Mike recounts his personal connection to osseointegration through his wife, who became an above-knee amputee due to cancer. Her desire for a more comfortable and functional prosthetic solution led them to explore osseointegration, a procedure that integrates the prosthesis directly with the bone, eliminating the need for a traditional socket. This experience highlighted the limitations of conventional sockets and the potential benefits of osseointegration, particularly for active individuals who struggle with the static nature of traditional prosthetic devices. Mike emphasizes the importance of understanding the patient's perspective and the psychological impact of limb loss.
The discussion shifts to the broader implications of osseointegration in the prosthetics field. Mike explains how this technology can significantly enhance the quality of life for amputees by providing a more natural and responsive connection between the prosthesis and the body. He addresses common misconceptions about the procedure, such as the risk of additional bone loss in case of infection, and highlights the thorough evaluation and patient selection process that ensures successful outcomes. Mike also touches on the role of insurance in covering osseointegration, noting that most major payers now approve the procedure.
We conclude with insights into the future of osseointegration and its potential to transform prosthetic care. Mike underscores the importance of a multidisciplinary approach, involving surgeons, prosthetists, physical therapists, and other specialists to provide comprehensive care. He also encourages prosthetists to consider osseointegration as a valuable option for their patients, emphasizing the need for continuous education and collaboration within the medical community. The episode provides a comprehensive overview of the advancements in prosthetic technology and the profound impact these innovations can have on the lives of amputees.
This episode is brought to you by Advanced 3D.
Mike recounts his personal connection to osseointegration through his wife, who became an above-knee amputee due to cancer. Her desire for a more comfortable and functional prosthetic solution led them to explore osseointegration, a procedure that integrates the prosthesis directly with the bone, eliminating the need for a traditional socket. This experience highlighted the limitations of conventional sockets and the potential benefits of osseointegration, particularly for active individuals who struggle with the static nature of traditional prosthetic devices. Mike emphasizes the importance of understanding the patient's perspective and the psychological impact of limb loss.
The discussion shifts to the broader implications of osseointegration in the prosthetics field. Mike explains how this technology can significantly enhance the quality of life for amputees by providing a more natural and responsive connection between the prosthesis and the body. He addresses common misconceptions about the procedure, such as the risk of additional bone loss in case of infection, and highlights the thorough evaluation and patient selection process that ensures successful outcomes. Mike also touches on the role of insurance in covering osseointegration, noting that most major payers now approve the procedure.
We conclude with insights into the future of osseointegration and its potential to transform prosthetic care. Mike underscores the importance of a multidisciplinary approach, involving surgeons, prosthetists, physical therapists, and other specialists to provide comprehensive care. He also encourages prosthetists to consider osseointegration as a valuable option for their patients, emphasizing the need for continuous education and collaboration within the medical community. The episode provides a comprehensive overview of the advancements in prosthetic technology and the profound impact these innovations can have on the lives of amputees.
This episode is brought to you by Advanced 3D.
Welcome to Season 8 of the Prosthetics and Orthotics Podcast. This is where we chat with experts in the field, patients who use these devices, physical therapists and the vendors who make it all happen. Our goal To share stories, tips and insights that ultimately help our patients get the best possible outcomes. Tune in and join the conversation. We are thrilled you are here and hope it is the highlight of your day.
Speaker 2:Hi everyone, my name is Joris Peebles and this is another episode of the Prosthetics and Orthotics Podcast with Brent Wright. How are you doing, brent?
Speaker 1:Hey, joris, I'm doing well. Man, today is going to be a fun podcast. I think you're really going to enjoy it, but we do have a sponsor, so let's talk about them.
Speaker 2:And who's the sponsor? Is it anyone we know? Is it some kind of magical company? Who is it? Brent?
Speaker 1:The sponsor of this whole season has been Advanced 3D, and Advanced 3D is a contract manufacturer that specializes in prosthetic and orthotic 3D printing. I'm a part of it, along with Paul and Tyler, and we just try to meet you where you are. So, whether you've never scanned before, never 3D printed before, or you are looking to go to maybe another level with definitive prostheses, we're here for you. So if you're interested in finding out more, just reach out to me. I'm always on LinkedIn or you can connect with us on Advanced 3D.
Speaker 2:All right, cool. So who's going to be joining us on the podcast?
Speaker 1:Well, today, I think we have a special treat. It's one that we have not, we've had some discussion about before, but we've never dove in. And so we've got Mike Jenks. He's a certified prosthetist and orthotist. With Integrum they make a bone anchored implant system called the Oprah, and so what that means is there is no prosthetic socket, and so this this will be kind of interesting, probably blows your mind a little bit, but here's another cool thing is, um, mike and I go, uh, actually way back.
Speaker 1:So, um, when I was a young person, I was on my way to Illinois to take a job as a technician, but I just had started dating my now wife, who was still in school in North Carolina, and so, literally about a month out from when I was supposed to move to Illinois, I was like you know what I think I could? I want to stay closer to my then girlfriend, now wife, and I need a job, and I need a job as a technician. And Mike was in Charlotte, north Carolina, still lives there and hired me on as a technician after college, and then I worked there for probably a year and a half, two years, and then I went off to school and then came back and did my residency with Mike and then we've stayed in touch here and here and there and uh really have connected over the last probably few months, uh specifically around the the bone implant system. So I'm I'm really excited to hear what he is up to.
