Can everybody hear me? Yes, we can. Okay. Good morning. I'm, this is Solon Rosenblatt, and I'm speaking to you from Colorado, and I want to, I'm going to be speaking with John Holmes, who's a psychiatrist, I'm sorry, a prosthetist in Houston, Texas, and we're going to be talking a little bit about osseointegration. I just revised all of these slides, just like an hour ago, because I got some input from a very close friend of mine, who's a physiatrist in Holland, who had a couple of really good comments. So I want to thank the association for inviting us to join you today and talking about osseointegration. So I have nothing to disclose. I did spend two years in Australia learning with Dr. Mujad El-Madaris, so a lot of my comments and thoughts do come from the two years I spent in Australia. By the way, if anybody has any questions, I assume we have some way of answering those. Anyway, amputations are unfortunately a way of life or a fact that we all have to deal with. Just in the last couple of years, due to enduring freedom and Iraqi freedom, two recent military encounters in the Mideast, 1,800 lower limb losses were incurred by our US military personnel. As physiatrists, everybody knows what the statistics are, that less than 50% of these lower extremity amputees can return to their work duties, and bilateral amputees usually wind up wheelchair-bound. So this presentation is going to have a couple of ... We'll start off with talking about the sockets a little bit, talk about osseointegration, the origins of osseointegration, the various surgeries that are available, what the current numbers are worldwide, and some of the ongoing clinical research. This photograph on your right is of a gentleman, a close friend of mine, Sergeant First Class Dana Bauman, and if you look closely, you notice on his left leg, he's a below-knee, and on his right side, he's an above-knee amputee. And Dana is not interested in osseointegration under any terms. He's very happy with his current setup, and he continues to skydive with the US Army Golden Knights Parachute Team, and is definitely not interested in osseointegration. So talking about the prosthetics, the socket that we all know and probably have grown to hate hasn't changed much in the last several hundred years, and in fact, a patient of mine back in 2015 came to me and said, Dr. Rosenblatt, there's got to be something better than this. And I said, I really don't know what is better than that. So he promptly started telling me about someone he had friended on Facebook, who you see here in this photograph in the white shirt, who went all the way to Australia, and of course I think all of us have these encounters in our office on a pretty much daily basis these days where they read about it on Facebook or some other social media, and told me that this guy in 2013 traveled to Australia and had this procedure done where they put a rod into his leg, and now he simply attaches his prosthesis directly to the rod and has no more socket problems, and it's great, and the guy loves it. So I was really dubious about all this information. I didn't believe it for a second. I'm an orthopedic surgeon, and I've always been told that if you have a piece of metal sticking out of your leg or any part of your body, it needs to come out. You don't put it in and have it sticking out of the skin like this picture you see on your right. So I actually flew to Las Vegas, where this patient actually lives, and decided to meet him because it sounded really completely unbelievable when my patient told me about it. This is the pictures I actually took in Las Vegas, so you can imagine, rather strange for me to fly to Las Vegas. This time I was living in San Francisco, and asked this guy, can I please look at your leg? So got a couple of interesting comments about that, and the rest is pretty much history. I flew out to Australia to learn more about osteointegration, and osteointegration, basically, we can pretty much say that it started with this gentleman, Dr. Brenemark, from Sweden, back in 1960s, where Dr. Brenemark was doing research with titanium implants, and basically is credited with starting the whole boom on tooth implants. And basically, this is what the original implant looked like. You screw it into the patient's mandible or maxilla, and allow for it to integrate, or allow for the bone to integrate into the titanium implant. And then the tooth was fixed to this top portion. Well, Dr. Brenemark happened to have a son named Ricard, who is pictured here on your right. And Ricard basically came up with this idea that, well, if it works so well in the mouth, with all the bacteria we have in our mouths, why wouldn't the same concept work for the femur? So he developed the original Oprah system, which you see here on the left. And this is the implant. And this is the portion that sticks out through the skin. And this is the connector. So that is the original Oprah that was started in 1990. And then this gentleman on your right, by the way, this is a gentleman named Eric Axe. Let me see if I can make it a tiny bit smaller. Nope. Not doing it. I want to make this... Anyway, Eric Axe is on the right, I'm sorry, on the left of this photograph. And he is actually the very first person to receive the Oprah device. The reason I have this picture here is because he's standing with Dr. Ashoff, who developed in 1999, this implant called the ILP or the Integral Leg Prosthesis. So