If you were here yesterday, you got to see an outstanding day of arthroscopy, smaller incisions and minimally invasive surgery. Today we're excited to bring in the other MIS, maximally invasive surgery. And so we have a panel of five esteemed arthroplasty surgeons. And then the rest of the meeting looks outstanding. Casey and Daniel have done a great job. Congratulations to Ken and Mac from yesterday. This morning, we'll start off with Bruce Sanjorsen from Seattle. And he's going to talk about what's your speech, total ankle arthroplasty versus fusion. Bruce. Okay. Good morning. So the topic assigned is what do you tell patients when they're coming to you for end stage ankle arthritis? I don't have any financial conflict of interest. So it's pretty simple answer that I do multiple times every day in clinic. One there's alternatives to surgery. We can inject, we can brace, we can change the diet, we can lose weight, we can take anti-inflammatory medications. All those things can be done and should be done because you want to wait until that ankle's really completely gone. And before ablating it with a fusion or replacement, also consider realignment if it's crooked and chiolectomy because those can buy you some time too. When you get there to end stage ankle arthritis, it is simple to say that the treatments are very effective. Both ankle replacement and ankle arthrodesis result in a clinically significant reduction in pain and inpatient reported outcomes. Both ankle fusion and ankle replacement are effective, but there are better outcomes and greater pain relief from replacement in the four to six year timeframe. And ankle replacement patients recover faster than ankle fusion patients do. And once upon a time, there was a difference in risk in adverse events with a higher number in the total ankle group, but that's no longer true. So how can I say that? It's a 15 year story, but basically back in 2002, we tried to discern what patients with ankle arthritis found important. So we tried to identify the functional impact of ankle arthritis. This was a study done way, way back in the day from the AOFAS Outcomes Committee, where we report on the issues of importance to patients seeking care from members of the AOFAS. It was done with an open-ended priority function questionnaire, which was administered to 235 patients presenting with foot and ankle arthritis, and it was designed to mimic the activities and importance that were discovered in the MacTAR. It's interesting that we're in Eastern Canada because that's where the MacTAR came from. And they identified walking, running, standing, and exercise as the key things that were impacted by the foot and ankle arthritis. Once we knew what they found important, we tried to identify a patient report outcome measure that covered those areas, and at a high ceiling, and was responsive to care. If you're going to compare two treatments that both work, you need to have a responsive outcome measure if you're going to find a difference between them. And finally, we directly measured physical activity in the patients who were having treatment. We then undertook a series of clinical trials with independent oversight, comparing treatment before and after in both treatment groups. So the process of identifying outcome measures was reported in this reliability study that was in the Foot and Ankle Journal, again from the Outcomes Committee. And we knew that FFI and AOS are not well-matched because of the low ceiling and the lack of functional markers in it. And we knew that the AOFAS was not reproducible and had a Monte Carlo effect and a number of other shortcomings that made it a not excellent outcome measure. We identified three different measures, two of them were the MFA and the FAM, which are valid, are reproducible, and are sensitive and measure functional activities. And then we set out to measure patients in a laboratory and in a real-world setting using a gait lab, force plates, the usual biomechanical stuff, and wearable technology that would actually track the level of activity. And we used the MFA to determine the impact of ankle osteoarthritis compared to a control group and patients who had had severe lower extremity fractures and found that the OA was actually more impactful than hip arthritis in some ways, including fine motor job function, probably because it's a younger population, and in housework, but that's probably because it's primarily men who get post-traumatic ankle arthritis. So then we measured physical activity, and patients wore a step watch activity monitor for two weeks before their treatment, and then wore that monitor again at six months, one year, two years, and three years after surgery. And in general, patients with end-stage ankle arthritis have pretty easy summary. They walk less, they walk slower, they take fewer steps, and have much reduced intensity of steps, which is basically the number of steps you take in a finite time period. We then started a couple of prospective trials. The first was purely observational, and it started as a one institution and expanded to a multi-institution. And critically, and maybe this was a mistake, we left patients out of the trial who were not candidates for arthroplasty because we wanted to compare apples to apples. So people with severe scarring or missing tissue who we did not think were candidates for arthroplasty were not included in any of the studies. Similarly, a history of poor healing, and those patients were excluded as well. We did include patients 18 to 85 with single limb disease, and no inflammatory arthritis or other diseases that would impact the outcome scores. They had to be appropriate for each, they had to be English speaking to match the validity of the outcome measures. These are other things that we kept out, anything basically that would negatively impact patient reported outcome were left out of the studies. We also set a bar for the surgeons, they had to be five years out of residency, they had to have completed a five year residency, they had to have experience with 100 weight bearing arthroplasty procedures, hips and knees included, so that they would understand the concepts of arthroplasty. And they had to have done a minimum of 30 ankle replacements and 30 ankle fusions. And we also excluded any new implant that they were doing, the first 10 could not be in the trial, because we didn't want to measure their experience, we wanted to measure the outcome. And we had to guarantee that all patients entered into the study would be measured in the following years. When we started the trial, there weren't a lot of options for ankle implants, there was agility, salto, and the in bone came in at the end of the first trial. And people did the fusions by whatever technique they had learned. So the first report outcome was this paper from the Journal of Bone and Joint Surgery, dated in 2016, and we compared treatment outcomes of arthrodesis and first generation, meaning the agility, and second generation, primarily saltos mixed with some in bones. And we had 273 patients in that group, and 103 had a fusion and 170 had an ankle replacement. The mean improvement in the MFA and the SF36 over the three year period were significantly better after ankle replacement than after ankle arthrodesis. And the difference between the two groups were slightly greater when the newer TAR devices were compared rather than the agilities. How about effectiveness and safety in a bigger group? So we expanded that to an NIH trial that was supposed to be a randomized trial. Unfortunately, about 2% of patients