Lawrence DiDomenico, DPM discusses current literature debating and comparing the outcomes of total ankle replacements vs ankle arthrodesis. Dr DiDomenico also discusses current total ankle replacement systems available and their major distinctions.
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TAPE STARTS – [00:00]
Male Speaker: This next talk is on total ankle replacements, the state-of-the art, and sort of complements the ankle fusion talk that I gave earlier. This is its counterpart. My experience now, coming at 17 years of total ankles is this is here to stay and it's going to be a procedure that's going to get better and better as technology and industry has really developed more better improved ankles. And I think there are more people doing it, more people contributing to the science of it.
As a background, I'll try to go through this quickly. But in the 1970s are really the first generation of implants that came out. And they didn't do well particularly because it was the design of the implant in particular because prior, foot ankle surgeons are doing the procedure itself, and finding that right type of development of the proper implant is a key for it. These were cemented. They did fail pretty well through the '70s. I wasn't around then, but just from historical hearing, folks that were around, this was not a good situation. So, obviously, the enthusiasm was untempered quite a bit because of the failure rate, and that's where the ankle arthrodesis procedure became truly the gold standard or the way to go moving forward.
And again, I think there is a misunderstanding of the implant. They are looking at hips and knees, and trying to mimic the same type of implant or similar type of implant, those who are doing it at '70s and '80s. But it's a different joint, different type of joint, functions differently, and also we all know that balance in the foot ankles are much different than performing a procedure on a knee or hip. As we know, the ankle has one-third of surface area of a knee but carries twice a load of a knee, so it's a different joint as I said. Most of these patients are post-traumatic and/or primarily osteoarthritis and rheumatoid. At least that's the way it goes in my practice. Again, as there is demand, patients don't want to have fusions if they can avoid it. The once who are knowledgeable, you'll hear that F word, and they think it's just not a good idea.
Again, this is our first generation, and for myself, these are the pointers. This is an implant we just took out that had been in the patient for 35 years. This one is unusual one. We just took this out Wednesday. Survival of 35 years, this gentleman was 70. He had this put in – or he's actually 69, I'm sorry. He had it put in when he was 34 for a tib-fib fracture. And it's amazing to me, this thing survived. So it's a polyethylene piece and this is the talar component that I just took out the other day. This is a second generation, which was the first FDA one I used, was the [indecipherable] [02:38], no longer on the market. It's a semi-constrained, two-part system. It means the polyethylene pieces get snapped into this tibial tray and that's our talar component.
And this is a Buechel Pappas, it never made it the US. It was on trial here but never truly get FDA-approved in the late '90s and early 2000s. Again, in anatomy and biomechanics of ankle, I'm not going to spent time going over that because I think everybody here knows it. So what is the ideal patient? It's still for debate. It's still changing. I could say this. In general, because every case is specific for each specific patient, it's older preferably, thin preferably, low physical demand preferably, and minimal deformity preferably. But that's not the way it always comes and they come in all sizes, shapes, and deformities, weights, and different things. And you had to look at that. And now, at this point in time, even some diabetics are getting total ankles who are non-neuropathic, spend significant amount of time demonstrating that they're not neuropathic.
And there are three component of design, such as this is a star as you see. This is one component. Two component floats completely independently, and the third component. So you can see, this is the only FDA-approved three-component design or mobile bearing in the United States, which we'll go over here. Most of these systems that are in the US are two-designed system. That means they're fixed-bearing system locks the polyethylene component to the tibial base plate, and that's really what most are.
Today, as we sit here, the management of end-stage arthritis, what do you do? Anti-inflammatory bracing, you can do an arthroplasty, arthroscopy. And I mean by arthroplasty, by removing resected areas. You can do an arthrodesis such as – you distract that joint. I found this will only be about 40% successful in my practice. The results published are different but I have not found that success mature from – I could do it better maybe, but I don't rely on this and short-lived, if you will. It's only going to buy you a certain amount of time. Arthrodesis, we talked about that earlier and ankle fusion works very well. It's very predictable for the right patient. And again, ankle joint arthroplasty, I think for the right patient, is a tremendous way to go, and I'm very pleased after 17 years. Again, but I think the key thing is right patient selection, knowing your indications and contraindications. So this is still a great debate.
