BIRMINGHAM HIP RESURFACING SHAWNEE MISSION MEDICAL CENTER SHAWNEE MISSION, KANSAS September 20, 2006

BIRMINGHAM HIP RESURFACING SHAWNEE MISSION MEDICAL CENTER SHAWNEE MISSION, KANSAS September 20, 2006 00:00:12 ANNOUNCER: A new approach called Birming...
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BIRMINGHAM HIP RESURFACING SHAWNEE MISSION MEDICAL CENTER SHAWNEE MISSION, KANSAS September 20, 2006 00:00:12 ANNOUNCER: A new approach called Birmingham hip resurfacing offers a new alternative to hip replacement for younger, physically active patients. Today, surgeon Dr. Scott Cook will demonstrate this approach in a live webcast from Shawnee Mission Medical Center in Shawnee Mission Kansas. 00:00:28 SCOTT COOK, MD: Hip resurfacing is a type of a total hip replacement where instead of removing the femoral head and neck with a total hip replacement, you just remove the diseased cartilage from the head and put a cap on the head, thus preserving all of that bone. 00:00:44 ANNOUNCER: Using bone-conserving techniques, surgeon Dr. Scott Cook will shave just a few centimeters of bone rather than replacing the entire hip joint. 00:00:52 SCOTT COOK, MD: By doing that, you’re basically preserving the anatomy of the hip. You’re replacing exactly what you remove. The benefit to that is there’s not such a risk for a dislocation event, even with more aggressive activities and ranges of motion. 00:01:07 ANNOUNCER: During the webcast, Dr. Cook will answer e-mail questions from the viewing audience. To send your question to Dr. Cook, just click the MDirectAccess button on the webcast screen at any time. 00:01:23 MARK RASMUSSEN, MD: Welcome, ladies and gentlemen. We are coming to you live from Shawnee Mission Medical Center in Shawnee Mission, Kansas, a beautiful suburb of Kansas City. Hi, I’m Dr. Mark Rasmussen, you’re host this evening. I’m joined in the operating room by Dr. Scott Cook, who will be performing the procedure to—excuse me – tonight. Dr. Cook is one of 40 doctors trained to do this procedure in the United States. Keep in mind that later in the webcast, we will try to answer questions sent in from viewers. You can send us a question now by simply clicking on the MDirectAccess button on your video screen. We welcome your questions and will try to answer them this evening. Now let me turn things over to Dr. Cook. Scott, can you let us know where you’re at in the procedure this evening? 00:02:06 SCOTT COOK, MD: Absolutely, Mark. Thank you very much. Before we get to the procedure itself, I’d like to take care of a couple of bits of housekeeping. I’d like to introduce my colleagues that are in the O.R. with us today. To my left over here, we have Linda Orrell, whose our surgical assistant. She’s been with the group for a very long time and has quite a bit of skill at doing these kind of procedures. Behind her is Sergio Valadez. He’s a surgical scrub here at Shawnee Mission and works with me on

a day-in, day-out basis and does a great job for us. Over here, we have a circulator, Kim Marshall, who will go through and help us out with getting instruments and whatnot from the outside. And then Linda Reismeyer is here with us as well to do the same. Behind the drape right here, we have Marlene Bailey, who is becoming somewhat of an internet star. That’s not always a good thing, but she’s an excellent nurse, anesthesiologist, and she’ll be helping us out from the anesthesia side. And so you can see that it really does take a full team effort in order to do this type of a procedure. Before we get to looking a the incision and everything else, I’d like to just point out a couple things and just talk to you a little bit about the patient that we’re working on tonight. This gentleman is a 61-year-old gentleman who is extremely active. He is a local radio broadcaster and is also starting a business, which has kind of been his passion – for baking. And so in doing that, he’s going to have to get down on the ground quite a bit. He’s going to have to be very mobile and agile in order to do that. He may also have to lift some heavy loads, and so he is a very good candidate for this procedure. Let’s take a look at his X-rays. And the X-ray that we’re looking at right now is just looking at his pelvis as if he’s facing us. And so the left hip that we’re working on today is the one with the arrow. Let’s first start by just taking a look at the right hip. The right hip is a good example of what a normal hip should look like. It’s a relatively smooth, round femoral head. It has an hourglassshaped neck, and you can see that clear space that goes around the head between the cup and the ball, and what that is is the cartilage. The cartilage doesn’t show up on X-ray. Now, going over to the one with the arrow, you can see it has not fared not nearly as well as the one on the right, and he does have bone-on-bone arthritis on the one on the left. He also has a fairly significant amount of osteophytes, or bone spurs. And so this hip’s been causing him incredible pain and really preventing him from doing what he wants to be doing. Now, just a couple of other things I want to point out. Number one, this is a wonderful thing, and I really appreciate everyone’s