Eric Axe is a good friend of Dr. Branemark Jr. And he accidentally lost his leg when his shotgun discharged, accidentally blew his leg off. And Dr. Branemark said, well, let's try my new implant, the Oprah. And so Eric is probably one of the oldest living osteointegration patients around, doing quite well. And then about nine or 10 years later, a couple of guys traveled to Germany and decided to learn more about osteointegration. This is the family of implants that was developed in Italy. And this is the implant that's basically being used right now in Australia by Dr. Almuderas. At the same time, the Dutch in the Netherlands developed a series of implants and started doing osteointegration as well. Both of these systems started around the same time, the year 2000. And so here's me in the center. This is Hank Vandermont on my left, and Hank happens to be a physiatrist. And he's the one who went over all these slides early, early this morning and suggested a couple of changes. The gentleman to my right is John Paul, who's the surgeon who performs all the surgeries in the Netherlands. Several other systems came out. This is a system that was designed for use in oncology and was then modified by Zimmer to use in osteointegration patients. There were several design improvements over the next couple of years. This is the German implant at the top that Dr. Aschoff developed. And this is the OPL, the Italian implant. As you can see, there's a lot of similarities between the two, and the Dutch implant is virtually identical to the one that's made in Italy. University of Utah decided to start a study looking at implants, and this is their implant. They did a total of about 10 implants and then stopped. Dr. Ron Hugate, who is in Denver, Colorado, developed an implant with Zimmer, and he did two of these implants and decided that it was too complicated for him to do by himself. So he's only done two. There's another company that's actually in Australia that basically took the design from the Italians called Signature Orthopedics, and that's being used right now in Las Vegas by Dr. Ron Hillock, who's done a couple. So these are basically the founders and the backbone of osteointegration as we know it today. In the center here at the beginning, in the far right here, is Dr. Brenemark, Ricard Brenemark, who started with the OPRA in Sweden. Later Dr. Aschoff from Germany developed his system. And then Dr. Munjit Al-Madaris, who's currently living in Australia, and then Jan Paul, who's in the Netherlands. They both got together and developed the newest implant, which is the titanium implant that we are basically using in most places now. So I basically kind of broke it down. This is worldwide. I called all these different centers to find out where they were at in their development. And basically the OPRA, which is the one that's been around since the 1990s in Sweden, this has about 300 total implants worldwide. Dr. Aschoff in Germany has done about 268. In most cases, includes transfemoral and trans-tibial, although the OPRA device is only approved for transfemoral. So these are completely, all 300 of these are in the transfemoral. The Netherlands developed their system, which they've done about 371. UK has an implant, University of Utah has 10. Again, like I said, the FDA is looking at their data before they approve any more implants. So we have about worldwide, my numbers came up with around a little less than 2000 total surgeries performed. So the question is, where are we in the United States? We're pretty far behind the rest of the world right now. And one of the reasons for this talk is to get everybody excited about osteointegration. And hopefully we can talk more about that. So some of the things I learned from my two years experience while living in Australia was that osteointegration is a life-changing procedure. But I do have to preface that statement with what Dana Bauman said at the beginning of this talk, and that's that osteointegration isn't for everybody. You're going to find a lot of patients who for one reason or another are not interested in osteointegration. Either they're satisfied with their socket, they're doing okay with their socket, or simply they're not good candidates for the surgical procedure. So John is going to talk a little bit more about how to plan ahead for the procedure. One of the things that I learned too is that if you have a bilateral amputee, you really don't want to leave one limb longer than the other, if at all possible. And again, John's going to talk about prosthetics. So here's a patient with osteointegration, the patient's down here at the bottom. And the dual cone is the portion of the implant that sticks out through the skin. So this is the connector in this particular case. This patient decided they wanted a rotator to give them more functionality getting in and out of a car. And then you've got the connector down here where it actually connects on to the prosthesis. So John's going to kind of address this a little bit more when I get done. This is, again, you need to make sure you know what type of prosthesis this patient's going to be using, and very important to coordinate with your prosthetist. This is a case where a patient had a osteointegration done on their left femur. And if you notice the rotation, the natural knee is over here. And this prosthesis is a little bit short. Some of the physiatrists I spoke to say that this is a good thing, because