Total Ankle Replacement Doctors Hospital Coral Gables, Florida September 18, 2012 Hello, I'm Diane Magnum, and welcome to ORLive. Today we're coming to you live via the web from Doctors Hospital in Coral Gables, Florida, where right behind me orthopedic surgeon Dr. Thomas San Giovanni is already underway performing a total ankle replacement on his patient. Now, you're going to be seeing that surgery live and hearing from Dr. San Giovanni in just a few minutes. But first, I'd like to bring in orthopedic surgeon Dr. Christopher Hodgkins who today has brought a model with him to help us better understand the anatomy involved in this procedure. Good afternoon to you. Good afternoon, Diane. Thank you. In layman's terms, can you explain to us what's going to take place here today? All right, so this model will help us see. This is actually a model of the ankle joint. And the ankle joint consists of the tibia bone, the talus bone, and the fibula bone. Now, obviously there's a lot of soft tissue that surrounds this ankle; and Dr. San Giovanni's already gone through that, but just a brief explanation. To access the ankle, we actually make an anterior longitudinal incision. About three inches long there? Only about 10 to 12 centimeters long. Okay. And we go through the skin. And then there are lots of tendons and neurovascular structures under there which we have to protect. And we go through an interval between two of the tendons, retract them to get access to the front of the ankle. And what will actually be taken out of this model and replaced with the prosthetic? What we take out essentially is the bottom of the tibia bone, which is the top of the ankle joint, and the bottom of the ankle joint, which is also the top of the talus. And we replace them with a metal, plastic and metal implant. All right, and you have another model here to show us what the prosthetic will look like. I do. So essentially, this is what the final product will ultimately look like. And you see the bottom of the tibia here is replaced with a metal prosthesis. Those are plastic implants in between that and the Taylor (sp?) replacement there. Perfect, I'm going to ask you to standby for just a minute here with me. And I'd like to bring Dr. San Giovanni into the conversation here. First of all, Doctor, thank you for allowing us to invade your OR this afternoon. It's a real privilege to be here. Well, you're welcome, Diane. Welcome, everybody on the webcast.

Thank you. What can you tell us about your patient first and foremost? Well, this is a patient – it's a gentleman, about 66 years old. He's still relatively active. He's actually a boat captain and a scuba diver instructor. Wow. He had had a fairly significant trauma to the ankle due to a motorcycle accident and has subsequently now developed a rather painful arthritis of the ankle where the joint cartilage has essentially worn down to bone on bone. So how long has he been living with this pain? He's been living with it for quite some time now. He's been waiting for something such as this, where he'd still be able to preserve some motion of his joint but would be pain free. And what made him such a good candidate for this procedure? A lot of it was his activity level and the types of activities that he desires to perform. Such as? Well, in terms of being a scuba instructor, he still wanted some flexibility to his ankle. He's not active in any type of, let's say, high-impact-type activities such as basketball or soccer or something like that. So those would be things that we would dissuade somebody from an ankle replacement. But he just wants to be able to walk, exercise. He could certainly play golf and other things where he could still maintain an active lifestyle without having his ankle fused. And how old of a man are we talking about here? This gentleman is 66 years old. Okay, so that puts him right in the middle of someone who would be a good candidate for this procedure. Exactly. All right, I understand this surgery is usually about an hour and a half to two hours long. So you've already gotten underway here. Can you tell us what you've done so far and where you are now in the procedure? Certainly, let me point out what we've done. We've made the approach to the ankle. And as Dr. Hodgkins had indicated, the approach is through what we call the anterior, which is the front aspect of the ankle. We've come through now, and we've moved the tendons out of the way. We make an interval between these two tendons, one that extends the ankle and one that extends the great toe. And the white tissue we're looking at there – that is the tendon? This right here is one of the main tendons that extends your ankle. Then there's another one here that's hidden within some of the soft tissue. Just deep to this is what's called the neurovascular bundle. So it's a very significant artery nerve that we gently sweep to the side so that it's out of our plane of our approach. All right, so this is all preparation just to reach the bone. Exactly, right now we are right along the anterior or the front aspect of the ankle. We're looking directly at the ankle joint. All right.

