do we have atraumatic cuff tears? There's obviously the issue of aging and degeneration of the tendon, but not all patients get these. Not all persons get these. Not all persons who get these are actually symptomatic. Why do we actually have them, and why does the tendon degenerate over time? I think that has been the holy grail, and that's been a million-dollar question as to why does this happen. We don't still know the answers to it, and I believe that that is one of the reasons we cannot find good treatments. If you look at both the operative and both the non-operative treatments, really neither one of them follows the biology. If you look at the non-operative treatment, you're simply strengthening the rotator cuff, and there are some stretching programs that are included. Yes, it does help the biomechanics of the shoulder, but it's not doing anything to change the intrinsic biology of the tendon. On the other hand, if you look at surgery, it's the same concept, where the surgery itself, the idea is that you can heal the tendon back on the bone. We know for a fact that the tendon never heals, actually, on most patients. I think we've sort of put the cart before the horse in some ways, where we've gone to treatments before really understanding what is causing these problems, and so that's what this study aims to understand, is there is some evidence that genetics plays a role in this, or there are genetic variants that are associated with tendon degeneration. There are some SNPs that are associated. Now, this evidence is fairly preliminary, so we proposed this study with the idea that this is a fairly ambitious study, again, that we would perform. The problem with genetic studies is you need huge sample sizes, and usually those are hard to come by in musculoskeletal or rehab research, so we have harnessed some of the biopository, and our aim one is to look at 10,000 patients and perform a genome-wide association study, and we are pretty close to it, actually, so this would be one of the largest cohorts of patients with rotator cuff tears, or shoulder pain, actually. Our aim two, we know that some patients improve after rehab and surgery, and some don't, and we don't really understand why some patients do well and some patients don't beyond psychosocial factors, and so aim two will take the patient, follow them longitudinally, and see if there are genetic variants that are associated with better outcomes of rehab and surgery, and third aim is to study the muscle degeneration that happens once the rotator cuff tears. There's a phenomenon called fat infiltration. Now, that only happens in about 40% of the patients, so why do some patients get it and some patients don't, and that's what aim three will study to look at genetic variants that are associated with fat infiltration. So, again, this is a pretty big effort with a multi-center study. We have six participating sites in this, not as many as for the clinical trial, but we have, to date, recruited about 1,100 patients. Now, about 2,000 patients will come from recruitment. The remaining will come from biopositories, and so recruiting 2,000 patients is a fairly big task, and so we have recruited already close to 1,200 patients, and we anticipate that in the next year, year and a half or two, we should be able to get to our target size of 2,000 patients. That will make this the largest longitudinal cohort for shoulder pain, and I encourage a lot of trainees to use this cohort. That is my idea with this. We consent patients for a lifetime, so the way we have consented patients is that we have said that this will be a lifetime cohort, so we will follow you for the rest of your life, and we follow them at three months, six months, 12 months, and then we follow them annually through questionnaire, and we can even bring them back, and we consent them in a way that we can share data across institutions. I learned this the hard way, so we can consent, we can share data across institutions, including the PHI, so my kind of vision here or goal was to make these, like we have the Framingham Heart Study, which is a lifetime cohort. You know, you have these cohorts in cardiology. You have the nurses' health study, and that was my goal with this, is to get this cohort so we can have young investigators use this data and propose other studies, so we are somewhat successful in that regard. We also have access to our biorepositories, which are primarily from Vanderbilt. We are working with Kaiser, and we'll likely get one from Michigan as well, so we will have enough patients here, so essentially, all of this, what it led to, eventually, the goal of this program, all of these studies, is to develop an institutional presence. How do you relate this to the general community, right? We can relate this to the PM&R community, but how do you make a difference at the institutional level? How do you bring PM&R to the forefront? How do you bring musculoskeletal physiatry to the forefront? So that was the goal, and that is what I personally wanted to accomplish, and so at my institution, the dean announced a musculoskeletal transport research program, which was a cross-institutional, non-departmental. The whole idea was to develop mentorship