any of the next generation are trained on, either the Moby C, Secure C, Prestige LP, or PCM, the last four they've gotten. If anyone has an approval on, anyone in plan any of those? We're getting a Prestige LP training like next week. Okay, so there's a bunch going on. One of the reasons that this is an interesting area, there's a bunch going on in this field. This is our crew in Charlotte, and I can't ever get a picture that's up to date. We're up to 35 guys now, so we're kind of getting bigger all the time. And everyone kind of has niches in the group, not just spine guys or aneurysm guys, but within that niche, minimally invasive, lateral, et cetera. And so, that's Carolina's Medical Center, which is kind of the big house in Charlotte. These are the disclosures as far as the devices themselves. Like I said, there are now seven FDA-approved devices. We're gonna talk a little bit about those, and we're also gonna talk a little bit about why you should be interested in arthroplasty, or why should we even be talking about it if it's just a niche kind of thing. This is our experience at CNSA. We've been involved with several ID studies, and we're doing this study right now, which is an ongoing study. Carl Loraes and I are the lead investigators for the country for this one. That's the M6 disc. These are all previous trials that we were involved with in one way, shape, or form. So we date back to, Brian, we put our first one in in 2002, so I've got 10-year follow-up on my first artificial disc patients. And it's kind of interesting, because you actually have to have 10-year follow-up on them. The FDA mandates that, and so you get better follow-up than even certainly for your fusions. But why should you care about arthroplasty? What's going on? And I think one of the reasons it's important to talk about, especially for you guys, is that you're generally being trained by older surgeons, and yet you're younger surgeons, and you want to be able to bring the latest and greatest to bear. But a lot of guys, as we've just seen, aren't really doing this kind of stuff. But yet, things are moving. In other words, there's the original three FDA approvals dating back to 2007, 2008. But then in the last two years alone, we've had four more FDA approvals. We've had approval for Cervicor, for Secure C, for PCM, for MoVC, and then just last month, Prestige LP. So we've got, in the last two years, four new devices, including one just last month. We've got a new indication, which is for two levels. So now two level, MoVC is FDA approved for two levels, so that's an on-label usage of arthroplasty. And we've got an ongoing ID study, M6 disc, like we talked about. That's the most popular disc in Europe right now. There's a worldwide experience in greater than 40,000 cases. And so now this is entering the United States, so this is gonna be something, again, two or three years down the line, or probably more, like three or four years down the line, we're gonna see an FDA approval. But this is an actively changing field where the devices are changing, the techniques are changing, and there's this active evolution. So I think it's important for you guys as young surgeons to really be at least aware of what's going on and be able to offer this to your patients. Here's the original FDA approvals. The original device, Pravin published this initial experience with the Prestige ST. There's a Prestige ST. Here's the ProDisc C, and then here's the Brine. We were involved with the Brine study. And one of the nice things about this stuff is that if you look at the number of patients, right now there have been over 3,000 patients that have been enrolled in these prospective randomized studies, and there have been seven of these ID studies that have been in peer-reviewed literature that are out there. So there's this incredible wealth of level one data. So when you get to talking about things like quality and evidence basis, there really isn't anything that has the evidence basis that cervical arthroplasty does. So one of the other things you say, well, why is arthroplasty not more popular than it is? It is becoming more popular, and it is not, even though the FDA studies compare it to ACDF, it is not versus ACDF. This is not an exclusion. You should be able to do both of these operations. In fact, and we'll talk about in a minute, also posterior cervical foraminotomy, you should have three good operations you can do. It's gonna make you a better surgeon. Here's another reason why you should do it. One of the reasons it wasn't adapted early on was because there wasn't a lot of insurance coverage. But we can see over the last several years that there have been several major national insurance companies that have issued national coverage decisions. Aetna has a national coverage decision, United has one, and United now has a national coverage decision for two-level arthroplasty, sticking with the on-label usage. Cigna does, Anthem does. There's a new code coming in 2015 for two-level arthroplasty, and so there's gonna be an actual code for that. And then this is a big one for its adaptation. The two big ones, the two reasons that it's kind of lagged behind is that number one, insurance hasn't covered it, and we see that that's changing now, and number two, it hasn't been advantageous for either surgeons or hospitals, and the new DRG that's been approved, this doesn't impact surgeons, it impacts hospitals, but starting now, actually October 1st was when this DRG comes into place, the hospital now is gonna get paid similarly to what they get paid for ACDFs. It's gonna go up from 10,000 bucks to about 18,000 bucks for your hospital DRG. That's gonna affect things, and you like to think that these things don't affect usage, but