I'm an orthopedic surgeon, sports medicine specialist in Sioux Falls, South Dakota. Very excited, as you can tell, to be here. Honored as well. I'd like to thank AOSSM. I'd like to thank the Aircast Foundation, all of you for being here, and especially the Sharks, okay? It's not just me, though. We're actually very lucky that my co-investigator, Dr. McFadden, is here as well. I'm giving the presentation. It's my device that I'm talking about and research study, but she's going to be demonstrating our Shark Tape device for all of you during the presentation. So without further ado, our disclosures. We have no financial relationships with anything that we're presenting here. We are faculty with the University of South Dakota, though, the School of Medicine, and so we do cheer for the Coyotes. So significance. I think this is something we're all familiar with. This is one of our basketball players at the University of South Dakota. She's MVP in the league twice. Here's just a routine practice. Boom. In that instant, she's torn her ACL. She falls to the ground. Her career is over. We were fortunate at USD to have six athletes go to the Olympic trials. This could have been number seven, but she had a warm-up run, an injury, that ended her career. Here's a young lady that during the COVID epidemic was starting a weight loss program, lost 20 pounds, and then boom, her fitness program's over. So this is horrifying for us. We've all seen this. We all know this. It's something that we can all kind of relate to, but that's why we're here. That's why we have AOSSM. We keep you in the game, and we have the Aircast Foundation supporting initiatives like this. So this is the problem. This is the issue that we're addressing with our innovation and this custom 3D printed device. So patients, when they have these injuries, they get that effusion. They get that condyle edema. They have pain. They can't get the leg fully straight, and this is a big problem. We treat this right after those injuries with prehabilitation. So working with a physical therapist, doing a home exercise program, and we know that this prehabilitation has a great impact on the outcomes of these athletes. We have to get full extension to have good outcomes in treating ACL injuries. This article by Gage et al. I showed that 12% of patients lacked access to PT before an ACL reconstruction, and they had the highest rate of stiffness. Here's another one by Roberts et al. that showed that not having full extension before the surgery increases the risk of complications and increases the risk of poor outcomes after ACL surgery. Here's one from the PT literature. So a systematic review shows from physical therapy literature that prehabilitation helps in the outcomes after ACL reconstruction. A meta-analysis also demonstrates that range of motion after ACL injury is a key factor for patient satisfaction. Now, if you've been at the meeting all week, also hot off the press, we haven't had time to put it in the PowerPoint presentation, but Dr. Webster and her crew from Australia surveyed an international population of physical therapists and found that 84%, 84% say their patients have no therapy, no home program, no treatments before they go into an ACL. So although we're very focused on the U.S. population here, we also have to think of this problem being more of an international and global problem that we're trying to address. And so you may be familiar with programs like this. Luckily at USD, we have great one-on-one interaction with a lot of physical therapists to help these athletes, but many of our more community patients have to rely on a home exercise program. And those issues with compliance, there's this proper form. I have no knee injuries, and to do what's going on in figure 4B would be difficult for me to demonstrate, let alone to tell a patient to go home and do that. And the patients have to take an active role. Now there's good literature to support that both in prehabilitation and in rehabilitation efforts that passive devices can actually also have a good impact on decreasing the swelling and improving knee range of motion. You see some of those here, but there's a problem with those as well. They're expensive and they take time to obtain. So in our market, the three that we most commonly see in the upper Midwest is this knee terminator, the Joss brace, and the elite seat. That knee terminator sells for about 40 bucks, and those straps are very uncomfortable. They're the cheap straps you see at Home Depot or Lowe's. They cut into the skin with any type of weight, and you're really limited on what you can put on this device. The Joss brace has a lot of good evidence, but you've got to get an industry rep to see you, and in a prehabilitation setting, that's just not practical. The elite seat is demonstrated here at this meeting this week, but it costs about 400 bucks a month to rent. And in a prehabilitation-focused stage, by the time you get the elite seat, many patients have already resolved the issue anyway. So these devices don't really work for our issue. So we know that prehabilitation has its benefits, but there's extra costs. There's device costs, and there's extra expenses in getting to PT. Having patients transport to this is a big issue for us in the upper Midwest, because our patients have to go over a long distance