I'm not just a panel. You are not just a panel, so if the other members of the panel can come on up. I know there's going to be a lot of questions, and we'll open it up, but we've got 20 minutes or so. Bringing it to the end. I'm actually going to start, and a little bit of this is going to be prefaced by a very public lawsuit that's currently out there where a player is suing because he got an injection for a rib fracture, ended up with a pneumothorax, and the lawsuit is over lack of informed consent. So we're doing injections, guys. How big a part is informed consent, and how big a part is documentation of informed consent? Yes and yes. So a couple of comments we've had, and we've had some mixed recommendations. So I think it's great to have this discussion on the panel. I think the informed consent with the athlete is most important, and then documenting it afterwards. So even the lidocaine soft tissue injections, we always put a note in the EMR that we talk to them about the risks, and even the game day or mid-game ones, we'll go back and make sure we document that at the end of the game. So there's always a note of that discussion in the chart. We've had some discussion with our legal counsel about should they sign a consent to do an intra-articular injection or do an AC joint injection. In the state of Ohio, you do not have to sign informed consent to do that. So our standard of care in the office is to verbally discuss it with the patient and document it in the chart, and that's considered acceptable standard of care of Ohio. So if we deviate from that and have them sign a consent, are we doing something different than we would normally do? So it's been a little area of discussion for us as to whether to have them sign a consent when that's not our typical practice. So we are concomitantly developing an abbreviated consent for all of those training room-based procedures, but we've had some mixed counsel as to how to approach that. Remember when we talked about it at the team physician meeting, the kids came up last month, a couple of weeks ago, in Indy. As I recall, the lawyers kind of thought we should do it, and we've not been routinely doing a consent document for sure, but we've not consented. But I think they said we probably should. We probably should. Yeah, we're at the same place as you are in Buffalo that I don't get informed consent in the office. If I'm going to give somebody an intra-articular injection, we discuss the risks and benefits with them, and we do the same thing with the professional athletes and then document that we had the discussion of the risks and the benefits. And for the same reasons. Now, my answer may change, and if you ask me this next year, I may say something completely different. So that's sort of the current state of things, but it's an area that's definitely being paid a lot of attention to right now. I think we should do it in this environment. Yeah, I would say at the college level, you know, I think we're behind a little bit. I do document Jim Nose, been with him for many years, he was with me at Missouri. So we always put a note in, but, you know, consent forms, no. You know, some of our athletes are younger, you know, the question is, you know, is that even worse that we don't get a written document? But that would add to, obviously, complexity of things. We haven't done it at all. You know, making a comment, we started doing informed consent for IVs, pre-game IVs. The goal was not to avoid the attorneys, but to deter the athletes from wanting it, because it basically says there's no proof that this works, thinking that that would lessen the number that desire them, and that worked miserably. But so the question is, you know, we've discussed this at our general medical committee meeting, if we do IVs pre-game, you know, how much of informed consent should we be doing? And then, really, the question is, how standardized should that be across the board? And raises the next kind of question, you know, the TORLAC inter-articular. So how much of a discussion, if any of you do that, is there that this is an off-label use, and how much do you document that with inter-articular TORLAC? Yeah, so I can take that. I'll take the first crack at it. I think it's not fair to always have it go to the person that's sitting closest to the moderator. Yeah, my mic. That's a, it's a panelist strategy. You can see where I sat after my talk. I did not sit right next to the moderator. You don't want to be at the ends. But anyways, I personally don't use inter-articular CORTORALAC. I know that some of my team physician colleagues do. If I'm doing an inter-articular injection, it is corticosteroid, and often plus hyaluronic acid, a high molecular weight preparation, and sometimes if there, you know, if there's a biologic involved, then a, you know, PRP or something like that as well. But I haven't used it. I know that it's a, it's an option, and I know that a number of my team physician colleagues do use that and combine it with others. Yeah, I'm not, I'm not used to it. Maybe I should. There's some data to suggest that the receptors are present in synovial tissues, but I'm not used to it. I just haven't. »» Yeah. So, you know, I think you guys have addressed this. But I think for everybody, you know, how would, you know, so again, there's kind of two options. And let's