This is known as Agility, the calcaneal osteotomy, ankle fusion, which do you for the patient? I think every case is specific. Every case is different. Every patient's expectations, where they are in their life, different things like that. But again, I will tell you, we're going to, I think start turning this way for that right patient. Whereas, years ago, this is more predictable. Well, this is pretty predictable now for the right patient. So again, if you have that right patient, I'm leaning towards ankle arthroplasty when possible because I know the outcomes are pretty favorable and pretty predictable at this point in time, but you have to have that right patient, if you will.
So ankle joint arthritis, the prevalence would never be what it is in the knee and hip market. That's about one-tenth of what the knees and hips are because we just don't have that much post-traumatic or end-stage arthritis versus the other joints. We know as the aging population in the US and worldwide goes, that we're going to have increased need, increased demand. Patients are living longer. So with this, there is need for more – keeping those joints moving.
Indications and pathology for total ankle replacement and ankle arthrodesis, again, in most of my patient practice, is the vast majority of post-traumatic, primary osteoarthritis, rheumatoid, and there's other ones that can occur. Indications are end-stage arthrosis at the tibiotalar joint that we're talking about. Again, relative indications, you like to have somebody to be older. But sometimes, we do these procedures on – perform these procedures on somebody who's younger who may be an RA patient or have other issues. Preferably not a laborer. Somebody's going to be jumping off in on and of trucks or roofs, whatever. The implant will not last that long. They have to have realistic expectations, activity, level of sports. They're not going to be playing Rack-A-Ball with these type of implants. And I will tell you this, most of these patients who come in are not very active because they're so limited by the end-stage arthritis.
And the two goals I always tell them is, our goal is to increase their function and decrease their paint. Those are our two goals. And typically, you can do that with a total ankle replacement. It's very predictably if all goes well. So most people have the expectation that, "I can get back to Rack-A-Ball," because when you have this type of deformity or pathology, these people have been limited for many, many years. This just does not come on quickly. It's usually a slow, gradual onset.
Contraindications are AVN in the talus. It depends on how much AVN but AVN takes a long time to really settle or have the end point, so I would caution on that. Cavus foot deformities if it's too much for high arch or nerve muscular foot. Neuropathic obviously is completely contraindicated. Severe osteoporosis, that's relative. Poor soft tissue envelope is a big concern. That one has to take into consideration. Previous arthrodesis or we're talking about a takedown of an ankle, previous ankle joint osteomyelitis. Again, how much is involved and where you're at? With that, again, these are contraindications.
Severe neuromuscular disorder where there's a lack of balance of the musculature is a contraindication. The foot need to be plantigrade. And again, if you have excessive coronal plane of greater than 20 degrees, you're probably not going to be able to balance out a total ankle replacement very well with greater than 20 degrees. Other contraindications are history of infection, vasculitis, or an open wound or an ulcer. Again, neuromuscular disease, neuropathy. Diabetes, questionable again. If you spent a lot of time with the patient for many months and get a track record of years of stable blood sugar, hemoglobin A1Cs, I would encourage to get the physician involved, to get neurological testing to see and make sure there's no neuropathy before embarking on that, and prove that the patient is not neuropathic.
And again, AVN, this patient here has AVN. If you look at this whole talar body has come out, so this patient is not [indecipherable] [08:51] it's all dead bone. This is not going to work for this type of patient. So whether the ideology is trauma, usually post-traumatic, fractures nonreduced, malreduced, cartilage and misalignment issues, chronic ligament instability, will eventually lead to deformity of the ankle joint. Mechanics, malalignments, structure bone deformities, muscle tension and imbalances, inflammatory arthritis, RA patient, the tibitalar joint, the TN joint, the CC joints, so potentially all the joints burned out. So put a total ankle in here, and fusing these other joints is the way to go for this patient. So again, continue to provide them some motion and they're not locked up with a pantalar.
Again, as I sit here from a prior medical-legal standpoint, or if you survey probably most of the foot and ankle surgeons out there from the multiple fields, they will tell you, the gold standard is still arthrodesis. It's still a very good procedure, good, predictable. But I will tell you, the patients want not to have a fusion if they can avoid it, and I won't blame them, why not. And I think I said this earlier, but here's a patient with a good arthrodesis, good alignment. The ambulation, the gait can be very, very good for these patients. We talked about this earlier about short-term outcomes of arthrodesis is not without prompts if you get down to the bottom.
