Okay. Good morning, everyone. I'll go ahead and get started. So I'm John Hermanson. I'm one of the amputee rehab directors out of Richmond, Virginia. I'm here with some of my team, and we're going to give a presentation on some of the advances in amputation care, rehabilitation techniques, some of the latest prosthetics that are out there that may be coming or things that we're actually finally using in practice. So disclosures, nothing financial. Like I said, collectively, we make up our amputee care team in Richmond, Virginia at the VA. For those that don't know, the VA nationally has seven centers of excellence where they specialize in amputee care, and the goal is to both provide the highest quality of care in a regional area and also to help disseminate and spread best practices throughout the VA system. And we're all involved in different areas of research, whether it's gait, osseointegration, some wearable technology studies that are going on. So, you know, we live and breathe this, and we're very fortunate to be in a system that is supportive of both PM&R and amputation rehab in general. So like I said, I'm John Hermanson. I'm the, we call it, RAC director, so the regional amputee center. I have two colleagues that are not here today due to some travel conflicts. Bill Lovegreen is our certified prosthetist orthotist, has a ton of experience in the VA and private system in prosthetics. He'll be giving his through a recorded session. Jennifer Floyd is our physical therapist and our amputee rehab coordinator, or our ARC. So she's one of our backbones and really helps connect us to the rest of the network as well. Douglas Murphy is the PASS director. This has stayed on as one of our practitioners and a mentor and, you know, guru of experience there. And Nathan McEntee is up here with us. He's our current amputation fellow in Richmond. So he came in with a lot of experience and motivation and happy to have him join us on stage today. So just a quick show of hands for our personal interest, how many people here care for patients with limb loss on, say, a daily basis? Okay, good. How about weekly? Monthly? And yearly or less? Okay, so very few. So most of you see these people on at least a monthly basis, sometimes much more frequently. Good, good. Hopefully, you know, at least give you some talking points today, kind of share with your patients and your colleagues things that may be happening or what's coming on in the near future. My portion of the talk, I want to talk about some of the emerging and existing surgical options for amputation. You know, traditionally, it was cut the limb off as low as you can get and see how it heals, right? And that paradigm hasn't fully shifted yet, although there's been some movement towards more precision amputation sites. But one of the big changes that's been happening in the last five years is osseointegration. Most of you have probably heard of it. It's the direct mounting of the bone. But in the last couple years, it's gone from something that you've heard about to you are probably seeing it in, you know, in the community. You might notice somebody walk by and they'll have a socket. It's pretty amazing the first time you see it. I'll focus most of my talk on that because that's something we're seeing a lot now. It's more common for an uncommon thing. But then at the end, I also want to talk about the AMI or Ewing procedure, and I'll explain what that is later, just because it is truly an emerging amputation technique and quite fascinating, if not done wildly right now. So as I mentioned, osseointegration, it's just mounting the prosthesis directly to the endoskeletal system. In this case, I'll speak mostly about a femoral mounting system. But basically, any bone that can handle a medullary fixture or any kind of implant could theoretically be a site for osseointegration. There are several different systems. I think last count was about five different countries have companies that have put these out. However, they all work in the same basic principle, which is coated in some sort of porous, usually titanium-based metal that lets the bone regrow directly into the implant and gives you that firm connection that is regenerative. It can re-interface. It can solidify itself. So where did it start? How did we find out that this can even happen? So in the 50s, there was a Swedish surgeon researcher named Dr. Branemark who was doing some experimentation with rabbits using titanium screws and realized as he was dissecting them after the experiment that they did not want to come out. So thinking more broadly, he decided to try this as a dental implant and had found great success for many, many years. I mean, the technology is advanced, but that core principle is the same today when you see the titanium implants. As it happened, he had a son, Rickard Branemark, who grew up to be an orthopedic surgeon in Sweden and took his dad's technology and decided to try and translate it into mounting prosthetic limbs. Actually, he did his first surgery, I think, in 1990. It was a bilateral transfemoral amputation. The patient was able to get up and walk. First time, pretty successful. A lot of development from his team and his side has gone on in the last 30, 40 years. Since the 1990s, they've been doing these in Europe and especially in Sweden quite successfully. So overall view, again, there's different systems, but they all share basic characteristics. They tend to be implanted in two stages. The first stage is the implantation of the fixture, so usually into the medullary canal, usually performed by an orthopedic surgeon or a reconstructive surgeon. So this particular example I show you is the Oprah system, which is the Swedish-based system. It's a little bit different. This has a tap and threaded insert, but that insert still has that titanium coating with the porosity for the bone reintegration. So in this case, they will actually, you know, ream and then tap the medullary canal, implant this fixture, put a cap, a graft screw or a cap screw on the end of it, and close everything back up and let the residual limb heal. If it wasn't the Oprah system, the alternative would be basically a press fit system, not unlike a knee or a hip arthroplasty. So then once you have that basic implantation, you move to the second stage. Usually it's three to six months that it takes for the bone to heal. They've really cut down that timing and some places have really squeezed into like the, you know, six to 12 weeks. But in general, you're going to expect at least three months between stages. In the second stage, this is usually performed concurrently with an orthopedic surgeon and a plastics or reconstructive surgeon, and they open the residual limb back up, make sure that everything looks good with the fixture, and actually place the abutment, which is that center portion that you can see that kind of, it screws into the fixture and goes percutaneously through a stoma that they create in the skin. So that part is pretty straightforward, but the artistry here is when the reconstructive surgeon comes in and they really have to reshape the soft tissues. You know, they usually will reimagine the myodesis or the tying down of the muscles, so you get more of a ring shape that's more of a consistent size and diameter. A lot of the extra subcutaneous tissue will be trimmed off because you do not want that hanging off. You know, as you imagine, unlike a socket, you're going to have hardware directly underneath the stoma or the abutment. And the actual skin right above the tip of the femur is very carefully prepared, so they'll get rid of all the subcutaneous tissue or fat, and that skin will actually be pretty thin and adhere directly to the end of the femur. And it turns out that's where most of the, you know, environmental sealing will happen, is between the bone and the skin, not between the skin and the implant or the abutment. So that is an area that still has not been fully finalized yet or is, you know, big room for improvement. So as I mentioned, there are several different systems. OPRA is one I've talked more about today because in the U.S. as of now, it's the only FDA-approved system. It was FDA-approved in 2020, although they've been doing these since, I think, 2016, and San Francisco was the first implantation here. But as far as FDA indication and approval, it's for transfemoral amputees only. However, if you have, you know, been around many amputees, you'll see other ones in trans-tibial, trans-humeral level as well. Not breaking the rules necessarily, just either be under a research protocol or more likely a humanitarian device exemption where you can apply for these kind of one-offs at a time and do these in a level that hasn't been approved yet. I'm from the East Coast of Virginia. Walter Reed's been doing a lot of these, some great surgeons up there. I think, last count, they've done 200 or 300 in the last few years, so definitely a lot out there. You know, this is actually one of our patients in the Richmond VA. So they're out there, and you might encounter them, even though that's not the current approval system. I talked about the secondary surgery. The prosthetic considerations, when you have an OI surgery, they actually use normal components with a big caveat. The current OPRA system that I mentioned that's FDA-approved has this expensive and very well-engineered adapter called the Axor. It's in the realm of $20,000 to $25,000 for just the adapter. So if you can get it, you don't want to lose it. What it does is it actually has a breakaway feature so that if you put too much flexion or torsion on the, through the abutment, it'll