Speaker 3:Well, I appreciate that, Brent. Uh, it's, uh, it was, uh. Those are good memories and again I think we're dating ourselves a little bit when we say how long ago that was. But kudos for you for continuing a fine career and furthering the lives of prosthetic and orthotic patients in a unique manner. For sure, it's great to see what you guys are doing as well.
Speaker 2:Cool. So, Mike, how did you get involved? How did you yourself get involved with prosthetics then?
Speaker 3:So myself I was actually. I went undergrad at Wake Forest, so I moved to North Carolina. I was actually a senior in high school and after graduating from Wake I was pre-med but also considering physical therapy and decided I'd go the physical therapy route. At that time we had to have some work experience to be able to get into physical therapy, graduate school, a master's program, and so I worked at a rehab center and one fateful day there was a piece of rehab equipment that had broken and I've always liked to build things and take with my hands. So I took it apart and prosthetist came into the clinic. He was seeing a patient and asked me what I was doing and I said I'm going to fix this machine. He's like what do you know what you're doing? I was like no, but I'll figure it out. And he said you need to come see what I do.
Speaker 3:And so I went to his lab actually after work that day and was just absolutely fascinated with the process of how to make both prosthetics as well as orthotics, and we spent some time, learned a little bit more about the career and went home to Western North Carolina a few weeks later, talked to my parents and they said you know, wait a minute, you've always been a responsible kid. Now you're going a completely different career direction. I explained it to them and after about 15 minutes they're like, yeah, you need to go do that. That's all about what you are Cause I really enjoy the patient aspect of it, but I enjoyed the creativity and the kind of the behind the scenes lab work, so work. So it's been a great career. I spent 27 years as a clinician practicing both orthotics and prosthetics and bringing up young, bright folks like Brent into the career, and really loved the aspects of practicing, and so that's kind of how things got started and evolved from there.
Speaker 2:I have to ask one thing that's really interesting. Very few professions are so focused on training and training people like bringing them up, if you will. I know that chefs do the same thing, but that whole aspect is that also really interesting, just taking in new people who know actually nothing and helping them become good prosthetists and stuff like that.
Speaker 3:It really is, and I think it's a great question that you asked because, um, I do think it's evolved um over time in terms of what that looks like.
Speaker 3:Um, I think early on, um, when I was being trained, uh, it was a lot more of a kind of apprenticeship type of thing, a lot more learning and refining your hand skills, and I think, as the profession has grown and evolved, it's taken a little bit of that hand skills but it's also matched with a lot of clinical experience, clinical expertise, and that certainly is addictive. Where we sit today, when we're talking about actually how to prosthetist interface with a bone anchored implant, where before I mean quite literally, it was you know how do we work with. You know laminations, wood, leather, metal, so it's, it's, it's pretty fascinating and it's all, but it all centers around how do we get people back to doing everyday, normal things despite limb loss, and so it's the, the tools that are available with us, and you look at what you guys were talking about with 3d printing. That's just another evolution in terms of how technology can enhance the lives and how we still have to have the, the knowledge, the hand skills and the skill set to apply that.
Speaker 2:And in those 27 years of reclination has a lot changed. Is it like a really different landscape for kids that are coming into the market now and setting up their practices or doing internships and things now? Is it very, very different?
Speaker 3:Absolutely. When I came into the profession I would say it was largely male dominated again, because I think it was a little bit more geared toward, you know, the skills and craftsman aspect of it. Now I think the ratio is 50-50. If not, I've even heard some slightly toward more females into the field and again, I think that's an evolution in terms of what the patient needs are, what the demands are, what skill sets we need to have. It's not as physically labor intensive as it used to be, but yet dealing with the human body, the various aspects of it, it takes a very broad skill set of both hand skills, clinical skills, psychological skills. You know how do we best support our patients, and so the demographics of the folks coming in have certainly changed in comparison to how to utilize the tools that are available to us to help folks out.
Speaker 1:That's an interesting perspective on the kind of the new generation coming in. What? What would you suggest people really focus on?
Speaker 3:You know, I think it's a good question. I think there's a couple of different directions that can go, and I'll probably just go ahead and interject my own bias. It is a fascinating field. It's something that is eye-catching from a curiosity.
Speaker 3:When we started in the profession, amputees wanted cosmetic covers. They want to cover their prosthesis as much as possible. Now prosthetics are so much more out in the open, both from Iraq as well as Afghanistan conflicts, and I think just social acceptance has increased considerably as well. With that said, I do and Brent, you can kind of quick, sexy aspect of the profession still need to realize there's patient lives that they've dedicated a substantial responsibility into your hands, and I think that's a responsibility that can't be taken lightly. You have to be ready to help with patients through difficult, challenging transitions, difficult, challenging times.
Speaker 3:There's also life events that are going to come along that an APT needs that support. They need a clinician that's willing to dedicate a little bit of extra time and focus in terms of how to meet their day-to-day needs and understand what that is, and I think with technology it's awesome because we can treat a patient quicker, more effectively, but that doesn't really diminish the amount of time that we need to invest in that patient to truly understand what are their goals and what are their needs. So, as someone that's kind of coming toward the back end of my career, I would say that you know, take the responsibility and the honor of being able to treat these patients appropriately and understand. Technology is awesome, but we still have to understand what the patient perception and what their needs are.