Amputation surprisingly was quite prevalent for these complications but the complications listed are non-union, infection, painful hardware, malposition, stress fracture, but amputation was surprisingly one of the ones in the literature review. And again, that doesn't mean that ankle replacement doesn't have the same complication, so bear that in mind. And again, we looked at this 10-year follow-up, people after arthrodesis have adjacent joint arthritis over 10 years. So usually near 20 years, 100% predictable. So again, you know what you're getting into. And I think it's important in a period of when deciding, when you're discussing this with your patients, you just talk about what you're thinking about on the day that you're seeing him. But moving forward, 10 and 20 years out, they didn't need a full disclosure of what they're getting into with that.
And again, looking at the downsides of ankle replacement, there are things that we talked about, hills and stair climbing, different things such as [indecipherable] [10:56] on banks, that lack of mobility, if you will. And as I said earlier, for non-neuropathic patient, the worst you can do is travel to ankle fusion, go to subtalar joint fusion, then you go – because these things progress, and this is the first ankle arthrodesis I ever did earlier back in the '90, early '90s, and just subsequently. And I could tell you, it's well-aligned but this patient is not happy. And I can't do anything but provide topical anti-inflammatory cream and different things like that and bracing in AFOs. And that's really just unfortunate.
Non-neuropathic patients, you want to stay away from this and this is another reason why ankle replacement is really a great option. Not only it does relieve the pain but also it maintains motion. And what that does, it allows more normal kinetics, if you will, of your ambulation. Ankle arthrodesis can relieve pain but it sacrifices motion, and that's the downside, and this is good. You have a great 10-year window, but after 10 years, this thing starts giving you some more problems that you have to think of. So again, I'm trying to make you think more globally for your patients.
Why total ankle replacement? Still not acceptable for ankle arthrodesis from the public. Again, as a patient, when they start looking online and start investigating, they realize, "Well, I can move versus not move. I would want to move." In most cases, some patients don't have that option given their condition. Loss of motion, again, this is joint destructive. Prolonged recovery, this is going to change your gait forever if you have a fusion. Overload to other joints, we already talked about. And again, the rate of complications may be considered moderate, mild or high. It really depends on what you read and how you deal with it.
Loss of ankle joint motion, at least you have normal gait patterns and causes restriction of patient activities. So there are secondary effects of the ankle arthrodesis. And again, as I talked about earlier, if you're performing arthrodesis, the key is making sure the alignment is maintained. Keep harping over the same facts, key points if you notice that.
A successful total ankle replacement provides a near normal gait pattern in terms of kinetics of the knee, ankle and tarsal joints. This is the literature to support this. It really demonstrates that the ankle replacement is going to provide patient in that more normal, if you will, situation. Gait analysis comparing ankle replacement versus ankle arthrodesis show that ankle replacement group had greater movement at the ankle, symmetrical timing of the gait, restorative ground reactive force pattern, and the gait was slower though. But it's, again, more normal, if you will.
If you look worldwide, over in Europe, there's well over 30 total ankles out there being used. So it's a little more free than we are here in the US. I'll go through the system. So the Agility is no longer in the market. DePuy Orthopedics has Agility. That's a first generation – I'm sorry, second generation, first one FDA-approved here in the late – at least when I started, late '90s, 2000s, but that's no longer in the market. Then we have INBONE and INFINITY, which now is owned by Wright Medical. It started out with Berkley then Topaz. It went to Raleigh Orthopedics'. But now, Wright owns the INBONE and INFINITY.
More recently, Integra acquired the Salto from Tornier. The Salto Talaris XT, which is a revision one on the market today as we sit here. And then, they have a new one with very limited use, it just got released. It's called the Cadence that I think it would be more released in 2017. Also, not on the market anymore is the Eclipse, as the only lateral approach part, the Zimmer one, the KMI, and then Integra had for a while but it's not being used. And then we have the STAR, which is Scandinavian Total Ankle Replacement, which was SBi. Now, it's owned by Stryker specifically. And then Trabecular Metal, which is owned by Zimmer. This is the only lateral approach one. So that's pretty much what our market is here in the US in terms of FDA. And again, I think you're going to see a couple of others come out this year.
So these are classified as two-piece systems. The Agility, the INBONEs, the Saltos, and the Cadence, the Eclipse again, and Trabecular Metal, and the INFINITY, I forgot to mention as well. And then, the three pieces and the only one that's FDA-approved in the US by Stryker is the STAR, the Scandinavian Total Ankle Replacement. That's the mobile bearing one. Again, all of these, except the STAR to be used with cement, the only system that I know that really, they push the use, is Zimmer, uses that they really try to push you to use the cement. Most of these other ones, nobody does, but it is on label for use with a polymethyl methacrylate, and only one that it is not is the STAR.