just say more of a soft tissue acute injury, you're either going to do steroid or PRP. So maybe comment on both. And then just kind of your return to ramp up protocol on that. Let Pat start. »» So for me, I've been more of a PRP, low white belt preparation person for my injections in the athletes, particularly in the ankle, syndesmotic injuries, deltoid ligament injuries, lateral ligament injuries. That's my preference over corticosteroid. We treat them the same from the rehab standpoint we've talked about. Obviously keep the mice down and get the range of motion and strengthen after that. But that's probably where I've used it the most other than the knee joint is the other I use that in. But for me, for the extraticular, mostly it was ankle primarily. And AC joint, that's one area where I will use cortisone more than I would use PRP. I generally do not inject the shoulders with PRP. I really haven't done that. »» And hamstrings? »» Hamstring, yes. And I'll make one comment about the hamstrings. I do all my own hamstring injections under ultrasound. The idea of getting the hematoma is not very easy. I don't know if you guys have experienced that, but yeah, you see it and trying to suck it out. Like you don't get like, I mean, some huge ones, but you know, those might be evulsions off the pelvis that you're going to have to fix. But typical, you know, and the NFL will correlate with that, we're seeing bicep femoris. We're not seeing high, you know, injuries toward the sciatic nerve up high. We're seeing distal bicep femoris. It's hard to get the hematoma. The other thing I do is they injure it. I don't do it right away. I usually wait 24 hours so that at least I can get some sign of where it is better with ultrasound before I inject them. So I wait 24 hours. And I always do a second injection five days later and sometimes a third. I think there is a benefit, particularly when I use low white cell, low platelet concentration in general. That's my preferred product. I think you have to do multiple injections. So I definitely do two and sometimes three. »» Would you use an ACP? »» Yeah, I would use an ACP. »» So I can speak to the hamstring thing as well. When I first started, well, we started to become aware, the world's all what you're focusing on, right? So we started becoming more and more aware of the time loss effect of muscle strains years ago and really started paying a lot of attention to that. You know, as orthopedic surgeons, we think so much about ACLs and that and that's such a big deal and fixing shoulders. And then you realize that there's this thing going on where there's a whole bunch of players that are unavailable because they're straining their hamstrings. So we really went into that world and started to become very proactive. This is probably eight to ten years ago and reviewed and have consistently reviewed the literature on PRP for hamstring strains and I think it's all over the place. If you look at the systematic reviews, it's hard to convince yourself that it's super useful. So what I personally do, and again, this is, you know, level five talking here, right, is I generally won't do PRP. We've got a pretty good group of people that takes care of our hamstring injuries. So I'll use it if the athlete asks for it and that's what happens in the NFL world a lot of the times is that you're not planning on doing it, but then they or their agent or somebody has had some good experience or they've talked to somebody. So in those cases, I do it, I like to do it in-house rather than have them go off to wherever and get something injected. And it's there as an option, but it's not kind of our standard. Can I make one comment about that? In college, so for us, it's the kids talk to the kids, right? And somebody had a hamstring strain and it gave them PRP and they got back in a week. So now, you know, that's been more positive at Missouri was that, you know, the teammate got better. So I want the same thing, Doc, that he did, you know. So consequently, I spent a lot of time on Sundays doing hamstring, you know, and going to the office because I got to get the centrifuge and so on. And the other thing I would make a big point is I'm super big on sterile technique. You know, I do a good three-minute prep, you know, wear gloves, I mean, I have sterile ultrasound gel. You know, Scott mentioned it earlier with the shoulder. I think you just got to be really careful. It's not just like clean off a little and put an injection in, so I'm really careful about that. Expose your foot. Yeah. We offer the PRP to every, our hamstrings and calf muscle injuries, mostly because the players come back the next, if they don't ask for it right then, they come back the next day and ask for it. So it's almost part of the initial injury discussion is offering it to them from that standpoint. And I did want to echo the part about the sterile technique, because often a lot of these AC joint injections or other injections you may be doing at halftime and they're sweaty and you dry them off and you clean them off again and then they're still sweating even while you do it. So take your time and really, I know everybody's rushing and wants to get them back out there to play, but you don't want to compromise the sterile technique part of things. We've discussed that quite often. It's the worst environment to be