Now, I've gone ahead and I've removed a fairly large bone spur which he developed in the very front of the ankle. And we're looking down into the joint. Now normal cartilage would be a nice, pearly white color. Now, what's happened with him is he's developed a rather significant cartilage erosion and deterioration where this is now bone on bone in some areas. And then in other areas, the cartilage is very irregular. So a bone spur would be defined as what, Doctor? Well, a bone spur is usually a precursor to arthritis – almost like the body is trying a protective mechanism to limit motion. If you have normal cartilage, motion is good and you're pain free. And when the cartilage is deteriorated or irregular, then motion is typically painful. Doctor, as you continue working there, I'd like to remind our viewers at home that this is an interactive webcast this afternoon. We invite you to use the icon you see on your screen there to send in your question to our surgeons, and we'll effort to answer as many of those questions as we can over the course of this hour. Dr. Hodgkins, let me bring you back into the conversation here. What causes this condition? There are lots of causes of it, but essentially arthritis is wear and tear of the actual cartilage itself. Of the causes of that, the most common really is post-traumatic; and that's the case in this patient. There are also other causes such as primary osteoarthritis and also systemic arthritides such as rheumatoid arthritis. And how common is this condition? Do a lot of people suffer with this kind of arthritis? A lot of people do suffer with it. It's less common than hip and knee arthritis obviously. But there are a lot of people out there who are suffering because they really don't want to resort to an ankle fusion because they don't want to lose the motion. And they've been waiting for such a procedure as this. Now, is ankle arthritis always treated with a surgical procedure; or are there less invasive treatments? There are less invasive treatments, and there's really a stepwise algorithm to how it should be treated. Over-thecounter anti-inflammatory drugs and medications is one method. You can try bracing to see if you can limit the motion and therefore limit the pain. There are some patients who would be amenable to maybe ankle arthroscopy to help some of those symptoms. But ultimately if they fail those conservative measures, they're really looking at surgery to alleviate the pain. All right. Dr. San Giovanni, I'd like to come back to you. Can you explain to us exactly what you're doing now? Exactly, Diane, what we're doing now is we've set up what's called a "tibial alignment guide," so it's precise points within the tibia, which is the lower bone of your leg, the larger bone. We've made reference pins. And these pins we attach a guide or apparatus that will help give us a precision cut within the tibia. So now, I've set the rotation. And with this device, I've determined which size implant that we're going to use and also set whatever we're calling "translation" in terms of aligning this properly. Proper alignment is critical in terms of the success of this procedure. So you've inserted what looks like a post up near the knee and another one close to the surgical area. Is that correct? That's correct. And that's to give you a clear line so that you're sure the prosthetic will go in exactly where the ankle was back in the day when it was healthy. Is that correct? That's correct. I'm going to bring in our fluoroscopy, which is our interoperative x-ray, let's say. And Lisa is going to do our fluoroscopy. I forgot to introduce my team here. We've got Fabricio Vina, who's my physician assistant. We've got Octavio, who is our scrub tech. And we've got Dr. Kao. We've got a class 18 here today.

Fantastic, and I should tell everybody at home we are all wearing these leaded vests because x-ray is a critical part of this procedure, correct? With this, I'd like them to get the x-rays so you guys can see. As you come down, we try to align everything correctly. So why don't you come down, Lisa? And can you explain what we're looking at in this x-ray? We want to make sure that the alignment jig is properly placed so that it is parallel with the axis of the tibia, so basically in line with the tibia bone. And now we've set these points that will determine my cut. And basically, that's exactly where I want to be. So we're going to go ahead and make the cut. All right, as you're doing that, Dr. San Giovanni, you talked about how this patient was a good candidate for this procedure. Who would not be a good candidate for this procedure? There are several groups – let's say somebody that's very young or younger. There's really no age limit at this time, but let's say somebody less than 40 or somebody that's very active still with high-impact activities like I mentioned, like basketball or soccer or jogging. And why is that? Because it would place too much stress on the implant, and the implant may fail quickly. And we don't want that to happen. Other people would be people that have, let's say, a rather severe angular deformity Now, having said that, there are some of these new implants can correct that deformity. But that's been in the past one of the contraindications. Once again, I'm going to ask you to explain to us what you're doing. It looks like you're using a drill there. Is that correct – or a saw? Yes, it's a drill, exactly. Now, I had a friend once tell me that orthopedic surgeons are just like carpenters. They have a lot of the same tools in their toolbox. Is that correct, Dr. Hodgkins? It absolutely is. I know that I took woodshop in high school. And I don't know if Dr. Togno (sp?) is out there listening, but I think he'd be very proud of me. And that's what led to this. And so now, Dr. Hodgkins, could you explain to us what he's doing? So he's actually placing the tibial cuffing guide on the end of the jig. And he's just making sure that's secure. He's fixing it in the distal tibia with pins so that it holds steady and allows him to make an accurate cut. Now, do these pins stay in the patient or they're extracted at the end of the surgery? You're exactly right. They'll be extracted as he moves through the surgery. Once he's finished making this tibial cut, he'll take those pins out and remove the guide so he can then remove the bone and move on to the next stage. It really is a construction project, isn't it? It really is – it really is. It's fascinating to watch. How was this condition treated in the past – before this kind of prosthetic was available?

Well, it was treated by a number of means. The traditional surgical treatment for it was ankle fusion. And that's still a valid treatment option for many people in many cases. Before you go further, can you explain to us what is involved in an ankle fusion? Ankle fusion is also called ankle arthrodesis. It's essentially -- rather than replacing the joint, you are removing the joints and joining those two bones together. So essentially the tibia and the talus are joined together, and they heal as one bone. So you lose the motion in the ankle, but it relieves the pain just as well. But you do lose the motion. And so it was treated with fusion for a long time; and as I say, it still is. But as I say, this is now an option for patients who want to preserve the motion. So do you also perform ankle fusions here at Doctors Hospital? Yes we do, we also perform ankle fusions. And besides losing the range of motion, are there other drawbacks to that procedure? Well, there are theoretical drawbacks with an ankle fusion. I'm going to interrupt you just for a second. Can you tell us what Dr. San Giovanni is doing right now? Now he is actually using a saw, and you can see that the saw is going through the jig so he can make an exact cut in the distal tibia. This is the cut to resect the distal tibia. So once again, the jig is there to make sure the cut is exactly where it needs to be on the body so that the prosthetic will fit where the ankle did back in the day when it was healthy. That's right, and so he attached that to the jig that he'd already made sure was parallel. And therefore he feeds off that to make sure the next cut is also correct. All right, I'm sorry I interrupted you. You were talking about why there are some other drawbacks to ankle fusion. Right, there's a theoretical risk that once you lose the motion in the ankle, the adjacent joints have to pick up a little bit of motion. And the results of that may have accelerated arthritis themselves. That's a theoretical risk, so it's something to conside when you're making the decision. And does ankle fusion actually affect your walking gait – your normal walk will be altered by this kind of surgery? It certainly does alter it somewhat. However, if you looked at someone with an ankle fusion walking down the street, the lay person wouldn't necessarily be able to notice that they'd had an ankle fusion. Dr. San Giovanni, can you tell us what you're doing now? Yes, we're making our initial cut in the tibia. So we're going to be resecting out this portion of the tibia. And once we make that cut, then we're going to start working on the talus, which is the lower bone. And can you tell us a little bit about the instruments you're using here? Yes, they're made specifically for this case obviously. And obviously we use drills and saws and all those fun power tools that we like to use. But all these alignment devices are made basically based on the anatomy of the ankle, and it's trying to make precision cuts. While we continue watching you here, Dr. San Giovanni, I'd like to tell our viewers at home that you are a recognized expert in total ankle replacement surgery here in the U.S. and that you're often chosen by your colleagues to take part in meetings for which you and other U.S. and international doctors exchange new thoughts to continue to improve this procedure. So I'm curious, what sparked your interest in this, and for how long have you been involved in ankle replacement surgery?