interest for taking a look at this hip surgery. This is by no means meant to be an instructional video or anything like that. I am not an innovator of this procedure. This procedure has been innovated overseas and in America and has really gone through a process of about almost 40 years in getting to the point where it is now. The second thing I’d like to point out is the incision itself, and this gentleman is a relatively thin gentleman. Let me see just a lap pad here. Relatively thin gentleman, and I will point out that this is not a small-incision surgery. If we were doing a standard hip replacement on this particular gentleman, I could probably do that through an 8-centimeter incision. And that would be a small-incision surgery. I don’t, however, think that that is nearly as important as what we’re doing today, and it seems that here lately in our country, a lot of emphasis has been put on minimal-incision surgeries. What we’re doing today is bone conserving surgery. And so in my mind, that’s much more important. Now, I know that the majority of the public that is viewing this is lay public and people that are interested or have painful hips. That are also probably some surgeons out there, and so I’m just going to point out a couple things that may be of slightly more interest to the surgeons. What we have here is a Charnley retractor. It’s a self-retaining retractor, and we’ve really exposed out the hip at this point. This is holding the gluteus and the IT band open so we can get into the hip joint. Underneath that, we have both the capsule and the short external rotators, which we have tagged, and I’ve also released the top half to two-thirds of the gluteus tendon insertion down here. And the reason for that is that the sciatic nerve, which is the main nerve that feeds sensation and motor control to the foot runs directly under that gluteus tendon, and as you’ll see, in order to get exposure, we have to put a fair amount of twist on the femur, and so we want to make sure that that nerve is not getting pinched. And that’s the way we do that. So let me just – Linda, if you’ll come back here for a second, we’re just going to

dislocate this patient’s hip, and with the – with the camera, what we’re looking at – the femoral head should be nice and round, and what you can’t see, because we’ve already removed them, is that this gentleman had a significant amount of osteophytes all the way around his femoral head. He has degenerative arthritis up here. Let me see. Do you have a free-er there, Sergio? Tremendous amount of arthritis – up here, this should be smooth cartilage. And so that’s why his range of motion was so poor, because these osteophytes weren’t allowing him to move like a ball and socket. You can see what kind exposure we can get on the head and neck, and that’s part of the reason for this incision. The bigger reason – let’s go back down to a more neutral position, and let me see that double-bent retractor. The bigger reason is the exposure that we need to get on the cup, and in order to see that cup, we put a retractor over the front portion of the cup. And that’s good there. And then let me see that right-angled retractor. And a mallet, Sergio. And so what we’re doing is retracting all of the tissues around that hip. I’ll take that back. Okay. The people in the audience might notice that we’re all wearing these space suits, and the reason for that is that it keeps the wound nice and sterile and allows us to have a full field of view. Now, let’s go back to the camera at the foot of the bed for just a second. And what you can see there, what we’re looking at, is the accetabulum itself. The femur has been retracted superior and anterior to the accetabulum. I’m going to see if we can push that – yeah, just drop that table just a little bit. And hopefully, that shows it even better. I can’t look at the camera and shine the headlight at the same time because it only looks where I’m looking. 00:10:02 MARK RASMUSSEN, MD: That looks good. 00:10:04 SCOTT COOK, MD: But this is the front part of the cup, or the accetabulum. This is the back part. This is the top part, and this is the inner portion, or the fovia. And so you can see that we get an excellent view of the accetabulum, and I think that’s much more important, especially with resurfacing than a small incision: getting a good view. And so now what I’m going to do: I need to change this accetablum because it’s not a perfectly hemispherical cup to a more hemispherical cup, and so we’re going to take a reamer and start reaming that accetabulum. 44, yeah. Let’s take a look. We’re going to 50. So we’re going to start off with a much smaller reamer. 