then you don't get, your foot doesn't catch as you're going swing through. Others would say it might be a problem, you know, with the patient's gait. But again, this is part of the planning, the pre-op planning that we will talk about in a minute. Again, this is a patient who was in Turkey, who was sitting having coffee one day with her friends when a suicide bomber decided to make a statement. She wound up with one femur slightly longer than the left. When we did her bilateral osteointegration, we did not shorten the left one, which I think in hindsight was probably not a great idea. She's not very happy with the fact that she has different length implants. So something to consider when you're talking about bilateral amputees. Also, soft tissue is not very forgiving when you're talking about having a piece of metal sticking out through the skin. So that needs to be considered. The other thing that I learned very quickly is that osteointegration does not cure chronic pain. So if you have somebody who's complaining of a lot of chronic pain, and they think that the osteointegration is going to cure the problem, it may not cure the problem. So it's something definitely to consider. The woman on the left had a lot of chronic pain in her lower extremity, and she elected to electively have an amputation done, hoping that that would get rid of her chronic pain issues. This is the gentleman on the right side of the screen, who's pointing to where he still has pain after the osteointegration. So we've tried a lot of different neuroctomies and try to do various other nerve studies and things like that. And it's a very challenging problem. So this is a patient who had osteointegration done. If you look at his thigh, you can see the years of using a socket. This is the chafing, the blistering, all kinds of problems he had from the socket use. And now that he's got osteointegration, of course, he doesn't have these problems, but socket problems are definitely real. I don't know any patients, and I'm sure anybody out there can tell me different, but I don't know any patients who like their socket. A lot of patients have learned to live with the socket, to accommodate to the socket, but most patients don't like their socket. There's heat rashes. The very first patient who went to Australia to have osteointegration done lives in Las Vegas where it gets extremely hot. He was all the time dealing with heat rashes, ulcers, blisters, perspiration. He would often take his socket off in the middle of the day and pour out several ounces of perspiration out of his socket. Another patient I had told me that he was working in San Francisco as a day trader, and oftentimes he'd get up to go get a cup of coffee or go to the bathroom and his socket would simply just fall off because his stump had shrunk so much that there was very poor fitting of the stump. All of these are things that I'm sure everybody's dealt with in their treatment of the amputee patient. These are some of the patients that do benefit from osteointegration, and bilateral amputees for sure. The energy expenditure that we all know about trying to ambulate as a bilateral amputee is extremely high and often makes it quite difficult to walk. Extensive heterotopic bone, as you see here, and patients, this is a patient who was injured by an IED in Iraq and was left with a very short bony residuum. This is, again, this is the same patient with all that heterotopic bone after osseointegration. And you can see that you don't need to take out the heterotopic bone at all. You just simply work around it. Simply put the implant in, close up all the soft tissue. And here's the gentleman on the left who now has this new osseointegration implant. So I don't think my videos are working, actually. I don't know why, but on the left, unfortunately you can't appreciate this, but on the left is a gentleman, if you go on YouTube at your leisure, look up Michael Swain, S-W-A-I-N. Michael Swain was a soldier with the British Army in Afghanistan and stepped on an IED and lost both of his legs. He was wheelchair bound for three years and he's now walking without any crutches or any assistive devices whatsoever. The video that you can't see, unfortunately, on this side, otherwise, let's see if I can get it to show. No, it does look like it's working. Sorry about that. I don't know why. But there's a video on the right side of the screen that unfortunately you're unable to see. And this gentleman was injured when he ejected from an F-18 and lost his leg. So preparing for surgery, there's some criteria that must be considered before you think about referring somebody to an osteointegration center. Now, if they've had any type of radiation to that limb or had chemotherapy within the last 18 months, you need to really consider the pros and cons to having an implant placed in that femur or tibia. If they have peripheral vascular disease, this is the transcutaneous PO2. If it's less than 40, also that would be a contraindication. Now, a lot of these exclusion criteria that I've listed here actually come from the various centers that have applied for FDA approval to do osteointegration. So right now, the only FDA-approved device is the Swedish OPRA device. It's actually FDA-approved. The other devices that are being used in the United States are done so through what's called an investigational device exemption. Both of them, FDA, both the humanitarian device, which the