doing an injection in when you're doing these in-game injections. So it's making sure you're taking your time and still following all those same techniques that you normally would of actually cleansing the area. Yeah. And I would expand on that a little bit as well. So we're fortunate enough that we've got an office that's right down the street from the Bills Stadium and I send them to our office to get an ultrasound guided injection, especially if it's inter-articular rather than doing it in the training room and I really, I think paid attention to a lot of this during COVID. So during COVID, one of the things that was happening is we're told that everybody's got to be super diligent about cleaning off the table in between things and everything else and you start kind of focusing on that. And I realized that that wasn't happening as much in the training room in between every single visit because I would have to task one of the interns or I'd have to go get somebody because on Mondays after the game, it's very, very busy. There's a lot of players coming through there, you're seeing tons of people and it slows things down for somebody to go in and like clean out everything in the room in between each player visit. And this is just honest speaking. Whereas in our office, we've got somebody who's, that's their job. Their job is to clean the room in between every single patient. It's a whole process. So I might be paranoid, but I do worry about the infection after particularly an inter-articular injection and it's close enough. It's like a mile away. So I have that done in the office and maybe that's paranoid. No, we do too. Any PRP, ultrasound guide injection, we're doing it at HSS at the hospital. So Scott on hamstrings, what's your approach with injections? We've used it intermittently. It's kind of like the guys here, we don't, we're not routinely offered it or promulgated it. Oftentimes it's a player request. I think it's safe. So it's reasonable to do. You know, the basic, we don't know the basic formulation. The basics I did, it would suggest platelet poor plasma, PPP is the best where you actually the plasma proteins. Now the studies I showed, I picked them for specifically because they both were leukocyte rich, a higher white count, you know? So point is, we don't know. I don't know. I looked at literature. I have no idea, Jim, which is the best to use. And just one quick point on the, on the hematoma aspiration and Jim, your point that it suggests to me those were higher grade injuries because I agree you rarely see a hematoma you can truly aspirate. You know, it's just kind of like this interstitial kind of feathery edema, but nothing you're going to put a needle in. So I was surprised they had that many, they could aspirate. Yeah, I was too. I was trying to get blood out of a sponge, right? Yeah. So what about a high school kid that comes into your office, do you, and with a hamstring? I said, you send them over to your office. Yeah. I mean, I think the, the elephant in the room is when there's no cost effect to the person you're treating. It's a little easier to do when there's a cost effect to the person you're treating with, with the results. And I think some of the, a lot of us in the audience and there's that question, you know, so. You know, Jim, you bring up an important point, you know, you, uh, let's talk about the placebo effect and then you've got the cost of this thing. I think it's a very important point, which is this, what I'm doing with my patient who's paying out of pocket. I'm careful to tell them, listen, this is not magic. This may not work because you can have a very disappointed patient who pays a lot of money out of pocket. You can't have your average patient do it for a knee OA or something, but it could be this true. Um, I, but at the same time, if you hang too much crepe, you can ruin your placebo effect. If the player has hope and the individual has hope, they're probably going to get a good response. So that I find that's a, that's a challenge trying to tell them, you know, be on one side. You want to be able to tell them later if they didn't do well, Hey, I told you so. But at the same time, you know, the placebo effect's real if they have some hope. Challenge. All right. Interestingly, we found in the high school athletes that tear their, or that have a hamstring strain. You know, they have an eight game season, it's not, or, or shorter than the NFL season. So they're actually, we actually have the harder time getting them to slow down versus the three weeks that it may take for the average hamstring. The high school kids are really pushing that and having trouble cause that's most of their season versus in the NFL. It's not, it's not quite as much time lost with the 17 game season. The other one we'll mention with, we've seen over and over again, the high school hamstrings where it's actually an apotheosial strain proximally or an apotheosial growth plate inflammation or injury proximally that they're treating as a hamstring that takes forever to get better. So those 16 and 17 year olds can still have open growth plates. It's often that instead. But if you're doing a PRP and you're a college player, you're a pro player, your high school players are going to go, well, I'm on it too. They're going to come in and you do it for them. So Scott, you brought this