Step into the cutting-edge world of orthopedic innovations with the renowned Dr. Garry Kitay, as we unravel the latest advancements in hand surgery tools. Ever wondered how a seemingly simple device like the hand immobilizer can revolutionize surgical precision and patient recovery? Dr. Kitay shares invaluable insights on this game-changer in the operating room, offering us a rare glimpse into how the new model propels the field forward, allowing unparalleled access and stability during intricate procedures. We also navigate the often-murky waters of medical device regulations, the FDA clearance labyrinth, and the pivotal role of informed consent — especially when it comes to off-label usage. It's a compelling narrative that exposes the intricate dance between innovation, regulation, and ethics in medical practice.
Shifting gears, we tackle the intense realm of sports medicine, where the stakes are ever high, and the operating table can feel like the last down of a championship game. Picture the pressure of surgical decisions that hold the weight of an athlete's career in their hands and the delicate dance of maintaining patient confidentiality amidst the scrutiny of the public eye. Our dialogue extends into the thorny issues of performance-enhancing substances and the ethical debates they spark, as well as the challenges in conducting research on athlete health outcomes in the wake of the COVID-19 pandemic. It's not just about the surgery; it's about the broader impact on the athlete, the sport, and society's perception of modern medicine and professional sports. Join us for a deep exploration of the intersection where surgical skill meets the ethical considerations that are reshaping the landscape of sports medicine today.
Take Home Talking Points: ✋Managing Hand Immobilizers and Patient Expectations ✋Pressure and Research in Sports Medicine
Check out the full series: ✅Part 1: Innovation and Ingenuity in Medicine - Released January 31, 2024 ✅Part 2: Pioneering Orthopedics and the Complex Ethics of Treating Athletes - Release February 7, 2024 ✅Part 3: Laughter and Libations in the Lab Orthopedic Advances and Scotch Studies -Release February 14, 2024
Step into the cutting-edge world of orthopedic innovations with the renowned Dr. Garry Kitay, as we unravel the latest advancements in hand surgery tools. Ever wondered how a seemingly simple device like the hand immobilizer can revolutionize surgical precision and patient recovery? Dr. Kitay shares invaluable insights on this game-changer in the operating room, offering us a rare glimpse into how the new model propels the field forward, allowing unparalleled access and stability during intricate procedures. We also navigate the often-murky waters of medical device regulations, the FDA clearance labyrinth, and the pivotal role of informed consent — especially when it comes to off-label usage. It's a compelling narrative that exposes the intricate dance between innovation, regulation, and ethics in medical practice.
Shifting gears, we tackle the intense realm of sports medicine, where the stakes are ever high, and the operating table can feel like the last down of a championship game. Picture the pressure of surgical decisions that hold the weight of an athlete's career in their hands and the delicate dance of maintaining patient confidentiality amidst the scrutiny of the public eye. Our dialogue extends into the thorny issues of performance-enhancing substances and the ethical debates they spark, as well as the challenges in conducting research on athlete health outcomes in the wake of the COVID-19 pandemic. It's not just about the surgery; it's about the broader impact on the athlete, the sport, and society's perception of modern medicine and professional sports. Join us for a deep exploration of the intersection where surgical skill meets the ethical considerations that are reshaping the landscape of sports medicine today.
Take Home Talking Points: ✋Managing Hand Immobilizers and Patient Expectations ✋Pressure and Research in Sports Medicine
Check out the full series: ✅Part 1: Innovation and Ingenuity in Medicine - Released January 31, 2024 ✅Part 2: Pioneering Orthopedics and the Complex Ethics of Treating Athletes - Release February 7, 2024 ✅Part 3: Laughter and Libations in the Lab Orthopedic Advances and Scotch Studies -Release February 14, 2024
Welcome to MedEvidence, where we help you navigate the truth behind medical research with unbiased, evidence-proven facts, powered by ENCORE Research Group and hosted by cardiologist and top medical researcher, Dr. Michael Koren.
Dr. Michael Koren:
Hello, I'm Dr. Michael Koren.
Dr. Garry Kitay:
And I'm Dr. Garry Kitay.
Dr. Michael Koren:
And Dr. Kitay is joining me in a really fascinating discussion about orthopedics and how people in the orthopedic world look at clinical research and some of the stuff that you personally have been part of, and you showed me this fabulous picture of what you propose my hands should look like, rather than what it looks like now, and I'm a little skeptical, I must say that. But there's actually a rationale behind this versus the other model that you're possibly proposing. So why don't you tell the audience a little bit about what you're doing and why you showed me this hand model?