to get access to care. And then what about another pandemic? What if we have COVID-20, and PT locations aren't even open, if you do have access to one of them? So that's where we enter this desktop 3D printing. So today, we've already heard about some very fancy bioprinters that cost six figures. Some even go up to seven figures. What we're talking about is a much more economical type of 3D printing that brings that manufacturer, manufacturing process to the clinics, to the surgeons, and to the patients. So it's giving us new options for patient care. You see three examples of desktop printers here, and with this technology, we can tailor the devices and the applications to the patient-specific anatomy. We can print these in clinic. The device that we're demonstrating today can be printed overnight. It has a 15-hour print time. The devices are very cheap, so if you filled up this entire print bed for this 3D printer, the cost is going to be a little less than $10. And these printers, yes, there is an upfront cost, but the cost for the ones we're showing here range between $200 and $700, so something that's well within the budget of an orthopedic clinic. And if you're the patient, it's roughly equivalent to one month of using the devices that we already demonstrated. So our specific aims for this research study are to develop a rapid and reliable 3D printing technique for a patient-specific knee extension device for at-home therapy. Now we're focused on the device, because that's what we have here to show, but it's actually much more than that. We're also talking about instructional videos to show the patients how to use the device safely and properly, and another video to demonstrate to the clinics how to set up these printers. We don't expect orthopedic surgeons to have a good background in this. We're going to walk them through the steps in short five- to seven-minute videos. And specific aim number two, we want to evaluate the knee range of motion outcomes associated with the use of this device compared to our standard physical therapy practices. So with your funding support, Sharks, we may be able to show by studying this topic if this is similar, worse, or better than current prehabilitation treatments. We'll see if this improves accessibility to the proper treatments, especially for our rural population at Sanford Health, and this may reduce the cost and time burden on our patients, physical therapists, athletic trainers, and medical providers. So the innovation, what we have passing around to you and what Dr. McFadden's showing here is our 3D-printed, customized knee extension device. And if you're not familiar with 3D printing, this is a picture, or a video here, of one of the 3D printers in action. It's kind of a glorified glue gun, if you had to think about it in a way. So the filament sits on those spools above the printer, goes down to a heated extruder. That's what you see moving back and forth there. And I've designed the CAD files that it's printing this device that you'll see passed around. So it kind of extrudes that material. It cools very quickly with some fans on it to make the structure that we're demonstrating. And so the print platform we talked about, this entire device, I've designed it so that it can fit on two build platforms, and there is no scaffold. So if you are familiar with 3D printing at all, one of the big issues or problems to people that are new with it, you have to peel off all of the scaffold that's made within the print. Well, our design has no scaffold. It's 15 hours to print, so you can do it overnight. Dr. McFadden's going to demonstrate the device down here for those of you that can't see it. But it fits conveniently within a hospital-provided or clinic-provided bag. It's customized to the patient's size, so we can do small, medium, and large. We've even explored accommodating different types of incisions. So whether you're doing a quad tendon or a BTB or a hamstring tendon, the cost for our device is about $6. So it's very cheap to print the entire thing. The other benefit is, unlike some of the devices I showed before, when you're done using this device with one patient, it's thermoplastic polyurethane. That's what the material's made out of. It's all made out of that one material. So we can chemically sterilize this and use it for another patient. You don't have to dispose of the item after one use. The device weighs less than two pounds. You'll see that when we pass it around. But it can support over 40 pounds worth of weight. That's the upper limit of what we've tested with it. We've designed it so that you can actually clip on other objects. You can hang other objects from the basket within it. And finally, your return on investment we were talking about before. There's a lot of opportunities for branding and marketing with this as well, okay? So three key components. I'll pass this around after I show it here. But it's basically a knee pad that goes over the top of the patella. There are connecting bars that pass through the basket and then interlock within that knee pad. And in this example here, the person has 25 pounds of weight in the knee basket, and they're feeling it. They don't have a knee issue, but even at 25 pounds, they're getting a good stretch from the device. So we'll pass that around for our sharks. So yeah, please take