release like a clutch to help protect that side a little bit more. However, once you get past that adapter, you can use normal MPKs. They don't have any specific recommendations. There's no special programming or anything like that. You can technically use a socket after the stage one surgery where the residual limb is closed, assuming that the incision has healed well, but it's been really, it's discouraged and, because we don't want to compromise that surgical site, especially in preparation for that more delicate second stage. And just important to know, these implants can be removed. If they have issues, if it's not what they want, if the, you know, if the patient changes their mind, you know, it'd be a long conversation, but it can be taken out. They can return to a traditional socket. So it's not a one-way street. There is a special, a very specialized rehab protocol, and my colleague Jen will be discussing that with us. But essentially it's a series of increases in weight bearing and forces applied to that abutment. But important to know that the process is not short. So it can take almost a year from the initial stage one surgery to really be ambulating with or maybe without or maybe even with still an assisted device. So a lot of our patients will still use a cane even at a year out. So it's not quick. It's not that fast turnaround like some people may have expected. So outcomes, you know, honestly people do pretty well with these, assuming you have a good initial patient selection. I'll talk about the next. But, you know, most of these patients are having problems with sockets, maybe having pain with pressure to the limb, you know, so they're not using a prosthetic as successfully as somebody else who's using it 8 or 12 hours a day. So it probably doesn't, it makes sense that prosthetic use increases almost by double. Walking speed increases by a third. It's more efficient. And quality of life has gone up because you're not dealing with chronic infections, you know, pain, trouble sitting in a wheelchair, all these things. So in the right patient, it tends to have very good outcomes. Same thing, you know, the FDA approval or clinical trial they used for the Oprah implant, these show the same thing, you know, improvements in quality of life, improvements in a series of, you know, walking scores, satisfaction with prosthetic, the sense of becoming integrated or having the prosthesis be considered a part of you, all those scores went up significantly. Big question is safety. So what happens in these patients? You do get skin infections. The nice thing is they're not uncommon, but they tend to be not too serious. Treated with oral antibiotics, usually a superficial skin infection. You can get some deeper surgical site infections there as well. It was more rare to actually have like a deep bone or osteomyelitis infection, which is nice. You know, the hope is as they improve that stoma adherence that these would even further decrease. If you fall on it, you can still break them. You know, you can break the abutment, although it's pretty stout. More likely you'll have a periprosthetic fracture. And you can repair those as well. You know, you have to have a surgeon comfortable with that. But you can plate and wire it around it. They can take out the implant, have everything heal up, and re-implant it. So that has been done as well. And sometimes you just don't have healing of the interface between the implant and the femur. Big thing to know when you're looking at these systems, you're not running, climbing, jumping anymore. And that includes jogging. And that may be solved with some technologic advances in the future. But that's a big deal for people that want to stay active. So you need to make sure that if you're even considering this discussion with your patients, that you're, you let them know this is going to preclude a lot of activities and make sure they're okay with that. Total weight limit for the whole system, including the body, is 270. So if somebody's 220 and their job is to carry 50-pound bags of dog food, that's pretty close. You know, that's going to, that might restrict them from being able to go through the system. You can cycle, which is nice. And there have been some trials in using a power to knee, which I don't think is formally recommended by the manufacturer. But similar forces as a cycling experience will produce. Maybe the biggest one for some people is you really should avoid bodies of water, which means, you know, if you're from the beach, you know, you don't want to get in the water, you don't want to get into lakes or rivers. You're probably safe in your own tub, but that's, you know, the interface between the stoma and the implant is not hermetic, right? So you might get some water in there and you just want to avoid over a higher risk of contamination that, you know, even hot tubs or jacuzzis may present for you. So that could be a deal breaker for people as well. Second amputation technique I want to bring up is called the agonist antagonist myoneural interface. So it's a mouthful. We call it Amy or also referred to as the Ewing procedure based on the first person it was ever done, performed on. And so it's actually taking, say a trans-tibial amputation and not just cutting through everything, reattaching the muscles and soft tissue and closing it up. It's actually taking the, like the tarsal tunnels, moving them up, moving them up onto the tibial, you know, the tibial shaft and creating these agonist antagonist muscle pairings with a tendon between the two. And so the tarsal tunnel lets some sliding of that tendon go through and you can, now you can actually contract those muscles and it, you get like a co-contracture or, you know, the agonist antagonist pairing of the comparable muscle system. So you don't just get a contraction, you're getting that stretching of like the Golgi, you know, sensors and the stretcher sensors in the other muscles, which gives you better feedback, helps control some of the errant nerve firing that may contribute to phantom limb pain or phantom sensation. So it gives you a lot more pre-preception and can reserve some of that feedback that you lose in a normal amputation. So you can kind of, you know, you're not just gaining or conserving muscle contraction, you're also conserving the stretching fibers, the positioning, sensing of the other muscles that are attached to it. So, and this is more intuitive. We already tend to fire muscles in parallel, you know, in pairs, right? So there's that agonist antagonist in almost everything we do. So this makes more sense versus somebody that has now is a myodesis and is trying to learn to independently control muscles, which is actually more, a little bit more difficult than it sounds. The downside to this is it's a technically challenging surgery. So I spoke to Dr. McCarty, who's one of the first surgeons to do this. When he was learning, a trans tibial was three to five hours. And so if you're getting paid, you know, by procedure, that's, that's a tough pill to swallow. But once you've learned how to do this, he was doing it in about an hour or less. The transfemoral learning experience is more like the six to nine hours. That's a long time in the operating room, again, for something that insurers aren't paying for. So you have to be aware of the system that you're operating in and figure out how to make this like a value proposition more than just a, you know, procedure per time unit. And it does require extensive reconstruction techniques. So it's not your bread and butter surgery by any means. So outcomes in this is pretty incredible. So the socket is holding, you know, kind of obscuring the view, but that prosthetic on the left is basically reacting to EMG signals on the residual limb under the socket. See if I can get that to go again. There we go. And so, you know, this has, you know, plantar flexion, dorsiflexion, plantar flexion, inversion, eversion, right, without any input from above the knee, which is pretty amazing. And not only does it preserve like this more advanced control system, but the phantom limb pain goes down. Sensation can go up, but it's more of a useful sensation because you actually have some feeling of where that is in space. And now that you have this really high quality interface in the lower limb, you can have more advanced prosthetics like this one. So this is commonly being done up in Boston, and MIT has a whole lab dedicated to developing more advanced prosthesis for this. Prosthetic considerations, there are really no commercially available prosthetics right now, so it's going to be really one-off. But you can wear normal prosthesis. You just have to make sure you're offloading some of these areas that traditionally you may not have worried about. But now that there's those tendinous junctures, you want to make sure you're not loading that and give some advice to your prosthetist there. And then just nerve modifications. This is the end of our talks. Pretty interesting field right now. But they can all be done with any of these amputations, these newer amputations. And combined myoelectric osseointegration exists, especially in Sweden right now, where the electrodes will go through the inner abutment. So you kind of quick disconnect, and all the electronics and the structural happens in one movement, which is pretty cool. When you're doing an AMI procedure, they are typically doing TMR or nerve modifications as part of that process. So I'll leave the specifics to Dr. McEntee, but these are all being done collectively for better outcomes there. So I'm going to help guide for our recorded session. I had a quick