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Virtual Didactic- Immediate Fit, Adjustable, Lower Limb Prosthetics: Technology & Scientific Rationale Led byTimothy Dillingham, MD
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Again, welcome to everybody. We are excited for the second lecture. We're here with Dr. Tim Dillingham, who is the Chair of PM&R at the University of Pennsylvania. We're going to get started here in just a moment. All right. Again, welcome. We already went through a lot of this information at the beginning, but just as a reminder, we're going to keep everybody muted and we're grateful everybody's here. Spread the word. If you have colleagues that haven't been participating, you do not have to be a member of AAP to view these. If you're unable to figure that out, please shoot me an email or find us on Twitter. And without further ado, we're excited to have Dr. Dillingham with us. Dr. Dillingham, welcome. Can you hear me okay? I can hear you. Good. Good. So I do share screen. Is that correct? That's correct. Okay, is this looking okay? Looks great, thank you. Okay, well so I should just get started I guess. I'd like to first off, my name is Tim Dillingham, I'm the, I work at University of Pennsylvania, I'm professor and chair and today I'm going to be talking to you about an area of our work with adjustable lower limb prosthetics. I'd like to thank the AAP for this kind invitation to speak. I'd also like to express my admiration and sincerest well wishes to our colleagues in New York and New Jersey who are grappling with a pretty intense COVID surge and doing heroic work. This study was funded for the last 10 years by a number of STTR grants, phase 1, 2, 2B, and I'm very indebted to the National Institutes of Health for supporting this work. I'd like to thank my team, they're really superb people from engineering, Jim Marshalak, we do the patient testing at University of Pennsylvania, and we have business and marketing folks as well. I do have a conflict of interest, I started this company that has been the recipient of STTR grants. I signed a National Institutes of Health compliance conflict of interest agreement with University of Pennsylvania and these views are solely our views and not the National Institutes of Health. The goals and objectives of this lecture are to review the epidemiology and the national and international needs for prosthetic services, discuss the shortcomings of current prosthetic fabrication, and begin to understand the advantages of adjustable prosthetic devices. We'll also review some of the clinical testing that we have done. The mission is to produce the highest quality affordable prosthetic devices that enhance the lives of persons with amputations. This was funded by the STTR grant mechanism and that's designed to take ideas from the lab, build them up, develop, test them, and bring them to the market as a product that's useful for people. Part of that is to develop jobs in the United States, so all of the parts and all of the systems that you see are manufactured in Pewaukee, Wisconsin. What I'm going to talk about is another end of technology and that is the devices that are very useful. There's a lot of really interesting research on mind-brain interface, prosthetic control mechanisms, and that's one end. The other end that we've tried to develop is to improve the basic socket comfort alignment and fit. There's a lot of people with amputations in the United States, about 1.6 million. It's expected to double by the year 2050. There's about 158,000 new persons losing their limb each year, and about 50% are either transfemoral or transtibial. Most are due to dysvascular causes. Now, in the early 90s, we published papers showing that the incidence rate was going up. Some of the contemporary studies have shown that there's been a decline in incidence of dysvascular limb loss. They also showed that there's a very high risk of limb loss in diabetics who are on renal dialysis, and they count for about 50% of all amputations due to diabetes. An interesting study in the New England Journal showed that with advances in care, medical homes, and really better coordination of care, they were able to cut almost in half the rate of lower limb loss, and that's a very positive sign. Concurrent with this is there's reports that we have a dearth of prosthetic services as we move into the future, with a higher demand than the amount of prosthetics able to meet that demand. Worldwide, it's estimated that there's 25 million people across Africa and Asia, Latin America, who lack a prosthetic or orthotic device. From just a landmine survivor standpoint, less than one in four persons who survive a landmine are fitted with a prosthesis, and back in 2004, it was estimated to be a $3 billion problem. The prevalence worldwide of diabetes is increasing, with rapid increases in developing countries. Now there's many barriers to prosthetics in other countries. Cost, access, and really few labs, lack of trained people. It's also time-consuming to fabricate a prosthesis, test it, and fit it, and often people need multiple different sockets. So prosthetic sockets currently, there's a need for advances in technology. The problem these days are prosthetic sockets are not sufficiently comfortable. They're often expensive, and because of that, access is limited for underinsured or uninsured people. Fabrication is also very time-consuming, a labor-intense