Well, it probably started back in 1998 during my fellowship. I was involved in a long-term study on ankle replacements, where we were looking at patients that had had the replacement about ten years out. And what we noticed is that there were a lot of patients that did quite well. And it was basically due to some of the technology or innovation changes in the initial implants. The initial implants I'm talking about were, let's say first generation, were back from the 1970s. And they typically didn't have a very good track record. And what ended up happening is the orthopedic community, at least most of them, had basically abandoned this procedure. And they felt the knee and the hip could be replaced, but the ankle could never be replaced. There were certain pioneers, let's say, in the field that continued to work on that. And then I kind of picked up on that with some of my research studies, and I've just maintained activity in this particular procedure. How much bone are you actually removing there because on this close-up shot, it seems to be quite a lot. Yeah, it's probably magnified; but it's about – we're resecting about 10 mm. And with this particular implant, we resect about 9 mm to 10 mm. Different implants you resect a different amount. This is one of the ones that you resect a little bit less, so that's why we've chosen this one for this particular patient. So even with the new technology, why is it that total ankle replacements are performed less often than other types of joint replacements? Well, part of that reason is it's not as common as knee and hip replacement. And then I'd also say too that many of the surgeons out there may not be comfortable with the procedure, just based on their training and experience. Dr. Hodgkins, is that why this total ankle replacement is performed less often than total ankle fusions around the country? Yes, I think so. There are a lot of surgeons out there who simply don't have the expertise or experience and feel comfortable with this procedure. And therefore, they resort to the fusion as that's also an excellent treatment for this. And a case can be made in most cases for either/or. Well, just watching this little bit of the procedure, I think everybody at home can tell that it does require a certain amount of training and expertise. How much expert training is required for you as a surgeon before you're able to perform this kind of ankle replacement? Well, we obviously go through five years in medical school, four years of undergraduates, and then a five-year orthopedic residency training. And then a year's solid training of purely foot and ankle orthopedic surgery. And then obviously Dr. San Giovanni has over ten years in practice performing these kinds of surgeries also. All right, Dr. San Giovanni, I'm coming back to you. Can you tell us exactly what you're doing now? Yes, now we're putting a reference pin in the lower bone, which is called the talus. And this is based off of our tibia cut. So it's trying to keep everything in line. And with this reference pin, I'm going to make the cuts in the talus. There are actually three cuts that we resurface. The top surface – we perform these cuts that are called "chamfer cuts," which basically means they're beveled or angled somewhat. And this is to accommodate the shape of the prosthetic? Yes, it is. And this is going to be resurfacing the talus bone. And how do you decide how much bone to take from each patient? I would think it's different with each patient. Well, it is different with each patient. And I'm Italian American. It's like asking somebody the right amount of time to cook the pasta – and it's "just the right amount." Well, and I guess your experience comes into play with that because the more you do, the more you understand exactly what will get the best results for your patient. I have to say, with this particular procedure, there's nothing that can replace experience.

I'm sure that's true. And a lot of this is based on some of our judgment as well. Dr. Hodgkins, how new is this procedure? It sounds like it's relatively new in the grand scheme of surgical changes. Well, ankle replacement has been around for a long time – since the 1970s essentially. But the very early prostheses were flawed in terms of their design. And so people abandoned it for a long time because they had very good short-term outcomes, but the long-term outcomes were pretty poor. However, a dedicated group of surgeons committed to making these designs better. And so these particular implants have been around essentially since approximately 2006, and is one of the newer generations. It's proven to be excellent in terms of long-term results. So the long-term results were poor because the prosthetic failed over a period of time? Yeah, we just didn't really fully understand the forces that go across the ankle. It's much different than the hip and the knee. And so the implants loosen, they subsided, and essentially the patient had very poor results. Dr. Hodgkins, I'm going to ask you to pick up the model one more time so that you can give us a visual reference with the foot attached exactly where Dr. San Giovanni is working now and what he's doing. So he has already taken away the tibial cut here. That's already gone. This is the talus; so this is the underside of the ankle joint. And he's now taking away some of this bone to essentially make a flat cut. He's cutting this side and also this side so that the can place the implants on the talus. Okay, let's go back to our surgical team. Dr. San Giovanni, you are using the saw once again. Is that what's going on? Yes, we're taking off the very top portion of the talus. And you said that there were three cuts involved in this part of the procedure. Right, exactly, this is the first of three. The first of three – and the other two? There's one at the back of the talus and there's also one at the side. And we'll see him do them next. This is stepwise. To make the other cuts, you have to make this one first. I understand. Dr. Hodgkins, how have these implants changed over the years? You say it's improved since 2006. Can you speak to the ways that the implants have improved? Many different ways they've improved – the actual composition of the implants themselves has gotten a lot better and a lot more durable. They have become more anatomic in their design, and therefore they have become a lot better at tolerating the forces across the ankle. And what is the implant actually made of? The implant is made of metal, plastic and metal. The metal is a cobalt-chrome, which is a metal alloy of cobalts and chromium. And then the plastic is actually called ultra-high-weight polyethylene. And how does the body respond to that? It's a fairly inert substance, and the body essentially tolerates it very well.