infrastructure, as well as an infrastructure that can attract talented scientists. They could be from any department, and I would say that has been a part of the culture that I personally believe in, where I'm fairly departmentally agnostic. I am responsible to my constituents and to my staff, but on the same token, I think everybody benefits if you think of the broader universe in some ways. My philosophy has been, I really don't care what your specialty is, what your background is. As long as you're willing to work in musculoskeletal research, I will be happy to mentor you, and I've had a lot more of my mentees. I'm obviously delighted, and I have a personal investment if there's one of the PM&R trainees who comes, or one of the junior PM&R faculty who comes, and wants to build their career in musculoskeletal research. But I haven't shied away from mentoring PhDs, or from folks from family medicine, or any other department. Orthopedics, for sure. So, kind of, this is connected to our clinical aspect as well, and I'll just kind of shift gears from research to the clinical. And in my vision, or opinion, the best way, and in some ways, the only way for us to provide musculoskeletal care is to partner with other departments, especially with orthopedics. That is our strength, and we are the best partners. Half of our residency is spent on musculoskeletal care, so we are in best position to be able to be non-operative partners for orthopedic surgeons. And it is in our benefit to partner with them, versus develop an animosity with orthopedics. And that's what I've seen tends to happen at academic institutions, especially. So, I've really kind of lived that model, and have seen, and research, obviously, investigation is a bridge to build those, is a way to build those bridges. It's a neutral territory, right? Everybody values it. And so that is a way, where one is, you can show your work. You can show why most orthopedic surgeons don't do research, but they're very interested in it. So, that's how medicine does it well, right? So that's the same thing PM&R can do. And that can build a bridge to your clinical service. And so, you have to work with both the surgical and non-surgical departments. There are other folks in MSK who have a skin in the game. It's emergency medicine, primary care. And I don't think we need to be territorial about this. We don't need to be territorial. We need to be inclusive about it. And obviously, if other people play in the sandbox. It's never as simple, but in general, I think if you follow that theme, I think it goes a long way, and people see it. I'm not saying you'll always be successful, but it's at least been how I approach it. So, to develop, I think an interdisciplinary musculoskeletal and sports service is really the way for PM&R to pursue musculoskeletal medicine in the future. Develop a partnership. It allows you an opportunity for shared leadership, institutional leadership. It's better, more efficient patient care. This is what patient-centered care is supposed to be like. It is essential for the fiscal viability of PM&R departments and for reputation. It attracts talent. I mean, the reason why our residencies in PM&R, in my opinion, have become more and more competitive, I've seen them change over the last 10 years. I think each one of you may have seen them change. We are getting very competitive candidates in PM&R. And I believe a big reason for that is musculoskeletal and sports medicine. A lot of these residents want to do sports medicine. And that's fine. They might change their mind later on, and that's okay. But I think that's exposed a lot more medical students to PM&R, even if they eventually decide not to do MSK or sports medicine. So it attracts talent. It enhances a residency program reputation. Eventually, in my opinion, it's essential for the survival of PM&R. So I'll skip, these are more kind of, I would say, from a, if you were to develop a real service line or develop a musculoskeletal institute, I have had some work and experience in it. And these are some of the operational steps with each of the goals, where you could have, how do you foster interdisciplinary collaboration across campus? How do you do patient-centered MSK care? How do you incorporate education in it? How do you incorporate musculoskeletal research in it? So these are some of the operational steps you can use. But eventually, an example of creating this is, you create a vision, and you have some major goals for such an institutional center. All of this lends to education, obviously. The more opportunities or growth there is in terms of the presence of PM&R in musculoskeletal medicine, it's going to offer your trainees, both fellows and residents, more opportunities to work in MSK, a sports clinic, true MSK sports clinic. And that's my, I put the word true in quotes. And the reason it's very deliberate, because when I was a resident, our MSK experience used to be trigger point injections, initially. And that has changed substantially since then. It's changed, I had to seek out other clinics, especially orthopedics, to actually learn true MSK. I think that has changed for the better a lot, but it is still not optimal. I think we still can enhance all those experiences for our trainees. And if it takes to collaborate with other departments, that's what we should do. If we need to send our trainees to orthopedics, to pediatrics, to family medicine, that's what we should do. Sports fellowships, again, that's another area that PM&R really needs to grow in. We can collaborate with family medicine and orthopedics to develop sports medicine fellowships. We do not need to reinvent the wheel. 