a look at that. We'll go over it a little more in the questions. If the people in the audience like to see Dr. McFadden's example too, she can show that as she's getting it in position here. So our approach for this study. Stanford Health, if you're not familiar with it, is a large health system, a rural health system in the upper Midwest. Even during the pandemic times, we saw over 300 ACLs, reconstructions in our clinics. So we're easily going to meet the study population that we're looking at with this project. We're spread across seven states. So one of the things that's very humbling to me as an orthopedic surgeon in this region is that I'll have patients drive seven or eight hours to see me for a five to 10 minute clinic visit. And then they go back home. And when they go back home, they don't have a physical therapist in their hometown. They don't even have a stoplight in their hometown. So I mean, they're kind of on their own for a lot of these therapy treatments and these home exercise programs. That's what kind of birthed the idea with us of how can we take some of these treatments, some of these devices, and make them more readily available to our patients in this rural environment and our healthcare footprint. So the study goals, these are in the LOI and in the handout, so I'll go through this pretty quick. But basically to make that instructional video, to teach the patients how to use the device and compare that to our normal prehabilitation program, refine the idea. So the device we're passing around is actually our prototype. This is actually, it's not the final project. We want to keep working on this before we actually use it in the study. And then the third is to teach clinics how to do this. So we're fortunate that we have a great residency program at Sanford Health. We would like to take a population of the residents and see if they can go through the process of unpacking a 3D printer, printing the device, and then implementing it in the clinic as well. So our study population, we're planning for 30 subjects, age 14 to 16 years of age. The exclusion criteria would be anybody that comes to our clinic and already has full of knee extension, or if they have open wounds, we don't want to jeopardize that in any way. Our subjects will be prospectively randomized into two different groups, and it will be a single-binded population as well. So as this flowchart shows, there's a portion, 15, that will get the standard physical therapy prehabilitation program, and that entails after seeing me, the orthopedic surgeon, they'll see the physical therapist to learn the home program, they'll have 15-minute session three times a day. And then in the study population, instead of going that route, we're going to provide them with the device, with the bag, they'll still do 15-minute sessions according to the video, they'll start at five pounds and then work their way up to an upper limit. We don't want to go any higher than 40 pounds. We don't think that's really necessary, but it'll be as they tolerate going up. And because this is a study design, we will start with standardized weights just to make it more uniform, but the whole innovation idea we have here is that they can clip on water bottles, they can attach canned food to the basket, they can put textbooks in it, they can put weights. It's going to be very versatile in whatever kind of weight that they want to use in the device. So our study design, both groups, once they have the injury, they'll come and see an orthopedic surgeon. They'll be either randomized to that control population where they'll meet with the physical therapist and do our standard prehabilitation protocol at Sanford Health, or they'll be provided with this bag and kit. Now, the difference in our study group is that they're also going to get the links to the videos, which is represented by that icon here. And one of the physical therapists on our team actually gave the input of, well, if our second time point is that seven to 14 day check, this is potentially a problem in our study because what if both populations have full extension by that time point? Well, it's not really well described in our orthopedic literature, but our PT team informed me that it is well established in theirs that there are knee clicker devices that after a PT session, they can sit on a hard surface floor, a wood floor, a tile floor, anything, put the device under the kneecap, and then they test themselves to see when they're able to get full extension and click the device. So although we got three time points with the orthopedic surgeon here, the patient's going to be recording in our REDCap database when they're able to obtain that full extension based on the clicker device and the PT literature. So our study outcomes, we're looking at a mix of both physician reported outcomes and patient reported outcomes. The main focus is going to be that knee range of motion. We have a research fellow with us that'll be blinded and able to take goniometer measurements of that at the time points. We're also going to do that clicker compression device I discussed that the patients will report from the REDCap database. There are numerous secondary outcomes, more than what are listed right here, but basically we'll be looking at their pain scores. There's a study listed there at the bottom that