Speaker 1:And I think you know one thing that I admire about you, Mike, is that you stayed really in the same place for 27 years.
Speaker 1:I mean your, your whole thing evolved and you know if I, you know, I look back at some of the time where, uh, even when you know, I went a different path, um and that, and now that I have settled in, um and been at the same place for for since 2000, let's see 11. How rewarding that is to see kiddos that you know you've, that have grown up with you, and things of that nature, and really it wasn't until me settling down that I truly, you know, and I hear the care in your voice about, like that period of time of settling in and really taking care of patients over multiple prostheses, life events and that sort of thing. That's where the richness of the profession, I think, comes into play. So if I had any suggestion for somebody in their youth, it would be hang in there. The grass is not always greener and you know you hang long enough and that's where the richness comes in. It really it takes a period of time rather than switching jobs or chasing a dollar.
Speaker 3:Very much true, and I think the reward and the dollars are going to come as a result of the work and the effort you put into it. So, no, I think that's a real good summary for sure, and listen to it as memories are flashing back and patients really do become close friends because, as prosthetists and orthodists, we're going to interact with them on a more consistent basis than really any medical professional, and that's something that can bring a lot of reward to it. Challenges at times, but certainly the rewards are a bigger part of that.
Speaker 2:And one thing I want to point out because, like, okay, yes, I love this idea of having like this long relationship and I agree that you don't have that much relationship with the other doctor. But how do you choose a place? Because you guys seem to kind of a lot of these people in this business kind of seem to bounce around kind of semi-randomly and like, oh okay, I ended up in phoenix, okay you know, and. But how do you choose a place?
Speaker 3:I mean, you know, do you look at like, or do you or do you do not choose a place this is just a happenstance, or you know, because it would seem that you need kind of a certain patient population, not too much competition, or you know, there's certain uh aspects here, right, no, that's a great question and I think early in my career I was very open to what the opportunities presented and I didn't let the challenges or hurdles of moving away from home and that type of thing Really what I based a lot of my early career decision on where did I feel like I was going to get the best training and the best knowledge and exposure?
Speaker 3:I went from school in Memphis, tennessee, then back to North Carolina, then to Connecticut, then school in Chicago and then actually a short time in Raleigh and then to Charlotte. So I was fairly open to what opportunities we're going to present and really that came down to the level of professionalism, the type of clinics that I wanted to be exposed to and to work with and also the flexibility to be able to pivot. I did a large time with just pediatric patients and then pivoted to prosthetics and it was, you know, really what I felt was, you know, both personal as well as professional development opportunities. And once I found my home again just kind of dug in and, like Brent said I like the way you put that Just really figure out how do I integrate myself into the medical community and find areas that there's deficiencies and be able to fill those deficiencies, but then also bring my expertise and professionalism to par and let it grow as well, super cool.
Speaker 2:And then, and do you now? So now you're not partitioning, like so, people that don't know, I'm kind of trying, I have no idea, I'm trying to figure it out, kind of. So you're not partitioning now Do you miss anything? Would you miss that contact? Do you miss like, oh, I wonder how Bob's doing Is Bob's doing? Is that the stuff you miss about having a practice?
Speaker 3:Yeah, I do, and I kind of I'm really lucky in that I just kind of forced my way into this last opportunity. So I'll kind of, you know, do a fast forward in terms of what my last few years have been. I worked for a large national company for 27 years and was at one point over several different clinics around the Charlotte area as well as doing clinical responsibilities, and it was a great career path, great career journey. In 2016, I was actually part of an education team. We did some presentations on upper extremity prosthetics at ISPO, which was held in Chicago at that time, and there was a big presentation on osteointegration there and I remember kind of sitting back as a practitioner going. This is really interesting, but I wonder if anybody would ever really want to do that.
Speaker 3:Well, fast forward, 2019,. My wife had lost her limb to cancer as a below-knee amputee. She subsequently became an above-knee amputee and you learn a lot about your trade when your spouse is an amputee and what you do well, what you don't do well, because they're going to be quick to tell you. So I definitely feel my prosthetic education was greatly enhanced by having a spouse that I had to take care of. So, fast forward, we were actually in airport New York, and we were running through the airport catching a plane, and she had a tear in her hamstring, so it was basically we were going to face a limb revision for her. And at that time the surgeon that we worked with here in Charlotte said you know, I think you need to look at osseointegration. I can fix your limb, but given your lifestyle, given all you do, I think this is something you would need to take a look at. And my wife said, yeah, I've done some research on it and, kind of to my surprise, I thought I was the one that was most educated in the household about osteointegration. And so we sat down at the dinner table that night over a couple glasses of wine.
Speaker 3:I'm like, well, you know, you've got the world's greatest prosthetist because, as Brent knows, all prosthetists think they're the world's greatest prosthetist. And you know you look at all you do. You run, you bike. You know we've got five kids. We're running around soccer fields. You know, what do you feel like you can't do?