90% of sports fellowships are family medicine-owned, usually, but that's okay. I mean, that's how you kind of develop a campus-wide program. That's how you collaborate with other departments. It is in our best interest. It is our strength. We should not necessarily, we don't need to compete with them. We can still excel in that. And encourage fellows to contribute beyond practice. What I mean by that is, this is something that some of the other medicine subspecialties do very well, where they encourage their fellows to do, to what you might call make a difference, or do something beyond clinical practice, and this by no means is trying to downplay clinical practice. But either they engage in investigation, they make a difference, or they can cover games, they can go to sports coverage, they can work in communities, they can do community. There has to be something beyond the clinical practice, and the fellowship is one right avenue for that, in addition to exposing our medical students. So, this is, I'm going to kind of abbreviate this part on disability advocacy. We call ourselves physicians for persons with disabilities. I think that is, in some ways, our identity. I don't think we have done justice to ourselves there, where we do talk a lot about disability, but what really is it that we offer that is a specialized body of knowledge that we can call ourselves disability doctors? Why would somebody send them to you? And I think that's a question we need to answer for ourselves. It's just not enough for us to say that we care for persons with disabilities. It is important for us to distinguish ourselves as to what do we offer these patients with disabilities. And the way you do that is by creating, supporting, and staffing medical programs for individuals. You have to develop a specialized body of knowledge, either whether it's medical knowledge, whether it's procedures, it has to be something specialized. And we have to be leaders and providers for adaptive sports programs, so I hear that all the time. But really, you have to ask yourself the question, would a PCP necessarily send you a person with disability just because you're a physiatrist? I don't think so. What would you offer that they wouldn't offer? And that's a question we should ask ourselves. So I kind of just had a shout out to the inpatient rehab. I know this lecture was meant to be MSK, but really, a lot of people have reminded me of this, which is we shouldn't forget the core of our specialty. And I sincerely believe that, that inpatient rehab is the core of our specialty, where it is our identity, and we should support and preserve it, and the advantages we have from one subspecialty or another should be shared across the spectrum. We create signature programs that are excellent, meet in SCI, meet in TBI, and so on. So I just end this with, I say at the end of it, it really is excellence that drives any specialty. And that is what should drive our PM&R specialty, which is the burden of proof is really upon us. It is not enough for us to say, I do X, Y, Z procedure, and that's why I should be allowed to do it, right? Be it PRP, be it, I mean, I just think that the idea that we do not have evidence for most of what we do is problematic, and in my opinion, is an existential threat to us, where we have to be able to provide evidence for every single thing we do. I don't think we could actually right now say that there is evidence that supports even our most core subspecialties like inpatient rehab. And that is a problem. We have to collaborate with our partners, and I think our best partners are orthopedics when it comes to MSK, on interdisciplinary service, and we need to show and prove our value. And we have to be, in its true sense, be advocates and providers for care for persons with disability, and distinguish ourselves with a body of knowledge that's unique to our specialty. So with that, I thank you for your time, and I'm happy to take a question or two, but I don't want to delay Dan's presentation. Thank you. Thank you, guys. I was just thinking about this beforehand, you know, when you have these presentations and you never know what you're expecting, when I saw the date and time I was like, oh, this is going to be fun, because I can at least say I know like half the people in this room and everything like that, sounds kind of cool, how you spin it. But I am going to present on the grant that our team received here where we were trying to validate a low-cost platelet-rich plasma. And I think what Dr. Jane was talking about at the end there is kind of our impetus for doing this, where I am a skeptic when it comes to new ideas, new thoughts. And so with PRP, I was like, ah, people are just trying to make money on it. As time goes on, you learn more, there's more good