So this is what the INFINITY looks like. It's Wright's newest device. Again, the idea is low profile tibial implant design. It's more of resurfacing, trying to preserve the talus as much. For good visualization of the talus, the idea is you can use the PROPHECY, which is a computerized system with this as well. And you can see, it has three pegs in the tibia. All these have porous coating, which allows for bony ingrowth into the porous coating. Now, I was fortunate to be one of the companies to look at the microscope porous coating. It's like mega Swiss cheese. And what happens, the bone just grows in there, anchors, and walks into the implants itself.
This is PROPHECY. It's a computerized based system, sort of gears, guides you on how to make your cuts and where to make them specifically based on your CT scans. The Integra Cadence, their implant again. As I told you, it's been limited use in United States and Canada in 2016. I think the big release will be in 2017. This has also three anchoring system on the tibia and you can see the talar component there. It's site-specific for left and right. And from what I've seen in the system, this seems like it's got all the upsides of all the other ones and just combine it into one implant. So it's very similar to some of the designs of the previous implants. But the little nuances, if you will, are here with the system, and it seems they have taken the best from all the other systems to be applied to. So this would be interesting how this works.
It's anatomically shaped tibial tray for tricortical endplate. This will give you coverage a little better on the tibial side, prevent subsidence. It's more anatomically designed compared to some of the other implants on the market. It's shaped for talar dome, anatomical or articulate and surface designed to recreate the chronic flexion and extension of the ankle. And again, there's a – you can mismatch this system as well and get many different combinations with it.
There's minimal talar bone resection with this, about four millimeters or so. So it's more of a resurfacing with the tibia and talus. You're looking about 15 millimeters. And they can afford to take a little more of the tibial tray or tibial side because of, again, the tricortical walls there, and that coverage that it's provided to you. So it gives you a little more stability, more proximate. So it looks like so you can see, it's more of resurfacing up here. And again, you look at the three prongs here for giving you some anchoring of it.
And this is what the STAR looks like. This is only FDA United States, mobile bearing implant. You have one component, the polyethylene. It's free and you have our talar component. And again, this is used without cement as well. So most of these implants, believe it or not, are very similar but they have slight differences, most differences are between the two and three piece design. And also, most differences are whether it's interior or lateral approach, which again there's only one lateral approach. Although Eclipse was a later approach, the Trabecular Metal from Zimmer is the only lateral approach. Today as we do it, it has many advantages going laterally. A lot of these are very, very similar in design.
The postoperative course, I will tell you, I have done two weeks no weight bearing, sometimes with the six. It's based on which design I'm using, what conditions, how much I'm doing, other conjunctive procedures I may be doing with. But typically, you're mobilizing for a significant amount of time where you feel like there's good anchorage of the bone, where the soft tissue envelope is sealed. And then at that point in time, usually, that can't boot or maybe having the patient start range of motion, then physical therapy. You may choose a brace or you may not as you wean off of the ankle – as you get away from the date of the surgical procedure. And eventually, you want these patients be in regular shoes or normal activity as much as possible. The bone growth in that porous coating area where it anchors down, it takes about six weeks. So you want to protect them or limit it for about six weeks in your postoperative course.
Can we do conversions of ankle fusions from total ankle replacements? Well, theoretically, you shouldn't be able to with this because you need a lateral post. We are actually looking at a paper right now. We're just two cases only where we've had shortened rotated fibula. We're able to do something with it. And also, another case, we're able to bring down the fibula and put it on as a lateral strut, creating the syndesmosis fusion and then going back. So there may be some other option. I've heard of some other people doing it. But in general, when performing an ankle fusion such as you want to keep the fibula intact, it's going to make it much more real or much more easier. I'm not saying that you can't do it but certainly it makes a lot less risky for that one.
In the coronal plane from which you see quite a bit with patients who have a PT10 and dysfunction four and/or significant various deformities, you look at valgus and varus. And the issue is, how much can you correct? Which is most predictable? Is it congruent joint or is it non-congruent joint? At the point in time, this really matters. And obviously, the congruent malaligned joint and the number that sticks out is about 20 degrees, up to 20 degrees, is about where you can correct with it.
When you start performing total ankles particularly for those who are in training, there's a steep, steep learning curve. And there's a significant amount of literature demonstrating that the surgery makes significant amount of errors in the first 50 and much less. So that's a lot of cases getting to your belt before you really get good at it. This is a paper from Jack Schubert. Looking at this and suggesting there's a steep learning curve with this, and with the perioperative complications being significantly higher in those first patients that you perform.