were willing to be randomized, so it turned into an observation study, and in that study we enrolled 517 subjects at eight different hospitals. And we completed, for this study, a baseline assessment and an assessment at six months, 12 months, and 24 months, and found the mean improvement mirrored what it was in the first trial and that the incidence of risks was the same in both groups. And at the two year follow-up, both total ankle and ankle arthrodesis were very effective treatments with improvement in patient pain and patient reported outcome without differences in the rates of revision and complication. We reported the complications separately and just to make it short, this was an NIH trial, so all the patients were monitored by an independent party. Everything was reported as an adverse event, fever, lung cancer, diarrhea, everything got on the list, so we couldn't miss anything. There were 628 reported adverse events, 50 of them related to the ankle, and again we found a small increase in the adverse events in the arthrodesis group, but that washed out after adjustment for the comorbidities. So we know that there's a little bit of a favor toward the arthroplasty with not much in the way of risk. What about recovery afterwards? I was convinced ankle arthrodesis was going to be the faster to recovery and found myself quite wrong. Using a step activity monitor, we again measured the steps they took for a two week period before surgery at 6 months, 12 months, 24 months, and 36 months, and found that the people who had arthroplasty were actually walking more with a greater number of steps and a higher intensity than the ankle arthrodesis group. That difference held on through two years, but by three years was not significantly different. The mean step activity is reported here, you see the two groups were similarly walking with the arthrodesis group a little bit more active, but at 6 months the arthrodesis group had not returned to their baseline step activity and really didn't until two years after, whereas the arthroplasty group had already increased activity at 6 months. We followed the same group for another couple of years and reported these just a couple of years ago, the same patients in the 517 group. We only followed about 87% of them, but the score stayed. The pain was better in the arthroplasty group and the patient reported outcome was better. These are two different data sets, but they were both flawed because they weren't prospectively randomized and I'm hoping Dr. Goldberg can fill us in on what a real prospective randomized trial will tell us. We got everything we wanted out of these except the randomization, we used whatever prosthesis happened to be there and we found that pain was better in the arthroplasty group and that stayed active until three years. So statistically based improvement in both groups, patients with newer implants have better improvements, younger patients do better than older patients, neither BMI or mental health is related to outcome. Thank you. Thank you. Thank you, Bruce. Next we have Konstantin Dimitrakopoulos from New York and he's going to talk about working up the painful total ankle. Konstantin. Okay, thank you. These are my disclosures. More important than these disclosures is this disclosure. This is the work of Jensen Henry one of our former fellows now new partners at HSS Joining us to do ankle arthritis and ankle replacement and I I Simply provided the the patients with pain for the talk. So in Thinking about a systematic approach of evaluating patients with pain who have an ankle replacement We created this flowchart So everything is in this flowchart now, we don't have time to go over the entire Thing in ten minutes, so we'll focus on the three factors that I was asked to talk about So when you're looking at a patient who has pain, this is somebody who had an ankle replacement two years prior to presenting You can see that there's sclerotic changes in the distal tibia the tibial components a little bit in valgus The first question that comes to mind you see periosteal reaction on the lateral x-ray the first thing that comes to mind is And should always be is it infected and an infection workup is key to any Reoperation or revision and ankle replacement So we all know how to work up a possible infection. You'll obtain blood work CRP ESR white blood cell count a synovial alpha defense and can be helpful Has been shown to be quite sensitive With still good specificity It's important to as best as you can ascertain the timing of the symptoms How long have the symptoms been present because that may affect the overall outcome? in the management and In considering joint aspiration, I always favor it, but I also do not believe in lavage So if there's fluid in the joint, I will sample it and if there isn't I believe that lavage is too flawed of a technique So there are some criteria, this is the musculoskeletal Infection Society criteria Well, if you have positive cultures the things infected, so that's easy enough If there's a sinus tract that communicates with a joint or if you can see the joint through the skin Well that's infected. So that's easy enough But usually it's not so simple. It's a little more Subtle and so you they've put out these criteria that's used another joints And I use it for ankles Now infection can happen and it varies I'll tell you infections never 0% but it varies from 0 to about 5% and we consider acute infection as Usually within two weeks of a symptom onset you could expand that to four weeks, but it's really Symptom onset within two weeks present to you for management. That's an acute infection Not necessarily with regards to the timing of the surgery And a chronic infection is something that's been perhaps more indolent going on for longer period of time so for acute infections, there is a role for irrigation debris and polyethylene exchange and an attempt at implant retention and In our hospital, we also believe in chronic suppression though. The data is not in any way conclusive For chronic infections, we favor a two-stage revision and studies support this To explant use a cement spacer with antibiotics and then to reimplant So how do patients with acute infection do? well, the two biggest factors are timing from onset to management and the type of bacteria so a shorter period of time of symptoms before management is Favorable as is a less virulent organism. So in this study They had a long-term failure rate of 54% So more than half the time it doesn't work. This mirrors the data of hip and knee replacement. So we shouldn't be so surprised But the two factors were the type of organism and length of symptoms So we want to get to these patients as quickly as we can now chronic infection is more challenging as you can imagine and Overall in infection, there's very little literature So I encourage you if you have patients if you have a series We really need more literature on the management of the infected total ankle But in this paper of 15 chronic infections, you can see that some were revised most of them were fused or on or had a Permanent cement spacer and the incidence of bologna amputation in this very small series was not insignificant So The other interesting factor is that for patients who do have a staged revision where you explant You use a cement spacer you treat them. It doesn't seem that Reinfection tends to be a problem. So it seems like clearing the infection becomes a problem, but it may be that they Reconstruction is a problem The other finding from this meta-analysis is that we're not very good at reporting