Dr. Garry Kitay:
Be happy to. Thank you. So this is called a hand immobilizer. I do quite a bit of hand surgery and when a patient has their hand on the hand surgery table, often they're under anesthesia and the hand is not controlled and the fingers curl up and often the point is to operate on the palm and the digits and with the fingers curled up it's harder to get access Instead of somebody holding those fingers down for you all the time. This is a device that can be used to curl to hold the digits and it can hold it in position so you can get to the palm, but, as you can see, it covers the fingers fairly well and the tips of the fingers, making it hard to access the whole digit, and this is something that I had recognized and thought I could improve upon. So I approached the company that makes this hand immobilizer and together we did improve upon it. Now we have a new product that's come to the market this year.
Dr. Michael Koren:
And is that the new product here? Yeah, okay, so why don't you show that? Show us the sample of it, show us the sample of that versus the old ones.
Dr. Garry Kitay:
It's very similar, but you can see that the digits are split and in that way it's easier to secure the end, because sometimes the end of the digit would slip out, and plus you can get access to different portions of the digit. So now, if you just want to secure the end, this is a more secure way. But for instance, you could also bring this down here and have access to the end. You can even use this to just grab the basis of the digits. So in that way it gives more flexibility and more access. And taking a relatively simple concept with an aluminum hand and making the aluminum hand plus just to improve upon things which we're always trying to do in orthopedics, hand surgery and medicine in general, I see Interesting.
Dr. Michael Koren:
Okay, so I think that's a good explanation and thank you for that, because when you first brought it in, I thought you were going to recommend that you were going to increase the number of fingers on my hands. No I think you have From five to 12. I think you have just the right number. In fact we were talking about maybe five is too many fingers.
Dr. Garry Kitay:
That's right, that's right. So a lot of times and I had one mentor who always stressed when people had injuries of the index finger not to fret too much because cartoon characters often they have four digits. They have four digits and like Mickey Mouse and he said, look at Mickey Mouse, he does great and he doesn't have that index finger, right?
Dr. Michael Koren:
Yeah, I've read that cartoon characters only have three or two fingers, so that it saves time in the animation Is that what it's?
Dr. Garry Kitay:
Yeah, well, I just thought it generally looks too busy. It looks like there's too many. That's true also. Yeah, that's probably part of it, as well Interesting.
Dr. Michael Koren:
So we talked in the previous session a little bit, and I'll just very briefly repeat it, that there are different levels of complexity of devices that we do innovations on, and this would be considered a level one device, correct Meaning that it's similar to what's already in the market. So there's not much you need to do in terms of FDA clearance. In fact, you just submit a 510K exemption and then you're allowed to market it. But as you get more and more complex, you may get to the point where you actually have to run a clinical trial and get pre-market approval from the FDA. So you were mentioning about whether or not you need to inform consents if you are using those different types of hand immobilizers in the operating room. So why don't you educate us about that?
Dr. Garry Kitay:
So every patient who's having surgery needs to give consent, and it's our obligation and it's also just good practice to make sure the patient understands as much as they're able to about the procedure and In general, you know the procedures are standard enough where they could be explained and the patient can understand it. Now there are sometimes there are certain problems where you might use a device that's not been used before or what we call as off label, not be used for that product. There might be a certain fracture that the current implants just won't fit very well and you might use an implant, for instance, that's normally used in the ankle and use it in the forearm and that's called in that case. Yeah, that needs to require extra explanation. Get the patient's permission for that and to move in order to move forward.
Dr. Michael Koren:
Can you always anticipate that, or do you do something in the consent process that's broad based, so you can cover those circumstances?
Dr. Garry Kitay:
Well, sometimes you can see something and and and. Pretty much be aware of that. But in the consent form it does give some leeway that the patient knows when you're doing the surgery and they're not able to be informed further, that they give you the permission to do what's in their best interest.
Dr. Michael Koren:
Yeah, now I'm sure you deal with people that have very different expectations in terms of what you'll be doing, personality wise. I'm sure there's some people that want you to freelance and do whatever you can to get the best results, and others might say, just do the minimum that you have to do. So talk to us a little bit about that personality type and how that affects the way you approach things, particularly if it's something that's innovative Right.
Dr. Garry Kitay:
Talking to me in generalities, I want to do the minimum to get the job done, to get the best job done, and I'll explain that to the patient. And there are sometimes when, if you're doing a certain type of shoulder repair, you just have to be frank I'm not sure you know exactly what we're going to encounter and how we're going to do it, and if it's going to be, you know, if it's going to be able to be completed, and I'll explain it to the patient as well. What we need to often pin down with the patient's expectations is because because you don't want that to be out of line with what the outcome is going to be, and that's often we have to let them know. Yes, you're going to be better, and I sometimes use a baseball analogy.