In [Mars and Marusic's] [21:04] article, they talked about 25 cases being, and they went back and they looked back at their complications that they had. So it just decreased after 25 for them. Integra also thought there's 50 cases where their number starts decreasing. So again, no matter what you believe or you read, you could take it that your complications are going to occur in your first several years of performing these procedures.
Whether the prompts with total ankle replacement wound is healing, if you don't have a good soft tissue envelope closed, your surgery is not going to go well. Any time you're looking at metal implants, you have to consider it infected and that's a big problem. So wound healings and infection potentially go hand in hand. A hindfoot arthritis as we talked about for these patients, malleolar impingement, too much bone resection, fractures of malleolus, one of the biggest complications, particularly in those first 50 cases that we talked about.
For patient's high performance as you can see here, the case early on I did, a very thin malleolus. This patient is doing okay, but you can see, this is an auto fusion at tib-fib area. So I took one big block of bone out, but you can see, sometimes the magnification of the x-ray is not real true with what you end up taking at and take out more. Therefore, thin fractures are cause of multiple prompts for patients postoperative. So that's a key thing to maintain that. This is doing an Agility years ago. This is a bone loss. If you lose bone like this, that's a big area to fill and a big gap to improve upon.
As we've seen in the last line, there are surgeons training in patient selection, improve their frequency of the complication and reduce the issues that you have. So the take-home message too is performing these on the "right patient" and nobody knows exactly what that right patient is. But you have to be very judicious on who you perform this on. Again, complications of wounds, this is an Agility patient, RA patient, thin soft tissue envelope, atrophic skin. This is a big problem. This is infection and oftentimes this lead to below knee amputations, if in fact you have infections of implants.
So I'll take three from a bunch of cases because they're a lot complex. This is a gentleman who came in and he – I believe he is in his 60s at the time. I'm glad to tell you, 14 or 15 years out and the Agility ankle is still doing well. It looks like he's got another 10 years with it but he has significant various deformity. He had a clubfoot deformity, previous surgeries, malalignment as you can see. And he wanted a total ankle and I wasn't so convinced I could do these years ago, but we did. So the first thing is getting the foot balance. We did a [indecipherable] [23:37] on, did a calcaneal osteotomy, and then we did a midfoot rotational, as well as – if I remember it right, I think it was the abduction type, otomy with a fusion, if you will, to rebalance his foot and ankle. And then stage it and brought him back and did a total ankle. Again, this is a 14, 15 years out now post-op. And if it gives you any idea, this is the patient's gait.
And this is a perfect patient. He's not too heavy. He's retired, love [indecipherable] [24:03]. He likes gardening, golf. He likes to get around and you could see by his gait, it looks very, very natural. So if we get these patients' balance into a good position, and this is an Agility, which is off the market. And again, there's no evidence this implant breaking down at this point in time, 14, 15 years out. I think he's going to get another 10 out of it because he's the right patient.
Here's the Buechel Pappas. This is put in the late '90s, maybe early 2000, by another provider. It looks like it was doing pretty well. Remember, this is not an FDA-approved ankle. These were being tested in the US in the late '90s and early 2000s. And this guy came to me for pain and I started looking here, suspicious of – this had to be put in from anterior to posterior, loosening all of the tibial portion, because I couldn't figure out why this gentleman was having pain, because he functioned well. His implant moved – I mean, his ankle joint moved well. It seemed like it looked good radiographically, but when we got a CT scan, we can see a cyst there. So to my commotion, there is never really anchoring of bone implant interface here at it.
So back in I think this is 2004, the only implant on the market was the Agility. We took out the Buechel Pappas. We bone grafted the area. And here, the Agility was a two-incision approach at the time. We stabilized this. This is the fusionly created pack, the serial bone graft, and he did extremely well for a number of years. Here's what he looks like by sole fusion across [indecipherable] [25:26] and osmosis, and this is what his implant looked like, functioning. We had a nice bone graft in this area. So these implants for right patient work very, very well in my hands, at least at the time. And that again, in the early 2000s, that's the only implants that were on the market.
Here's a patient presented with an end-stage osteoarthritis post-traumatic. And here, we used an INBONE. This is around 2006, 2007 because this was the next implant that was FDA-approved after Agility. And the external alignment guide really makes it very precise and really a nice endplate.