00:10:48 MARK RASMUSSEN, MD: That reamer looks like cheese grater that will just gently scrape the surface of that bone to get it back to a more cylindrical shape. While he’s reaming that, I want to show you a few of the slides that we have that shows you the difference between a resurfacing replacement versus a total hip replacement. Do we have those slides up? A total hip replacement replaces the whole neck and head of the hip or the femoral component, where a resurfacing replacement only replaces just the head. So we’re really preserving the bone stock of the neck of the femur in that situation. I can’t see if we have those slides on. So the slide on the left will show you a total hip replacement, and you can see the pin going all the way down the shaft of the femur and then the socket – slides are up? The slide on the left will show you the artificial hip with a total hip replacement. You can see the whole neck of the femur has been removed and a new socket has been placed. On the slide on the right, you see the resurfacing, where we maintain that neck and basically resurface the head to allow for a much more conservative resection. Here you can see what he’s looking at in the wound just a minute ago was the head and neck. Feel free to interrupt me at any time there, Scott. On the left of this slide, you see a total hip replacement with the stem that’s placed down into the shaft of the femur. On the right, you can see that

resurfacing component which is, as we said, very conservative compared to a hip replacement. 00:12:44 SCOTT COOK, MD: Let me see that half-inch curved osteotome back. 00:12:26 MARK RASMUSSEN, MD: I think we have – here you can see what the X-rays will look with the resurfacing versus a hip replacement. We have those slides up now? If we do, the slide on the left is the artificial hip. So you can see the stem that goes all the way down the shaft. You can see the neck has been removed from the hip and so has the artificial head. On the right, we have a resurfaced head. SO you can see how we still have the neck in place. The head component is cemented onto that reamed head, and then we’ve got an artificial socket. This is what the Birmingham component looks like. It’s a metal-on-metal prosthesis. 00:13:31 SCOTT COOK, MD: 50. 50. Thank you. And I’m sorry I’ve got to get in the way of the camera here, but in order to ream this in line with the accetabulum, I’ve got to reach across a little bit. 00:13:47 MARK RASMUSSEN, MD: While we’re – while he’s doing some of the resurfacing, we have had an e-mail question come in from Maria that says: What makes her a candidate for this procedure? And if we have that slide up at this stage, as you can see, young, active patients with hip arthritis who are likely to require a total hip arthroplasty at some point in the life or approximately people that are 60 years of age or younger, people with avascular necrosis of the femoral head, people with hip arthritis in the context of proximal – in context with a proximal femoral deformity, somebody that’s had a previous fracture, previous surgery on their hip as a child, or somebody that has a neuromuscular disorder that would predispose them to some sort of instability. This hip tends to be a much more stable hip due to the size of the femoral head and the socket compared to a standard hip replacement. We’ll see how Scott’s doing. 00:14:51 SCOTT COOK, MD: We’re just removing a couple more of the big bone spurs from the front of the accetabulum just to ensure that we’ve got a good clean view at it and we can put our cup in now. We’ve got it shaped to a hemispherical shape, and so it should be nice and smooth, and we should be able to get that cup in there quite nicely. I think that, you know, Mark has shown, you know, what the differences of the surgery are, and I think one of the important things with the surgery – yeah – is who is a candidate for the surgery and who is now. I mean, the one thing that we know is that total hip replacement works very well, especially in the population over the age of 65. What we have seen is that historically, total hip replacement has not worked nearly as well in the younger population or those 55 and under, and as we get more and more active – and of course, we think that’s related to activity levels. And so this is why the Birmingham hip replacement is important. So the number-one criteria for being a good candidate is somebody who’s not a good candidate for a total-hip replacement. In other words, a very young and active person with bad arthritis. 00:16:25 MARK RASMUSSEN, MD: I think we also have a little slide that talks about what would prevent a patient from a resurfacing procedure. 00:16:32 SCOTT COOK, MD: And let me just – let me just show this component a little bit. This is the cup itself. You can see the inserter, and basically, the entire inside of this cup is hollow. The outside part is coated with beads that the bone can grow into and

also a material called hydroxapetite, which basically allows the bone to grow on even faster. I’m sorry, Mark. Go ahead. 00:17:01 MARK RASMUSSEN, MD: Oh, the – we talked about people that probably aren’t good candidates for a resurfacing procedure. As Scott just talked – Dr. Cook just talked about: patients over the age of 65, somebody that has severe loss of their femoralhead bone, because we really depend on good bone quality to be able to cement this femoral-head prosthesis in place, somebody that has a bad deformity of their femoral head or of their femoral neck would not be a candidate for this or somebody that has very large femoral-neck bone cysts, somebody that has osteoporosis – we depend on good bone stock in the neck so that somebody will not fracture through this bone. So poor bone stock or osteoporosis is a contraindication also, and that leads to people with rheumatoid arthritis or people with renal insufficiency who tend also to often have poor bone stock. As you can hear, Dr. Cook’s impacting the accetabular component into the accetabulum as we speak. 