non-infection complications When we are writing infection papers So we should be better. So what that happened with this patient this patient had a two-stage revision with a cement spacer Once the infection cleared the patient could be reconstructed with a stemmed implant All right. So if it's infected you'll treat the infection if it's acute you'll try to retain the implant if it's chronic You'll do a two-stage revision. How do you decide between a revision implant or a fusion? Well, dr. Easley may touch on that but I would say it's really dependent on available bone Now what if it's not infected? The next question is is it loose or subsided? So here's a patient actually don't look terrible But if you look a little bit closer, you'll see a little bit of lucency around the tibia The tibia is a little bit posterior. There's bone overgrowth anteriorly. The talus is sitting a little bit low So your suspicion for subsidence should be high in this patient How do you confirm subsidence? Well, you can use advanced imaging. This is a spec CT We did a study looking at spec CT that found that it correlated Reasonably well with our intraoperative findings. Sometimes it's hard to know if it's micro motion Is it subsided a little bit? Is it really gutter impingement? So it's never so clear But in our study, we found that there was reasonable correlation spec CT findings to intraoperative findings But MRI can also be helpful But it's not just any MRI So this was a study by loose shown that looked at a very specific sequence a turbo spin echo That showed that you can minimize the artifact from the implant to look at that bone metal interface And you can be more accurate in your findings on the MRI when you do so we published a similar study And we use a hyper maverick sequence Which is a way better name, obviously, so it has to be better But you ultimately when you get an MRI and an ankle replacement You want to refer it to somebody who has experience whether a radiology department or radiologist that has experience with artifact? Subtraction metal artifact subtraction because that is key to being able to see Now we know subsidence is a common complication. This is Glaze Brooks article from 2009 Happens about 10% of the time and that's really reflected in a lot of the literature over a thousand ankle replacements more than 10% revised due to loosening 3 over 300 integrous 20% revision rate more than half due to loosening. So loosening is remains a problem with ankle replacement. So the suspicion has to be high What are the risk factors for subsidence? This was a great paper by one of my partners when she was a fellow at Duke Looked at over 500 replacements and they found two independent risk factors One was associated hind foot fusion either prior or concomitant which I think we can all agree changes the mechanics of the ankle in the hind foot and there could be an association with implant type here in this implant a More a saddle shaped Taylor component with a single point of fixation May not be as stable as having more than one point of fixation or having more constraint at the articulation So there could be something to implant type could be something to associated procedures Similarly The the Duke group also published a randomized controlled trial. That's our highest level of evidence and They found that Taylor subsidence Can be a problem in Taylor components that are more chamfered that take more volume of bone away And that has led most of us many of us to favor lower profile Taylor components that preserve bone So What can we learn from this? It's hard because you can't just analyze one implant versus another versus another it's difficult to know So there may be some answers in computer modeling and finite element analysis and this was a study that showed that implant micro motion is affected by design and positioning so the implant and the surgeon and that having more than one point of fixation or really having Rotational control is important for these ankles The other is that while malposition can be a problem Having the implant fully seated on bone may be the most important factor. So having that contact throughout the implant Interface is important. So what do we do for this patient? Well, if you have a subsided implant, you can certainly revise it with more robust fixation So can it simply hurt can it just hurt is there unexplained pain? Well, there might be unexplained pain, but if you can't seem to find a reason don't forget about gutter impingement Now here's a patient I did in 2018. I thought the x-rays look great. Maybe it's in a little bit of varus Maybe the tibia is a little bit lateral, but the implant was well fixed I mean I obtain a spec CT and there's activity in the gutters And what I say is nothing ruins a good ankle replacement like gutter impingement. What are the factors? It could be implant type mobile bearing has less constraint so it can slide and impinge on the medial malleolus or the fibula Overstuffing the joints particularly oversizing the talus or undersizing the poly you want to distract the joint to open up the gutters malpositioning the implant various valgus or more importantly in rotation can cause gutter impingement and Of course inadequate to breed men at the time of surgery. We've gotten better at Lowering our incidence of gutter impingement post-operatively as we've become more aware of this condition and I Would say that currently what I tell my patients it is it's about a five to ten percent incidence of gutter impingement post-operatively gutter Debridement is effective and I favor open debridement My thought process is that if I had the ankle open at the time of surgery and I debrided it and they still got gutter Impingement I should probably go back in an open fashion to debrided so you can do it as a separate arthrotomy in this case You can see here an antral medial arthrotomy This was a an ankle that was performed through a lateral approach So it's a separate incision or you can certainly reopen the anterior ankle incision And perform a gutter debridement both on the medial and lateral sides So in conclusion number one rule out infection if acute Explain to the patient the risks of implant retention if chronic to a two-stage revision is a looser subsided Serial x-ray is probably the most helpful Followed by advanced imaging look for change in alignment and don't forget about gutter impingement Be aggressive at the time of surgery and be mindful of rotation at the time of implantation. Thank you Thank You Constantine So next we're gonna try and figure out what to do with these Lucencies and cysts that we see sometimes around the ankle arthroplasty Steve had ad from Chicago is going to talk about osteology without slides, Mark, you know that. So, I do have some disclosures, I do work with Stryker and ankle replacement design, but I can tell you that this talk really is independent of that work and nothing here that I'm going to present is corporate funded. So, the enigma of total ankle arthroplasty is real because we're sort of littered with myths and chest-thumping ideology encapsulated in a world of self-marketing paranoia. Solid evidence be damned. I weigh my weight, bear my patients right to the recovery room. Some people say that. Some people say I've never performed an ankle replacement that became infected, but I've seen plenty from others. Ligaments are unnecessary. Anything could be tensioned. I've never seen osteolysis in ankle replacements I've performed. So, I take advice from my 18-year-old son who tells me, facts, dad, and we will try to work through some facts