Dr. San Giovanni, we're looking at your shot now. You have what looks like five pegs in there. Can you tell us what's happening? Yes, this is the apparatus for cutting the top of the talus bone. And basically, those pegs go just underneath where I'm going to cut. And so they almost act as like a guide, and we cut right over the top of those. And once again, you're using what looks like – what is that called, first of all – the hammer or--? Oh, that's a mallet. A surgical mallet? When I get upset with my team, I knock them over the head with it. It's a nice size mallet too. Let's hope everybody stays in line today. And once again all of those pegs, Dr. Hodgkins, are just temporarily in the patient? Exactly, they're just so he can essentially (inaudible) off the top of them and make his cut; and they will come out soon, as you'll see. And did you say that this particular prosthesis has been approved since 2006? Approximately 2006. So is it safe to say that thousands of these surgeries have already taken place across the United States using this prosthetic? That is correct. And the track record, I would assume, is very good. The track record is good. And when you look at angle replacements in general, the newer generation of ankle replacements – there is long-term data suggesting that they have essentially a 90% success rate. Now, Dr. San Giovanni, you said this particular patient suffered an injury years ago forcing this surgery now down the road. But for patients who are facing ankle replacement because of arthritis, is it common that if you have one ankle done down the road you might have to have the other ankle done as well? Well, a lot of times it's from trauma. So it's not as common, let's say, as having both knees done or both hips done. So it's usually a different cause for this. And Dr. San Giovanni, what are the risks involved with this particular procedure? I think the early risks are very similar to any type of procedure in that the early risks are related to infection or wound healing, and might be slightly higher in terms of wound healing just based on, let's say, the neighborhood we're operating on. The lower extremity just doesn't have as good blood supply. But that's the early risk. I think the long-term risks are whether the prosthesis is going to loosen or fail over time. Does that happen often? I won't say it happens often, but it can happen. And what happens if it fails? If it fails, what you can do is you can do is if it's feasible, you can revise it – meaning like you put in another implant. Or if it's not feasible to do, due to whatever reason, then you could always fuse it. Now, you can fuse it even though you've taken out this portion of bone?

Yes, you can. It makes the fusion definitely more difficult, but certainly we've done cases that are difficult before that. So it just makes our lives a little bit more difficult, but that's what we have to deal with. I think our viewers at home might be surprised at how clean of a surgery this is. Your patient suffered very little blood loss during the course of this surgery. Well, it's performed under tourniquet. So there's a tourniquet that goes on the upper leg -- that helps. And my mom always said, "Keep a clean room." There you go. I'm sure mom's very proud. I didn't always follow that rule though. Now, tell me what you're doing now. It looks like you're taking the pins out. Yep, we did. And so that's our first cut of the talus. And then we're going to move on now to our second cut. And the second cut then, remind us, is to do what? The second cut goes more along the front part of the talus bone. So this is going to match our implant. So it's designed specifically (inaudible) of the implant. How do you decide what size implant to use? It's based on – sometimes what we do is preoperatively, we measure the x-rays. And we have these templates. So we use the template preoperatively. And then intraoperatively, meaning in surgery here, we double-check and we measure. Dr. Hodgkins, can you explain what Dr. San Giovanni is doing there in terms of taking tissue away? Yeah, he is essentially just cleaning up extra little bits of bone that weren't taken away with the saw. These cuts have to be very exact. And so once you take those pins out, there are always little bits of bone that are sitting up. And you need to take them away; otherwise the implant will not sit down properly. And if any of those bone spurs are left in, that equates to pain for the patient down the road? Possibly, yeah – certainly if they impinge, they will. Okay, we were talking before about the risks involved with this surgery. Have those risks lessened over the years? Absolutely, as the implant designs have increased significantly, the risks have decreased substantially. I'd like to remind our viewers at home that we are involved in an interactive webcast here. And as you continue watching Dr. Thomas San Giovanni operate on his patient involved in the total ankle replacement surgery, we invite you to send in your questions via the web. There's an icon on your computer screen. Once you send those questions to us, we will ask them of our surgeons. And we will effort to answer as many questions as we can during the broadcast. We just got one question from a viewer at home. Perhaps they came in late to the broadcast – wanted to know, again, what the implant is made of if you wouldn't mind repeating that. It's made of two metal components and a plastic component that sit in between. The metal is a cobalt-chrome, and the plastic is an ultra-high-weight polyethylene. Now, Dr. San Giovanni, I'm watching your work here; and I know you're very gentle and very skilled at what you're doing. But in order to carry out this procedure, you're opening up an incision. You're pounding on some bone. You're taking away some bone. How much pain does that equate to the patient once they wake up in recovery?