they do. And here's another thing that affects usage is this concept of what the surgeon gets paid for as well. And so these are total RVUs, and if you look at it, ACDF, the actual code for ACDF, or the fusion code, is very similar to the code for arthroplasty. It's 47 versus 46. Now with ACDF, you have these add-on codes that pushes it up, but don't get used to 22851. That one's going away, and as Jack talked about, if you're doing a standalone, which a lot of people are doing nowadays, is standalone to zero-profile devices, you should not be using 22845. Even though you're putting in screws, that's not technically anterior instrumentation. And again, there's a word for that, and the word is called fraud. So most people, if you're doing a standalone, this is what you should, the RVUs you're looking at, this is what you get for arthroplasty. I think this is one of, you know, and again, you're going to get paid less on the upfront if you're doing arthroplasty or you're doing posterior cervical, both of which I do, but the bottom line is your patients are going to do better. You're in it for the long haul. If you're a neurosurgeon, you're going to start up in a practice, you're going to get to a good practice, you're going to be there for a while. Your life's blood is going to be your outcomes, and we haven't measured them effectively right now, but it still is the thing that allows you to be a successful or non-successful surgeon, and so if you're doing the right thing, and Jack talked about this, if you're looking in the mirror and you're doing the right thing, you're going to get better outcomes, and it's better for you in the long term. So what are the indications? So this is pretty much FDA indication. C3 to C7 at one level. Now with the MOBY-C, we have two levels. You know, standard failed six weeks conservative therapy, unless they have progressive neurological deficit or they're just in agony. So radiculopathy, this is an arm pain operation. It's not a neck pain operation. It does effectively deal with neck pain, but you shouldn't be operating on people with primary axial neck pain. Certainly, I don't think arthroplasty is an indication for that, and obviously you have to have some sort of radiographic correlation, so pretty straightforward. The thing to take away from this, and we'll talk about it in just a second, these are similar indications to ACDF, but not the same. There's a different set of ideal indications, and so when we talk about ideal indications, it's not just what it's indicated for. It's not an on-label usage. It's where you should be doing this. This is primarily for soft disc herniations, for early disease, younger, healthier, more active people, one and two level disease, soft disc disease, not advanced spondylitic disease. This is what you want to be looking at, soft disc disease, decent disc space height, not an osteophyte, not a lot of facet disease. Question is, all right, if they have radiculopathy, why aren't, could you do a posterior foraminotomy here? If you have the apex of your herniation is medial to the lateral aspect of the cord, you should never be doing a foraminotomy, because you can't really tease that out posteriorly. I'm a big fan of foraminotomy, but when that apex is medial to the lateral aspect of the cord, foraminotomy should be off the table. So what are some of the relative contraindications? We talked about good indications. So if someone has advanced spondylosis, beaking anterior osteophyte, those people are trying to fuse, let it fuse. Go on and fuse them. Don't try to turn the clock back to arthroplasty. If you're going to do that, you're going to see more heterotopic ossification. If you have advanced osteoporosis, again, you don't want to operate on anyone with osteoporosis, but the bottom line is we get a bunch of patients, people living longer, we see more and more osteoporosis. You shouldn't be operating on people with osteoporosis. I usually use negative two on the dexas to drop dead, but probably one and a half is, anything beyond one and a half, negative one and a half is probably not where you want to be. Advanced facet disease. You're maintaining the motion, you need the facets, and if the facets are bad, if the facets are a potential pain generator, then don't do an arthroplasty. If there's a question about the facets, always get a CT scan. Your foraminal anatomy and your facet anatomy is night and day better seen with a CT scan. So this isn't really for advanced foraminal stuff or bony foraminal stuff. And certainly with any kind of global kyphosis or instability, infection, tumor, et cetera, obviously these are not good indications for arthroplasty. Those, by the way, are very good indications for ACDF, and that's what I mean about these are not competing with each other. So I'm going to go case study, because I think it's going to really show some of the indications, but then also some of the techniques, because at the end of the day, it's important to talk about that as well. So this is a 32-year-old guy. He's had a previous shot and he's had a previous fusion. He's done well. He's very motivated. He's a huge guy. He is like 6'6", like 260 pounds, and he works at the hospital as a security guy, so he's not a guy that I'm interested in pissing off. So he comes in with a pretty straightforward C5 radiculopathy. He's got a pretty good-sized disc herniation. His is complicated by he's got a smaller disc at C6-7. And so you can't really see the disc here at C6-7, but you can see it here on the axial. So he's got that little guy at 6'7". He's got a much more prominent disc, and that fits his symptoms. And you can see on, and Jack had talked about a myelogram. One of the reasons I got the myelogram is because I was