here. First being the material. We recognize that ultra-high molecular weight polyethylene is a subset of thermoplastic polyethylene and it's the most common plastic used today in primarily in packaging. The ultra-high molecular mode itself is extremely long chains of plastic that can provide better transfer of load, increasing toughness, and better impact strength. So, under tensile load, of course, it still deforms in the mode of creep. So, what's medical plastic? Well, it's been clinically used since 1962 by Sir John Charley emerging as the dominant bearing material for total hip and knee arthroplasty in the 1970s. But there have been modifications over the years by other companies to try to make polyethylene more durable. In the 1970s, Zimmer blended carbon fiber with their plastic, but they found overall they did generate inferior performance and that was abandoned. In 1980s, those of you old enough to know, hyalumer by Depew was gamma-irradiated in air, but it was susceptible to oxidation, again, leading to inferior results because of the free radicals developed. And of course, later in this talk, we'll talk about highly cross-linked polyethylene to go through that component. It's also important to note that plastic isn't a static structure. It does erodes faster than global warming taking out the glaciers. Ultra-high molecular weight polyethylene does wear through mechanical impact through that device itself. But the point of the wear particles are that size matters here, that anything greater than about seven microns or so really doesn't have much of a response. And in fact, if you have larger particles, then you're theoretically safer in what you're generating. In addition, the morphology matters. If you have roughened particles that have a more fibular surface to them, they also evoke a greater response in the world of polyethylene than smoother, more granular particles. It's been compared before to total hip arthroplasty or total knee arthroplasty. This study by Charlie Saltzman group took synovial fluid looking for polyethylene particles in both well-functioning total ankle and total knee arthroplasty patients. This group found that between this, the particle size was actually almost identical, as was the concentration. In fact, the size itself and the total ankles were more round than those seen in the total knee, which theoretically should elicit less of a response to the plastic than what you might see. However, the long-term results like we expect then to be similar to total knee arthroplasty simply doesn't bear out in the world of total ankle arthroplasty. They're not similar. In fact, if you look at this study by Paul Fortin's group, he looked at failed agility arthroplasties and demonstrated significant impact to the polyethylene itself by the implant. And in that case, he found third body wear from titanium fragments dislodging into the polyethylene, creating secondary wear patterns to the poly. And he also found that not only was edge loading present, but there were actually imprints into the polyethylene by the prosthesis itself, creating further distortion, deformity and secondary wear patterns. Paul found that the weight-bearing concepts on an ankle replacement itself increase both the contact pressure and yield stress beyond their industrial limits of the plastic. And 7 of 8 had contact pressures greater than that in hip replacement upon that plastic. So polyethylene that was less thick, less than 6 millimeters, the contact stress increases exponentially. So put that in your mind next time you're doing an ankle and thinking about the thickness of the polyethylene that you intend to use. We know the literature doesn't lie. We recognize, in fact, that polyethylene rates of wear patterns to implants or osteolysis is high. This study, 37% at 40 months. This study, 24% osteolytic cysts, large cysts, at 2 years. This study, 35% osteolysis recognized over a 43-month period. And finally, this study, looking at 29% over 7 years, had marked osteolysis. So it happens. And why does it happen? Well, we all don't want to get rankled about this, but we do have to know a little bit of basic science. Accumulation of the polyethylene particles is associated with a marked increase in receptor activator of nuclear factor kappa-ligand, or rankle if you've heard that word. And these little particles get in and they promote osteoclastic differentiation and then secondary osteolysis. So we must feel, then, that that is a particle causing this problem, correct? Well, what if it's not the particles? Other authors have questioned this. Helga Koivu out of Finland looked at AES implants, which was discontinued for high rates of osteolysis, and found that macrophages were certainly frequent in what she saw in the microscopic analysis. But she did find, however, that polyethylene particles were actually scanty. That's the word she used. There weren't many within. The foreign body giant cells were frequent. And so the question then becomes, was peri-implant osteolysis due to early failure caused by a rankle-driven pathway from something different? From banging in your implant aggressively, or mechanical factors, or range of motion creating fluid pressure that leaks into the area between the bone-implant interface and creates secondary osteolytic wear because of it. And there were other ideas, too. This study in 2016 looked at the coating on implants, sampled 71 implants that were revised for osteolysis. And in this case, they looked for calcium deposits. And what these authors recognized that your chances of getting ballooning osteolysis was 300 times greater if your calcium content was greater than .5 milligrams per gram in your periprosthetic tissue. The calcium being not organized in the bone trabecula, it was independent and became a secondary factor in potentially generating osteolysis. So this suggests that hydroxyapatite coating may be a contributor to osteolysis because of it. And what if the cysts were there all along? Andy Goldberg took a look at some patients, 93, looking at preoperative CT imaging and arthritic bone cysts. Andy found that 60% of these patients had cysts not visible on plain radiograph, but visible instead on CT scan imaging. He utilized a PSI system looking for the resection margins of the implant itself and seeing which cysts themselves were taken out by the implant and which were not. He found that of your implants done, 78% of patients had cysts that were retained after removing the implant itself. So he postulated here, is osteolysis simply the expansion of preoperative bone cysts? This is an interesting theory, but it's not been proven because there's no long-term follow-up on these patients to see if that's the case. I believe otherwise. We did this study a while back, Oliver Shipper and I, looking at 57 patients that were grafted for cysts versus controls. The time to grafting, about six years in this population. We chose oil red o-stain, which many studies did not use, which was much more specific for the polyethylene particles. We found that these were ORO positive in 93% of this cohort and birefringent in almost 97%. There was abundant polyethylene in these cysts, both intracellular and extracellular, so we suggest that it's much more likely that implant wear by polyethylene disease or particle disease plays a more significant role. How about locating the cysts when you do suspect one is present? We did a helical CT study back in 2007, looking at average follow-up time of only 23 months, and found a substantial difference, a significant difference in your ability to detect