up and a lot of these people want to go elsewhere, anywhere. Some people that are getting paid lots of money, some people that have lots of money for their Regenekine, what have you, you know, now how do you counsel a, your patients? I say that it is hard for me to evaluate the treatment they're getting overseas because we don't have complete information. Now there are some more legitimate places. I mean, if you want to go to Dusseldorf, Germany, you'll get ACS probably done well. It's the guy who developed it there. But frankly, Seoul, in Seoul, Korea and Japan, actually they were in cell therapy the right way, legitimate. That's a big, that's a big deal. I mean, you fly halfway around the world. So, but I tell the athletes when they ask about it is it's hard for me to evaluate this because, and thus you're doing this at your own risk. And there have been complications and, you know, in particular positive drug tests, you don't always know what you're getting. And more of these, you know, fly by night clinics in the Dominican Republic or even guys going up to, you know, Toronto it's happened. So I'd be very careful in, in supporting what they're doing, just let them know they're making an informed decision. They're at the risks on them. It's like supplements in our athletes, you know, in the Olympic level, take it your own risk. Other thoughts, guys? Similarly, we don't, we don't prohibit them from, if it's a, if it's a player for, we don't prohibit them from doing it, but we don't endorse it, right? They're doing it at their own risk. We can't guarantee what's going into their body. So if they're going to go somewhere else, it's on their own dime and, and they're taking the risk. Again, we don't stop them from doing it, but this is a plug for the, those going overseas. We do have at our institution, an FDA approved IND clinical trial to grow and to grow your cells. So we harvest from the hip, identify those, those pluripotent cells that we can call a stem cell culture, expand them in the lab, and then come and inject them two weeks later. So that is a clinical trial that's, that's registered at clinicaltrials.gov, one that's going on now. Awesome. We are, we have tried to do that in the more scientific way to tell you, here's a way to do it in a clinical trial setting. But in general, we tell people they're doing it at their own risk when they go outside. Yeah, I wouldn't, I don't think I really have much to add to that. It's the same process with us that we'll make these different things available. If the player is going to insist on getting some type of a biologic that has unproven benefit, the ones that we'd offer as part of a menu would be PRP and some type of a BMAC thing, because like Scott said, there's not cells in there. And if they're wanting to do that, then I'd rather have them do it with us than go someplace where we don't know exactly what they're getting. And if they are flying away, we're saying, you know, that's got to be on you. And honestly, you're happy that they're telling you, because a lot of times they're going and getting this stuff done anyways, and then you find out later on that, you know, they're going down to Mexico or Puerto Rico or something and getting something done. And Pat, at the college level, do you find that the resources just limit that? Yeah, I was going to say, our college guys used to not have money now with NIL, you know. This may change, you know. If a guy's making a bunch of money, he may be, you know, taken off. But it has not been a problem, but it could. All right. Any other? I don't want to steal all kinds of questions, but audience, any questions, thoughts? Let me ask you guys one question for the panel here. What if your general manager asks you, but that player wants to go offshore, should the team pay for it? What do we tell them? No. I tell them don't let them do that for a variety of reasons. Like if they're asking to do that, or if they're insisting on doing it, then it would be that conversation. It's unproven. You're going to some place where we don't know exactly what you're getting even. There's the whole like positive test issue. There's the whole infection control issue. You know, let us control what we can control, and the team shouldn't pay for that. Now it's very challenging, right? So if Josh Allen wants to do that, I'm sure that that's a different conversation with our GM and our organization. Now, fortunately, that hasn't happened, but that's going to be different than if it's somebody that is barely going to make the practice squad, right? That's the reality. I agree. They have to know what the wording is in the collective bargaining agreement, because in the agreement, of course, players can get second opinions, and the team pays for them, but how far? Is that domestic? I don't know the answer. Maybe someone in the room does, but it would be interesting to know if that has come up. Yeah, and in the CBA, it says that they can't get a procedure done without the team knowing and approving of it, but we know that that's not always the case. That would be a procedure. That's absolutely anything that violates the skin, I think we could call a procedure. Well, great session. So G, Craig, come on up for last comments. Good thing.

informed consent

documentation

injections

risks and benefits

consent forms

treatments abroad