quiz. What is the oldest recorded prosthesis that's ever been found? Transmetacarpal? Any hands? Transfemoral? Halex? Nose? Index finger? The oldest one we've found so far is actually a toe, a great toe. 950 BC, the Cairo toe. So these things have been, you know. Hello everyone. My name is Bill Lovegreen. I'm a certified orthodist prosthetist with the Richmond VA. So this is Bill Lovegreen, my colleague. Today's presentation is on prosthetics past, present, goals of prosthetic intervention. First, our form and function, restoring a person's physical ability and body image. In other words, as one of my professors said, put their head first and then their body. And then second is recovering the loss of one of their senses. Reconnecting that person with limb loss with their environment. In the United States, by the numbers, there are over 2 million people living with limb loss today. And by the year 2050, there will be 3.6 million. So lots of people with limb loss. Aero-toe was the earliest example of functional prosthetics combined with cosmesis. Provided both push-off and the ability to wear a fashionable footwear at the time. In the 1900s, the melding of humans with artificial components became especially strong. Between World War I, World War II, Korean War, and Vietnam War, new surgical procedures that connected a person, especially with upper limb loss, with their prosthesis. The actual procedure was called autumnal synoplasty. In this example, in this picture, it shows that the synoplasty, you know, with the bicep synoplasty, that actually looped a piece of tubing through a muscle that had a skin flap and was sewn. And then when the biceps actually fired, it actually controlled the terminal device. You actually still see patients who have this surgical procedure back from the Korean War. This eliminated the need for the figure-eight ring harness, the cabling, and out to the external mechanical hook. Here's a great example of a hybrid synoplasty, where they use a single piece of tubing. Here's a great example of a hybrid synoplasty, where they use an electric hand with a transradial synoplasty that controlled the actual switch signal for that hand. So the hand was actually powered by a battery, but it opened and closed through a switch control on the synoplasty. Truly hybrid. A second really big component that happened during post-World War II was a MALC-SNS knee. It's a hydraulic cylinder that controlled the knee both during swing and stance phases of gait. Still kind of a gold standard today. In the 1970s, endoskeletal form of prosthetics for the lower extremity was born. It is when we started utilizing components made out of aluminum and titanium to replace the exoskeletal hard legs that were made out of wooden foam, allowing the prosthetist to make alignment changes and component changes. You know, different knees, different feet. In the 1980s, the Seattle Foot was born. So this is when the first foot that allowed some energy storage and then push-off by allowing a person with lower extremity limb loss to actually get a little bit of push while they walk. Prior to this was the side foot, the solid ankle cushion heel. The next development came in the 1990s, and this was by a man named Ben Phillips. He created the first flex foot by utilizing carbon graphite laid up in a vacuum in a J-shape, allowing a tremendous amount of energy storage and push-off. There are well over a hundred feet that have similar design, and he's really created the gold standard for what we're utilizing today for prosthetics. So microprocessor knees became very prevalent, are very prevalent at this point. The otoboxy leg leading the way is still one of the leading microprocessor knees that have a computer chip controlling a hydraulic cylinder that allows control of a patient's both stance and swing phases of gait. Another popular knee is the Rio Osir, and there are many other knees currently available commercially. One of the big knees right now is the Otobox X3, which allows a microprocessor knee to get wet, actually to nine meters. Myoelectric upper extremity control prosthesis became very popular at this time. So you have EMG-controlled surface mount electrodes inside the prosthesis, allowing the person's anatomy or muscles to control the prosthesis. So the electrodes would fire, whether it's flexion or extension. You're not utilizing those muscles. Or open and close the hand. At the time, though, it was just flexion and extension of the elbow and just a three-jaw chuck of the hand. It's an open and close thing. Currently, our goals for our current time are creating better connections between the human body and the prosthesis. Control systems for the prosthesis better, whether it's lower or upper extremity. Real-time neurological feedback, hepatic feedback for hands. And utilizing new technologies to actually make the prosthesis, whether it's 3D printing, control systems like BCI or osseointegration for connection of the prosthesis. And then creating components with even more active movement. Examples of powered components is the PowerKnee Bioserve. This is a microprocessor knee with active knee flexion and extension. Real muscle power. This is in its third iteration. And it's gotten lighter weight. The battery lasts a lot longer. And it's a lot more user-friendly as far as patients. A second example is the EmpowerFoot by Autobot. Active plantar and dorsiflexion, giving patients real-time push-off and the ability to walk. Upper extremity is also coming along. A good example of this is the ILM Oser. Multi-articulated hand. Michelangelo hand, same with that, but with flexion and extension. And the most advanced arm is the Leucon blade, Mopius Bionics. Several degrees of motion, both flexion and extension of the elbow, internal-external rotation, supination-pronation of the hand, flexion and extension of the wrist, and multi-articulated hand. The downside is it's still very heavy. So prosthetically, some of the big breakthroughs now is the digital age of being part of the fabrication of making the prosthesis. So we're now utilizing scanning techniques of scanning the residual, rather than taking a hard impression or a cast. We've been modifying that mold through a CAD program and then 3D printing it, or carving it and then 3D printing it. So it allows us more time patient care and less time fabricating the prosthesis. So the future is here. We now have pattern recognition. In other words, a multi-site EMG microprocessor recognizing a person's intention, allowing a smoother control of the terminal device. Multiple EMG sites that recognizes the person, what they want to do with that hand. So as they reach out or create a certain motion, the hand will react to that. We have hepatic feedback, so it's a touch of where that hand, so the person that gets feedback from the hand or fingertips back to the residual limb. Internal and external electrodes for EMG. We're seeing implantable EMG controls for upper extremity. Also for lower extremity. EMG versus EEG, so we're also looking at BCI, brain control interfaces. And then of course, artificial intelligence, which is starting to be built in everything. In reality, this has already happened. So at Chalmers University in Gothenburg, Sweden, they actually have a transhuman patient who's got EMG electrodes implanted in his muscle. The wiring of this goes through his atrial integration into the prosthesis. So no external wires, no external electrodes. It's all self-contained to a multi-articulated hand and elbow with flexor and extension. So we are in the future now. A great example of all of this is the Utah Bionic Bike. The University of Utah, their bionic engineering lab, created this new transfemoral lower extremity components that have a powered knee, powered foot and ankle with artificial sensing and control and literally artificial intelligence. Long-lasting battery. This will be commercially available probably within this next year or so. You'll be seeing this. Thanks for your time and attention. And my apologies for the audio. That did not translate well across the digital divide. But there's definitely some interesting things coming out and even in the pipeline right now. So to integrate or segue into our next portion, a little quiz about walking after osseointegration. May have already given this out, but how long do you think it takes from the initial surgery to independent ambulation? Four weeks, three months, which might be more like a traditional, six months, 12 months or more. And so we thought it could take 12 months plus just to get back to walking with the cane. So obviously that could be a three or four day conference, right? Therapy approach with prosthetics. So we're going to do a nutshell version of this. I just want to emphasize because you as a PM and our docs are who the patient are going to come to in clinic and go, gosh, I really want to try this thing I saw on Facebook. Or I met somebody in support group and they have this really cool knee. How do I get it? Or, wow, can they stick a thing in my bone so now I don't have to wear a socket anymore? And so I want to just go over the componentry and some of the programming and safety features that come with these more advanced prosthetics and how they may benefit your patients as well as a little bit more in-depth on the timeframes and rehab processes after osseointegration. So for our transfemoral prosthetic rehabilitation, there tends to be a bit more advanced componentry for transfem. There are a dozen microprocessor knees on the market. There are only a few microprocessor feet. And that's because those carbon graphite feet work so well that the weight and