OPRA device has, and the others, which have the IDE, the FDA is demanding that all of them follow the same exclusion criteria. So these are those exclusion criteria that have been agreed upon by the FDA. So people who have any cognitive impairments, for example, that they can't follow medical instructions or they some tend to fall a lot, they would not be a good candidate. If they're immunocompromised or any type of immunosuppressive drug use, if they've had like a kidney transplant, things of that nature, they would not be a good candidate. Now, I will say that Dr. Almoderas in Australia has, doesn't have to follow the FDA guidelines because he does all of his surgeries in Australia. And as such, at the end of this talk, I do have his contact information and you're more than welcome to contact him to see if you happen to have a patient that may not meet these exclusion criteria, but might be able to be done in Australia. When I was in Australia, we did quite a few patients with diabetes and they actually did quite well. We did 10 while I was there and all 10 of them did very well. We also did quite a few surgeries on people with peripheral vascular disease and the having the osteointegration allowed them to actually resume exercise and their peripheral vascular disease actually improved. So, but these exclusion criteria that I've mentioned here are done so considering what the FDA is going to require. And these are some of the criteria that need to be followed if the procedure is going to be done here in the United States. So again, as I mentioned before, this is the guy that came to us in Australia with this low, this is a trans-tibial amputation, draining pus and not the greatest candidate. We wound up having to do a couple of procedures to clean his stump up and get him ready for osteointegration but I wouldn't put an implant in that right off the bat. The gentleman on the left, back when I was in medical school, I'm sure several of you have probably heard the same thing, but there is some type of relationship between the amount of tattoos and the psychological ability for a patient to follow instructions. So this guy actually failed in that category, I should say, or whatever, but he actually did quite well. So even in spite of the 50 some odd tattoos that he has, so he surprised all of us. So preparing for surgeries, you need to get the right x-rays. This is a CT scan where we, this is a patient who actually had osteosarcoma but it was her lower leg that got the radiation, not the upper femur, wound up resulting in an amputation. You can see that's a bunch of bone cement that's in her femur that had to be removed. And on your right side of your screen, you can see the actual implant that was used. And so it's part of the whole planning process. Now, post-operative rehab, again, this is a video over here on your left, which obviously is not working today for some reason, but the standard protocol for most of the osteointegration programs are that you start standard loading actually three days after you finish your surgery. And this is a patient that's standing on a scale. You can see the scale here and the patient looking down and they can see five kilos, approximately 10 pounds. And they're doing the loading in five kilograms, 20 minutes for twice a day. And then after a couple of days, they then go up to slowly get up to 50% of their weight. Once they're 50% of their weight, then John Holmes would come in and start fitting them for a prosthesis. So these vary with the various implants and the various centers. So don't take this as written in stone, but this is the basic concept of the post-op protocol. Again, these are two videos that unfortunately aren't working, but this is Cindy who lives in Florida and she had a lot of socket problems before she had osteointegration. She was out of work probably two to three weeks every year because of socket problems. And now she has not missed a day of work at all due to her prosthesis. And gentleman on the right is another amputee that... I really apologize that my videos are not working today because they're really quite good. This is a patient named Jeff, who some of you may know. He is a recent retiree of... He just retired as a family practice physician in Denver. And he has a bilateral amputee from private aircraft injury and came to Australia and had both of his tibias done simultaneously and is now doing everything back to flying and doing everything that you can imagine. So this is just one study I wanted to show you the results of, the clinical results. This study was written by Hank Vandermont here. He's a physiatrist, so you know that this is extremely believable information. And this was published just recently in 2020. Looking at their series of 100 osteointegration patients and they're showing that prior to the osteointegration procedure, patients were using their prosthesis on an average of maybe 52 hours a week. And two years after their operation, it went up to 85. So essentially doubled. And so as they wrote here, 63% increase. So these are quite impressive clinical results. Let's see, I see there's a chat down here. What's the chat says? Oh. Okay, so I see that. Then, so this is probably the most important slide of my whole talk because osteointegration in the United States is far behind the rest of the world. We have some resources here for you that should you have a patient who you think might be a good candidate for