Speaker 3:And she said you know, I know the socket that you make is great, it's comfortable, it's as comfortable as it can be, but it's still a socket. And of all the technology that she has seen over her life as an amputee. I said you know, you show me different knees, different feet, but the sockets essentially are still pretty much the same materials. There's, you know, some that are a little bit softer, some a little bit more flexible, but it's still a static environment that my limb is in. And if I drink a little too much one night, or if I have too much salt, or if I gain weight, if I lose weight, if it's hot, it's sweaty, those are all body changes and a socket doesn't change in accordance to that and it sucks. And every time I have to deal with a socket issue, that's a reminder that I lost my limb to cancer and that's a mental hurdle that I got to overcome every day. And if osseointegration can give me that opportunity to remove one of those reminders, then I want to look at it and I really had to sit back and like, wow, you know, that was, you know, as you know, at that time, you know, 20 something years into my career, that was, you know, a revelation that you know, I really never heard it put exactly that way. And is osteointegration for everybody? Absolutely not. But for the right patient, I think it can eliminate a lot of those challenges that you know I just saw my wife go through on a daily basis and never really had a true appreciation for what impact that was, and I think that's where osteointegration is a really that was, and I think that's where osseointegration is a really amazing opportunity.
Speaker 3:And I did spend a few years actually working up at Walter Reed after I left Charlotte and so I got a very large exposure to osseointegration, what it could do for certain patients, and I was certainly very intrigued. During that time I actually came back to the Charlotte area and helped start the osteoimmunization program at Atrium and one of the things that was really intriguing to me at that time was when my wife there was no other practices or hospitals that were doing it outside of Walter Reed except for UCSF in San Francisco was the first private hospital and when we went out there there was a entire team that we had to sit down and be interviewed by, and that team was, you know, certainly the physician, the plastics, the orthopedic surgeon, the plastic surgeon, but also prosthetist, physical therapist, psychologist, nutritionist, and they all sat down and asked why we wanted this procedure, why we thought it was good for us. We asked the questions to them. What were our medical concerns? But then both parties parted ways and they basically had a team meeting to discuss whether or not we were an appropriate patient for that. And then we had to decide is this something we want to venture into? And just the comfort of knowing that there's an entire team that's working very closely together for the best care of my wife was something that I really was so taken back and impressed by.
Speaker 3:And when I sat down with the surgeons in Charlotte, I said you know what? And when I sat down with the surgeons in Charlotte, I said you know what? From my perspective, both as a clinician but also as a spouse of someone that's suffered limb loss, I really think this is the right way to set up a program. The physician, who's a good friend of mine, said and that's great, but that might be a little bit pie in the sky. I don't know how realistic that is, but let's certainly try for it. And to his credit, he was able to set up that type of program.
Speaker 3:And when our company goes to talk to different medical centers, one of the things that I teach folks is this is really a program, not a procedure. So about a year ago I joined Integrum and that's what my role and responsibility is now is to go to the different centers that are in my region and see what the program looks like, make sure they have all the pieces and parts, but then also give feedback in terms of what the patient's experience are as they go through that program and ultimately they make the decision to have the procedure done. So I get to still wear my clinical hat, still get my patient interaction. I'm not as much hands-on every day as I was before, but I still don't feel I feel like I'm still able to get that reward from a lot of the patient interaction and plus, teaching a large group of folks new technology and a new procedure is is really rewarding, really exciting that's very exciting, okay.
Speaker 2:So there's a lot to unpack here. So first, so first, you know lawyers. They always tell lawyers like, don't be your own lawyer, right? So the best lawyers in the world, they get another lawyer if they get in trouble, right? So would you recommend the same thing if you know? If it's going to happen to people we know? Right? So you know, if you have a close loved one, you know you can give them advice. But should you be their prosthetist? Should you be so much in the driving seat or should you kind of be in more in the backseat, kind of like more as a partner, as a husband, than a prosthetist, let's say sure.
Speaker 3:Well, ironically, my, my wife, was a lawyer, so so she, she, she didn't want anybody else, kind of said, because we had to trust together that. And you know, I certainly stepped back enough and sought advice and sought input in terms of what was work, what would work, what wouldn't work. And, ironically, she would have other amputees that would come to her and say you know what, you need to try this, and many times it was something exact same thing that I had said and she's like yeah, but you know, when Bo, who was a good friend of ours, who was a runner, was teaching her how to run, I was like, but I believe it when he says it, I don't really believe it when you say it, because you still have 10, toes. So I think having that kind of check and balance is important as well, and different people have different needs in terms of how they're going to respond to that. But we were able to get a pretty good balance there.
Speaker 2:Okay, and then making that decision, I mean, was there like okay, so it seems that active lifestyle thing really was like really material for you guys. I mean, was there like okay, so it seems that active lifestyle thing really was like really material for you guys? You know what are the main reasons why, as a patient, you should want to do this, Like you kind of mentioned it. But I think it's a big, you know it's a big decision, so what?
Speaker 3:are the main reasons you should or shouldn't want to do this kind of a procedure Absolutely, and I think there is some to unpack there. I assume integration I literally just had a phone conversation before we hopped on this call, and when I sit down with a patient, it's never a situation where I'm there to talk them into osteointegration. I think if a patient's having to be talked into it, it's a recipe for disaster and something, honestly, that should be avoided. That should be avoided. If you look at what a traditional socket isn't able to do for a patient a difficult limb I think that's where osteointegration needs to come into play.