Dr. Garry Kitay:
I think I think that this is going to be, you know, analogous to a double, maybe a triple, but it's not going to be a home run, it's not going to. You know, this risk now is not going to be the risk you were. It was when you were born. You're going to have less pain, you're going to be able to play tennis, but it's not going to be just like. So. I think expectations is often what we spend a lot of time having the patient understand.
Dr. Michael Koren:
Right yeah, and I know that you deal with a lot of high profile patients, such as professional athletes, who probably have extraordinarily high expectations of the procedure and a lot, of, a lot at stake in terms of what the outcome is. So tell us a little bit how you handle those type of folks.
Dr. Garry Kitay:
Right. So when you're dealing with a professional athlete, especially a local professional, and football players, a local professional the first thing that in Europe and in the docs approach is and you let the patient know that most of the often is I'm not a fan on your doctor, you know you're not here because you want the team to get to the Super Bowl. That would be great. But your, our obligation, of course, is to the patient, and number one I'm not a fan, I'm your doctor and that's my only interest.
Dr. Garry Kitay:
And then you talk to the patient is I'm interested in what this is going to do to you a day from now, a week from now, a year from now and 10 years from now when you're done with your career. How's it gonna affect you a decade from now? Not just getting you back to the next game, and we go through that. What are you gonna be like? So tomorrow, if we do the procedure, you're not playing tomorrow as opposed to maybe you could play and then deal something at the end of the season and how does that affect you? And we go through that and in the end, we want them to return to play at their highest level of performance with minimal risk and not having any diminution of the outcome over the long term.
Dr. Michael Koren:
And that's kind of what's drastic. It's gotta be a lot of pressure. So you're dealing with a baseball pitcher or a quarterback and you're doing a surgery on their hand or a finger and they don't perform well, is there pressure on you? Does the whole city hate you because you did a poor job of getting them back to their previous state, right? Do you ever think about that?
Dr. Garry Kitay:
Well, it is a higher pressure environment. It's something that you mentioned as going to surgery. It's something that I think a lot of surgeons enjoy and trying to get people to that highest level of performance. It's something that I enjoy and I think, without kind of enjoying the pressure, I don't think you really go into surgery for most of us.
Dr. Michael Koren:
I see Okay, so you are the quarterback, you go in and you revel in the pressure. Yeah, maybe so, and you don't care what the fans' reactions will be if the outcome on the field is as good as the outcome in the operating room.
Dr. Garry Kitay:
Well, we want it all. We want to be excellent in the operating room, be excellent in the field. We try and get it all. Yeah, Absolutely, absolutely.
Dr. Michael Koren:
How about in terms of dealing with publicity? That must be another element of treating high profile patients in general, particularly professional athletes.
Dr. Garry Kitay:
Well, here you know, and I mean, it's all, it's HIPAA. So we never discuss anything, we don't let any, we don't kind of disclose any information to anyone. So generally it's not something that people even know about. There's patients I've treated, you know, this year, this month. Nobody knows about it and of course I don't disclose anything and it's just a private matter between the patient and I.
Dr. Michael Koren:
Interesting yeah. Do you ever get pressure from coaches or owners or other people in terms of your decision making?
Dr. Garry Kitay:
So one thing with treating a professional athlete that's different is you're treating more than the athlete. So if you're treating a child, of course as a child, and the parents, if you're treating an athlete, it's often the athlete, the family, the trainer, the head team doc, the agent, the coach, you know. So there's a kind of a lot of different interests, but for the most part you know, like I stress, at the player, it's. You know, I work for you and let's figure out what's the best thing for you.
Dr. Michael Koren:
Yeah, it can be hard. We had a situation during COVID where the NBA became very interested in the work we were doing with COVID-19 vaccines and I had a number of discussions with executives in the NBA and they broadly wanted to be supportive of the research. And obviously we're leery about the concepts of clinical trials where we are just the independent testing agent and we're interested in objective parameters for seeing whether or not things worked or didn't work. So, for example, if we mentioned something about would vaccinated versus non-vaccinated players have any difference in their performance and whether or not that's something they wanted to look at and they're very leery about it honestly, and I understand why that was their sensibility. But I can imagine that some of those elements of what we do that we consider objective may be a little bit different in the sports world.
Dr. Garry Kitay:
Well, I would love to have seen that study you know, to have that study done to see how many you know to have those patients and you know what kind of performance they do per. You know by the minutes, by their points per game, and then see what happens after the vaccine. I think that would be fascinating.