research that comes out, and you say, hey, maybe there's something to this. But the cost of it was always what got to me. It's always the cost. It's always, why does this have to cost $1,000 or $1,500? It makes no sense to me. And then when you try to do research on it, you can't pay for it. So I'll kind of talk over a few things with it. But originally, I was going to do a poll everywhere, but there's like four people here, so we might skip those. So let's talk about what PRP is here. Briefly, it's taking your own blood. You spin it down a centrifuge, you take out certain layers. Came in the 80s, and a lot of times, it was originally used for burns, where they thought, you know, when you cut yourself, that's where platelets go. When you burn yourself, that's where platelets go. So let's just use a lot of them. And nowadays, it goes all the way into cosmetics and lots of other things, but it's become a lot more popular. The concept, which to me was a bit of hand-waving, is saying there's growth factors. They just magically go in there and fix everything. But there are real advantages. It's your own blood, it's autologous, and definitely has a lot less side effects known compared to other things. There is a lot of evidence now. So this was my poll everywhere, I'm going to just skip over that. So point number one that I just want to go over is it definitely does not regrow cartilage. This is one of the selling points that I think a lot of people use. It's very clear at this point that no, it does not have anything to do with regrowth. There's very good evidence, though, that it works for NeoA. So tons of systematic reviews have come out even recently. There's 31 RCTs there in that one, comparing PRP to different treatments. And it is very clear it works. That I think we can say. If you compare it to high ironic acid, definitely better. If you compare it to placebo, usually saline, it's better. Compare it to corticosteroid, it's better. But then there's the big ifs. So if you use enough, if you have the right type, all the other ifs that come along. And that's where the insurance companies usually come in and say, well, we're not paying for it because of these things. I'm going to talk about this in a minute. But when you spin that down, you can get white blood cells out of it. There's been a bunch of reviews of this recently, too, that show it doesn't really matter. And I'll get to why that matters here in a second. It's expensive. It's not covered by insurance. And that is the thing that really gets to me. So at least where I work. I work at an academic center at the University of Utah. And I would estimate 75% of our patients are not going to be able to afford this. That's what I would guess. We charge $500 for an injection, which we actually had to work to bring down. It was originally $800, and it was a fight to get it to come down. State laws, all sorts of things that were kind of playing that game. But how much does it cost? On average now, it's about $1,000 for an injection. If you compare, I was just talking to a colleague from Boston who said she got a PRP injection and it cost her $1,200. The cost is a big deal. If you look at different areas, they used to be a lot more different. And now everything is just like, well, I'm going to do the same thing, so we're just going to charge the same amount. So for the most part, it's around $1,000 for an injection. Vial of cortisone, $10. So you can understand why payers would want to pay less. Makes sense. It is becoming more popular, so we're seeing more and more of these. I think it's becoming a lot more known in the general public as time goes on. It's becoming less and less common that a patient hasn't heard about it, I find. They'll be like, oh, is that the blood thing, or is that the plasma stuff? I get that a lot more nowadays. And I actually find that there's more patients who come in saying, I want PRP, even if they don't know the reasons why. And then the talk of excellence that Dr. Jain was referring to about how we need better data. That was one of the final things for me, is in order to run these studies, it's expensive. And if we can reduce the cost by bringing it down to 3% of what it otherwise would have been, that's going to make a big deal. So there's all these recommendations about how you should do PRP research. This one was from 2018, so five years ago. And this has been talked about many, many times. So those were kind of all of the ideas. I was going to ask people here in the room if they thought they would do PRP or cortisone for their knee. I get most people be like, I do PRP. But that's if it was free. And if it was $1,000, would you do it? I don't know. There's a difference. And then, to be honest, like most of us are, so it would be less of a big deal for us than it would be for most other people. And so that was kind of the genesis of this whole idea. One of our spine physicians, his family member is a physiatrist in Canada, and they had developed this method. And I'd heard about it and talked to them about it, and again, I'm a skeptic on it all. And so they said, yeah, in Canada, the system's different, obviously, and this is how we do it there. And so they implemented it at our VA. And I