maintenance of a powered foot may not always balance out the ease and efficiency of an energy storing and returning foot. But when we start talking about controlling two joints when someone's had a transfem, then all of those electronics and componentries really start to show much improvement in function, not just, oh, I like it better, but people do better with them. So one of my plugs for the physical therapist is not waiting to send somebody to PT when they get their prosthesis, making sure that they're involved in physical therapy from the time of surgery all the way through or until they're truly independent with the home exercise program, maintaining strength not only in their leg but in their core and range of motion as well as sound limb preservation and fall prevention have to be such a big focus for our patients after limb loss surgery. And then when it comes time to start training with a transfem prosthesis, having the patient learn to trust their prosthetic knee is the be all end all of having an effective prosthetic walker. The microprocessor knees, except for the pyroneed, do not have active extension, but they do help in the essential control for stand to sit. Many of them have a stumble recovery, and if you've not seen this out and functioning in the world, it works like our own knee does. If you're taking a step and your right foot is mid swing and you catch the threshold to a door, you don't buckle, do you? No, your quad fires and you have time to have a recovery step with your left leg and you don't fall flat on your face. But if you have something with a free swing knee that you catch it midway and then it's gone. And so the stumble recovery features of our microprocessor knees are phenomenally effective in fall prevention when the patient trusts the leg and gets good at using it. They also can assist with stand to sit. Again, the pyroneed assist with sit to stand, but all of the microprocessors knees have almost an eccentric descent feature. And so getting people to go back to putting weight on the side that has a prosthesis during stand to sit can help protect their other joints on the other side for years to come. And then in the microprocessors, depending on which level of functionality you're getting, they can have activity specific programming for variable tasks. If you think of a microprocessor knee that lets you sit, it's giving you eccentric control. But you're always half sitting when you go snowboarding, aren't you? And so being able to tell the knee, I'm going to swing a golf club or I'm going to go snowboarding or I'm going to ride my jet ski. Not with your osseointegration. Or I'm going to get on a bike so that the knee responds differently. And that is in the world of, there's an app for that. Literally our patients keep their cell phone on. They can go into their microprocessor knee and switch which componentry or which setting they're going to be in instantly. Some of them respond automatically depending on which knee and which programming. But most of them you can go into an app and change things. So when we start talking about those osseointegrated, because that's where your patients are going to get on the web and they're going to be like, I want this tomorrow. And you're going to be like, let's talk about it first. So except for the power knee, the componentry is the same as with the transfemoral MPK. Slow but steady progress through their rehab process is really important. But those outcomes spoke for themselves. Patients wear their limbs longer. They have less energy consumption. They go faster. They feel where they are because now they're putting weight through their hip joint again instead of putting weight through all the soft tissue around it. They're also getting some muscle feedback because now their hip muscles connect to their femur again instead of connecting in some messy mess at the bottom that moves and jiggles all over the place. And then again improved control for those same reasons is you're putting muscles to the bone where they're supposed to have control instead of having them swimming around the soup of a socket. So the OPRA system has been FDA approved for transfemoral only. You may see some transfemorals and trans-tibs. I saw somebody in Kroger the other day grocery shopping. I'm walking around behind her looking at her trans-tib osseointegration while I grocery shopped. I'm going to go over them quickly, but there are careful inclusion and exclusion criteria for the successful outcomes. We are not going to put an osseointegrated prosthesis into an 80-year-old diabetic patient with a hemoglobin A1C of 11.5. That's none of your patients, right? They all have a perfect hemoglobin A1C and they're 60 years old and they were running a marathon when they lost their leg. So our inclusion criteria, skeletally mature, so it's also not for children, preferably traumatic or cancer limb loss, but it can be dysvascular or metabolic because they're now well controlled. This is really for people who have tried and tried to use a limb and can't. Now these criteria may change in the next five or ten years. This is what it is today. Recurrent skin infections, pain in the socket, or poor suspension. Someone with an unusually shaped residual limb or a very short residual limb, they just may never be able to suspend a prosthetic socket on their limb. Scarring or skin grafting that, again, may not tolerate the suspension systems that we currently have on the market. A very short residual bone, which means you have no lever arm for controlling a socket, whereas when you do that with an osseointegration, you have a little bit more input. And then for some people, some range of motion limitations can be an issue. Now exclusion, not yet. Skeletally mature, again, no kids. They can't have osteoporosis or osteopenia. They have to have an adequate cortical thickness for them to remount that medullary cavity and put that componentry in. Otherwise they're just going to have a broken femur when they get up and moving. No active fracture at the time of repair. Soft number at the beginning, 65. It's going to push up. Because we all know that every 65-year-old is the exact same age, right, when you put them in a metabolic. So our 72-year-old who seems like they're 52 may be a better candidate for a 52-year-old who seems like they're 72. And so those are somewhat soft, but the lower end of the age is pretty firm. And then metabolic health has to be reasonably well controlled. No uncontrolled diabetes. No active metastatic disease. So the cancer that they may have had bone loss or limb loss for needs to be resolved. And then uncontrolled neuropathic pain is not going to necessarily be improved by this. And so if they're not wearing a socket because they have such terrible neuropathic pain, not having a socket on it, if they're having pain in or out, that may not change it. So surgery one is that fixture implantation that Dr. Hermanson talked about. And the focus after rehab is just protection, protection, protection, range, strength, core strengthening. No weight bearing through that residual limb, period, the end, stop, no further. And a minimum of three months between those first and second surgeries. And I put that on there because when somebody says to you, I think I want this, giving them this information ahead is so important. Like this is going to be a year-long commitment of time, change in mobility, and expectation of taking the best care of themselves they probably have in their whole life. So after stage two, again, it's protection at the surgical site. And when the tissues are healed, then progressing to weight bearing and distractive forces through the abutment. The abutment is the little metal piece that sticks through the skin. You can almost think of it like an LVAD driveline when you start thinking about infection issues. It's the same thing. There's just a permanent stoma with something coming through the body and into the body. Protocol progresses both through time of healing and meeting milestones. So if somebody has excessive pain, they have to stop in the protocol, back up, and start again. And so pain monitoring really is the number one thing that you have to do during the program. No smoking. That's probably the number one thing during the protocol is bone healing and healing of the surgical site is so important. Someone needs to commit to stopping smoking, not just now, but stopping smoking. And now obviously we can't control what people do in the future, but assessing for that commitment and having someone consistent with it is very important for their healing. When I say they have restrictions in those first few weeks, no hip flexion beyond 45 degrees for five days after the second surgery. It is such a detailed plastic surgery that they are in bed using a bedpan for five days. Not everybody wants to do that. They can get up and out of the bed if they can do it without breaking hip flexion, range of motion, nutrition, hygiene, and tobacco avoidance, and then wound care. So I'm not gonna go through these. I just wanted them there so you can access them later. Again, weeks two through three, it's basically like having a new hip replacement on a leg that you're not putting on the ground, and they can start light tapping on the end of the abutment. We're not talking the desensitization. We PTs teach people on well-heeled limbs, but just tapping that metal abutment so they start getting vibratory sense into the bone. Lots of stretching, but avoiding shear at the surgical site. Did you catch where lower extremity strengthening core comes in? They start using their abutment a minimum of a month, and probably