describes the technique for measuring that circumference published in OJSM. We'll also be doing that to measure the effusion. We're going to be looking at patient compliance. Are patients actually even using the home program we send them with? We're not entirely sure. Time of use that they use and what weight they get up to on the device as well. And then finally, patient satisfaction and also the clinic satisfaction of those individuals we look at that are testing the videos for clinic workflow. The analytics plan. We can't really do a power analysis for this study because there's a lack of research looking at these effective devices. Surprisingly, Knee Terminator hasn't published that result. And so it's an exploratory study, but we can perform an interim analysis once we get this study underway. We're going to use a linear mixed effects model to assess the magnitude of change over time in both the control and the experimental groups. And then the resource sharing plan for our study. Our files are going to be tested on multiple different desktop printers. That's why we need the SHARKS funding support. We can't do this on just one or two printers. We have to test it on many for generalizability, and we have to check many different flexible filaments. The GPU that we're using is readily available, about 20 bucks to get an entire spool on Amazon. So we need to test this on multiple devices as well. And finally, when we refine that prototype, these files would be shared with AOSSM as part of the return on investment and offered as a supplement for the publication to go along with that. And so we're talking about the return on investment as well. This is where your dollars are going. So we actually already have access to an Ender Pro 3D printer, to a LulzBot mini printer, and to a MakerBot. The two that we're missing to gain the majority market share for these desktop 3D printers are the Prusa and the Creality 10 that you see there. We have a large amount of our budget allocated to filament because we need to refine this prototype. We're going to make a lot of mistakes. We need to test a few more variables before we actually make the final products. We're also doing participant incentives. So our study is easily going to be completed within a year timeline, but we do need a lot of data from those patients in the first month that they're in the prehabilitation phase. So we'll give gift card incentives to help with that. We do need staffing support for the data analytics and the single-binded aspect of our study. And then for our research fellow, we're hoping to get travel assistance to present the results at a meeting. And finally, we need the video production equipment and editing software to help us with making those instructional videos that could be housed with AOSSM as well. So our research team, the environment that we're in, we cover all the necessary basis and expertise needed for this study. We've designed the prototype that is close to completion. We have the REDCap database to do the follow-up as well. The thing that we're missing is the funding. We need that piece in order to execute this project. And we have a long way to go with this, but this is the first step in assessing the safety and the feasibility of this kind of project. I think an obvious question from the sharks will be, well, why not look at the post-op rehabilitation? That's where we have the bigger issues. Well, that's true, but we have to prove the safety of it and the feasibility of it first. If it just doesn't work, or we can't get the printers to make the devices reliably in a normal timeframe, well, we haven't answered the first question of this whole project. In the future, we can expand this to looking at more patient-reported outcomes through our EPIC database. And we also know that there's many opportunities within military applications. They're looking for the remote creation of devices. You can't exactly mail in a device to the front lines. And same thing with NSPIRES. If you're not familiar with NASA, they have a big focus right now on long-duration space flight missions. And the ability to 3D print medical devices like this is something of great interest to both of these entities. So we have a long way to go in exploring this technology. I think that hopefully what you've appreciated from this is that 3D printing is having a bigger impact, not just in the automobile, the aerospace industry. It's also in our medical industry. And if we don't get at the forefront of this topic and do it in a safe and healthy way, our patients are going to explore this technology on their own. And I think it would be better that we can do the research, we can test this before patients get access to it. So if we're looking at the potential benefits versus the potential harms, I think our research team has gone to great lengths to make sure that the potential benefits here, we're doing it in a very safe and slow method, starting with prehabilitation. But we have the ability, if the findings are positive, to then expand it into other applications as well with your financial support. So on behalf of my research team, SHARKS, please help us help our patients. And I'd like to acknowledge the other investigators who aren't here with Dr. McFadden and I today to present Kevin Feltz, Ben Noonan, Colin Bond, and Nicole Bell. So thank