said, why aren't you guys studying this? And it's, well, it's too hard, too much time, all the other stuff. And so I asked them if I could, and they said yes. So that's how it all came about. And basically, here's how it works. It's a very simple process. You just draw blood. You literally put it in a centrifuge. And then you take out what you need from the centrifuged blood, and then you just inject that. So there are commercial kits, and that's where most of the expense comes from. So these kits can be $300, $500, it just depends. And that's where the cost comes from. So if you want to administer PRP, you have to pay for the machine, and you have to pay for the kit for each patient. As you can imagine, you don't want to have blood contamination. There's a lot of things you have to watch out for with these. So when we did this, we looked into the regulations of it all. And ultimately, FDA has not approved this. So every person who gets PRP is using an off-label. So it's an off-label product, and it's generally looked at very differently than pharmaceuticals, because it's considered to be a biologic product. And so when we did that, here's how we do it. I kind of showed you this. This is what we set up. We have a bunch of syringes there. We have gauze. We have some stoppers. We have something to draw blood with. That's it. So that's what is required. You need to have sodium citrate. Sodium citrate is very cheap, is extremely cheap. So we had a bunch of little vials that we would draw sodium citrate out. We would have our research assistant, but generally speaking, it would be a medical assistant, do the venipuncture. We would draw out 13 milliliters of blood into three syringes. So each one of these syringes has a little bit of sodium citrate in it. You draw out 13, and then you're at 15 milliliters per syringe. And then you use these very expensive medical devices known as gardening shears, and you cut off the tip of this, and you cut off these, and now it fits into a centrifuge. And that, honestly, was the thing that made this very cheap. So we put them into the centrifuge. There's three of them, and then there's one that just you put in saline as counterbalance, and you spin it down. There was a lot of testing back and forth of finding the right amount of RPMs, how many minutes do you do it, everything like that. And we spin it down, and what you're left with is that picture we saw, where you've got plasma on the top, red blood cells on the bottom, and then a layer of whites in the middle. And as you can imagine, heavy things go to the bottom, that's why red blood cells are down here. Light stuff, which is mostly fluid, is at the top. Our platelets are mostly right next to those white blood cells. So you have the option of saying, do I want white blood cells or not? But if you do get white blood cell, or if you don't want white blood cells, you have to be a little more careful, and you have to probably miss some of the platelets. So we kind of balanced all that, and that's why I brought up that other point, leukocytes don't matter that much. Everybody talks about it in the PRP world as, oh, you've got to have poor or rich or poor or rich. Nothing really has shown anything on that. So to me, I'm like, whatever, we'll have a little bit of leukocytes in there. And it does seem like it's a little more painful if people do it. I will say, from our experience, there was one patient who said it was uncomfortable after it. Everybody else was like, it just felt full. So I don't think this really increases pain much. And then I somehow convinced our orthopedic center to get a cell counter so that we could actually look at the cell counts of this. What are we injecting? What were we pulling out of their blood? So here's the math for all this. If you take three syringes, and we pull out, give or take, three MLs on each one, that gives you nine milliliters of PRP. That's what we would inject into a knee. Now knees can take nine milliliters. That's no big deal. If this was a CMC joint or something else, this process may not be the best. Hips could take nine. Shoulders can take nine. Large bursa can take nine. But once you get out of that, not much else can. But there are other ways of doing it. And the thing we were worried about is, what if we give somebody an infection? That's a big deal. Joint infections are catastrophic, to be honest. So the teams that I had talked about had probably done 2,000 of these injections and never had an infection, never had any problems where they gave someone else someone else's blood or something like that. So we were really big on labeling. And to this day, that's still the one thing I worry about, is if somebody messes up someone else's blood. So that's the thing to always consider with these. What we wanted to know was, could we validate that our system works? So is it as good as publicly available compositions from commercial kits? And what we wanted to know was yield. So if your whole blood has, say, three billion platelets, or sorry, your whole blood has four billion platelets and your PRP has three billion platelets, then you've just saved 75% of those platelets and you've lost 25%. So that's yield. We just want to know, are we getting most