00:18:00 SCOTT COOK, MD: And we want to really make sure that we get a good, solid fix with that cup, and you can see that when I move this now, it moves the patient’s entire pelvis. And so I do think that’s well-fixed in there. Okay. 00:18:26 MARK RASMUSSEN, MD: As with any procedure, there’s risk, and one of the questions that we’ve had tonight: What are the risk of doing this hip-resurfacing procedure? One of them is a fracture of the femoral neck. Since we aren’t removing that femoral neck, if the bone quality is soft here, there is the potential for fracture through this region. Osteonecrosis of the femoral head: since we are not removing the femoral head, the blood supply can be disrupted with this procedure potentially, which can lead to de-vascularization or lack of blood supply to the femoral head, which can end up in collapse of the structure that we’re trying to cement into. Loosening of the implant, which is a potential complication with the total-hip procedure also, and also, this is a metal-on-metal procedure which – some total hips are similar, but there’s also a potential unknown effect of these metal ions in your body from metal-on-metal implants. It’s been routinely used in Europe, and it’s becoming more routinely used in the United States. 00:19:43 SCOTT COOK, MD: And let me just see that rongeur for just a second, Sergio. And I think you hit on all of them, Mark. I think that the – you know, there are – this is another reason why hip-replacement surgery is not necessarily minimally-invasive. There are risks with this procedure no matter what, but the big additional risk with Birmingham would be the risk for femoral-neck fracture because you’re actually saving that bone. And so it has the potential to fracture, whereas with other types of replacements, it certainly does not. Let me see the rongeur one more time. I’m sorry, Mark, I was just going to say I’m just removing a little bit of extra bone. We want to have a rim of bone over the front part of the cup, and – which we do. And the reason for that is because we don’t want the neck or the tendons over the front of the hip to impinge on the metal. And so I’m just removing a little bit of that excess bone, and I think we’ll be able to get to the femoral-head side. I think that looks real good. 00:21:07 MARK RASMUSSEN, MD: One of the other questions that comes about is” What’s the benefits of doing a hip resurfacing over a total hip replacement? Bone preservation is probably one of the number-one benefits, as well as stability of the joints. We talked about, with this very large-size head on a very large-size socket, you get an excellent range of

motion but also a hip that is much less likely to dislocate than what we use for standard total-hip replacements. A potential benefit also is the physiologic loading of the femoral bone, which hopefully prevents osteoporosis around the implant. And a last benefit is ease of revision surgery. If this hip does loosen with time, then hopefully, this can be converted to a standard total-hip replacement rather than a revision total-hip replacement that’s necessary after a – a regular primary, standard total-hip replacement. 00:22:01 SCOTT COOK, MD: And – absolutely, Mark. And, you know, as someone who does a – there – a fair amount of revision-type hip surgeries in the community, you really learn the importance of that bone preservation and the ability to convert if necessary. Now, obviously, hopefully, that’s never necessary, but right now on Birmingham, we only have very early clinical data, and so at this point, we think that the data looks just as good – the midterm data – as standard hip replacement, but we probably won’t know about the 20 – well, we won’t know about the 20-year data for another 12 to 15 years. What I’m doing right now is just placing my guide pin, and this is probably the most critical part of the whole procedure as far as reshaping the head. You can see, I am not – let me take a look at that view. I am not in the center of the head. What I’m really going for is the center of the neck .The head is deformed. The head has worn at the top. And so if you shoot for the center of the head, then you’ll miss it. You’ll miss the center of the neck. And so what you want to make sure is that this stylus can go all the way around. And this is absolutely critical. And you can see, I’ve also drawn some lines on the head. That is just a technique of double-checking my placement. And this one is fairly close. I’m going to take my time on this. 00:24:16 MARK RASMUSSEN, MD: Scott, we have a few more e-mail questions, and one of them: What is the recovery period before full activity is resumed from this procedure as opposed to a traditional hip replacement? 00:24:30 SCOTT COOK, MD: Say that one more time, Mark. I’m sorry. 00:24:33 MARK RASMUSSEN, MD: That’s all right. The recovery period for the Birmingham resurfacing, is it much different than the recovery period from a total hip replacement? 