interested to see is this causing a problem down here. I didn't show the actual myelogram, but he was filling out his C7 root even though he had a pretty good-sized bulge here. And so this guy came to me because he had seen a first surgeon they had recommended three-level ACDF. And so this is another thing that Jack was talking about. A lot of, it's amazing to me how many people I see for two- and three-level ACDF that end up with one-level foraminonomies or one-level arthroplasties. And you're not treating the x-rays. You're treating the patient. And so this guy's x-ray, he's got two-level pathology, and you could see how someone could talk themselves into an ACDF. He's got this at 6'7", here's a major problem. He's got this down here. We can't trap this in between two fusions. So boom, 32-year-old guy with a three-level ACDF. It's not where you want to be. Everybody, we've been involved with studies since 2012, so everybody's getting validated outcome measures when they walk through the door. So this guy needs it. Every device has its nuances. There are several different devices. That's why you kind of have to train on each of them. So I'm not gonna go through the technique for all of them. I'm gonna talk about the M6. I picked that one because it's kind of a neutral one since it's investigational, even though it's an active investigation going on now. It's a very popular, it's the most popular disc in Europe. It's a nice disc, but every disc has its little bit of different nuances. And so when you get your disc, the disc that you want to use, you're gonna be able to figure out how to do that. It's gonna be a little bit individualized to that. But this is basically what you're looking at. You're looking at some sort of sizing, trialing. You always want to be in the midline. Usually there's some sort of keel or something you have to cut for stabilization, and then you put in your disc. It's actually very straightforward. So it's really a standard ACDF. People talked about bigger exposures at the beginning. I don't use any bigger exposures. I do most of my 1, 2, and 3-level ACDFs. I don't do that many 3-levels, but I do, I'm like Jack when it comes to that, but I do them all outpatient, and then we do all these outpatient as well. Not all of them, but I would say 90, 95% of 1, 2, 3-level ACDFs and 1- and 2-level arthroplasties are done as outpatients. And so you want to do midline verification. You have to use fluoro. If you put your distractor pins, you spend some time on the up front, and you put your distraction pins in the midline, that's gonna, you can go off of that for the whole rest of the case. You don't have to get another AP. And then you do a discectomy. Again, it's not exactly like ACDF. It's a little bit more symmetrical. You need to avoid drilling. You need to not get into the end plates. So trialing, pretty straightforward. You gotta stay in the midline. That's a critical aspect that you'll hear over and over again with arthroplasty. And this is one of the rare instances in life where bigger is not better. You don't want to overstuff your arthroplasty devices. Generally, every time, if you just had a five or six millimeter device, it would cover 99% of arthroplasty. Five, six millimeters. And then remember when you're cutting your keel, the device will never go any further back than the keel. So if you're not happy with your keel, then's the time to change it, not later on when you're trying to put a device in. And then you clean out your keel tracks that you put into your artificial disc. Pretty straightforward. Let's see if we can get this guy to, this is a little moving. It's only a little over a minute. I'll see if it actually works. So again, this is an M6. So cast bar pins, you make sure they're there in the midline. You do kind of a standard discectomy, but you want to minimize your drilling. The other thing you want to pay attention to is symmetry. Even if a patient like this patient had unilateral symptoms, you decompress equally bilaterally. You want to get to the back. You want to do a posterior release. So you have to resect the PLL. Most people do that nowadays. But you kind of take off. You also want to do a proximal resection of your ankle vertebral joints. You want to do that symmetrically. And so you kind of get back and you can see there's the dura back there. And even though you're, again, it's unilateral symptoms, you're looking, you can do it for bilateral symptoms. This guy had unilateral symptoms. You have an equal decompression. You get a trialer to give you an idea of what size you're looking at. You can see the dura, the PLL is resected. Again, you're doing this under lateral fluoroscopy. You're making sure you're right in the midline. So these caspar pins are in the midline. So then you know you're in the midline. You can go off the caspars. You don't have to get fluoro back and forth. It's not like doing a lateral where you're going back and forth, back and forth. It's all, you should get one AP at the beginning, know where your caspar pins are. Here's your keel cutter, very small keel. This is one of the difference with some of the original base devices. They had much bigger keels. These keels are very small. And then there the device sits and you can see the retraction. Even the Jack talked about, you know, just the caspars laterally. You don't need anything up and down except for your pins. And pretty straightforward. What's the name of that disc? That's the M6. So that's the investigational one. It is a, it is one of the reasons that it's a new generation disc is number one, it's titanium end plates as opposed to cobalt chrome, which is kind of the newer device that are coming out with more MRI compatible biomaterials. And so it has a