these lesions on CT scan versus plain radiographs. So much so that you're almost required to do a CT scan if you suspect osteolysis. But of course we have some fiction, and the fiction in the fact world is, how do we make a plan to treat osteolysis? Because most plans are subjective. They're based on your own ideas on what you think should happen. The bottom line is, you must gauge your impending implant failure to decide whether bone grafting or revision becomes an important component. And this matters in large cysts like this because you wait years saying, well, the patient's asymptomatic, we don't have to go ahead and graft it, we'll give it some time. But what has been recognized over time that if you wait too long, the implant subsides aggressively like some of the x-rays that Constantine just showed. It's important to note, however, that the grafting has to be meticulous. This is not an operation that's just a simple little thing that you do for patients. You have to treat this seriously and take your time to remove every ounce of residual bone tissue which may have been impacted by the particle disease at the time. If you're not meticulous, you will get recurrence. And this is a tedious operation. It could take upwards of an hour and a half to two hours to just do the simple bone grafting, which you will certainly get sick of. If you do such a good job, by two years, theoretically, you should then have a filled and consolidated cyst. Until you study your CT carefully and recognize that, even with your good work, you may have left some areas untouched because they're behind posts or pegs in an implant, making them almost impossible to reach. This has been studied by a couple of authors. This study here out of Duke suggested that out of 31 patients, that this population had success rate of, in the early phase, at two years, 91%. However, after they followed these patients out further, they found that this dropped 30 percentage points to 61% at four years and then four failures, of course, within. So the question is, bone grafting cyst, does it actually last well over time? And these authors suggested that it did not. It was generally affected. The second study looked at by Helga Koivu again out of Finland and her group looked at 34 ankles. They used CT scans before surgery as well as once per year and found that osteolysis progressed after grafting in 68% of these patients. That's stunning. 71% showed improvement in function, again, not great odds. So I would suggest, perhaps, they didn't do an aggressive grafting in that case. I'd have to discuss that with Helga. So let's look at our final fact, and that, of course, is to stop the crumbling fact. I briefly mentioned highly cross-linked poly in the beginning of this talk, which came about in 1998 involving gamma irradiation or some type of electron beam radiation at the time of sterilization. It was a great idea. It was initially done in an oxygen-free environment to minimize that secondary risk of oxidation that I told you about before. That was a critical element to minimize the generation of free radicals in this patient population. And, in fact, in doing so, they recognized that free radicals do create increased oxidation and increased brittleness of your plastic, causing it to crumble interoperatively, shear or fracture as a part of that reconstructive effort. So ideas came about. Methods to change that with highly cross-linked polyethylene to make it more durable and thermally processed here to improve the oxidative radiation was good, remelting or annealing, but not really perfect. So ideas came about to use alternative methods. Brittle polyethylene, like I said, via delamination, is not an advantage over ultra-high molecular weight polyethylene. Both of them matter, and both of them then become essentially neutral. In 2007, however, authors and industry started incorporating antioxidants into the highly cross-linked polyethylene to take away some of that free radical component to it. Vitamin E became the most common, and antioxidants to suppress free radical generation introduced by the radiation of highly cross-linked polyethylene avoided that need for post-thermal processing and made highly cross-linked poly much more durable in doing so, a huge advantage in that case. So is that really what goes on? And we took a look at it to see if we knew that it was actually better. This was a non-industry funded study. We took a look at comparing polyethylene wear rates, size, particle shape, and two different fixed-bearing total ankle arthroplasty systems. Oliver Schipper and I did this study, if Oliver's out here, great job. One used ultra-high molecular weight polyethylene sterilized by traditional ethylene oxide. The other component used highly cross-linked polyethylene sterilized in gas plasma. And we looked for the important points. We took these two implants, we took four implants per system, we tested them at 5 million cycles, and then left one as a control to soak this, and then every 500,000 cycles, we took it out for this gravimetric analysis. It's not a cheap study, fortunately we got a grant for it. Outcomes in this case, what did we look at? We looked at mean wear rate, we looked at particle size, we looked at particle shape in this case, everything that was important in making the determination as which polyethylene had less of a risk of generation of particles, which could lead to secondary failure in osteolysis. We found something very simple, that in highly cross-linked polyethylene, the mean wear rate was statistically significant improvement over conventional ultra-high molecular weight polyethylene. The mean size of the lesions in this case, again, significantly smaller in highly cross-linked polyethylene. And of course, the mean shape, again, significantly better in highly cross-linked polyethylene. And a huge improvement, be the plastic alone, should lead you to believe that, you must study your particular implant and make sure that it has it. So ergo, we know that highly cross-linked linings have a much lower wear rate because of it, significant wear, and rounder particles, which again, are much less reactive. 3.1 times lower than standard ultra-high molecular weight polyethylene, that was a fact I thought that mattered in this case. So in conclusion, the facts, as my kid would say, total ankle arthroplasty kinematics and disruption of the anatomic center's rotation could certainly cause osteolysis by one of many methods. Polyethylene debris seems to be the most common. There are suggestions that bone implant overload, et cetera, and necrosis, and even fluid generating into this region, can stimulate the same rankle pathway that particle disease does. I would say that's a potential for early failures, but not for late failures in ankle arthroplasty. Also recognizing the surgeon should have a heightened awareness any time three years post-implantation and generate a CT scan to truly understand the size, location, and impending failure of her lesions. In addition, the surgeon must look for subjective factors to decide when to bone graft, and I would suggest that you do that when you see an impending failure or even sooner if you know you have a rapidly expansile lesion. And finally, particulate wear seems to be the major root cause. It's been shown by both corporate-sponsored studies and independent examiner studies that highly cross-linked polyethylene satisfies the goal of durability at a lower particulate wear rate. And when wear occurs, the particles are smaller and rounder. So eliminating the free radicals is equally