osteointegration. These are some of the people you can contact. I put me at the top. Unfortunately here in Colorado, we are having an extremely high increase of COVID cases. So as an orthopedic surgeon, I have no elective cases anymore, all of them have been canceled because all of our inpatient rooms have been taken up by COVID patients. So feel free to call me anytime I could use the company. This is also my email address. They're more than happy to email me and we can talk about any patients or you can send me x-rays and I'm more than happy to discuss patients with you on the phone or via email. Hopefully this COVID will come under control, but right now I've got plenty of time. Second on the list is Munjad al-Madaris. I put him number two behind me because he obviously has the most experience in the world of performing osteointegration and he's more than happy to talk to anybody. You can send him slides, pictures, x-rays of patients and discuss with him about a patient you might have if you have a complicated patient. Also on number two, probably the second most experienced person in the world is John Paul from the Netherlands and his partner, Hank, who's the physiatrist. You can reach either one of them through the website that I have listed there. AOFE is the Association of Osteointegration for Europe, the foundation in Europe. And they have the largest osteointegration clinic in the world is in the Netherlands. So in Europe, they have basically delegated the Netherlands as the center for osteointegration. And that is being run by the two individuals I mentioned, John Paul Froek and Hank Vandermont, who's the physiatrist. Horst Aschoff is also performing osteointegration in Germany. And as is Ricard Brenemark in the United States. As I mentioned before, the Integram implant is the only implant that has actually received FDA approval in the United States. It was done as a humanitarian device exemption, which means that every case does have to be presented to the FDA, but it is approved. And so there are ways of getting insurance companies to pay for it. The other implants are all being done in the United States as an investigational device exemption, which gets a little bit more complicated, but the various facilities can tell you more about it. Dr. Rosberg in New York, Hospital for Special Surgery has done over a hundred cases, and he's a phenomenal surgeon, really good friend of mine. And he's more than happy to talk about any cases you might have that would like to be done in New York. And Jason Stonebeck just recently got started in the last year or so in Denver and is doing a beautiful job with his facility. I think he's probably done around 25 cases so far. Richard O'Donnell is one of my former colleagues when I was at the University of California in San Francisco, who was actually responsible for actually bringing Dr. Brainemark to the United States to start performing the procedures here. And the plan was for him to do the operations in San Francisco. So they're predominantly doing the Integram or the OPR device in UC San Francisco. And that pretty much winds up my talk. I want to thank you for inviting me. This is a picture for those who don't know it, is Australia, Sydney, Australia. And that is the very famous Sydney Opera House behind my thank you. So I'm going to turn over the talk to, oh, I see there is a question here. Let's see. Can the implanted portion be engineered to telescope to adjust the length when needed? We've never done that. There is a device that we've used and I can talk to you probably offline if you want. That's called the Freedom implant that we use, put it into some people with some very short residual bone. And with the Freedom device, you can using a magnet, it slowly lengthens the femur to the portion where you can then put in an actual osseointegration device. So another question that came up is what are some of the complications? I don't know if John's going to talk about that. We can see in a little bit, but virtually everybody, every osseointegration patient that I know of gets some form of a superficial infection right after the surgery around the stoma. That usually is taken care of by just using some Keflex four times a day or Cefedroxyl twice a day, something like that. Sometimes it requires some special cleaning. I should say by the end of the first year, most of those infections go away. In my two years in being in Australia, we only had to remove two implants that we were unable to really get a hold of the infection and similar to a regular orthopedic implant, like a total knee or total hip. After several attempts, you wind up just removing the implant, giving them IV antibiotics, then putting the implant back in six weeks later. In the two years I was in Australia, we only had to do that twice. Let's see. The OPRA device received FDA approval. Yeah. So I think I mentioned that, that the FDA, someone said, oh, Blake mentioned it, kind of the OPRA device received FDA approval. So again, as I mentioned before, the OPRA device is the only device that has FDA approval. The others are all being used on a investigational device exemption. So that's something that each individual facility can tell you more about it. So I think that about rhymes up. I'm gonna turn over the mic to John Holmes. So thank you much. And again, like I said, feel free to give me a call or email. John, can you hear me? I can. Okay, I'm gonna turn off my video and