process that leads to variable quality with the final product. Fundamentally, limbs change. They change in shape and volume throughout the day sometimes, or over time, and we're constantly trying to make a hard rigid socket fit a soft limb with bony prominences. And with that, we felt that it was time for a fundamental change in this paradigm. Some of the current shortcomings in fabrication are very time-consuming, and it relies on individual craftsmanship. They make a cast of the limb, a positive mold, build a socket over it, a check socket, and this often results in a hard socket as a final product. Some of you have walked into your prosthetics labs. This is the type of work that's done. A positive cast is made, and then the prosthesis is built up on it. It can take weeks to months until completion. It also needs a laboratory with a lot of equipment and resources, and as we're going to see later, you can't predict tissue compressibility. When you do have a socket, a conventional socket, that doesn't fit as well, there's really only a few things you can do. You can use socks, you can pad on the inside, you can grind it out, you can remake it, or you can use increasingly heavy thick silicone liners to accommodate the poor fit. 3D printed technology has now come on the forefront, and the machines tend to be expensive, but it can be useful for people who don't have any other options. However, the materials are just not as strong as conventional laminated materials. So with that, another thing that has become very evident, this was a large study that we published many years ago of 960 ACA Amputee Coalition of America members, and 30% of them were overtly dissatisfied with their prosthesis. If you received the first prosthesis after 60 days, it decreased significantly your use and full use of that prosthesis, so it's optimal to get people fit early on. And incidentally, this experience is duplicated in other studies where persons with limb loss really are not as satisfied with the long-term comfort of their device. So what does modern science have to offer? Well, there's many new materials. Injection molding can give you consistency and strengthen quality. Some of these metals are space-age, aircraft grade materials that are stronger than metals. Modern engineering design and mass production can scale up many good ideas and make modular devices that can meet the needs of these patients in a more timely fashion. This is my family. So designing a prosthesis, and this is part of an STTR grant, and we made this figure, and I think it shows you some of the struggles you have when you're trying to take an idea from academia or a research lab and bring it to the forefront. I read where 98% of ideas never make it to the market or never make it into production, and that's because you get stuck in this cycle right here. We did this for a pediatric grant, but it equally applies to other prosthesis we were designing. You have to get in the ballpark with some dimensions and then you design a prototype prosthesis, then you take it to patients, and when you, a good idea in the lab or on the computer screen rarely makes it with a real patient, and so you go through this process over and over until finally you have ideas that, yeah, the patient kind of likes it. Then you enhance the design. You go back, and incumbent in here, you ought to try and get end users of the product, people, physicians, surgeons, or prosthetists who may be using this, and you continue to enhance it. Then you have to make that final decision, and that decision is when do you make tooling for injection molds to produce the product, and this is an expensive decision because if you make a wrong decision, you spend a lot of money on a mold that may not give you a part that you needed. So we attempt to have no regret decisions when we proceed up this arrow to that block. Now, here's the types of sockets we usually have are quadrilaterals or narrow MLs, and this is really 50-year-old technology and design. So the quadrilateral, you sit on your shield tuberosity. With narrow MLs, you grasp the ischiorhamus and the greater trochanter and pull those two together. What we found, and as we'll see in the study I present, as we were doing this trial, we just kept cutting the socket lower and lower, and you realize you don't need all of this upper socket when you have an adjustable socket. This is what a narrow ML looks like. It has a large brim that fits up into the perineal area and can be uncomfortable with sitting. It also goes over the greater trochanter and pushes up into the tensor fascia lata area under the iliac crest. So how did we start? Well, we purchased limb scans, a database of 3D limb scans, and then we modeled the heights and circumferences to try and get us in a ballpark. And this is what we initially used as a design start for designing the prosthetic sockets. What you find is there's a lot of range here. 80% of the population are covered by wide margins of prosthetic sizes. This is an example of what we finally got to in our study with a low-profile sub-issual socket that uses a hydrostatic force and a compression to lift the leg and support it. Here's from the back, a rear view from the posterior. Trochanter's up here, ischium and ischial tuberosity are here, and you're way below that. This design includes a flexible inner portion and rigid outer portion. We used thin suspension for all of our devices, and