titanium end plate. And so you can image MRI. It also has both a polyethylene core and a polyurethane wrap. So it has an ability to actually have some compressibility instead of just maintenance of motion. It also has some compressibility. That's why I think it's important to keep up with the disc because things are changing rapidly. This is still really early on in its evolution. So like I said, this guy, you can see nice motion. He fish mouse nicely here in extension flexion. He straightens out. He's got good lateral bending. You can see a shunt in here. And I didn't have anything to do with that. I'm one of my, one of the things I stand on is that 16 years of practice, I still get to revise the shunt. And so I thank my pediatric partners for that. So he's five and a half years out. So these are the guys that we follow on out. And again, they're maintaining their motion. So as far as pearls go, patient selection, and you'll probably hear this as a recurrent theme. This is the most important determinant of what your outcome is going to be. It's not your, it's not even your technique. It's certainly not the device you use. It is your patient selection. If you're choosing the right operation for the right patient, you're going to do better. That's why it's important that you know how to do more than one or two types of operations. You need fluoroscopy for this. It's not a ton of fluoroscopy. It's not nearly as much as lateral, but you need it. You need a midline. You need a midline verification. You need to make sure you've got the proper sizing. And when you're putting the trialer in or keel cutting, you need to do that under live fluoro. You need to mobilize the disk space. Anytime you're talking about arthroplasty, you have to have motion of this space. So you have to release the PLL. You have to be symmetric, proximal frame anatomies. It's similar to ACDF as you just saw, but it is not the same. There is definitely more attention to detail. There is definitely more nuance. Definitely, I try, I don't even have them open a drill. When I do my arthroplasty, I say, do not open the drill. Now, sometimes I need it, you know, there is some more spondylosis that makes it ideal, but I don't even want to use a drill during the arthroplasty period. And so I have not opened one. I use two weeks of nonsteroidals afterwards. I think it cuts down on HO. And then again, bigger is not better. There are challenges just like anything else. And people see me as an arthroplasty advocate. I do many more ACDFs than I do arthroplasties. These things are not mutually exclusive. And that's the thing that I would try. The one thing I would try to leave you with, everyone tries to set them up because the FDA sets them up one against the other. It is not a fight as arthroplasty versus ACDF. They're both good operations, and they both have their sets of concerns. So, you know, yeah, there's a ton of level one data out there for these things. I mean, a ton, over 3,000 cases, seven studies in the literature, but there's bias involved with that, as experimenter as well as patient bias. The things you worry about, subsidence, dislocation, those are concerns. Wear debris, especially with the metal-on-metal devices, you can give a talk just on that. Different kinematics, different devices, which one should I use? And a lot of it is what you're comfortable with. You can give a talk only on that. Heterotopic ossification, that is something that's generally not a clinical concern. People with heterotopic ossification generally don't have clinical correlation, but they stop the motion, so that's a big deal. You want to cut down on that. And then adjacent level disease, which you can give a talk just on adjacent level disease as well. So the bottom line is, there are three efficacious procedures that exist for cervical radiculopathy. There is no question about that. And you can actually add a fourth one there. I don't happen to do what Rusty does, laminoplasty, and so I think the indications are probably not necessarily for single level, but I would really say there are probably four efficacious procedures that you can do for, but these are the three that I do. I do ACDF. This is for people with radiculopathy and neck pain, just like arthroplasty, radiculopathy and neck pain, but their imaging looks a lot different. This is for advanced spondylosis, multilevel disease, kyphosis, instability, trauma, ACDF all day long. Arthroplasty is reserved for younger, healthier patients, focal disc disease, soft disc disease, not a lot of facet disease. For aminotomy, this is a great procedure. This is, also we do this outpatient. We've done over 2,000 of these in our outpatient center, and these things are indicated for unilateral radiculopathy, pretty much without neck pain, so I think the reason ACDF gets set up against arthroplasty is because what the patient presents with is similar neck and arm pain, but the reality is is that they should have very different looking x-rays, and again, these are your ideal indications. Obviously, if you were gonna put a circle at each one of these, there would be some overlap in the middle, but that overlap is a lot smaller than you think. If you pay attention to what your patient is complaining about, you pay attention to what their imaging looks like, you're gonna have very clear lines drawn between these three things, and you're gonna be a better surgeon if you could do all three of these than if you're really, really good at just one of them, and that, to me, is the take-home message. Thanks for your time this morning. I'm happy to answer any questions. Thank you.

cervical arthroplasty

artificial disc replacement

motion preservation

patient selection

complications

level one evidence