of those platelets? And there's always this talk of concentration, where concentration is actually how much of those platelets are you per fluid. And the reason I bring this up is people talk about it a lot, but honestly, at the end of the day, all you want is a lot of platelets. It doesn't matter what the concentration is. But if it's a small joint, you can't fit a lot of fluid in there, so you need it more concentrated. So in our case, we were like, we don't really care how much fluid there is. As long as it can fit in a knee and it's not uncomfortable, we want to get as many platelets as possible, because that's the idea of what's going to help you. So the second goal was we were going to look at pain and functional outcomes at six months, and the third, probably the most important, is we hired a health economist. That's where most of our grant went, and to look into the cost effectiveness of this PRP. So just because you can do it, and just because it works, doesn't mean it's actually cheap. What if, to do all the work we needed to do, it actually would have still been cheaper to use a cortisone injection? So that's the question that we wanted to propose, and we were pretty confident that number three was going to at least be a wash, if not better, than cortisone. So here are the inclusion criteria. Grades one through three, knee OA. They had to have done stuff for the knee OA. Recent radiographs. We excluded a fair amount. So BMI greater than 40 was a big one for us. Recent knee surgery. If they'd ever had an orthobiologic, or any injection within the last six months. Those were the main ones. So we did have to exclude a fair amount. I didn't put that information in here. There's talk of taking ibuprofen, Aleve, those kind of things. So we made sure we avoided those before and after. And then we really wanted to know about any adverse events for these. And here was our timeline. So we consented them. We did two injections for each patient. And then we monitored them for one, three, six, and 12 months. See how long, see what we saw during that time. We did not have a control group for this study. It would have been a lot of money in order to do that. Dr. Jane's studies just boggle my mind after doing this. And how much money that must take to do. So we made sure we did it with ultrasound to ensure that we were in the joint. I was the lucky one to get to do 60 injections. We asked them if they wanted to do anesthetic, we would do it, but we would just keep it outside the joint. So it didn't really confound the study. And then we used different measures to monitor them. It's a balance between taking tons of measures and time and survey burnout. So we really tried to minimize that as much as possible. And then the cost effective analysis, I don't know. It is way too complicated for me, but I've just recently met with our PhD again and he's doing it. It seemed it's a whole other world of research compared to what we do. So here's what we found. This is why grants matter. We actually got to the point where we were turning subjects away after a month because we recruited so quickly. As soon as we opened up, we started just very gently looking for the first two months. We didn't even advertise or anything. And then as soon as we advertised it, it was full. And we, to this day, I'm still getting people asking about it. So the foundation for PM&R was gracious enough to give us $30,000 to do this. And it also allowed us to follow up with patients because we paid them. So if we paid them to do it, our response rates were much higher. We had a research coordinator. So the University of Utah, where I work, allowed for matching funds to pay for that. The health economist was paid for by the original grant, supplies we needed, and then the, like I said, the reimbursement. Keep moving here. So here were our subjects. So there were 20 subjects, 30 needs. This is what we ended up with. Our goal was 30 subjects, and that, like I said, took a month to recruit. We were done with all of our interventions within three months, which was, we were supposed to do it in a year. Made it much easier. BMI was 27, mean age was 49 years old. These were the analyses for those who were really into these types of numbers. So whole blood platelet values were on average 190. Concentration later was 480. We were able to save about 80% of the platelets with the system. Second injection, similar. We were able to save about 90% of the injection. I do think there was a bit of a learning curve for doing this, where we learned how to do it a little better by the end. Our outcome. So we were able to get 100% response rate at one and three months. Their patients overall, how do you rate your knee, a global satisfaction rating for their knee did significantly improve at one month. The three month value, I don't know if that was significant or not, but definitely compared to baseline. Six month data we're getting right now. Global satisfaction as time went on, basically you want gray and green. You can see that people did get a little bit better. This was just how satisfied are you with your knee? That's the question. There were still some unsatisfied people at three months. How satisfied were you with the