we developed a customized offset. Here's somebody sitting with it, and you can see that it ends well below the buttock region where you have to sit. You also find you have much greater hip range of motion. This incidentally was described a while ago, but the technology, the adjustability of what we're doing allows us to execute this pretty well. Just another view of the buckle system. Here's the alignment. The key is to get the center of mass in front of the knee joint. As we'll talk about later, we used a MALC knee or a POSER safety knee. This is what a typical patellar tendon bearing or total surface sockets look like. PTBs have this ridge that puts pressure on your patellar tendon. To develop the trans-tibials, we used the same type of approach and analyzed digitized images and found, again, fairly wide ranges of people, so we had to build sizes that would cover this range of limb sizes. Here's an example of... This is a person we fit. He hadn't walked in about eight months because his prosthesis didn't fit too well. He got very emotional. So we built different socket sizes to cover that range from standard to a little bit more advanced. This is an example of a standard socket. This is a standard socket. This is an example of a standard socket. Cover that range from standard, wide, extra-wide, tall, and we've actually found a great need for the ultra, and this is a larger socket that can open up and fit people over 300 to 400 pounds, and it's very useful for those folks who are otherwise able to walk but have difficulty fitting a standard device. We have a narrow device coming that'll be useful for pediatrics. Here's our size chart, and this tends to work well, and there is some overlap between sizes because of the compressibility of the soft tissues of the limb. We have a standard and a wide prosthesis. We have our offset that aligns the force vector up through really about the hip joint. The iFIT system is made of high-strength polymer materials. It's injection-molded. All the components are injection-molded, mass-produced. There's an inner liner for comfort. It has a locking pin system, and they're all waterproof. This type of technology can greatly expand prosthesis capabilities with less cost. There are immediate services. It's fit in about an hour, one visit, and you can walk out with a comfortable device. It accommodates volume change, and as we'll see, for international efforts, it's easy to ship. You don't need any laboratories, and for health systems, it can be a solution. This is one of the people who used it, and I show her, oh, incidentally, everybody shown in here signed a release that we could use for this. We're gonna use it for a few months. Everybody shown in here signed a release that we could use for marketing and education, all of these patients and consumers. This is a person who found that the prosthetics were very easy to adjust, and helped accommodate her swelling. What's interesting, she had meningococcemia, and she lost some of her fingers, and was still able to use the buckles quite effectively. Patients with very challenging limbs, there's heavy-duty componentry that our device works with that can accommodate people with higher weight. The prosthetic socket was designed to work very well with standard pylons, offsets, and prosthetic feet that are common in the industry. Other people we found that works well with are those with fluctuating limb volumes, like persons with heart diseases, kidney diseases, edema, using diuretics for hypertension, sometimes can change the shape of the limb. Persons in the first year after amputation is what's called a preparatory device. Those people who are tired of hard sockets. It was also designed very forgiving, so it can meet the needs of many of your challenging patients. This was a woman that was very pleased with it. She was considering surgery to go above the knee because she had so much discomfort, and she was able to forego that transfemoral amputation and continue to function with our prosthesis. It's designed with pads that can be moved. It's very patient-centric. We wanted something that patients could take the lead on their care. It could be easily adjusted if there's a painful area. With this padding, it also means that you need a very thin silicone suspension sleeve. So this is a silicone sleeve with a pin suspension. So you don't need the big, thick one. And I'll tell you, much of the prosthetic weight is in some of those very thick nine-millimeter liners, which weigh up to a pound and a half. We also worked with a company that developed memory foam, but it's a little thicker and is useful for certain patients, but it's not used for everyone. We did design these to be waterproof. And the pin suspension shuttle lock made by Bulldog, we tested in saltwater for a month straight and took it apart and found that they weren't rusted. There were no failures. And so the company, Bulldog, has approved us to say that their product can be used in the water for a year. And so this is really an ideal product for the beach and outdoors. This is one of our users, and she was most satisfied because she didn't have to deal with socks. She had a lot of edema that changed throughout the day. So she'd have to go find a bathroom, remove the prosthesis, put on socks and get dressed again. This way, she just has to unbuckle the buckles and loosen it. Now, building prosthetics, you have to make sure that they are strong