Speaker 3:We spend a lot of times throughout our career as prosthetists. We talk about different type of suspension systems or we talk about different type of knees or different type of feet and the benefits and the trade-off for each one of those, and I think a socketless approach, meaning osteointegration, is just another tool to be able to sit down with the patients and discuss the pros and the cons of that. With that said, I think there's several centers throughout the United States that do osseointegration and one of the prerequisites is that a patient has tried a traditional socket prior to being considered for osseointegration and that's not 100% across the board. There's certain times that trying the traditional socket may actually do more harm to the patient than not, and so osseointegration does, in certain situations, become a direct path of care, but normally it's going to be. They've had experience with a socket, but it could be volume fluctuations, it could be lack of control with the socket, it could be difficult with Don and Dauphine, it could be perspiration, it could be difficult with donandophene, it could be perspiration, it could be scar tissue, numerous different things that a socket can be managed somewhat, but it still has a drawback and has an impact on a patient's day-to-day life that just doesn't go away.
Speaker 3:And I think that's where osteointegration becomes a tool or something to be discussed with these patients, becomes a tool or something to be discussed with these patients. What can we do to be able to give you, you know a higher level of activity as the technology is involved? I think impact on folks suffering different levels of limb loss is. It can be even more impactful If we talk about transferable amputees, and that's an area where they can greatly oh, one second there. That's an area where they can benefit pretty substantially as well as patients that like a transhuman amputeutee. It's hugely impactful from that standpoint for them to be able to have some benefits from it and okay.
Speaker 2:And are there people where it's like, okay, you should actually not do this, like okay, apart from just being uninformed? Are they just like is it like just certain conditions or certain scenarios where you're like yeah, you should probably not stray away from this or stray away from?
Speaker 3:this Sure Right now. Diabetics is a contraindication, especially if it's a poorly controlled diabetic. That's an aspect where the risk of healing are a little bit too complicated. Risk of healing are a little bit too complicated.
Speaker 2:Also, if a patient has you know a long history of infection, that's going to be another consideration to where they may not consider that Okay, and then so, like, just from a technical point of view, we're trying to, you know, essentially like join the yeah, the, the yeah, the prosthesis with the bone, right, I mean at the procedure itself, that could be quite impactful, I'm guessing, right? I mean, is the recovery time very long? Is it, like you know? Is you know other type of things that you have to kind of like say, okay, you're going to need 12, one months, or you're going to. You know what kind of like thing am I looking at at the beginning of this process?
Speaker 3:Sure For our implant. Uh, it's a basically a two-stage surgery. So the recovery time for that um is actually a roughly about three months in between the two um surgeries. Um after the second surgery, roughly about three weeks after that, they're going to begin the weight bearing process and um. At that point, once they're through the weight bearing process, which takes roughly four to six weeks, then they're going to be given the okay to get back into their full length prosthesis. So um, short answer is or looking roughly about six months, um, but part of that six months are they are actively um utilizing um, you know, their prosthesis and getting back toward the ambulation levels they were at before.
Speaker 1:So that's after the bone. So so, essentially, you have the prosthesis that's set inside the bone, you cover that back up and then you're off to the races in your current prosthesis. While you're healing, everything's uh going. And then you uncover it's similar to the stuff that goes on in your mouth right, and then a little bit later you you open it up and then put the percutaneous part in correct.
Speaker 3:So, um, our implant actually originated from a dental implant, so you're you're right on base as far as that goes. The one thing you don't always go back into your prosthesis in between stage one and stage two because it's a relatively short timeframe, so they're usually ready. Once they're ready for the second surgery is about the same time that they're healed up, so they wouldn't always go back into a prosthesis at that time.
Speaker 1:What is the feedback that the patients have that say that are longtime wearers of a prosthesis and then they go into something like the osteointegration or the Oprah implant? What is the most surprising thing to them?
Speaker 3:um, I would say down the road. One of the most surprising things that we've seen is, uh, the patient's um, feeling of the osseopreception, um, and so what that is is pretty fascinating in that how much sensation a patient can get through, basically the response of their bone and vibrations in the bone, so their awareness of where their foot is in space, the placement of their foot, the type of surfaces that they're walking on, how different prosthetic componentry feels, even just alignment of their prosthesis itself and the changes that the prosthesis is doing to the patients. They can really give you some very, very accurate and immediate feedback and response in terms of what's working and what isn't working. I think the ease of dying and adopting and how much more a part of their everyday activities that they feel connected to their prosthesis. And it's overly simplistic to say, well, yeah, they're connected to the prosthesis because it's attached to the bone, but connection in terms of their prosthesis doing exactly what they want it to do.
Speaker 3:And then also from a lifestyle standpoint, one of the stories that my wife would tell folks she was getting ready to go into the courthouse. She had a suction socket. Her leg wasn't on quite right, so she took her suction valve out, took her prosthesis off and she's trying to get everything rearranged in the parking garage outside of the courthouse. And you know, to be able to get an above-knee socket on, she had to pull her pants down part ways and she's trying to figure this out. And before she realized it, there was an audience looking at what was this woman doing, halfway undressed in the middle of a parking garage, and that's where she said you know what the heck with this? I don't want this headache anymore. I'm ready to go through osseointegration. So that's a lot of different aspects of that answer, but I think probably the biggest thing is just how much more natural it feels with osseointegration.