closer to two months after that second surgery, and that's in a shorty prosthesis that's set to knee center so you can do quadruped work in it, but not on a full-length prosthesis, because until weeks 14, everything should be direct axial loading. So there's no walking at all for 14 weeks or more after this surgery. No twisting, no rotation, and it's starting with a weight restriction of 40 pounds and going up to 20 pounds a week or less as tolerated. Again, limited by pain. Continue with the exercises. Distractive forces. We've got a metal piece and a bone, and now we're gonna hang a microprocessor knee and component tree and a foot and a shock absorber off of it. So as you can imagine, you've also got to pull on that abutment by hanging weights on it so people can get used to those forces before using a prosthesis. They can progress to a full-length prosthesis, so just a straight pylon or a locked knee, basically, and then increase their weight bearing. Start, you can put a foot on it. Yay, it no longer has a stomper on the bottom of it. And begin low-resistance exercise in a bike and walking in a treadmill, walking in parallel bars or with double upper extremity support crutches, axillary, or a loft strand. At week 16, the PT gets excited, because now we get to do something other than stand there and weight shift. This is a long PT session, I will tell you, it's a really long PT session. So then we finally get to do the fun. Unlimited wear time, start pivoting. Again, there is a fail safe built into the connector that if you have too much shear, it will break away, too much twist, because they don't want to ream it out of the femoral canal. Transitioning finally to a single-point cane. So this is week 16 of surgery two. So if everything went perfectly, we're talking six and a half months from the first surgery. Stairs, slopes, obstacles, cycling with resistance instead of just a free bike. And Dr. Hermanson did them, but I'm gonna go over them again, because for some people, this is the deciding factor. Never running or jumping in this prosthesis. And I've had friends I explained this to, and they're like, why in the world would anybody have this done if you can't do those things with it? When you go back to that inclusion criteria, the people who are deciding to do this can't run or jump already. Their socket doesn't fit. They can't keep a socket on their leg. They have pain every time they put a socket on. There's some reason that they're not already a functional prosthetic user who could do these things, so they've already probably given these activities up, but in pressing on somebody who already runs, somebody who runs three times a week, you're not ever gonna be go running again. They may decide their socket's not so bad after all. Hyper-extension of the knee joint is an issue because it causes pressures in the bone. Not, again, avoiding that twisting and torque, so there is the breakaway fail-safe in the Axor, but they're also recommending that people get a shock absorber, torsion absorber in their distal part of their prosthesis before the prosthetic foot or one built into the foot, and then staying out of lakes, streams, still bodies of water, public pools, public hot tubs, et cetera. And then for the first year, vitamin D and calcium supplementation, obviously for bone healing, and it's not on here again, but not smoking. Not smoking, and then again, not smoking. And then there is a little device that people put on the abutment when they're gonna be out of their prosthesis. It looks kind of like a hockey puck that hooks around that abutment, but it basically just puts some protection around it so that you don't, if you do happen to bump into something or have a fall, there's some additional cushion there. So all of this is to say that the technology is amazing, but only if your patient can use it, and so having them have realistic expectations of what the technology can do for them as well as to have realistic expectations of their time commitment to learn to use this technology is really important. Now, AI is coming, or it's here, or it's been here and coming again, and there may be a time in the future where there's less training involved because we start using other technologies and we start linking into our own neural networks so that our control stops being so volitional and starts being back to automatic. On that note, brain control interfaces, where might you think those, other than prosthetics, I already gave you that one, where might a brain control interface have an application? After a stroke when somebody can't use one side of their body? Spinal cord injury certainly could use some help. Amputee care, obviously. The use of exoskeletons, or all of the above. I think it's the last one, right? All of the above. And Dr. McKinney's gonna come show the next one. Can I give it? I'm good. I have an extra one. Thank you. Thank you very much, Jen. I think just the only thing I'll add to that discussion is a summary statement that Dr. Murphy actually explained to me was for OI, and your patients in the mid-range of function are really who you're targeting for that. Someone who's a very high-functioning K4 who's out there running, jumping, doing all this stuff, probably not for that patient. Very low-functioning, probably not for that patient. Somewhere in the middle there's a sweet spot where OI is a good option for that patient. That said, Dr. Murphy, unfortunately, couldn't join us today, but he is very much the heart and soul of our program. Veteran of the Richmond VA here with us, and he is engaged in a lot of different research, including on brain-machine interfaces, 3D printing work, robotics, all things of that nature. If you have questions about his part of the talk, Dr. Hermanson is the most qualified to discuss those, as I just got there. But we'll be happy to meet up with you and answer any other questions you might have as well. Hi, this is Dr. Douglas Murphy. I'm a physiatrist in Richmond at the VA Hospital. And I'm going to give you a brief introduction to the use of the brain-computer interface for amputee care. So here's a general definition of the brain-computer interface by Wolpaw, and Wolpaw in the Handbook of Clinical Neurology. I won't go through it, but you can read it. This is a fairly sophisticated version. In the following slide, I'll give you a more basic introduction there. So basically, the purpose of the brain-computer interface is to connect thought to the action of a device. For someone who is unable to do this in a normal fashion, who's lost the connection between their arms or legs or whatever, and the interaction with the environment. So generally speaking, the device will trigger on a specific thought and will trigger on the electrical activity of that thought. And then it will extract that electrical activity from all the surrounding electrical activity, and will also ignore irrelevant electrical activity so that the device is not triggered inadvertently. So there's some initial filtering and decoding, and then this is inputted into another system that is connected to some sort of output, such as a switch or some other mechanical system. In that way, the individual is able to interact with their prosthesis or something else that is advantageous to them simply through their thought, and thus re-approach with a lost, through some amputation or whatever. So a lot of activity has been focused on upper extremity amputees in this area. However, as most of the amputees are lower extremity amputees, systems that address their needs will certainly address a wider population. And in the following slides, I will go over a pilot project that we did that specifically looked at lower extremity amputees. So we used surfaced electrodes. And to do this, we had to focus on a potential that was high enough that it could be detected and filtered from the surrounding electrical activity. And this was the event-related desynchronization, which occurs just before an actual action is taken. It is a very quick wave, and not everyone can produce it, actually. So you have to test the individual to see if they can produce this in a way sufficient for using the brain-computer interface. And this is generally done over the electrodes, over the premotor cortex, and I'll go over that system a little bit later. So we used an individual with an above-knee amputation, and thus we had made a specific prosthesis for him that had a single-axis knee, and that he could unlock at will with the brain-computer interface system using surface electrodes. This prosthesis had a cam system. A motor would turn this cam system, and thus disengage the lock. It was activated through, initially it was activated through wires directly to a laptop computer, and we had to walk along with him as he walked. We improved this to where the, it was Bluetooth to a laptop computer, and thus he was free of that connection, which gave him more flexibility. So various methods were taken to maximize the potential. Electrodes were placed on his scalp over the central motor areas, C5, C3, C1, and CZ, C2, and C4 were also used. It was a Laplacian array, which is done to maximize the EEG potentials. The electrodes were secured with a plastic cap. Then there was an amplifier, custom-made digital amplifier embedded with a ADS-1299 front-end system, on-chip biopotential chip. This system had advantages in that we got reliable signals. The disadvantages of this initial study was that there was a lot of, the cap was somewhat cumbersome, and there were a lot of wires and electrodes that were very obvious coming off of his head. So after the signal was taken from the electrodes, it