enough, durable enough to withstand the rigors of your patient's life. And so there's these international standards testing. Three million cycles at 300 pounds is the standard. We put that through our sockets. This was designed to be really military-grade tough so that it wouldn't break on folks. We have several testing machines, but this is one of them. Early on, we found one of our buckles did break in prototype testing, and so we redesigned it and tested it to ensure that it would not have any breakages again. It withstands 278,000 cycles at 50 pounds. Goes in the water. It actually has neutral buoyancy because of the neoprene liner. It will float. We recommend people have additional foam so that if they got caught in the surf or something, it would be something that would help float them rather than pull them down. We use the College Park foot in our study by Breeze, or Breeze foot by College Park. So at this point, I would stop and see if there are any questions. In the words of John Bon Jovi, whoa, we're halfway there. I don't see any questions yet, but as they come up, I will definitely let you know. Everybody is asleep. I'm the second lecturer in the afternoon on this virtual medium. Okay, well, we'll keep plowing through here. How's that? It's a prosthesis in a box. This is what it was designed to be, to be modular, easily shipped, and easily put on. It works with commercially available feet, and you only need a few tools to put it on. This is a pipe cutter. I'd recommend if you do much of this, you get a chop saw for your lab to prevent yourself from getting a carpal tunnel or your prosthesis from getting overuse upper limb syndromes. This is what it comes with, a pylon, socket, various buckle-sized cables, the liners, adjustments, and spacers. If you're a little short, you can put that in the bottom to optimally fit the patient. And an optimal fit is with the patellar sitting about right here. That's the sweet spot. This is Advanced Design Concepts in Pewaukee, Wisconsin, and this is really where the magic happens. We've had a nine-year collaboration. They do rapid prototyping, product development, injection molding, and production. And having all of that under one roof has allowed us to have really good quality control, really good time, both production, design, and patient feedback into one very adaptable and responsive system for quality control. Here was our ISO standard testing. With ISO standards, you have to go three million cycles at 300, but you also have to have a maximal failure load, and it requires 900. This went up to 1584 and 2050, so these injection-molded sockets are very strong. Here's what it kind of looks like. Our engineer shot some different colored sockets just to show we've got new things coming out. It is very waterproof. It dries very quickly and the neoprene doesn't absorb the water at all. Now, this is all very interesting, but does it work? And that's really been the subject of a lot of our effort to really validate whether this is a reasonable and rational technology. We just published a paper and we have two more papers being submitted actually during this COVID teleworking. This was our funded pilot trial to determine the feasibility of a system in persons with trans-tibial limb loss. We included people who had ambulated with a standard prosthesis. They were six months or more since amputation and we included people of all causes. We excluded them if they had skin ulcerations or other central nervous system disorders that would prevent them from walking. They were excluded if they had severe phantom pain or limb pain or they were heavier than 260. That was the weight limit for the components we used. We actually had very little difficulty in recruiting subjects. We used newspaper ads, flyers, and letters. On visit one, and if they were screened and if they were acceptable, then on visit one, we asked about their conventional device and then fit them with the iSET device. Two weeks later, they returned to clinic and we completed their questionnaire and did pressure analysis and gait biomechanics. We used a standard biomechanical analysis system. This was the Fujifilm and it was very easy to use. We could put it on without disrupting how the limb went into the prosthetic socket. We used the Prosthesis Evaluation Questionnaire for comfort, stability, and ease of use. We modified it so it would have seven questions because it's a very long questionnaire. It's well validated, but for our purposes, we just wanted to focus in on how the prosthetic was being viewed and used. We recruited 26 participants. Four were lost to follow-up, and so 22 completed the study. There were no falls, no limb ischemia. Incidentally, the prosthetists were worried that there was going to be limb ischemia with people tightening the buckle too tight. We have never seen that. People usually have enough intact limb sensation to not have it happen. Two persons had some minor skin breakdown on the anterior tibial area that resolved with some adjustments, and all of the subjects wanted to keep the device after the study. They're about 50 years old. We had a pretty good female representation, the sample size. Most were dysvascular, some were traumatic, and many had comorbidities, diabetes, clearly. Their conventional prosthesis most used a pin for suspension similar to ours, and they all used a hard socket. There was no adjustable areas of their hard sockets. We looked