Dr. Michael Koren:
Yeah, and that's my internal medicine thinking was in the same direction. But, unfortunately, the association wasn't really interested in that because of the implications to the athletes and their contracts and other things of that nature. They did have a lot of data, a lot of health data, and they were willing to share that in a de-identified way. And of course, all this could have been done in a de-identified way, but they were concerned that that confidentiality could break down at some point and that would have perhaps negative implications. So it's a tricky area, yeah.
Dr. Michael Koren:
Tricky area, but again make it clear that they were very broadly supportive of the research work that we were doing.
Dr. Garry Kitay:
Essentially. Yeah, that's something I'd love to be involved with. For instance, I mean there's some data on forearm fractures, but you mentioned orthopedics. We need to work a little harder on collecting data. But, forearm fractures and professional football players in general. Once you have one, your career is a year shorter. But it's hard to go back. And what specifically cause it, when the outcomes are generally very good? Why is that? What leads to that shortening of the career? Of course, that's not something we want for our patients.
Dr. Michael Koren:
Yeah, and sometimes the process of looking at things objectively may seem a little bit awkward to people, and so, for example, if you ask for certain types of testing to be done to professional athlete strictly to look at a medical issue, they might look at a scans at you. To my knowledge, it's really hard to do those sorts of things. Even for performance drugs that we talk a lot about, it's done purely on an anecdotal basis and the complications of it are done in an anecdotal basis. One argument could be that okay, well, why don't we look at safe performance enhancing drugs? Why don't we actually take these things and do them in clinical trials, see if they make a difference and see if there are any downside risks? And that gets into a very different point of view with regard to sports and how science and sports can make a difference, because training methods are certainly looked at in terms of helping athletes do better. But if we asked about a drug, for example, that would help you hit a baseball better, all of a sudden we're talking about cheating.
Dr. Garry Kitay:
Yes.
Dr. Michael Koren:
And so it's a very different mentality than other ways of improving performance.
Dr. Garry Kitay:
Yeah, just mentioning performance enhancing drugs, that is something that is a question we'll often ask, because if something like steroids is used, that generally can negatively impact the outcome, especially if it's a soft tissue injury. So that is something that we know can adversely affect the athlete after injury.
Dr. Michael Koren:
Yeah, so I remember when I was taking testing for medical school, I read an article that different foods prior to testing were looked at in terms of whether or not they improved your test scores, and the only thing that was proven to work was albumin. According to this result, and I always wondered why we didn't do more of that. Maybe just a pure protein substance that you ingest would help your concentration compared to something that was high in carbohydrates. Was chicken soup tested? Well, that's a good question, but why?
Dr. Michael Koren:
not why not? Why don't we do randomized studies? And again, we could de-identify things and look at people taking the SATs, for example, take 1,000 people and give them one diet, another 1,000 randomized to another diet, and see what makes a difference. Yeah, that type of research would be fascinating. It could help people. But it's not done because of the sense of cheating. So interesting area.
Dr. Garry Kitay:
Yeah, I don't know if it's. I could see that with certain performance enhancing drugs that sometimes are used by students now commonly in colleges and sometimes at the high school level, but for things that are legal foods I'd be very interested in that?
Dr. Michael Koren:
Yeah. Well, there are ADHD drugs that are felt to improve performance, but they're given because you have a diagnosis. But you need to have a diagnosis to improve performance, right? They?
Dr. Garry Kitay:
are given for diagnosis or illicitly.
Dr. Michael Koren:
Yeah, exactly, that's right, so I'm sure you have a lot of those discussions with your professional athletes. Obviously it's all confidential. You don't have to disclose that, nor would I recommend that you do, but that is depending on how you look at it. You can make the argument that some of these things should be subjected to the rules of clinical research, and if there is a nutrient or a supplement that enhances performance and it doesn't have downside risk, why not?
Dr. Garry Kitay:
For sure I agree, especially now you see so many things that are advertised on television that claim to do so many things Right?
Dr. Michael Koren:
Right, they're unproven.
Dr. Garry Kitay:
Yeah, let's see the proof. Okay, and I'd love to have more clinical research and I would like that to direct me and my diet to improve my performance.
Dr. Michael Koren:
Well, with that in mind, we're going to do a little experiment between the two of us in our next session. Okay, and we're going to reproduce a very, very famous experiment called the Lady Tasting Tea Experiment. Okay, and we're going to call it the Ortho Sipping Scotch Experiment.
Dr. Garry Kitay:
Ortho, ortho and cardiologist.
Dr. Michael Koren:
There you go, okay, well you're going to be the actual test subject and I'm going to be the research heart in this particular case. Okay.
Narrator:
Thanks for joining the MedEvidence podcast. To learn more, head over to medevidencecom.