was processed in a laptop, as mentioned previously, and the software that was used was the MATLAB Toolbox, B-C-I-T-V-R. The ERD was in the beta band, 16 to 24 hertz. It was calculated in real time, and we had to experiment to see which thought would generate the best potential, and for him, it ended up being a thought concerning flexion of the amputated knee, the knee that he didn't have, and that actually worked the best. And strangely enough, when he did that, he began to experience feelings they hadn't experienced since before the amputation. There was also, as mentioned here, an offline linear discrimination analysis for detection of the subject's intention to activate the switch. So in this slide, as you see, some prototyping of the system. It was done, in this case, with a bent knee prosthesis, and one of the graduate students was trialing it. And at this point, we've gotten a fairly good reliability with our system, up to 100% in some trials, and as low as 50% in other trials. However, we need to continue to improve on reliability. We also need to improve on the miniaturization of the system and the cosmetic aspects of the system so that somebody can walk around using it and no one in the environment would be aware that such a system was being used. All right, and thanks to Dr. Murphy. I'm gonna close out this session with our last section, which is on targeted muscle reinnervation and the Regenerative Peripheral Nerve Interface, or TMR, and RPNI. I'm Nathan McKenty. I'm, again, the fellow at the Richmond VA and amputee in musculoskeletal medicine. Thanks again for coming here in the morning. The fact that you're here today means that you survived last night. And we're happy to see it. So a couple quick points just to make, so a couple quick points just to make in case some of you might be unfamiliar with this area a little bit. It's just that a review of amputee pain is needed to understand this, right? So 80% of people after their amputation are gonna have some form of chronic pain. And the distinction between phantom limb and residual limb pain, many of us are familiar with this, but just to clarify that phantom limb pain is pain in the amputated limb that's no longer extant, and the residual limb pain is localized pain in the residual limb itself. Now, 60% of those end up being caused by neuromas, which is the most common reason for that. So targeted muscle reinnervation, to explain what this is, is sort of like rewiring the musculature to different spinal levels and different nerves. You're sort of taking the brachial plexus in an upper extremity and reconnecting it to different places. So it's kind of upending the anatomical things that we all learned in residency and what our EMG signals mean. And I'll explain that a little bit more. So targeted muscle reinnervation is when you're taking the end of a transected nerve, so look in portion A there, imagine we're transecting the median nerve in the case of an upper extremity amputation, and then you take a muscle belly that's still there. So let's say that that's the biceps, long head, for example. You take that transected median nerve and you're co-opting it to a motor terminal in that muscle belly. So you're not just burying the nerve deep in muscle tissue like the old way of doing it, you're directly co-opting it to an existing nerve terminal on that muscle. What that does is, in the words of the person who invented this, it gives the nerve something to do and somewhere to go, and it keeps it out of trouble, right? So in the olden days, the old nerve bearing technique was you would take the transected end, you would bury it deep in muscle tissue and hope that it was okay. And that recognized some important things, one of which is that the microenvironment really matters for nerve growth. But unfortunately, the outcomes with that aren't great and actually tends to increase a little bit the incidence of phantom limb pain when done the old way with the nerve bearing. So that's what TMR is. The reason why it was developed originally was really for prosthetic control. As Bill touched on earlier, prosthetics have become extremely advanced. They have a lot of different degrees of freedom. So imagine for someone with a glenohumeral level of amputation, how are you gonna control something with six or seven different degrees of freedom in multiple places at the same time? It's really difficult. So what TMR allows you to do is to generate more what are called myosignals than you would normally have in an amputated limb. So what this looks like is sort of like this. So in the conventional anatomical orientation on the left there, you can see that you'd have two different myosignals in that upper extremity. You'd have the biceps and you'd have the triceps, right? But if you repeat TMR twice in that upper extremity, you're connecting one side of the biceps and one side of the triceps to a different nerve. Now you have four. And you can see how with an electrode array like in that prosthesis, now you have four different signals to pick up rather than just two. And you can see how that's gonna increase someone's ability to control a complicated prosthesis. Directly recording these signals like this with this kind of array that's called direct capture, that's sort of the classic way that this has been done. But now we have pattern recognition, which is able to take that pattern and learn the intent of the patient behind what they're doing. So in this patient, I believe it had a glenohumeral level of amputation. His pectoralis muscle has been surgically separated and co-opted with three or four different nerves from his upper extremity. So now his pectoralis major has four different myosignals attached to it, right? So the pattern recognition EMG array that you see attached to him there is able to record what the patient does when you tell him, for example, okay, try to open your hand. That heat map matches his intent. And then it's able to kind of interpret what the patient intends to do using that pattern. So this outperforms the direct capture in almost every way. It's just a little more complicated to do. But TMR allows you to generate something like this. Whereas before, you would just have a single muscle signal from the pec major and it would be kind of difficult to do that. The other thing about this is that you don't need to train them to achieve a new type of pattern. You're just using what they're already creating when they're intending to make that motion, right? So I think the only way that you can really see this is really just showing you, right? So on the left side, this is from the 2000s when this procedure was invented. This patient's been using this prosthesis setup for about 20 months on the left. He's using the old co-contraction method to switch between hand and wrist function. So you have to co-contract to switch to something different so he can't do multiple things at once. And on the right is after TMR and after only two months of training. And the difference is pretty stark. It's amazing. So the difference being on the left, obviously he has to switch between every different mode every time he wants to do a different action. on the right with the TMR, he's able to control multiple simultaneously. It's much more intuitive, it takes less training. So you can see the benefit for that patient was pretty incredible. So this procedure was originally developed by Dr. Dumanian, which was at Northwestern, I believe in the 2000s. It's come a long way since then, but the basic principles are still the same. The other one that I'll mention is called the Regenerative Peripheral Nerve Interface, or RPNI. Sort of a cousin of TMR that was more recently developed, I think in 2016 at the University of Michigan. This is sort of similar, but you're basically using free muscle flaps that you free up from tissue, and neurotizing the ends of the nerves to those free muscle flaps, instead of to an existing muscle that's where it anatomically is supposed to be. So you're basically creating these little, it's like taking sensory nerves and co-opting them to these free muscle flaps to create these new myosignals. The thing about this that you also can do is that since these are sensory nerve endings, it actually is able to give proprioceptive feedback if you stimulate them with electrical signals distally. So imagine you did this in someone's arm, you can actually use electrodes there to stimulate and send sensory feedback back to them. So it's also been shown to increase per person's sensation, and they've been working on some prosthetics to give people more haptic feedback. It has similar outcomes in pain so far, which I'll discuss later with the TMR. It has a lot of benefits for residual limb and phantom limb pain. It's a little bit less time demanding for surgeons, but finding someone who knows how to do this is difficult at this stage. A lot of the younger surgeons who have experience with TMR and RPNI are starting to come out in the field, and you'll meet more and more people who know how to do these things, and we're trained on doing them. And I'll speak about the head-to-head so far. There isn't really anything comparing. People in the studies generally compare these things together as a group. But if you have a surgeon who's able to do either of these procedures, consider yourself fortunate, and your patient might be able to benefit from that. It comes down to their experience and where they trained. But some of the pain outcomes are actually pretty remarkable. So for secondary TMR, which is done after their initial amputation, right, secondary, there was a nice study, a couple from 2014, there