at the average wearing time of the conventional device and the iFit device, and the conventional device and the iFit were pretty comparable. A few more people wore their conventional devices a little bit longer. Now, I hope you can see this because the screen is kind of in my... There we go. Let me move it here. I'm going to move Sterling's face off the screen. He keeps looking at me. In the questionnaire, we did a very rigorous intention-to-treat analysis that included those four dropouts as if they were all worse off than the group, and even with that stringent criteria, it was significantly better in the direction of the iFit device. When you just analyze the group that completed, the 22, it was highly significant in favor of the iFit device for self-reported comfort, walking, and satisfaction. With respect to biomechanics, there were no significant differences across any of the parameters, limp index, stride length, double support in favor of either the prosthesis, which means that the adjustable device didn't cause any gait deviations or anything different than the conventional device. Now, this was the peak intra-socket pressures, and the iFit device in red was always less than the pressures in the conventional device. It's not surprising, since there's a soft neoprene liner between the socket and the silicone sleeve, and was significant on average over the tibia and over the lateral side. In conclusion, this seemed to be feasible, and there was some efficacy. The iFit system was safe and compared favorably to the participants' conventional devices. Now, we did a second study, and this was because we changed the geometry of the socket. Because those two people that had some skin breakdown, we wanted to change it, wanted to change the closure system, because some of the feedback was that it was bulky. So instead of just adding these people to the first trial, we did a second cohort. It's a very similar two-week home trial. It's currently in review, and Chloe McCloskey is one of our residents who worked on this project. Same inclusion-exclusion criteria. We enrolled 27 subjects, with 24 subjects completing it with an 89% retention rate. We like two-week studies because we get a good retention rate as well. For three of the 24 participants, this was their first prosthesis. We liberalized the protocol so that if somebody was ready to wear a prosthesis, but they just hadn't gotten one for a variety of reasons, usually cost or insurance, then they could participate. We had zero skin breakdown. No falls, no irritation, no device breakages. So I think we improved the internal geometry. In comparing all of the questions, about half of them, over half of them, were significant. Volume changes was better. Skin breakdown, walking comfort, standing comfort, walking stability, standing stability. We also noted, this is a question we added about temperature perception and sweating control in the residual limb, and the eye fit was markedly better than the conventional devices. This just kind of shows that difference, and it could be due to, we don't use any socks. A lot of people that come in with their, they have their silicone liner. They have some socks they put on. They may put on another sleeve to pad things. Our neoprene is, some of the neoprene is perforated. We also have an open area in the back that allows for some airflow. In addition, we use a much thinner silicone liner, and that's light, and these are probably the reasons that temperature perception was viewed that positively. So with the second cohort, same as the first cohort, the eye fit adjustable socket was superior in self-reported comfort and function, superior in self-reported limb temperature, and worked well as a first device for those three people that we used it for. So we're at the scientific validation of the transfemorals. We used an inclusion criteria of, you ambulated with a standard prosthesis or you were cleared for ambulation. Well-heeled residual limb and persons with limb loss due to all causes were included. Similar exclusion criteria is with the transfemoral patients. The transfemoral cohort, again, we have no problems recruiting. We got a lot of people interested in the study, and this study has been shut down because of COVID, and so we analyzed the amount of subjects that we have currently. Again, the initial visit, they were fit, and then they returned in two weeks for outcome measures. So we were shooting for a sample size of 20, but we decided to analyze our 14 that we have. One subject, this was their first prosthesis, so there was no previous device to compare to. For the subjects, we did not let them take the device home for two weeks, as we and they felt that the knee and foot mechanism is so different. This is one of the unanticipated issues with studying transfemoral prosthetics is that people come in with a computerized knee, and it's very hard for them to get comfortable using a non-computerized knee. We used a MALC knee, which is a hydraulic knee that's of extremely high quality, and its cost is consistent with grant funding, but for these four subjects, we didn't let them go home. What we did is we put them in our best knee, let them walk around the lab and the building, and then had them rate the socket at that time. There were mostly males, good African American and Hispanic representation. Most were dysphagia, but good traumatic, and we had one person who was of congenital causes. The