But in the downside is you're going through the bottom of the foot, plantar aspect of the foot, the subtalar joint. And you have a big tibia, you can make these smaller. I've chosen to a go a little bit higher that day, but you can make – it's still going to the tibia, but you can see the amount of extension and flexion this patients gets in here. I'm just trying to stress and to demonstrate how stable these implants are, given it's done right, that they're very, very stable. And again, just a clinical exam showing the flexion, extension with this implant to give you an idea of what it looks like.
Here's another patient who's post-traumatic arthritis, an older female. And here, the next implant that came out in my hands is around 2007, 2008, I don't remember the exact date. This is a Tornier, now the Salto, and you can leave the hardware in there. It's an anterior approach. As they call it, the equipment is mobile bearing or forgiving, if you will. And this is what the Salto Talaris looks like and this lady had this in here now in a nice eight years or so, plus or minus, doing extremely well it.
Here's another gentleman who came to me with an end-stage arthritis of implant with INBONE. As you can see, you get a nice coverage with it. And here's his clinical extension and flexion. As you could see, it works well, and here's the gait. And I try to show you these gaits because you can see, these gaits are very important if you get these balanced nicely, they function very, very nicely. Here's another patient with end-stage arthritis. You can see we took out the hardware and bone on bone at the tibial talar joints. And here we put a STAR, Scandinavian Total Ankle Replacement. Again, the tibial, the polyethylene and the talar component. This floats independently of these two. And the idea is to decrease the shear forces of the bone implant interface by having a forgiving mobile bearing area.
Here's another patient. This is Zimmer, a lateral approach. As you can see, the fibular osteotomy. The nice thing in this case, you have an external fixer to use with alignment check. It puts it very precise. And the nice thing about this, once you have everything set up, it's very, very reproducible. There's no "Kentucky windage" associated with this. This is what I like about this system myself.
And this is drill holes, and then some resurfacing, and we're falling a natural arch of the talus and the tibia in terms of how the amount of bone implant versus bone surface area it covers. You're covering actually more versus a flat top area and also the most strongest born is right – or subchondral so you're getting more stronger bone if you're sticking here versus going across in the cancellous area of the bone. So there's many advantages of this. The downside is fibular osteotomy but I've not had any issues with that from an aging standpoint. This is a much more friendlier way to enter into the ankle going lateral than medial.
These are the trials – or not the trials, but the measuring, if you will. Prior to putting the trials on, you want to make sure you get perfect circles. Get this talar component to sit flat on the talus. You can see very little talus is removed, very little tibia removed. And then once you buy it, you buy it. Try your trial implants, and then here's our – I'm working through if you're working this, this is what it looks like. That's our implant and there's our plate that we use for fibular osteotomy with this. And this is what the patient looks like. They have a polyethylene piece in there as well, but very little bone resection again. More bone surface contact and it's more in stronger bone or more subchondral bone, which is your best bone to use it with. So here you can see what that patient looks like.
So what have I learned? Total ankle replacement is not a forgiven procedure if you make big mistakes. So you've got to think about this thoroughly. You have to be very well prepared for it. You need to use good, cautious judgment in your decision making. A lot of times, patients will come in who are not the right patients and they'll try to push you into it. And don't let them push you into it because that's where you'll get yourself in trouble. Use your gut feeling. There's a lot of pathology out there that just continue to develop as times go on, so don't let the patients talk you into it. You need good people around you in terms of vascular surgeon if you're concerned about vascularity. Plastic surgeons possibly or somebody who can do flaps if you do come across wound problems.
Certainly, the infectious disease team as well if you get an infection or soft tissue problems that lead to it. So I would tell you this, patient selection is critical. And I've been very fortunate over the 17 years now. I think I've been very selective of what I done so I really have not had much problem with these patients, and I see a lot of others creating bigger problems because they're not picking the right patient. So I think this is critical with doing this. If you have the right patient, I think this is very, very successful. Not easy to do, complications can be significant if you run into problems.
So, again, this leads to this if you don't pick the right patient and you have to pay attention to detail even from whoever is retracting from you, spending time retracting. Every little piece of this, it's a high stress of why actually experiencing with all the foot and ankle surgery that I've done. And again, just select the right patient because we just want good outcome. We want these implants to be around forever. We want out patients to be happy and get to a good outcomes with this. So pay attention to detail, select the right patient, and I thank you for your attention.
TAPE ENDS – [31:12]