Well, certainly any type of bone work is painful. The good thing though is there has been – besides our field, there's also been advancements in the anesthetic field – in anesthesia. And this patient, besides general, had what's called a "popliteal block." And what a block means is behind the knee, they'll actually put an anesthetic. So that when he wakes up, he shouldn't feel much at all below the knee. And that can last for a good 12 to even 16-18 hours. Wow, that's amazing. So it gets them over the main part. And what kind of medication will he have to be on post-surgery to handle the pain? We'll put him on what's called a PCA pump. So when the block wears off, they'll have an IV that goes in. And he'll just hit a button, and the button delivers the pain medicine through the IV. Eventually, we'll get him off the pump and we'll put him on an analgesic – like a brief narcotic for a period of time. Dr. Hodgkins, how long is the patient in the hospital? Only for about two days after the operation. Sometimes that stay needs to be extended to three days, if they need a little bit of extra help getting up on their feet and they maybe need an extra day of pain killers before they go home. And how soon do you try to get the patients up on their feet? The next day they're able to get up on their feet. The next day? Absolutely, with the help of a physical therapist. Now, obviously, they can't walk on the operative leg. That will be in a splint. But with the aid of either a walker or crutches and a physical therapist, they will teach them how to walk using those walking aids and the opposite leg. So how long will a patient be in a cast and using crutches? That's a good question. Normally, the patient is in the splint, which is a half cast, for two weeks after the operation. They then come back to the office, we take the splint down, possibly take the sutures out at that point. And at that point, generally we put the patient in a cast. And they will be in that cast or a walking boot at that point probably for the next four weeks, which will bring them to the six-week point at which point they'll come back to the office again and then, if they were in a cast, they'll be placed in a boot. If they were in a boot, we will continue them in a boot; but we'll actually let them start putting weight on it at the six-week point after the operation. So this is a major surgical procedure. And anybody facing it needs to understand that this is not a get up and go two days after you've had the surgery kind of deal. Absolutely, that's right. You can be mobile, and certainly younger patients are very mobile with crutches and can get around very well. But no, you're right, it's certainly not something that you can get up and run around the next day. And there is no option such as that for this pathology. Dr. San Giovanni, let's bring the conversation back you – if you could please explain to us what you're doing right now. Okay, we're making that third cut now in the talus. And this resurfaces the outer portion of the talus. There's like a little wing device here that we measure right to the edge of the joint, and that sets our cut. And we're going to drill -- what's called a "Bell" drill – that's going to make a little hole in the talus which is going to be used to set up what's called our "fixation point." And can you explain to us what that is?

Yep, I'll explain it in a second. Fabricio is going to put this in here now, and this is going to hold our cutting jig in proper alignment for us to make the cut. This will eventually come out. And then as you see at the very end, I'll show you the prosthesis. There's like a little end stem that goes into the talus, and that's where this drill hole is being made for – to prepare for that. So you're basically doing the same kind of cut on three different locations? Yes. And you go through the same sort of course of events in terms of setting the jig and taking out the material. Exactly, and everything feeds off the original jig. The tibial cut feeds off the original jig and the Taylor's cut feeds off that, making sure that everything stays parallel and in anatomic alignment. Dr. Hodgkins, you talked about physical therapy. Is that important to a patient's recovery? And if so— Absolutely, it helps them get their strength back, it helps them get their balance back, helps them get their mobility back more quickly. So what kind of physical therapy do they undergo, and how long does that physical therapy last post the operation? Physical therapy normally lasts for about six weeks. And once they come out of the cast, we will commence that. We can start it earlier if necessary. And that will be a couple of times a week for about four or six weeks. Some patients need more; some patients need less. And the aim again is to just get the motion back, decrease the swelling, make them more mobile, get their strength back as well. So we hear from Dr. San Giovanni that there is a block that helps with the pain right after the surgery, that there are other narcotics given in the few days after the surgery. How much pain is involved in the rehabilitation process? The rehabilitation process is uncomfortable for sure, but most patients that pain is easily controlled with analgesics at home; and we send patients home with that. Again, all patients are different. Some patients don't require any analgesia after they leave the hospital, and some require some until up to the six-week point. And that's fine. That's to be expected Now, is swelling a big problem after the surgery? Swelling – it's not a big problem, but it certainly does occur anytime you perform surgery. Especially on the foot or ankle, swelling is prevalent. And we ask the patient just to elevate the limb as much as possible and just be very sensible with their activity to try and decrease that – especially in the acute period. Until the wound is healed, certainly we worry about that a lot more. Well, let's talk about that wound a little more. Dr. San Giovanni talked about the fact that there's not as much blood flow to this part of the leg. Would that preclude someone who is a smoker from being a candidate for this procedure? No, not necessarily – that's not a complete contraindication. We would rather they stop smoking, and we would obviously keep a much closer eye on those patients and just warn them that they do have a slightly increased risk of wound complications. Once again, as we're watching this procedure, can you talk us through what Dr. San Giovanni is doing right now? So he is -- once he gets his hand out of the way— Well, I'll ask you, Dr. San Giovanni. Where are you now in the procedure? We just made the third cut of the talus, and so we're moving right along. Things are going very smoothly. We're going to now set up the trial tibia. And the prosthesis has a stem, or what we call a "keel," that actually goes into