types of sockets really spread the gamut. Suction was the most common, pin, lanyard, and when you took out the people that just wore it in a lab and compared the people that wore our device home, the walking was pretty much the same as with their conventional device in terms of the amount of hours they walked per day. Even with a small sample size of 13 subjects, four of the questions were significant. Two of them are really very close, approaching significance, 0.051 and 0.055. Full intense purposes, standing comfort, walking, on-off, fit alignment, volume changes, and sitting comfort were markedly better in the adjustable IFIT direction. When you got the summary score, it was significantly in favor of the IFIT. Now, one of the things that was really quite stunning to us was the amount of tissue compressibility. So we actually measured that. We measured inside the socket at the point after they wore it, what the internal diameter was. And we found that there were huge compressibility of these soft tissues when you buckled the adjustable socket at a comfortable, very functional geometry. And this, you know, eight centimeters is five centimeters. This is a lot of compressibility that you can't predict from a digitized image. We've looked at this and it seems to be correlated with body mass index. So this appeared to be a major issue and it was a pretty high magnitude. And I think it illustrates why 3D printing or casting frequently leads to a suboptimal fit because you can't accurately predict what the compressibility is. So this showed better self-reported comfort and fit with the transfemoral socket. One area that is interesting and I think needs more study is skin health. Total contact sockets that we've built seem to provide a better skin and limb tissue environment. This was one of our subjects. And this is his standard device. It had a lot of rotation. It was a little too big for him. And when, here's the iFit device. What we found with him was when we initially saw him, here's what his limb looked like. It had some warty, like Verrucas hyperplasia and skin changes. And then I had seen him between this time and thought maybe his limb's looking a little better. So we decided to follow him up at routine intervals. And here was the change in pictures. And you can see that this got much better and he decreased in size in his residual limb. Another person, a person that we didn't fit but that purchased the prosthetic, the prosthetist noticed this as well that with a total contact socket over a one month period, this began to heal, this sort of warty-like, probably edema-related skin changes. So the skin, what we found also is that there's a lot of change just immediately after starting to wear the prosthesis. And this is why people often have to adjust it. This is a... This is a prosthesis, this is a prosthetic as well. It takes care of it. But what do you mean by that? What do you mean? Sure, what? Well, I know mine is a progression where in the morning, I'm sicker and what's up in my leg, I shrink down. I know that. I know by two o'clock, I'm at my smallest mass. So the fact that I can wear a leg, I don't have to worry about what I have to do is okay. But I know, I can feel it. I know when I'm shrinking down. I'm almost done with it. It's definitely tightening up, I'm good. And in my mind... And this gentleman had polyneuropathy and was blind in one eye and had renal issues. We did very well, your more challenging limbs. And now the final aspect I wanna talk about is international. People in poor countries and resource challenged countries really have culturally, their cultural roles, their body image, their ability to work profoundly affected. A number of other organizations have tried to address this problem. And it's a real challenge and these very well-meaning efforts, unfortunately, take a lot of time and prosthetic ability to remodel prosthetics into limbs to meet the needs of people in some of these impoverished countries. This Haiti, after the earthquake, there were a lot of people who had crushed limbs and needed prosthetic devices. We work with an organization called Friends of the Redeemer in Jamaica and we give them prosthetics. And a physical therapist, Beth Wolf, was trained by us in how to fit these devices and now she fits people. This was one of our first, this is our first person fit and he's now become a technician and peer counselor for other people. These again can be fit without a lab by Dr. Wolf, our physical therapist. She has a PhD in physical therapy. And here are the first five we've done. We've now done, I think, seven of these folks. We sent down five more prosthesis. I haven't heard how they've went, but many of these people went for many years without walking with a prosthesis after their amputation and most of them walked with crutches because they didn't have a prosthesis. This person, after nine months, the foot wore out, but the prosthetic socket did pretty well and we followed all of our sockets that are being used there and we've not had any component failures at this point. This was, again, someone fit in an austere clinical environment. This is a 12-year-old boy who is a congenital amputee. He had never walked other than with crutches. He was fit in one day by death and did well. They followed him up in one month and he was doing well at that time. He's been wearing it now for probably 12 months since it's April. The modular and