was 26 patients who underwent it for prosthetic control purposes, and 14 out of 15 had a complete resolution to the pain that they had before the procedure. Just to let you know, it didn't generate any new pain in those who didn't have any pain before. All the ones who underwent the procedure didn't have any pain after, so it didn't create new problems for them either. There was another review done of 28 amputees. It was a randomized control trial, and it was a head-to-head of TMR versus the traditional kind of nerve-burying procedure. The limb pain difference and the phantom pain difference, you can see in the TMR on the left, was a significant difference from before and after. The nerve-burying didn't have a significant difference, and maybe even a slightly increased, excuse me, incidence of phantom limb pain, which I kind of mentioned before. So it had a very significant difference between the old method and the new. And so that actually spurred some interest in primary TMR, which is done at the same time as their initial amputation. That can't be done in everybody, but in some patients it can be, and it's shown a lot of good evidence for actually preventing the development of phantom limb pain and residual limb pain in these patients. So this was a review that was done in 2022, and again, this considered TMR and RPNI as the same group of procedures. And the incidence of the pain in their residual limbs and phantom pain afterwards was quite significantly changed. There was another one that was done in 2020, a relatively small retrospective case series, but again, reduced the development of neuromas after the procedure, and the incidence of residual limb pain was very, very much reduced in people who underwent this. Okay, so who among your patients are gonna benefit from this? This is a procedure that is really targeted. A lot of the pain benefits are obviously gonna be for people who have chronic phantom and residual limb pain. That can be at any age of amputation. So someone who's new, old, even someone with an impending amputation with certain criteria, which I'll discuss in detail. But this can be done in a prior amputee who might have an opportunity to use a myoelectric prosthesis more effectively with more myosignals. And like I mentioned, if someone has an upcoming amputation but doesn't have an infected surgical site and they have intact limb sensation, then this could be a good option for them too. But it does require a healthy nerve to be transferred. So if the patient is insensate in that limb, not much to really be done with TMR in that case. This is a schematic that was developed by a group led by Alexandra, which we agree with. So if the patient's undergoing amputation and they're insensate, there's no point in offering it. You need a healthy nerve to be able to transfer. But if they are sensate and the site is clean, TMR could be done either primarily or shortly right after their initial amputation. And if it's an infected site, this is something that has to come later. Most of our patients obviously are probably in that infected category. So if it's done, they can do the initial amputation, allow it to heal up, go back in and perform the TMR, sometimes in a less invasive manner as well, depending on how experienced the surgeon is. Their specific rehab needs afterwards are relatively the same. So the initial healing and care is really quite similar. It may take some months for those nerve coaptations to fully grow in. So that's three to nine months to reach that full reintervention and really start to use the myoelectric prosthesis type functions. But the patient's residual and phantom limb pain usually starts to fade out within a few weeks after the procedure. Dr. Domani and the surgeon was mentioning in a few of his talks that a week or two after, they're like, oh, it feels the same. But then like four or five weeks after, they'd start to smile at him and they'd say, you know what, I don't notice that as much anymore. It's starting to get better. And so that's generally what you see after this kind of procedure. And the feedback-driven neurorehab program is essential for them as it is for most other patients. It's harder to teach the new function to someone who was an amputee much longer ago and then had this done more recently rather than someone who had it done primarily as you might expect. There's some controversy over patient selection and access. As with many new surgical procedures, right now the criteria are most limited to people who are kind of the ideal surgical candidates. But a lot of our patients don't fit a lot of those criteria. A lot of them have more comorbidities. They have ESRD and diabetes and poor vascular status and all the other things that most of our people have. But there is some evidence. There was a recent study done with a group of patients who underwent TMR and there was a really comorbid group of 100 patients in that data set. They all had diabetes and peripheral vascular disease and 43% with the ESRD, for example. And they had a lot of significant benefits on ambulation and pain compared to the usual neurectomy compared with TMR. So even in those patients with comorbidities, there's a lot of chance for them to improve. The statistic that popped out to me from this study was that 90% of people in that study, that highly comorbid group who underwent TMR were ambulatory while only 70% were with the traditional neurectomy. Obviously, as PMR doctors, we know how important that statistic can be for people. So a quick closing call to action here among us also. I know we're all kind of physiatrists, I think, because we like to see the potential in our patients for something to be better in the future or at the minimum, not to get worse, right? Amputees, I think, many of you are interested in this field, but in our field, I think sometimes it's a little bit like a forgotten stepchild. It's all in our textbooks. It's like that core part of our training, but a lot of people either don't see people enough with amputations or don't know about some of the new stuff coming out. And what we're excited about today is giving you a little bit of a flavor for what the potential for your patients might be. And when you go back to your communities, the knowledge that you guys have of this kind of little subfield might be the only connection or chance that they have to get that kind of care. So we really encourage you to reach out to other people in this group, with the communities online through APMNR, reaching out to us, learning if there's surgeons and people in your area who have access to techniques like this and other rehab protocols that can really benefit them. Obviously, amputees have lost a real tangible part of themselves in a way that other patients have not, and we have a really unique opportunity to give something back to them. So we really urge you to explore that. We have some resources. You can connect with us and connect your patient to the amputee system of care within the VA. There's also a lot of resources through the Amputee Coalition, which are fantastic for any patient with an impending or old amputation. We have links to Dr. McCarthy's team, which is for the AMI, the Amy Procedure-related questions. And we also would like to give a plug also for fellowship training opportunities. Of course, I'm one of those, and I highly recommend it if you're interested. At the VA system, there's three main ones. There's Richmond, Seattle, and Tampa. Those are part of our big regional amputation centers of care. There's also an academic affiliate fellowship through Spalding. These fellowships, again, they don't take one every year, but some years they take two. There's options for people who are interested in training. So if your residents are interested in it and want to explore more, let us know, and we'll be happy to chat with them. Thank you so much. And save just a few minutes for questions, but we're happy to talk outside, too. We're good with time for lunch, enjoy. Weight limitation for osseointegration, max weight. Max weight for osseointegration of a patient. Yeah, the max weight takes into account the person and the components. Oh, excuse me. So the max weight, technically, is about 270 pounds for the OPRA system. What that translates into in our protocol is we tend not to take patients over 220. And it gives you, because patients, you know, there's three, six months of inactivity. They're actually gonna pick up weight in most cases, too. So we give them some buffer for personal weight plus carrying daily activities, those sort of things. And a lot of, 220 is a big dividing line in componentry, too. So staying under 220 lets you use cheaper, more readily available components underneath. Okay, and in regards to, okay, when you're looking for surgeons that would do the TMR type of techniques, should you try to reach out for plastic surgeons, vascular surgeons, or orthopedic surgeons? Typically, which ones are more prone to be trained on this? That's a good question. And we've actually been working on our system to find access. And I've had most luck with the plastic surgery side. There's certainly orthosurgeons that have more of a reconstruction flare and can do those things easily. But plastics, that's really part of their core training. And I've found that even the surgeons I've approached to that don't do it are very interested in learning. You know, they just haven't had the strict application to try. So they've been very welcoming there. The last question is, so I work in a C-bulk, a patient C-bulk, in semi-rural, not super, but I do have several patients with us integration. And I have a difficult time