the tibia bone. And we're going to do what's called our trial. So we're actually going to put a trial implant in. This is not the permanent one. But this is like a pretest, let's say, to make sure that we're happy with the size and we're happy with the motion and the stability. So you're looking for a particular size. You're guessing on the size, but you'll know after you put it in if you've guessed correctly or if you need to go up or down. Yeah, we're pretty sure he's a size 2. So all guessing aside, we're getting close to the end here in terms of making our final decision in terms of the size and everything. So right under that— So this is the Taylor trial. So once again, like we said, that drill hole that we made that's kind of circular-shaped, there's a stem right here that goes in the talus; and that's going to fit into the talus to give it stability. And this is the trial once again. The actual implant – the surface of the implant on the bottom, as well as the surface that's on the tibial side, has a titanium spray. And the titanium spray actually encourages the bone to grow into it, and that also adds stability to these implants. And that's one of also the design modifications, or let's say improvement, because before all these implants had to be used with cement. And we found that the better you can get away from that, it's better in terms of the ankle to be without cement if you can. Yeah, we've actually learned from past procedures that the body loves titanium. And the bone gravitates towards the titanium and holds it securely into place. It actually grows around it, correct? We use titanium a lot, and it's not just in golf clubs – especially for fracture fixation now. The titanium itself is good on the surface of the bone now. The actual implant itself on the top surface is not titanium. Now, explain what you're doing there. You just inserted what would be another part of the prosthetic, right? And what are you looking for between these two things that you've now placed in your patient's leg? Well, this is the tibial implant. And attached to it is the insert. The insert is going to be plastic, which is polyethylene. So now we're checking the size. And right now, we have a size 8 – which means 8 mm of the polyethylene. If I don't like that, I can always go up. So I'll show you on the back table in a second how you can go up and down with the implant. They're modular, so you can kind of adjust. And before you put the lower piece in, we could see that it had what looked like about a dime-size circle in it. And it was your goal to match that same dime-size part of the bone so they would fit together perfectly. Right. So actually that fits pretty well. And so why is it necessary to use all of these sizers before you put the final? Because you want to get the right stability. You can put in some that are too loose or too tight, and you also have to make up for the bone that you cut out. So you'll see – I'll show you in a second. Let me try a size 9. We're going to go up one, and we're going to see if I like that better. And again, there's a bit of a feel to this. I was going to say, "What exactly are you looking for?" Like I said, there is some feel to this that you have to judge. Let me have a knife. We might have a little bone fragment here. So you want a certain amount of tension from the body on the prosthetic? Yes. Let me just see. Let me just remove this little piece here.

And again, you say you felt a little bone fragment there – a little spur? Yes, a little extra bone fragment when I put that in. It felt a little tight. And if that happens— Well, I just know enough that there's something that I need to remove here. And as we're watching this surgery underway, I'd just like to remind our viewers at home that you are watching a live surgery – part of a series of webcasts brought to you by Baptist Health South Florida – all of this in an effort to broadcast innovative procedures on the web. And we've learned, over the course of doing a couple dozen of these webcasts, that they are wonderful learning tools and a wonderful example of how patients can take some of the fear out these surgeries by being able to see exactly what happens in the OR before they make a decision as to whether or not to go forward with surgery. So now I'm trying a trial 9, and the 9 actually fits quite well. And what I'm trying to look for, once again, is the range of motion -- which he seems to have pretty good range of motion even with the 9 -- and then stability. If we have a little bit of tightness – he had a little bit of tightness of his Achilles. And I might do a little Achilles lengthening in an effort to try to gain a little bit more motion for him. So an Achilles lengthening would involve what? It involves making a small cut in the back of the ankle, where we actually tease away some of the fibers and just basically stretch the muscle at the tendon muscle. So it's a way of doing the Achilles lengthening, and it's called the "gastrocnemius recession." The gastrocnemius is your calf muscle. It's a way of doing it without losing all the power of your Achilles. It's a neat little trick. It takes me basically five extra minutes, and it could gain you a good 10 degrees extra if you have to. Where do I sign up for that? That seems a lot easier than all that stretching you have to do in yoga class. We'll see. We perform it maybe about 30% of the time. If they don't need it, I try to get away without it. But if they do, like I said, it does help. So we like this side, so let's go with the drill. Dr. Hodgkins, can you tell us what was going on there? It looked like some irrigation taking place. Yeah, you need to keep the surgical field clear at all times so you can see exactly what you're doing. And the irrigation just helps do that. And Dr. San Giovanni obviously is moving the patient's ankle. Since the patient is asleep, he's replicating what the patient will be doing once he's awake and using his ankle again. Exactly, and that's where a lot of feel and expertise come into it – knowing exactly what feels right and how much motion in all the different planes is right, and what's acceptable and what isn't. So post-surgery, what kind of restrictions are placed on a patient whose had a full ankle replacement procedure? Well, apart from the obvious ones that we talked about before, once everything's healed and the patient is back to normal, we really tell them that with the ankle replacements, we don't want them doing any high-impact exercise activities. And really that starts at jogging. We really do discourage jogging and obviously any kind of running – basketball, any cutting kind of sports. So for the rest of their lives? Yeah, I think that's an unrealistic expectation with this implant. What is somebody is an active tennis player? Would they not be a candidate for this?