adjustable devices worked well and they appeared to hold up well in the heat and rough terrain. In terms of meeting international challenges, I think you have to bring to bear the full spectrum of industrial manufacturing to scale up what would need the amount of prosthetic services and devices it would need to meet the needs worldwide. You have to build an adjustability, use low-cost, high-strength materials. Once you have the injection molds, you can then injection mold different parts at a lower cost. You have to find durable feet. The real issue is to distribute services and prosthesis across countries and regions by training allied health professionals, people in country who can then become fitters and go to rural areas and fit and align these devices. You can use fitting bands or existing clinics. This is ideal for COVID care. We actually have over 400 of these sold and they've been fit in people's homes. A prosthetist wearing appropriate protective equipment could go out with hand tools, some pre-cut pylons and fit these in a home. Even with COVID, people who otherwise could potentially walk shouldn't have to wait two, three months. By then, you develop contractures in your knees and hips and it's very hard to do so. Telemedicine is ideal for telemedicine. You can have a technician or someone skilled and work with a prosthetist online, fit it, align it and empower the patient to give greater control. This device, these adjustable prosthetics are very congruent with recently published guidelines by the VA and Department of Defense. I didn't go into it because we didn't have time, but you can use these devices slightly modified as rigid dressings or removable rigid dressings. You can have one of these in the physical therapy area while a person is in the acute rehabilitation phase and they can have some controlled weight bearing, walking and can get people going. Initiate mobility training as soon as possible and early gait retraining. This is where iFit can really help patients. You don't have to wait weeks to months to have a prosthesis fabricated. This was a model of what some of the cost savings to a health system, a conventional using L codes, standard L codes that CMS bases all their payments on. The iFit was less than a third of what the cost would be and for a large organization, you could save some substantial amount of money, about 20 million if you took care of 1500 people. This is a cross comparison of conventional prostheses, which is about 14,000. This is a trans-tibial prosthesis and then this is over a one year period of time and this is what it would be for a iFit device. So in terms of a value proposition, quality over cost, you can increase value by improving quality and decreasing costs. So in conclusion, these adjustable sockets provide better comfort, function, temperature control than conventional devices. They're superior to conventional devices in sitting comfort and general comfort with respect to the trans-femoral devices and they seem to be pretty durable and workable for low resource environments. They can help people with fluctuating limb sizes. They're well prepared, well suited as a preparatory device. We do have a few other subjects I didn't present, teenagers and they accommodate well growth for these kids. That's a whole different aspect that we're trying to address and it's ideal to get people out doing the outdoor activities that they wanna do. It's ideal for mobile care and telemedicine care and can enhance prosthesis capacity and with that, I will stop.
Video Summary
The video features Dr. Tim Dillingham, Chair of PM&R at the University of Pennsylvania, discussing adjustable lower limb prosthetics. He starts by thanking the AAP for the invitation to speak and expresses admiration for colleagues in New York and New Jersey dealing with the COVID surge. Dr. Dillingham explains that adjustable prosthetics are a fundamental change from the traditional socket design, which often requires multiple adjustments and can be uncomfortable. He highlights the need for improved prosthetic fabrication due to a rising incidence of limb loss and a dearth of prosthetic services to meet the increasing demand. Dr. Dillingham describes the drawbacks of current socket designs, such as cost, discomfort, and variable quality. He introduces the iFit system, an adjustable prosthesis that aims to improve socket comfort, alignment, and fit. He discusses the design process, the materials used, and the benefits of the iFit system for patients with fluctuating limb volumes, those in the early stages after amputation, and those with challenging limbs. Dr. Dillingham presents the results of pilot trials for transfemoral and transtibial amputees, showing that the iFit system is safe, improves comfort and function, and provides better temperature control. He emphasizes the potential international impact of the iFit system in resource-challenged locations, including Haiti and Jamaica. Dr. Dillingham concludes by discussing the low-cost and telemedicine applications of the iFit system, its alignment with recently published VA and DoD guidelines, and the potential cost savings for healthcare systems.
Keywords
adjustable lower limb prosthetics
traditional socket design
improved prosthetic fabrication
rising incidence of limb loss
prosthetic services
iFit system
socket comfort
alignment and fit
pilot trials for amputees
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