injection? Basically, almost everybody was satisfied as time went on. For six month outcome data, we've had 13 of the 20 respondents. Everybody has responded, so we're still at 100% response rate. Global satisfaction for the, again, how is your knee, 23% are unsatisfied. Everybody else is close to satisfied. How satisfied are you with your injection? Pretty much everybody is satisfied, which I don't quite understand, but, hey, we'll take it. And then the WOMAC values significantly improved at one and three months, and they're still improving at least to date. And then we'll have 12 month data in another seven months or so. So that's been the study so far. I think for us, the big thing is the cost effective analysis. That's what we're really going to look at. Our six month time frame is our main point. So we're going to have that probably in another few weeks. And so everything should be in, and we'll be able to look at that. I think big thing for me is that we can use this to make a system that is open to everybody. That's the whole idea. There's a big controversy with insurance in the sports medicine and pain medicine world where if insurance pays for it, the thought is that they're going to drive down reimbursement. It's a balance. I don't know the right answer to it. But at the same time, I think it's a price I'm personally willing to pay in terms of some equity. And it's already used this way in other countries, I think. Second, the big goal, too, in terms of clinical care is going to be research. And so I think this will really allow us to do larger studies as well. If anybody has questions, please get in touch with me. Any questions? All right. Well, thanks for doing this. Yeah, I think, I'll paraphrase because I think some of this is on Zoom too, is for the future, what is the effect on those who are currently using this system or other systems? And I think one aspect is going to be, some people use similar things already. So some people just manually create their own PRP and then they still charge $1,000. And that's okay. That's totally their choice. I think that as prices come down, that will not be something that they will be happy with, to say the least. Second would be people who are currently using commercial kits are forced to charge more. There's just no way around that. They have to make that money back. So if they have another option, I would hope that they would say, hey, I made $100 on the injection before. The kit was $400. I would charge $500. So now, since it cost me $10, I'm going to charge $110. I don't know if that's going to be the case or not. But I do think that actually it would, it will probably, I don't think they will still charge the $500. I think for the people who are trying to, you know, make it available for everybody, I don't think so. But I also think that in a, from a bigger picture, as this becomes more common, that is just what happens with everything, everything, the price is going to come down. There's no patent on this. There's nothing that is going to be special. So I don't think that we did anything groundbreaking, by any means. I think this is already out there. I think that as time goes on, prices are going to come down. It just might speed that up, is what I would hope for, honestly. And then the question of insurance is the big question to me. So if insurance coverage occurs for this from a large payer, I think the dominoes will fall pretty quickly. And I think that will make some people very upset, yeah. We did exclude any kind of blood cancer, but we didn't exclude other ones. Yeah. We, if I remember correctly, and I have to look back, I think we did exclude all patients with kind of a known diagnosis of diabetes. So if it was an unknown diagnosis, we didn't check into their records or anything like that. It was just within the exclusion criteria they could say yes or no. So because we have already implemented this at other, within our department at the VA, there was nothing with that because it's already been proven numerous times over. So the IRB didn't have any issues with it. The hospital safety didn't have any issues with it. So for us, it was no, it wasn't anything. Other institutions, I don't know. It's a great question. Well, thanks. Yeah. And I think that as one of the challenges there is, like you said, it doesn't happen in the U.S. much, even though it happens in other areas. And I think that commercialization is present in a lot of what we do. And I think that hopefully just realizing that it's not that hard, if nothing else, will open eyes. And at least for me, just doing this study, that was the first thing I noticed, is I'm like, that's all it is. You know, it's always like a black box of, well, you need this special fancy kit to do it. And I'm like, actually, no, I just like dropped it in there and ran the centrifuge and pull it out. I'm done. And I didn't even get into like doing leukocyte rich or double spinning and all this stuff. And I'm like, it's so simple. I didn't realize it. So, yeah, I did. I agree with you on that part. So. All right. Thanks again.

platelet-rich plasma

musculoskeletal medicine

PRP

pain reduction

orthopedics

cost

research

low-cost PRP method

collaboration

disabilities