I honestly don't think that if they're a tennis player, they would. It's very controversial, and so I think we're all still learning what should be done – what can be done. I think anybody who's going to be playing competitive tennis, probably not. It would not be something – and even singles, I think it's up for grabs there. But doubles tennis, you may be able to do. I think we'll have better data on that as time goes on. And is another reason why you don't recommend this for young patients simply because you just really aren't sure how long these prosthetics will last. And if you operate on somebody 16-17-18 years old, it's likely they would face another surgery down the road? That's true. Exactly, and once we get longer-term, let's say long-term meaning 20-year data – some of these implants have not been out that long – when people ask us how long this will last, we have to tell them basically what the data is, which is we know that there are some studies that are coming out now with about 15-year data. So we'll be able to report back to them. But they are definitely showing encouraging results, and we hope they last like that. Now, Dr. San Giovanni, it looks like you've made a keyhole there. Yes, I have. Tell us exactly what you're doing. That keyhole is going to be where what's called the keel of the tibial implant will sit. And it's basically a circular stem. And you'll see that once we put that in, it will fit precisely in that hole I just made. So how much extra training was required for you to be able to—I mean, you look like you did with a stencil, it's so perfect. The jigs help you, and also I tend to try to be a little bit of a perfectionist in some ways. He's being modest. He's really good, right? That's what we need to say here. He's really good at what he does. I try my best; let's put it that way. I know that I have a patient that's on the table, and they're putting their trust in me. And I have them for about an hour and a half. And I know that whatever I do in this hour and a half can certainly impact the rest of their life. So I do take that very seriously. Well, Dr. San Giovanni, let me sing your praises for just a minute. I think our viewers should know that you've been named one of the top ankle specialists in the entire United States every year since 2005. And that you serve as the orthopedic surgeon for the Miami City Ballet and foot and ankle specialist for the Florida Panthers, the Tampa Bay Buccaneers, Florida International University and Miami-Dade County Public Schools. You've also assembled a pretty amazing team here. Can you talk to us about your team of surgeons? Yeah, like I said, we've assembled a very knowledgeable, caring team here at Doctors Hospital. I think we are all passionate about bringing some of the innovations that have come in our field to our patients for better patient outcomes. So I think we're all dedicated and want to help people. And what are you looking for now on the side table here? We're just looking for the implant. This is the formal implant that we're going to place. So this is the tibial implant. And you can see, this tibial implant has a beaded surface. That's the titanium spray that we're talking about. I see.

And this is also on the undersurface of the talus. Now, the top part of it is a metal that's similar to be used in knee replacements – more like a cobalt-chrome. So now we're going to play the other component, which is the poly, which we're opening up over here. I wanted to show this as well. You can see that they're different sizes, and these all are dependent upon the patient's anatomy and everything. And it's a matter of fitting the right size to the right patient, what poly you use. And they're very slight differences from one side to the next, so you really have to be experienced and skilled at figuring out what's going to work best for your patient. Octavio usually arranges them like this because whenever I look at this at the end of the case, I always think to myself, "Don't worry. Every little thing is going to be all right." Perfect. I think some people got that. I got it instantly. How many of these procedures have you done over the years? I'd probably say maybe about 200. Now, while you're doing this, what's happening with the patient behind you? Fabricio and Dr. Kao are over there irrigating – getting everything cleaned out, ready for me. And how close are you to finishing the procedure now? We're pretty close – probably within ten minutes. Oh, no kidding. So we'll have everything in. This is sliding the polyethylene, which is the plastic piece, onto the tibia. And we're going to – we use this clamp to hold that in place. Okay, and that snaps right in. It looks like a garlic press. Now, there are certain different implants. Most of these are similar in that they have three components – the talus, the tibia, and then an insert -- a polyethylene insert. Where some differ, particularly some of the ones in Europe -- and there is one here that's FDA-approved that has a mobile bearing that kind of slides back and forth. So this one can be free in certain implants. This implant in particular, it's called the Salto Talaris. The one in Europe has a mobile bearing, so this was based on that one. It's a rather large piece. I mean, it's not huge; but will your patient be able to feel the implant in his body, or he'll never know it was there? They typically don't know. I'm sure it feels a bit strange at first; but they're just so happy that they're out of pain, it becomes them after a while. So we're going to be putting in the Taylor implant. So this is the permanent one? This is the permanent, formal one. So what we're going to do is put the talus in first, and then we're going to impact that into position. And once again, I'd like to remind our viewers to send in your questions from home. You can do that via the web. And we're going to ask those questions to our surgeons in just the few minutes we have left in this procedure. Dr. Hodgkins, can you explain what's he's doing right there? He is impacting that talus into the cut that was made for it, just to make sure that it doesn't come lose.

So if you had to equate that, that's almost like putting a crown on the spur of the tooth, correct? Exactly. And again, if you could explain to us what's happening now. That's been secured into place. What happens next? So he now probably just wants to check an interoperative x-ray – to use the fluoroscopies – and make sure that everything looks good. So x-ray is used several times during the procedure? Exactly, you're essentially just double-checking everything – making sure everything aligns nicely, making sure everything looks nice. And, Dr. Hodgkins, what are the long-term benefits of this particular procedure? The number one benefit really is preserving motion, preserving activity, and just being able to increase the activity level of patients with ankle arthritis as opposed to those who undergo fusion. And patients who've had this procedure, what do they tell you about how much their pain is alleviated postsurgery. They are very happy in terms of pain relief and even happier in terms of motion. So once again, this x-ray machine – is that a portable x-ray, and it's just sort of slid into place around the patient? That's correct. It's on wheels essentially. It is plugged into the main's power, and it's then plugged into a monitor so you can see exactly what's going on. Do we have much research to know – we talked about this before, but how long this particular prosthesis will last? There is no long-term data simply because it hasn't been round long enough. But certainly the data of implants that have been in for at least ten years show that they have over a 90% success rate. Really – 90%? Does that equate pretty much the same for hip and knee replacement? No, hip and knees have a lot longer data because they've been put in for a lot longer; and the implants got a lot better a lot more quickly than the ankle ones did. So the reason we can't say this will last longer than ten years is essentially because we don't have that long-term data. But there are a lot of people around the country, as well as Dr. San Giovanni, who are collecting that data with long-term studies. Now what are we looking at in that x-ray? This is the tibial prosthesis that's going in. And we're actually looking at from the side so you can see the keel. And Dr. San Giovanni is impacting, and he just wants to make sure that it goes all the way back and yet it isn't actually (inaudible) at the back. And now the implant's in. Wow, look at that – fit perfectly into the keyhole. And you say that's the skill of the surgeon? Absolutely. That will be quite good motion. Yeah, you can see that. Isn't that great? We're almost done with basically the insertion of the implant. So what we're going to do is we'll fill in the front part with bone graft.