my mute. Okay. So everybody got that? There's my first slide. I'll comment to a couple of those questions. I mean, first and foremost, it's pretty easy to make a prosthesis longer. So I wouldn't want to spend a lot of time working on making their abutment adjustable. It's pretty easy to add a piece to the prosthesis. So it'd be much simpler. And then the complications, I don't talk too much about the complications, but the obvious complication is infection. And that can be anything from small to big. And we've had some small and we've had some big. I follow about 25 patients right now that have had osseointegration. And we have had some issues with infection, but none have had to be removed. Okay. I have no relationships here. John, I'm sorry to interrupt. We can't see your slides yet. Can't see my slides. About now? Yes, thank you. Okay. Okay, so now my disclosure statement, I really have nothing to disclose. I have no interest in any of these implants, but I do own a private prosthetic company here, and like I say, I do follow about 25 OI patients, so we have seen quite a few things. Okay. Advance. There we go. So people ask me all the time, because they're doing their research, what is OI? What does that mean? And from my point of view, it is eliminating the need of a socket. When I tell that to a patient, sometimes they say, well, wearing a socket's no problem, just like Solanus mentioned Dana Bowman, they're not willing to risk the infection and the things that you have to do, because wearing a socket to them is no problem. Other people are mildly interested, some people are extremely interested, so just depends on where you're at on the limit there. What I believe is OI is indicated for the difficult-to-fit amputee, and specifically the transfemoral amputee. My statistics say about 2,000 have been done in the world, so pretty close to what Solan said as well. But, you know, the patients we look at are the ones that have a lot of HO, a lot of scarring, a lot of different problems. When their socket fits perfectly, they do fine, but, you know, sockets just don't fit perfect every day. So, it's a class 3 device, which means it's subject to FDA regulations. First patient I had went to Australia in 2014. He was the number 99 guy in the world. We studied it hard, and he made an informed decision, sold his truck, and we live in Texas. He sold his brand new truck, bought a used one, and went to Australia and got it done. I was taken to task by many prosthetists that I was willing to help these patients, because they told me it was beyond my scope of practice. So, I figured out we needed to study and learn to care. There's no books on this, especially back in 2014 and 15, and so, we had to figure out what to do. So, I went to Australia. This young lady, 26-year-old young lady, she came to my office. I had Mugen Al-Madaris here and did an in-service, and had about 25 patients that I thought were people that might consider it. She thought it seemed extremely repulsive having that thing stick out of her stomp, but she had tons of HO, lots of scarring, didn't do as well as she wanted to with her socket. So, when he came in October of 15, she left my office and said, oh, this is not for me. And I said, okay, well, when you change your mind, give me a call, and we'll go to Australia together. She called me about a month later and said, we're going to Australia in February. So, I went down there for about three weeks and studied all I could, went to the rehab center every day, went to the prosthetist's office, and learned what I could because I wanted to be able to help these patients without a socket. Why would somebody pick this? This is also a study done by Hank in the Netherlands. It's a little bit older, but why? Because they use their leg more. They can walk faster, less energy. The quality of life has improved a lot. So, people that have lots of socket problems, this has really helped them increase their quality of life. Hey, John, can you drag your Zoom controls down to the bottom of the screen? It's covering some of the presentation. Yeah, maybe. There you go. Maybe the lower right-hand corner of your screen or something. Okay. Is that better? A little bit. Can I make them go away? If you stop your screen share and restart it, but it'll stop you from sharing. If you turn off video optimization, it'll go away. All right. I'm just going to leave it there for now. I don't want to mess up. So, anyway, they did the studies and it clearly increased the quality of life. I've had several patients that have had some bad infections that it was considered that they might have to do something drastic, like take it out, probably three times. Never happened, but all three of them said, well, as soon as they take it out and they get rid of the infection, I'm having it put back in. Almost every patient that I've seen in the 25 said, used the same word that Solon did, life-changing. So, the different systems are out there. There's quite a few. Solon went over them, but from my opinion, the two that you need to know about or the two differences are screw fixation, which is part of the Oprah situation and the press fit. So, there's several people that do press fits, but those are very different techniques and have different protocols for rehab and are, you know, they're just very different techniques. People ask me, which one do I prefer? I don't prefer either one of them, but I think sometimes one is