important, which, again, in this day and age, vitamin E is the primary antioxidant. I'd like to thank you all much. I'd like you to welcome you on my tour in the Chicago Architecture Center, which is a lot more interesting than talking about osteolysis. Thank you very much. Thank you. Good thought there, Steve. Next, we're going to look at the impending wave of revisions. As we do more arthroplasties, we're going to see more complications and more failures as these talks have led up to. So Anish Kodakia is going to talk to us about what we do and how we consider the possibilities of revision. Good morning. Now that Steve has told us we're all pretty much hoes, because we have a lot of ultra-high-molecular polyethylene sitting around a bunch of implants, I'm going to go through the numbers and explain to you, are we ready? Do we have the techniques? And so thank you. And if you do Instagram, I've got some cool cars on there, but I'm sure some of you have better. So these are my disclosures, and none of it's actually relevant to the talk today. So what's the point of this talk? We know revisions are coming. Well, we can always cut them off, so there's always a solution. We can fuse almost anything. So even if you have a bad-looking ankle, you've got a problem, we can always fuse it. I've got this dual bone block snowman technique. If you've got skills, you can do a multi-planar bone transport. So we have lots of options already. And revision isn't that hard. When you look at some of the speakers that have already given their lectures and some of the cases we're going to have, you can revise ankles. So who cares if we're going to see a bunch of these? Well, you have to tell the patient really what the consequences are. And I think in medicine, and especially surgery, in life, I tell my children, everything you do has a consequence. We bear the consequences of our actions. Whether we like them or not, it doesn't matter. Whatever decision we make, we pay the price for it. But in medicine, it's very different. Whatever decision you make, the patient pays the price for. You get paid. It's a very unique experience. And I think it's very important to be honest with yourself and the patients. You'll also be asking, why is Karakiya giving this talk? I know I do more ankles than he does. Does he even do revisions? I ask myself that same question, but regardless, mistakes were made, and here I am in front of you. I have no skin in the game. I could care less if you fuse them, cut them off, or replace them. There's no relevance to my pocketbook in any way, shape, or form. And this is not a personal opinion talk. This is a review of the literature. If you don't like it, hate the data, not the messenger. And as you know, I'm always up for a fight if you so choose. So that we look at the data that's out there. There's a 10-year revision, there's a great meta-analysis, Contemporary Total Anchor Plasties by Van Dyck, who came and spoke to us yesterday, and I was stuck at home because my flight got canceled. When you look at the total hip arthroplasty in the NICE, I don't know how they call it, the National Institute of Health Care and Excellence for the UK, you have to have a .05% annual revision rate for that implant to be allowed to be used in the country. Which amounts to about 5% revision rate at 10 years. Well, we know we're not there yet, but are we? Well, you look at their data, it's 22% is what they show. So they looked at 269 articles, multiple prosthesis. Now, some of these are now all been modified since we've looked at this article. When you look at it, the annual revision rate for the entire group was 2.2. So 2.2% basically will fail per year. Compare that to the .05 in total hips. So we have over four times more revisions, and there's no total ankle that can meet the total hip arthroplasty criteria. You may say the prosthesis I use is better, which is, as a surgeon, the thought is either I am better or what I do is better. And the truth is, probably not, unless you're using the Salto Teleris. Because that seems to be the only one that was slightly better, but still that one doesn't even meet the criteria for a total hip. Taking out the ACL implant, which is not available in the United States, you can assume maybe a 20% is a fair estimation for 10-year revision rate. So that means we're gonna see a bunch of these. What about other implants? Well, this is a different implant that wasn't studied, and they also have revisions too. So nothing is perfect. This study showed a 10% failure rate at 13 months, and you can argue with the study, and I know some people have. But regardless, it's probably around the same, about 20% failure. No one's better than anybody else, but this is not the adaptus porus metal version that we currently use with the polyethylene that has just been described. So these are the older implants that we're looking at. This is a nice study by Steve and his team, and long story short, they looked at the second generation implants, 23% failure rate, so about the same. When you look at this, which was presented in 2018, again by Steve and Chris, and you can see that there is the same study. So we're not, we're same results, about 24% need for revision, or survivorship's only 76%. So we haven't come that far. So the data that we've seen, if you look at multiple systematic reviews, are about 20% failure rate. So does the data that we have apply to what we do today? So when you talk to a patient, it's the historical data that we have relevant. Well, it's hard to answer that. We have new implants that may perform very differently. They may perform worse, right? Metal on metal, when I was a resident, that was a savior for all hips. And you can ask one of the partners at Northwestern who basically killed his career because he put a bunch of those in. So what we have today may not be better. So we're constantly improving, and polyethylene has improved, as Steve has already given us a beautiful lecture explaining that. We have to prepare, though. There's a bunch of these out there that are gonna go bad. So two out of 10 patients that have their ankle 10 years ago in 2013, or 2012, will not have their ankles now. Do we relay this to our patients? What do you tell your patient? You're gonna fail? Eight out of 10 are gonna be a problem at 10 years? Or do you say we have better implants, and so we shouldn't tell them such a bad failure rate if it really isn't gonna be true today? How many are gonna need revision? This is actually hard in America because we don't have a registry here. And I know the society has tried, but obviously we're very independent, so it becomes a problem. When you look at this article, the rate of replacement was 1.59 replacements for 100,000 people in the United States in 2019. And as you can tell, the trend is increasing and more and more. And I'm trying to do every patient that has an ankle, if I can replace it, I do, right or wrong. And we've all changed how we think about total ankles. So if you look at some of the data that's out there, Worldwide National Joint Registries has given more accurate representation. We're actually in the middle of that ballpark, but New Zealand had a hit peak rate of 3.3 for 100,000. The US population about 332 million when you look at the census in 2022. So the estimated number of ankles that theoretically would be performed is about 11,000 at that rate per year. Reasonably assuming that we take what we had before 1.59 and assuming a linear rate of increase, you've got about 6,000 cases are gonna be done this year. That means of those 6,000, 128 are gonna need