Speaker 1:And can you jump into a little bit of the clinical side of things? Right, I've never fit one myself. I've seen a few just around shows essentially, but I've never been say in the room with that what are some things that you have to look at as a clinician when you're looking at aligning some of these devices?
Speaker 3:So, yeah, before we get into that, brent, I think one aspect of it is, when you have a patient that's undergoing osteointegration, realize that you're on board with their journey. They're looking at you as their prosthetist, as an expertise. We talked about at the beginning of our talk how, you know, valuable and important that relationship was and just the consistent interaction you have, you know, with that amputee and so you as a prosthetist, when the patient starts to consider osteointegration, they're going to want your feedback and they're going to want to, you know, look for you for that vote of confidence and some of the guidance along that route. And so one of the things that I do in my current role is I ensure that when a patient is coming in the clinic whether it's, you know, the numerous clinics that I interface with throughout the East Coast is that that prosthetist is part of that journey, is that that prosthetist is part of that journey. And so it's my job to let the prosthetist know that. You know I'm going to train them and support them and teach them about you know how to help their patient through this. But there also doesn't mean that you lose that patient relationship because they're still going to need you even if you're not making a socket.
Speaker 3:So more to the point of your question, alignment I think it really comes into those small alignment changes that you know the patient may or may not appreciate. We're really left up to the eyes of a skilled clinician to be able to see where we're improving their gait. Well, now you've got a new partner in that scenario, because they're going to give you so much more quality feedback in terms of what an ideal alignment feels like to them and how well a different componentry is working. So I find that I would spend a lot more time on the stool in the parallel bars or out in the gym watching a patient walk and making those changes and knowing how to make those changes, but also being ready for what that feedback was from the patient, because it does take some more time to alignment.
Speaker 3:Even if a patient's experienced some discomfort, it's usually going to be based on the performance of the prosthetic componentry or the alignment of that prosthesis that's going to be responsible for it. So I think our time and understanding of what the component to alignment looks like becomes vitally important, which, again, that's one of the higher level skill sets that clinicians bring to the table, and the time of you know the patient's prosthetic visit being while we're in the back lab gluing pads or heating and flaring. You know that's really of no value to the patient because we're not having that direct interaction, in fact because it might make them more comfortable, but it's downtime for them. Now it's a lot more directly working with the patient.
Speaker 1:So would you say, alignment, as far as with the bone implant, it truly is what helps them walk the best and, whatever that alignment is, that implant is good with it, for sure, for sure. Okay, so there's not like a bench alignment, or don't go this far past a certain weight line, or too much flexion, or too much anterior, you know, or posterior of the knee, uh, any of that. It's just truly, how do we get symmetry, how do we get them walking the best? And I know that's simplifying it because it's a lot harder than that, but that's what we're looking at no, it is, and again we're doing doing.
Speaker 3:Physical therapists use the term open chain versus closed chain, and now we're truly closed chain because you do have a direct attachment to the bone. So the efficiency that you're able to utilize the muscles in the residual limb is so much greatly enhanced. And in doing that I encourage all prosthetists when they have an OI patient it's not like hey, let me know if you have any problems. They're going to get better, they're going to get stronger. Their muscles are going to develop more and when they do that we need to spend a little bit of time kind of tweaking and fine-tuning. We keep using the word alignment, but really this is the performance of their prosthesis. To kind of match what they're able to do is pretty fascinating.
Speaker 2:And what's the most gratifying thing with the work you do? Now it's very different, but what's the great bit now? Is it that matchmaking kind of thing?
Speaker 3:It's a good question. I think it's the matchmaking thing, but I would say just being able to really be at the forefront of the prosthetic industry, and I really do feel that osteointegration is going to play a huge role in the future care of that. Some of the things that I've seen develop is not just the surgical techniques of how to do a bone anchored prosthesis, but what's the next level that we can take. So when we talk about a myoelectric prosthesis, being able to have electrodes that are implanted within the muscle and the connection point can actually run through that bone, through that metal attachment, so now we have a direct connection to the prosthetic devices and so the amount of control is so greatly enhanced by the patient. It's just, it's truly fascinating in terms of how, how natural we can have someone suffer limb loss, be able to move, be able to place a terminal device, if we're talking about upper extremity prosthetics, just the amount of control and and being at the forefront of that and kind of bringing patients along with that journey is so so rewarding.
Speaker 1:I think the other interesting thing that you just kind of expressed a little bit, but I'd love for you to dive into it a little bit deeper is there's a lot of focus on the quality of the surgery with. This is super, super important. Focus on the quality of the surgery with this is super, super important, whereas there hasn't been a focus historically on prosthetic amputation and the quality of it. Can you speak to that a little bit Like what are they doing different as far as muscles, say, the IT band, all that stuff that people are going to argue all the time on which way you need to do it in a traditional amputation? How does osteointegration help some of that and then put some of the onus back on the surgeon for a good outcome?