better than the other for an individual patient, depending on all the differences in the two things. So, we discuss the pros and cons of each and figure out what's best, and it's a hard decision to make right now, but they are different. It's from my point of view, it's almost like a prosthesis. Somebody asked me, what's the best prosthesis? I want the best one. Well, the best one is the one that is best for you, and so the different types need to be studied and figure out what's better for each person. Okay, this shows the direct skeletal attachment. A new word we've coined is osseoperception, because these patients can, they can feel stepping on a rock now because it's direct, you know, through their femur, and there's no socket that's taking away a lot of this stuff, so that's quite amazing. Yeah, people ask me, one of the first questions when they're trying to figure it out, they ask me, does it hurt? And the answer is no, not one patient tells me it hurts. This slide emphasizes that to me. This bilateral transfemoral amputee, when I was in Australia, this was her second or third day of standing on her brand new implants, less than one week in her body, and as you can see, she's drinking her coffee, she's paying minimal to no attention, her husband in the background also paying minimal to no attention, so she certainly is not in pain. Just a different little standing technique, so you have to start with a slow program. Yeah, sorry. Start with a slow standing weight-bearing program, depending on whether it's screw fixation, or whether it's a press fit, the protocols are different on that, but, you know, they're pretty easily defined and pretty easily followed. Okay, we had the fortune, I guess, of seeing one transfemoral patient, there's only been about a half a dozen transfemoral patients done in the world, but one happened to live here in Houston, and had the implant put in four or five years ago. We had to make a training device for her as well, no prototypes or anything, this was the first and only one, so we just made it up. Prosthesis basically hangs more, an arm prosthesis hangs more than you weight-bear on it, so we built a situation that she could put on there, get some distraction. Actually, as she got better, we added weights to it, put a device on the bottom, not sure where to put this, put a device on the bottom so she could actually bear weight, and it worked out pretty good for her. There are many different connectors. This is a simple connector, has a little bicycle handle, I call it, lever, so you put your abutment in there and tighten it down, works quite well. Most commonly, there's, this is an OPL-AQ connector, but use a little four-millimeter wrench to tighten that one up. MAC, very similar, these are all similar, just different systems. The issue for me is all these patients have different systems, so I have to have lots of different parts in case they break something. These connectors, the first three I just showed you, cost about $2,500 a piece, and you know, so I have to have some stock in case people make them, break them. I can get one usually in one or two days, but they don't want to be without their prosthesis for one or two days, so it is a complication. See if my video will work. Okay. That's not good. Uh-oh, guess I need some technical help here. Am I able to help, John? Yeah, I'm not sure. Where'd my slides, where'd everything go? Okay, it looks like you've shut down your screen share. Okay. So go ahead and open that back up again. Then you may need to manually go back over to PowerPoint to start things back up again. Okay, so go, huh, okay. Okay, are we back? No, not yet. Okay. Okay, so I'm back on mine. John, are you see, did you click on the share screen button in the zoom window? I think so. I mean, there's my zoom window. A little green button in the center down at the bottom. Yeah, but seems like every time I go to that, my slides disappear. I have the PowerPoint on my, or I'm sorry, I have the PDF on my end. Would you like me to share that? You won't get your videos, but that's okay. I'll take what I can get. It's okay. I'm still trying. just let me know when you'd like me to advance the slide. Okay, please advance. I thought I had mine going there though. Let me try here. Advance, please. Keep going. Keep going. Keep going. Keep going. Right there. Back one. Okay. So, this is my video that won't work, but that's okay. He uses a wrench, and he unscrews a screw, pops his leg off, and he can easily pop another leg on. So, yeah, I would have showed him putting on his other one. Okay. Let's go next. Same slide that Solon showed, basically, just shows you the parts that come out of the body. So, the stoma is very important. That is your opening to your body. What's the problem? The problem is infection, and the idea is you have to keep things really clean. Okay. Let's move forward, because I'll run out of time fast. Each system has a little safe, fail safe. So, this has some little pins that fit into those holes, so if a patient falls, those pins will break and keep it from breaking the stoma and breaking the parts. Next. Okay. Next. Just shows how you have to change the parts out. Takes two people. Next. Okay. Next. Lots of maintenance on these systems. Some people are very mechanical, and it works real well. Some people not. My one young girl I showed you, she lives in Mississippi now. Her prosthetist in Mississippi will not help her, because