revision 2023 alone. Well, now let's look at this. So let's try to figure out how many revisions we're gonna need. So assuming a linear failure rate, the total number of ankles that have been implanted over the last 10 years since 2009 is all the data I have is about 51,000. Kind of doing a little bit of math on Excel, I calculated the remaining total ankles are about 45,000 ankles are probably walking around most likely more because this doesn't capture all the ankles. If 2% fail a year, that means we need 902 revisions this year alone from the ankles that are walking around. And as we know, this is not a linear failure rate. It does increase over time. So now we have implants that are available for revision. Shockingly, none of these have actually been reviewed in the literature besides the inbone itself, but the Envision, the SolidOXD, we don't actually have data, but there are problems. Significant bone loss of the tailored bone is still a very difficult problem. The only real way that I know of, and correct me if I'm wrong, is that we really only have custom tailored implants for that. There's no commercially available implant, and that's an FDA issue, but we don't have a way to deal with tailored bone loss. And that's why it's very important to prevent that, like Dr. Haddad has already said. There's a lady that came in with an infected paratotal ankle that had a cement spacer. She didn't want an amputation. There's no way to do a total ankle in this case. She has no calcaneus. I tried this idiotic operation. She lost everything. Her leg is off now. And, you know, so there's not always an easy fix for these patients. And I'm gonna keep showing you cases. Their situations were unprepared for, because the whole point of this talk was, are we ready? Well, I don't know what to do with this. She came in staring at her total ankle. So we cleaned it out, like has been told to, by Constantine, cement spacer. But the fun thing was, she had the first case of resistant Canada in Illinois. If you ever dealt with resistant Canada, you don't want to. Nobody felt it was safe to be in the room with that patient. They sent the foot guy in there to go deal with it. And I had my four children, my little baby at the time, and I'm the one, I'm sure I have resistant Canada, so don't shake my hand. After I saved her leg with the help of plastics, not that I did anything, I just put cement in. So after Dr. Dumanian saved her leg, she's like, when can I get my total ankle? I said, never. You're living with this thing, get out of my office, never come back again. I'm not touching this thing. So yes, there's bone stock. Yes, it's possible, but this is not a situation that you can deal with. And it just gets worse. So this lady came in, she had this total ankle done. Looks really good. However, she had a chronic plantar wound. Nobody could get it healed. She came to us. She said, it's probably infected, but we can get it closed. I got it closed. At six weeks, she came back, gave me a high five, said, you're a great doctor. I said, well, that's shocking. I thought this wouldn't work. A week later, she called me, says, my leg's really swollen. I said, come on in. I poked it, pus shot out, we cut her leg off. We didn't cut her leg off. We did this, and she's got a massive cement block in her leg. How do you reconstruct this? We don't have implants that can deal with this amount of bone loss. So yes, we can do this stuff. And then there's this. I don't even know what this is. She had an in-bone done. Done well, actually. We look at the initial x-rays. Three years, she has an ankylosed ankle. How do you revise this? Is this revisable? This is not what's in the literature. When you look at the literature, these are not the revision cases that you see. So you can't take what you read and immediately apply it to your patients. There is good literature, and how do they do? Well, the truth is, we don't really have great data. This is a nice heart open in 52 patients out of Duke. 21.2% revision rate at most recent follow-up, which is really about four years. 9.6% second revision, but that doesn't count. That's not actually bad. What really matters is that about 10% failed. About 90% survived that 3.1 years. So that's not too bad for a revision ankle. This is the same group looking at PROMIS scores. Sorry, I'll go back there. And 89.6% survived rate in 29 patients. And one thing to know is, in general, as we know, they also showed this nicely, revisions don't do as well as primaries. So it's not the same getting it twice. This is a different article looking at this. 87% survival rate at four years, but look at that pre-op problem. There's not a lot of bone loss. There's not a lot of deformity. This would be a quote-unquote easy revision. This is not the one that stresses you out. Then there's osteo-lucency, or lucency around the implant and a painful total ankle like Konstantin has said. These do really well. There's not a lot of bone loss. There's not a lot of deformity. The implant survival was 97% at 40 months. So aseptic loosening is a quote-unquote easy revision. Those are good. I think we have to kind of separate revision from the proper bone stock to the ones that have no bone stock because those are not the same. Those are apples and oranges. This is a nice article out of the North Carolina group, and these patients had problems. They had pre-op osteolysis 40%. Subsidence was severe post-op. As compared to the study I just talked about, their survival rate was much worse. Is it because there were surgeons? Of course not. It is because they're dealing with more complicated problems where we have no stock for that implant to sit on, and that's very important for us. So my conclusion, we are not completely ready. Well, we can't handle the problem. So we're gonna see about 1,000 revisions this year. When you talk to your patients, make sure you look at good bone stock versus non-good bone stock. Not all revisions are the same. Tailored bone loss is very difficult to deal with. We don't have good implants right now. Hopefully over at some point we'll get it. The question is do we do a sub-tailored fusion for bone stock? I have a lady now with no talus. I'm doing an idiotic bone block to give her a new talus, and then I'm gonna put a total ankle in. Most likely she'll end up with the BKA, but we gotta try. Do we do a custom total talus for these patients if they can afford it? My hospital doesn't approve it. They refuse to eat the cost, and that's 14 systems in Chicago that refuse to allow a custom total talus, so a patient has to fork that over. So it's not fair. It's not an option for many patients. We can always convert to a TTC so we're ready, and luckily the BKA rate, I showed a case or two, but they're actually pretty low, so we're not gonna amputate a lot of legs. We have very limited data on the survivorship of revision total ankles. None of the implants we put in today have actually been, that are designed for revision, have actually been evaluated, and one thing I found out when looking at all the literature, failure rates don't occur in the first two years. When we look at total ankle data, the first two years may be a wash. It doesn't matter if you do a good job or a bad job. They don't seem to fail. If you really start looking at three, four, five years, that's when you're really gonna understand if what we do actually works, so be careful taking two-year data and running with that to your patients. The good thing is, we have a phenomenal group of surgeons in the room. We're gonna improve on this. We must continue to try. It's a