you very much for your time and attention. It's a good, very interesting, very interesting idea. I think it's a great idea. So a couple of questions. One is, so you're 3D printing it. Did you say it's specific to the patient or it's just being 3D printed? So it's 3D printed, but we can base it on the size. So that device just to stay closer on the patella. Okay. Because you mentioned reusing them, but I wasn't sure if you could, so both are patient specific if you're going to reuse. Patient specific from a sizing standpoint, not like there's one just for you. I'm sorry. Okay. No, no, that's okay. And then one of the questions I have with the study, and this isn't, you may have an answer to this, but you know, when they have that clicker to say that they've gotten full extension, who's coaching them on how to know that they have full extension, right? Yeah. So a lot of times, as you know, think that they are achieving something, but they are woefully short of what they think. So how do you get them to make sure that they are actually getting full extension? This is all new to me and the PTs at Sanford Health kind of informed me of, well, duh, this is well known in our space, which is very interesting, but it's something that is pretty straightforward. I mean, once you see it, and that's part of our goal with the instructional videos is that we would demonstrate that to the patients as well, how to sit on a hard surface, how to place it under the knee to get them, when they hear the click, it's a very well-defined moment that they can then record, well, it was day four at my third session that I actually got the click. The videos are not something we can really showcase today, but it's a critical part of this that we're proposing because to reach that rural population, we don't have a PT that can teach them how to use the clicker device. Like that's a, it goes hand in hand with this project proposal that we'll be able to instruct them over a video. That makes sense. And as far as that, I know you talked about the numbers and hard to do a power analysis to say, do you think 30 is enough? I mean, I feel like you want to have- That's why I included the line about the interim analysis, because we anticipate we'll need more. That's also why I said, we're fortunate that we, even in the pandemic, got over 300 ACLs at our clinic. We can easily scale that up if our power analysis shows we need to do more patients, yeah. Kind of along those lines, and I agree with Brent, I think this is really exciting, but I would encourage you to still add a power analysis. I think your design is like a non-inferiority study, just saying, does this perform worse than traditional PT? And I think you could define a percentage increase in lack of extension or a time delay to extension, and just use historical numbers for regular PT, no PT. And I think you could still have at least some suggestion and then maybe refine it down the road, but I think having that as part of your application would really strengthen it. Okay. Now we can include that. Thank you. Hey Nathan. Hey. Great to see you again. Thank you for your presentation. So Nathan was one of our fellows at Mass General, so he grew up in the Harvard Shark Tank, so welcome back. So I presume there's no real IP that could be generated from this, right? So our legal team at Sanford Health almost matches one-to-one our research team that we have, because when we said we have a new device that we want to give to patients, oh, their eyes got big and they got all excited. And then as I told them about 3D printing space, how a lot of this is open source, no, we would not be planning to patent any of this, not protect it in any way. It's basically something that would be available to the patients, and I think you've hit on a really key point. I mean, IP is a really hot topic in this, but it's also that patients have access to this technology, and so what we have to be careful of is, what if we do show this has a great benefit for an ACL, but if a patient has access to that file, and let's say they have a bucket handle tear, we've got to be really careful how they use it if we aren't protecting the technology, if it is open source. So it's another reason why I think we as a society, as a profession, have to get ahead of this technology so we can describe it in safe ways, because we can't really protect that IP. It's going to be open source at some point anyway. Two comments for you. One is the international part I think is important, so when I did a traveling fellowship to Asia, Freddie Fu took us to a hospital where they told us they keep patients in-house for four days after an ACL reconstruction, because oftentimes they don't come back for follow-up. Yes, that's very common. So that's something that's important to know. And then I can connect you with a wearable device company, you can put in a couple of sensors, and you can get it on your app if the patients are actually achieving full extension. Yeah, that would be great. Thank you, Sharks. Appreciate it. Thanks, Nathan. And I do want to clarify, you may have matured in the MGH Shark Tank, but you were born and bred in the Wash U Shark Tank. Okay. Thank you, Sharks. I just want to clarify that. Bluecomb.

ACL injuries

prehabilitation

desktop 3D printing

patient-specific knee extension devices

outcomes

funding