he's not allowed to by his company policy, so she has to fly in here to do some of these simple procedures. Next. But if, you know, if these crazy OI guys patients want to skydive, next, then they're going to break this. And this is a pretty reasonable guy. You can see his cloak in the background. He's a Catholic priest, and he broke it while he was he broke it skydiving, but it actually broke in half while he was performing a funeral. Next. So taking it out is a hard chore. Next. We actually had to design a custom tool. Next. And pull this thing out of their body. It's not simple, took us a couple of days, and it is why many prosthetists don't want to fool with this, because we're doing things we've never done before, things we haven't been trained to do. Next. Oprah has a really nice connector. It doesn't require any tools. It has two fail safes. Next. Shows you on the prosthesis. Next. Slips in, no tools necessary. You tighten up that black part, and it's all good. Next. Again, next. Next. So two safety functions. So if you fall backwards, it'll break loose, or if you rotate, it'll break loose. No parts are necessary to change it. They just pop back into place, and it's a much cleaner, nicer thing. Also costs lots more money, so goods and bads of everything. Next. OTN from the Netherlands. It's similar to the others. It's a press fit, so it's similar to those first ones I showed you. Next. But they have really clean, nice material over there. Next. Next. Okay, just shows one I've made here. This one cost me 80 bucks. Next. Utah one. They really have suspended that program, so they're not really using those anymore. Next. Dynamic alignment is hard, and we have to work really hard at it, but it's like any prosthetic thing. It's something that's hard to get at, but the patients don't put a lot of weight on it, so it does mean we get to see these patients a lot as their weight-bearing progress. Next. Transtibules are really hard to get the alignment right. I worry about valgus and varus moments that harm the ligaments. Next. Next. This slide shows a lot that just shows how those angles are really hard, and prosthetically we have to work hard to get it done. Next. Lots of clicks and rattles and rolls. They feel everything, but it's just something we have to work at. Next. Component choices. We prefer microprocessor knees because we don't want these people to fall, and they have the best stance control. Torque absorbers are very useful because that takes some of the torque into the prosthesis and not on their abutment. Any foot should work. Next. Just shows our bilateral patient. And one more. Shows all her different devices. The ones on the left she used for training, the ones in the middle are her activity legs that she goes to the gym with, and then her daily legs. Next. The future of OI, especially in upper extremity, is just crazy. We could be putting things in, targeted muscle reinnervation, implantable electrodes, it's just amazing what we think we can do with OI in the upper extremity. Next. So we need to collaborate and everybody communicate. We shouldn't have the fear of added liability. We just need to learn about how to take care of these individuals. Next. And research will be the key for our future advancements. And that should do it. One more. Feel free to contact me if I could answer any questions. I see there's some stuff in the chat here. Okay. Transtibial amputation. I think I answered that. It's not my favorite, but I do have a few patients that have had it done. Not my favorite because I said it should be due to socket problems, and I believe I could fit most any transtibial patient. Load limits? No, we don't have any data on load limits. It's just the material stuff's just not there yet. Yeah, we do tell people to keep things clean, so it says limitations of no swimming. Yeah, we don't like you to go in dirty water. So, I mean, anything, you do have an open wound to the outside, so you have to limit what goes in. Hey, John. Yes. This is Solon. Hopefully you can hear me. We used to suggest in Australia that as long as it was a flowing water, like if they were in an open bay or open ocean, things like that, that was okay. But if they get into like a river, that slow-moving river, they're more likely to get infected. Pools, only if it's a saltwater pool. So regular, if you go to a regular community pool where the little kids are in there doing all kinds of crazy things, we don't recommend that. But if they have their own private pool, like they keep really clean and it's basically saltwater, there's no problem with that. Agreed. Yeah, I tell them to use their good judgment. It says any information on the load limits of the implants? Well, they're not highly tested, so no, but don't jump out of airplanes, and we don't suggest running or weightlifting. I've had a few patients that have told me, no, I don't think I'm a good candidate for this because I'm too active, so possibly. I agree with that. We definitely don't recommend any high-impact activities. So I always tell patients, same exact thing, I agree completely. All right, so I think that covered all the questions. I think we ran a little over because of my little mess up with the slides there. I don't know what I did, but anyway, thank you very much.

osseointegration

prosthetic limbs

socket elimination

difficult-to-fit amputees

scar tissue

heterotopic ossification

implant

screw fixation

press fit techniques