And why is that necessary? Where that keel is, that stem, it's inset somewhat – a few millimeters. And what you want to do is you want to put some bone graft there so that it will also bind to the prosthesis. Now, is it often that that bone grafting fails? Does that happen very often or not usually? Not often in this instance. So there's our implant looking at the front view, which is called an AP view. And it really looks dead on. It looks great, so I think he's going to be quite happy with having an ankle that doesn't hurt anymore. And it does look right center of the bone. So the technology has finally caught up with this procedure. Would you say that? I do think so. Obviously, we need long-term data to prove that; but we really have a lot of faith in these new implants. So the bone – is this his own bone that is now being reused? Yes, right, waste not. So this is the bone you took out before? Yes. And you're putting it back in. And that bone will be viable and living? Absolutely, and it will incorporate and essentially heal like any bone would heal. And it's his own bone. That's amazing. So we're going to just fill this little gap. So once you're finished with the bone grafting, what's the next step, Doctor? The next step is I'm going to assess whether I need to do anything with his Achilles. And then we're going to close. We'll close the wound in layers. On the approach, I tagged – put a suture in certain layers; so I want to get a very precise, tight closure, let's say. Dr. Hodgkins, can you speak to why that's so important? Why closing and layers are so important to the healing process? Well, because essentially you want to decrease all chance of wound complications. And you want to try and restore the natural anatomy that you disturbed by approaching the ankle back to how it should be. And the more respectful you are of the soft tissues and the more anatomic that closure, the better the tissues will do postoperatively. So, Dr. San Giovanni, how long are most patients under general anesthesia for this procedure? I'd say it's about an hour and a half. I think as the surgeon gets more comfortable with the procedure and his team gets more comfortable, then certainly that would shorten – I think somebody starting out doing this, it may be about two hours – two and a half hours But like you say, as you do something often enough, you get better at it. Sure. Dr. Hodgkins, is this covered by insurance by any chance? It absolutely is, just like any other procedure would be.

That's fabulous. Let me just show a front view, just to show you guys. This is a drain. Sometimes we'll put a drain in so that after surgery if there's any oozing or bleeding from the bone, which we anticipate, that it won't collect so much underneath the wound and cause any pressure or problems with the wound. How long does the drain stay in? Usually 24 hours or less. That's all. If you've got a top view – so here's the implant that's in. Okay, we've got the bone graft. As you can see, it's the metal, plastic, metal. The surfaces that were very arthritic when we started the case have now all been resurfaced. And you can see, now it's mimicking or coming very close to what we want in terms of ankle motion. You can see – you go up and down like that, and these surfaces are congruent. They're made to match each other. It seems very stable. I think he's going to be quite happy with the results of this. So we're going to go on. I may do a lengthening of his gastrocnemius. I'm going to try to get a little closure, and then that's really about it. All right. Dr. Hodgkins, let me ask you, why should a patient come to Doctors Hospital for this procedure? Well, first of all Dr. San Giovanni is a world-renowned expert in this; and he's been doing this for a long time – has a lot of experience, both with the old and the new implants. And he's assembled an excellent team here who really take care of the patient from the moment they come into the office to the moment that they're fully healed. And I'm biased of course, but I think we provide an excellent experience for the patient. So what's your best advice for somebody who, like this patient, has been living for years and years and years with this kind of ankle pain? To at least come and let us assess them and have a discussion. We're not going to insist upon anything, but we can simply tell them what their options are. And then they can consider them once we've educated them and decide what's best for them. And, Dr. San Giovanni, this patient will be in recovery how long? This patient will be – in terms of recovery room? Yeah. For about an hour, and then he'll go back up to the floor. Okay, and on a normal diet? Yes. And this is the drain you've just inserted? Yep, this is the drain. It's just amazing how well the ankle moves. The mobility is fully restored using this prosthetic. Yeah, I hope everybody has gained some knowledge about what we do here. It's something that's taken a long time to train with. I have a friend named Gus who says, "If I watch two of these, can I start doing them myself?" And I told Gus, "It's not that easy." But he still doesn't believe me. I'm sure it's not that easy. Is training for this particular surgery done at this medical facility?

Training is not done here – excuse me. Let me state that correctly. We do have a fellowship in our group – a sport medicine fellowship. So we do do a lot of training, and we do do a lot of teaching medical students as well at the university. So the training for this prosthesis though is typically done at one of the centers for let's say a specific company that is going to train doctors on this procedure. And I would encourage that for anybody that's trying this. So your best advice, Dr. San Giovanni, for somebody facing this kind of ankle pain, how do they decide where to get it done and who to allow them to operate on them? I think number one is you have to do your research. You have to do your research. Part of it is word of mouth. And I think it's also you have to feel comfortable with your physician. You have to feel that it's a caring physician and that you have, let's say, the confidence and trust that not only is he going to do a good job for you but he's also going to be a caring doctor. And on that I think we'll leave it. Doctors, we thank you so much for letting us into your OR today. This has been a very informative hour. By the way, if you missed any part of this webcast, you can see it anytime, 24 hours a day/7 days a week, on ORLive or at baptisthealth.net. That's also where you'll find all kinds of information about the cutting-edge procedures now being offered by this world-class medical facility. I'm Diane Magnum. Thank you for joining us. We'll see you next time right here on ORLive.