Speaker 3:Yeah, it really does, and I think there's two answers to that question, brian, or that comment. I think the centers that I work at not every patient that comes in there ends up walking away with osseointegration, but because the surgeons are so invested in the amputee population, because they really have to be able to be approved by our company or be able to set up an osteoimmunization clinic, that they really become a go-to expert in amputee care. And I think historically, so many times amputees were really seen as a failure or the surgeon saw it as well I couldn't save the limb, so I had to do an amputation almost kind of a disappointment. Where now I think orthopedic surgeons and plastic surgeons that are involved in osteointegration, they have really developed an interest in the amputee population and realizing how impactful their techniques and their skill set can be to this patient population a TMR or a nerve addressing a nerve problem, or addressing a soft tissue problem, shaving a bone in a certain manner, because they've seen what works in a socket and they've seen what doesn't work in a socket. So really they become, you know, centers of excellence for amputee care and I would encourage patients that if they, even if they're not considering osseointegration at this time. If there's a surgeon that is doing osseointegration and they're having problems with a traditional socket, they may be a really good resource to go to for some fairly simple fixes that could enhance their overall prosthetic experience. As far as osteointegration, the teams that I see most successful are typically made up of an orthopedic surgeon as well as a plastic surgeon. And one caveat to that a lot of orthopedic surgeons have done fellowships in plastics and it's kind of developed a new specialty called orthoplastics and I think that's a. You know, someone with that amount of experience is excellent for osteointegration but also excellent for prosthetic care in general, because they see the blend of how the bone and the soft tissue is going to interact together.
Speaker 3:One of the things that our company prides itself on is the penetration site, or where the attachment of the bone and the skin is. The skin in our implant is actually scarred down to the end of the bone and the abutment, the piece of metal that the prosthesis attaches to, is actually in a fixture that's well within the bone. So our penetration site doesn't have it's technically a metal sticking out of the skin, but the skin is so securely scarred down to the bone and that's anatomy to anatomy. So from a surgical technique, I think that that's critically important for reduction of infections down the road. Also, debulking and shaping the limb appropriately so there's not a that they're getting into the bone itself, and how secure that implant is. So you know a highly skilled orthopedic surgeon from that standpoint.
Speaker 3:And then the last aspect of it that I think is critically important and we spoke to in the beginning is really that physician's capability and willingness to interface with the team.
Speaker 3:I know at Atrium in Charlotte, where I live, I still participate in their OI clinic calls once a month where every single team member prosthetist, nutritionist, psychologist, physical therapist all have an active discussion on each patient and how they're doing and the physician is kind of the team lead on that and he's processing that feedback, making sure that patient can get in with the various professionals if they need to and that there's no problems that kind of creep up that we're not aware of and are not able to address. When the team lead for the hospital in Charlotte sat down with a group of fellows he said look, if you're interested in osteointegration, you need to understand that this is a patient population that's going to need you to be invested, need to be responsive, because these are patients that long after the surgery, they're still going to come back to you with questions and concerns, and you need to be willing and dedicated to be able to answer those, and so I think that's another characteristic that the surgeons you know. It's vitally important to assess an outcome of this.
Speaker 1:Wow, I can see why you're get excited about this. I mean, sounds like a dream come true. You have all those people available to a as an option. Um for sure, and I I love that.
Speaker 2:It's pretty exciting yeah, I can imagine it's really exciting to again. Yeah, I agree with the brand. You, michael's, want that interdisciplinary approach, which is super absent from other areas of prosthetic care. Right, everybody's on a little island like, oh, okay, and now all of a sudden, the idea of getting everybody who's relevant, like the nutritionist, I think is brilliant. We always hear from people like that weight loss and gain is an issue and stuff like this. And just having all those people working on the same patient with the same challenge at the same moment, I think is absolutely fantastic.
Speaker 3:And you know I was exposed to that in my wife's journey with cancer. In my wife's journey with cancer, the different institutes we would go to and very much an oncology team is going to pull that into the same framework and that's one of the parallels that I've seen. In fact, dr Brandemark, when he goes and looks at different centers, the oncology orthopedist many times the team leads for it because they're used to that. And again I go back to when I work with the different centers. They truly need to understand this is an osteoimmigration program. It's not an osteoimmigration procedure because so much of the success is downstream how the patient goes through that recovery process after factor are supported and all the different aspects of it.
Speaker 1:I do have another question. I feel like there are some myths around osseonegration that probably get perpetuated by prosthetists that think that you know it's coming for their jobs or whatever, or other people. What are some of the like crazier myths that you've heard that you could just say it ain't true?
Speaker 3:yeah so I'll speak from from two angles of that brent. For first, medically and it was one of the things that we looked at was like my wife had a fairly long residual limb and when I look at other patients in there're going this gosh, if I get infected, I see where the metal ends. Now I'm going to go from, you know, a long to mid-length AK to a very, very short AK, and I think that's a big myth. Our the reason that our implant was chosen by Walter Reed as part of their initial study is because each implant comes with a specialized drill bit that can remove the threads of that implant so it can be extracted and the patient doesn't lose any additional bone length at all when that extraction occurs and essentially, if they wanted to, they could go back into a traditional socket just the way they were prior to having the implant done. Is there a risk of them losing additional bone? There is, but it's actually very, very low because the undo factor of that is fairly straightforward and it's something that can be done without losing additional bone length. Without losing additional bone length.