good surgery, and the first total hip didn't work that well anyway, so we have to improve, and we can't quit. Thank you very much. Thank you. All right, so Mark's gonna bring us home here. Mark Easley is gonna come up and talk about the decision-making and how to stratify what choices to make in terms of what to do with these complicated problems. Do we revise? Do we fuse? Do we amputate? Do we do other? Mark. All right, that's gonna be absolutely impossible, so we got five minutes left, so this has been one of the heaviest sessions I've ever been. I feel like it's the research session, so what we're gonna do is, everybody get up to your microphone. We're gonna have a little fun. You'll see a few of my cases. I was just gonna run through some cases with the group, but let's do this instead, okay, and find these guys after the meeting if you have some questions, because we'll never be able to get good questions. We have about five minutes, okay, you ready? So name the Canadian-born celebrity, okay. Who is it? Dan Aykroyd. Dan Aykroyd, okay, good. I'm sorry I have to flip through my talk because I put him through the talk. This is just a case of where I did a little osteotomy, got the varus ankle aligned. Who's this? Justin Bieber. Beliebers, we got a few Beliebers, good. Okay, it looked pretty good at first, and then I went, I wound problems, so, you know, plastic set, it was just superficial. Who's this? My wife. No, you're married to Deadpool? Who is it? Who is it? Ryan Reynolds. Say it, come on, help him. Ryan Reynolds, okay, good, all right, good. You know, looked pretty benign, it's all good, but then it's this, looking at the metal problem called infectious disease, metal gotta come. Who's this? Trudeau. Quick. Trudeau. Okay, good, we gotta hurry here. Okay, so Nunley said, just put a cement spacer in, leave that in, this ankle will do fine. Had a flap, and the cement spacer spit out. Who's this? Jim Carrey. Jim Carrey, the mask, okay, good. All right, so the cement spacer split out, I got this cement spacer here, flap's looking better. And who's this? Who's this famous Canadian? Glazebrook, I heard it, okay, good, perfect. So the ship's going down on this patient, infectious diseases, get the damn thing out, which I did, here's the metal. Who are these guys? Nobody? Very good, AU Hoser, that's perfect, okay, good. We got that Saturday Night Live, okay, good. Cement spacer, did a flap, looks good, but then the thing got infected, still was infected. So I went and did an arthrodesis after I cleaned it up, and looked good, looked like it fused. Who's this? Keanu Reeves. Keanu Reeves, there you go. Okay, another famous Canadian. Then I'm thinking it's okay, but it swelled again, metal had to come out, still active, and tried some other things, and flap sat down, put an X-Fix on, just trying, trying, trying. Who are these famous Canadians? Monica and Ruth, right, okay, good. Montreal, from Montreal, okay, good. So here's a follow-up of this, looking good. Looks like it maybe is fusing, maybe not. X-Fix, and I removed the X-Fix. And who are these guys? Come on, Steve, you're a musician. The Bare Naked Ladies, that's exactly right. Okay, good, and this thing is still painful and draining, and still a problem, so amputation. So there you go, and at some point, you gotta go. I should've gone earlier. Who are these guys? Vancouver. Yes, Murray and Alistair, very famous people. Good, okay, so here's one. You can see the thing has collapsed, total ankle. So you can do this with a structural graft. Think about the post-year approach. Yeah, he's not running marathons, but he's totally functional, back to doing the things he needs to do. This was mentioned. Here's good bone stock, eight years out. Every time I do one of these, there's hardly any bone ingrowth. It's amazing to me. So you can see here, structural graft. I was able to preserve the subtalar joint, though, so you can do that on occasion. Who sang the theme song? Celine Dion, wonderful, okay, good. This is one, this'll be finishing up here. As you can see here, this is one. Don't ever do this, don't do a mobile bearing with a syndesmotic instability. She did okay at first. Who are these guys? Who's the famous Canadian? Tim Daniels. Gosh, this group has just gotta wake up. Okay, good. Pain after six years, please don't do it. My ankle's been so good, Dr. Easy. Don't take my ankle out, please. And so you guys see this. You know, I see this. It's like, God, how can you have that big a cyst? It's awful. And so I do, I know it. I'm just gonna cement this. It'll be fine, she'll walk on it right away. Sure enough, a year later, whole thing has collapsed. Falling out. What do I do with that? It's a problem. Metal comes out. Cement comes out. Giant gap. Revision surgery. Good. I just happen to have a custom talus, though. No, you have to plan it with the other side, right? So I did a total talus. Who's this famous Canadian? Pamela Anderson. I didn't know that, actually. Okay, there you go. And then you see the big gap. Gonna try to do a total talus there. You see it, it actually looks pretty good. She's happier, she's able to walk. And she gets back to her ballroom dancing, which was it. So I don't know what this'll do long-term, but she's about five years out and doing quite well. And to finish up, here you can see this ankle. I thought it looked good, no problem. And then he had a wound dehiscence. And they did a beautiful flap, the plastic surgeon said, don't worry, it's gonna be fine, looks good. He looks good. And just like Casey's shown, at four months, it's wonderful. Who's this famous Canadian? Shania Twain. Looks good. All right, so it looks like we made it in this case, but sure enough, right after it looked great, here comes this big puss pocket. And so I went in and I had to clean all that out. And I'm thinking, I can still save it. It must've been acute, right? I mean, it was fine, and it just suddenly was acute. Well, I washed the thing out. What do I do? Scraping it, trying to get it all clean, saving the metal, exchanging the polyethylene, putting that flap down with the plastic surgeon. Who's this? William Shatner, famous Canadian. Then sure enough, just a suture reaction, I'm hoping. But no, when you do this, like Constantine said, probes right down to bone, that's a disaster. Big problem, that's out. Metal component's completely stable, but I'm not able to eradicate this infection. And so I actually had to go and take this metal out, even though the ankle looked good. This cannot help him with his infection. Then I made a cement spacer and put that in. And you can see that here. Who's this famous Canadian? Gretzky. Okay, good. His son-in-law is Dustin Johnson, just in case you don't know. All right, good. So here it is, and it looks good. At 20 months, here's it. And then to finish up for the group, here he is at 20 months, uses a brace. His motion's actually pretty good with a cement spacer. And he's actually is pain-free. He is not in pain. This Alabama shirt pains me a little bit when he comes to my clinic. But you can see he is walking okay. So what do I do now? He's almost two years out. This is the last slide. What do we do? DC for life. What's that? Discharge for life. Yep, that's it. So let him go. We'll see what happens. But anyway, thank you very much. Everybody did a great job. And find these guys for your questions. Great session. Give them a round of applause. Thank you.

revision surgery

total ankle arthroplasty

challenges

considerations

failure rates

patient expectations

complications

future procedures

bone loss

infections