with communication between your teams and us, and then kind of navigating the system when the patient is back in their rural area after the two-year thing. You're within the VA? Yes, I am. No, you and I talk outside. Sounds good. Okay. I've got your answers. Okay. Just an example. So Jen is one of our arcs, our regional coordinators, and they have really tight mesh work. And so if you reach out to anybody in that system, we provided the link on the slides, they may not know or be the right person, but they certainly are willing and able to connect you. Hi, my name is Minju. I'm a medical student. And so all of this is new to me. And thank you for your amazing presentation. It was actually really insightful. My questions are kind of like, what are the success rates for these different kinds of prosthetics? And if patients are struggling through it, are they able to switch between different things? Or do they just get like longer PT maybe? So her question was about, for patients learning to use a prosthesis with advanced componentry, if they don't succeed, then what? Yeah, and like, what are the success rates? Like how many do struggle with that? Oh no, like even just, yeah, that's fine. So in the Medicare world, patients are going to start with a lower K level. So what their expected functional outcome is, unless there's some really good documentation upfront that they're going to be a high end user. Now, if Dr. Hermanson were to lose a limb tomorrow, who cycles regularly and runs, it would be really easy to say what he needed upfront. But the patient who says, oh, I want to go back to running. And you're like, well, when did you run last? Oh, I ran hurdles in high school. It's really hard to say they need a knee that will accomplish long distance running. And so there's always a balance, and this is where the prosthetist and the physical medicine rehab doctor who writes a prescription work together, is there's always that balance between the stability of the device and the ability of the device. The more stable it is, the less cool things it does, typically. Except when we talk stumble recovery, and now we've got a knee that does great things and gives you stability in a setting that those old basic knees never make stable. So it really, this is why there are prosthetists out there. And when you're out and practicing, if you have a large amputee population, getting to know your local providers and including some input from them for selection of devices is very important. And sometimes insurance says, sorry, you can't have it. And then we all say bad words. Right, we progress patients through with an emphasis on safety, right? So they graduate from maybe a more basic unit to something more advanced, and then we look for opportunities to move into something if there's an opportunity for them to improve. Thank you so much. You're welcome. Hi, my name is Victor. I'm an intern, I'm a current applicant. And maybe, I don't know if you spoke about this in the beginning. I've missed a little bit of the beginning, but, and you kind of alluded to it. I'm sorry, can you speak up a little bit? That microphone is a little bit quiet. This is better, can you hear me? Okay, yeah. So question is about what does, coverage by insurance look like for these things? You kind of alluded to it just now, but from what you talked about, around what range, or is it not so much of an issue of coverage, or I was getting? We are all spoiled and work in the VA. I'll start with that. But in the outside world, so there were some changes with the Affordable Care Act that there's not, there used to be policies out there that someone's prosthetic coverage was $1,500 a year. Wanna guess how much of a prosthesis that gets you? Two. A liner and a pylon. That's what you can buy for $1,500. Have fun going somewhere with that. And so in the Affordable Care Act, they did change some of those limits. So it really is medical justification. It's, you're not going to put the X3 that Bill spoke of very briefly, you're not gonna get for anybody with standard insurance. It's available through the DOD and the VA only because it's a super waterproof version of a knee called the Genium. But you can get a Genium. If you as a young, healthy person dropped a motorcycle, lost a limb, it takes lots of paperwork and lots of documentation and lots of support, but you can get the componentry. You're just, it's gonna, it's like everything in healthcare. You've gotta ask permission from the bean counters. Right, and the only other thing else, I'll use that as a plug. If you work at the VA, you get to play with the cool toys. Yeah, we do. And I think there is a shift slowly in the private world that they're covering more and more. Being the VA, it's closest maybe that we have to single payer style where they do throw a lot of resources at our veterans early. One, because it's the right thing to do, but it also tends to save money and improve outcomes long term. And so, and the VA is on the hook forever, right? And so I think as we see a shift from insurance companies and insurance models shifting to rehab value-based, you're gonna see, hopefully, more inputs put in early on, the better componentry, better approval rates. Because if you don't get somebody a knee that's useful, they're gonna stay in a chair, and that person is not gonna have as high quality of life as they could have had. All right, thank you so much. You're welcome. We can just hand it to the person behind you if you want. Oh, yeah, I'll receive it. Thank you for the talk. My name's Nike. Actually, it's been a while, but I did my PhD with Dr. Kiken, who developed the procedure with Greg Germanian. So I was just, I have always thought that if it's available, if there is a plastic or a neurosurgeon available, one should just always have TMR at the time of their initial amputation, if it's not like a emergent, like trauma, because what are the downfalls? In the context of the amputation and how long that takes, the actual TMR takes a couple of minutes. You've got the nerve, and you suture it to your end points, and so it doesn't take that much time. It's got, and not just control, but benefits of pain, so I don't see the downfalls of just doing that from the get-go, if it's, ideally, if there's someone there with that expertise. So I was just wondering if, from a clinical insurance perspective, where are we with that? Is this something that, for everyone who has experience, is this something that is being done, especially for a planned surgery? So a couple things on that. One, totally agree with you. In the patients in which it's indicated, there's no downside to it. If you have a surgeon who's able to do it, the right patient should be done at the time of the amputation, in my opinion, every time. But unfortunately, the constellation of things that are needed for that to happen include a qualified surgeon, the patient who has the surgical site at the right time and place, and it's healthy enough, and all these other things that have to happen. And it has to be in the right center that's done it before, basically. Those things don't happen for a lot of our patients, especially if it's an emergent amputation, or they're septic and need something done, which is the vast majority of our patients don't have the convenience of a planned amputation, which would be great. I wish we could. But a lot of people would like to have it done later. Unfortunately, a lot of the surgeons operating at many of these centers are maybe older, they don't have that kind of training, but it's becoming a lot more common. Like I mentioned, a lot of the younger surgeons now, in their orthopedic residencies, I've seen this technique disseminating really rapidly in orthopedic residency training, vascular surgery training. So almost all of them have at least been exposed to it if they haven't been directly trained on it, and they're willing and able to learn it quickly. And like you mentioned, if you know what you're doing, it doesn't take very long. When it was initially developed, it adds like an hour or something to the procedure, but not anymore. And RP and I coming out too, I'm sure there's gonna be some people that prefer that method. I'm sure they'll have some surgical arguments over it, but both of them are effective. So yeah, I mean, I agree with that. I don't think from an insurance perspective, I don't think there's necessarily a limitation on that. From that perspective, it's more about, are the right players in place to make it happen for that patient at the time that they need it, which is unfortunately not the case everywhere yet. But I think it will be. One day. And I'll also add, so who, oh, it's done, okay. So most of our surgeons are vascular surgeons because of the nature of our patient population, and that's just a little bit out of their wheelhouse. And I had a good frank conversation with one, and what she told me was, amputation is probably their lowest paid procedure, right? How many patients have we heard say, oh, they just wanted to get paid to cut my leg off? The truth is they get paid the least to cut people's legs off. So an amputation, I think, pays around $700. And so they wanna get in and out. I mean, the logistics of a financial system mean that you can't spend another 30, 40 minutes. And to your point, once you learn, it's pretty quick. But I think that's another obstacle that we're seeing. Thank you. Thanks again.

osseointegration

AMI procedure

physical therapy

microprocessor knees

microprocessor feet

pattern recognition

haptic feedback

brain control interfaces

3D printing

abutment devices

prosthetic devices

brain-computer interfaces