Speaker 3:The interesting thing is I have seen a few cases that patients did, you know, make some bad life choices. They did let an infection go too long before talking to their surgeon and the implant did have to be removed and every single case that I've seen that happen, the patient said I'm willing to rededicate myself, make sure this doesn't happen again. How soon can I be re-implanted, because it made such a difference in my life? So I found that to be really, really interesting In terms of drainage and opening and the stoma. Is it a little unusual to see a piece of metal sticking out of a leg? It is, but again, I think when the surgery technique is done properly, it's a very clean penetration site. There's not a lot of drainage, if any drainage at all, and the patient's limb is overall very healthy. Once they've gone through recovery process, you did speak to like oh gosh, the prostate is going to lose their job.
Speaker 3:And you know, brenton, you and I were, you know, shoulder to shoulder back in the lab for several years and it's great when we have that really difficult patient and they come to us because they heard. You know we're the problem solver. We can, you know, handle these difficult, challenging patients Well. A lot of times that results in a lot of different test sockets, a lot of time with the patient and all that time that we spend with these very difficult, challenging patients isn't necessarily a time that can be reimbursed.
Speaker 3:You know, our business model is based on a device and a device only, and when you look at a lot of the patients that are appropriate for ICU integration, it's the patients that, if you really looked at it from a business perspective, we spent a lot of unpaid time with these patients and the patients also spent a lot of time in our labs and in our facilities. That were time away from their family, a time away from their jobs, and a positive integration can solve a lot of those problems. From a financial standpoint, it's much more financially beneficial for the patient because they're not spending downtime in our prosthetic labs and as prosthetists, we're also not spending so much time making multiple test sockets, multiple revisions, redoing things that we know that the margins in our industry are not that great that we can go upside down pretty quickly if we experiences of prosthetists that you've got to look at this as not, oh, I'm going to lose all the revenue for making the different sockets when in reality you're doing better for the patient and you're also spending your time much more effectively.
Speaker 1:Can you speak to who's paying for this? That always seems to come up right. Do insurance companies pay for it? You got to pay out of pocket. Only veterans are getting it. What is the truth?
Speaker 3:Most insurance carriers now have been paying for it. With our implant being FDA approved for the transfemoral it's a full PMA FDA approval so the insurance companies can't deny osseointegration with our implant saying it's experimental. You don't get PMA FDA approval for an experimental procedure, so insurance companies that doesn't mean they might not try to deny it doesn't mean that we might have to battle just like we do with other technologies, but generally speaking, the approval for that. Once they have the approval for the surgery, the downline approvals tend to go fairly easily for it. So most of the major payers, including Medicare, do pay for ICU integration.
Speaker 1:Now and how would you suggest? If there's a prosthetist listening to you and hearing some of the benefits, right, and I have a patient, that just kind of pops to mind that I think it would be very interesting, but I've never brought the subject up with him. Um, is that something that's appropriate? I mean, to me you want to educate your patient and say, hey, yes, you can have a prosthesis happy to help you with that. Have you looked at, also considered, other options? What? How do you approach that? And then what would be the next step? To be like okay, how do I connect somebody that knows something about this so they can start their journey?
Speaker 3:on evaluation of the technology, Sure, and I think you know much the way that I talked about before Brent is, you know, I think OSgration is another tool that we have in our tool chest is prosthesis. So I think being informed on that and discussing with the patient hey, these are some of the challenges we have with your socket, these are some of the challenges that may or may not be eliminated by osseointegration. Let's explore it a little bit further. So I think that's where the discussion starts. The second aspect of it is getting in contact with a osteointegration center that can sit down and do an evaluation on a team and properly educate that patient in terms of you know what would be the benefits and challenges undergoing that, undergoing that and you know that.
Speaker 3:And then my role, you know, with Integra was exactly that sit down with a prosthetist, a patient prosthetist, and kind of discuss the pros and cons and then plug them into the appropriate center that may be geographically best for them, maybe based on some of the unique challenges they have, you know might be geared toward their surgeons or the OI surgeon specialties to be able to address some of their needs. So I think that would be the next step to be able to and what I always tell patients is you know, sitting down a physician doesn't mean they're going to do surgery for you? And the osteonegration teams that I interface with, again, their goal is not to talk everybody into osteonegation surgery, it's to understand what the challenge is and present to the patient what their possible solutions could be.
Speaker 1:Awesome.
Speaker 2:All right. So thank you so much, Mike, for this fascinating story. Thank you so much for your time today.
Speaker 3:Absolutely fun guys. I appreciate you guys having me on and uh like said, it's uh gonna be cool to see where things go for us perfect and thanks, uh, yeah, thanks as always, to you as well, brent oh, this is, this is great.
Speaker 1:and uh, yeah, I appreciate mike just kind of opening the the door and, uh, you know, lifting the veil on something that probably we don't have enough education. I know we don't have enough education and I hope that the listeners will feel more comfortable asking the right questions and knowing where to go after listening to this. I think this was great.
Speaker 3:Fantastic. Well, it was great catching up Brent and I hope to catch up face-to-face here shortly.
Speaker 2:All right. Thank you everyone for listening as well. This is another edition of the Prosthetics and Orthotics Podcast with Brent Rodney RSVS. Have a great day, thank you.