00:24:41 SCOTT COOK, MD: No, I really don’t think it is. I think it’s not so much a matter of the recovery period. I think we can get good recovery on standard total hips now as well as Birmingham. What is more important is the long-term benefit. And so, you know, it’s not necessarily what we see in six weeks. It’s what we see at six months and a year as these patients become more and more active. I think that looks pretty good. Let me see the mallet. And let me just take it around one more time. You can see how important this is. But that looks like we’re making clearance all the way around. 00:25:31 MARK RASMUSSEN, MD: Some people have asked what the name Birmingham has come from this hip, and I believe, Scott, that’s from the city in the United Kingdom where this hip was designed by Dr. McMin. 00:25:45 SCOTT COOK, MD: That is correct. Used to be called the McMin prosthesis and… 00:25:53 MARK RASMUSSEN, MD: Later was changed to the Birmingham. 00:25:56

SCOTT COOK, MD: Exactly. Mark, I’ll be with you in one second. Let me just take a final feel on this and make sure we’re looking okay. He has a very – one that I want to be careful with. 00:26:11 MARK RASMUSSEN, MD: No problem. 00:26:16 SCOTT COOK, MD: He’s got some softening on his cartilage that makes it a little bit difficult to gain purchase with this. 00:26:25 MARK RASMUSSEN, MD: While Dr. Cook’s doing that, we’ll just give you a little – 00:26:28 SCOTT COOK, MD: Let’s just see the pin, Serg. 00:26:29 MARK RASMUSSEN, MD: A little bit of the data that’s available. We just lost our slide there. Some of the recent European data where a lot of these researchings have been done over the last 10 years – one of the studies by Daniel showed 440 hip resurfacings with patients all under the age of 55 years of age followed for a mean of 3.3 years and a maximum of 8.2 years. In orthopedics, we do like a long-term follow-up, but with this prosthesis only being out for a shorter period of time, we do not have the five- and ten-year-type follow-up. A little more – we – we – with – with those 440 hip resurfacings, there’s been one revision to date, which is a revision rate of .02 percent. 31 percent of the men in the study had jobs considered heavy or moderately-heavy labor. 87% of all the patients in the study participated in leisuretype sporting activities. We’ve had a few questions of whether somebody can return to playing basketball or football, and I think with this type of procedure, we would not recommend any type of impact sport. With total hips, we do, on occasion, allow people to play doubles tennis, and I think this type of prosthesis would still be able to allow you to do that type of activity. 00:28:00 SCOTT COOK, MD: Yeah, absolutely, and, you know, in Europe, they’ve been a lot more liberal with their activities. And so, you know, if you go on the Birmingham site, then you can see people jogging, et cetera. They’ve had a man that’s jogged the London Marathon. They have a world-champion judo champ contestant who has had this done as well. I think until more long-term data’s available, you know, we’ll have to wait and see what the longevity of this component is with those kind of activities. But certainly, you know, the range of motion and having no hip restrictions is a very large benefit and even the possibility of more activity is wonderful. What I’m putting in here is very important, Mark .This is a vent, and we know that any time that we pressurize inside of a bone, we release boney and fatty emboli into the tissues, which can then go to the heart and from the heart to the longs. And so what we do here is we put a suction vent in there, and it prevents most of that fat from getting through the tissues. Mr. McMin – and we call him “Mister” because surgeons in Europe – or in England are called “Mister” – is the one who basically – who studied that and is published on that. 00:29:29 MARK RASMUSSEN, MD: While Dr. Cook’s doing that reaming, we have another email question: Why don’t we hear more about the resurfacing procedure here in the United States as compared to the total-hip procedure? And I think part of that is it’s just been recently FDA approved to be performed in the United States. Since that approval, there’s been over 400 hip resurfacings done in the United States. So you’ll probably be hearing more and more about it with time to come. 00:29:55

SCOTT COOK, MD: Yeah, it’s very interesting. Let me see that drill reamer back for a second. In – in Europe and in Australia – and Australia – and they both have about the same prevalence of hip resurfacing versus total-hip replacement, and it’s about 20% of the total patients that go in with hip arthritis end up with a hip resurfacing. And so what that goes to show you is that number-one, it’s good because it means that, you know, most people are not these really young people who you hate to see with this arthritis in the first place. Let me see that – yep, the stylus. Thank you, Sergio. I’m going to check this again. That’s a continuous, constant theme here is that we check and recheck 00:30:53 MARK RASMUSSEN, MD: …so important, Dr. Cook, is we don’t want to notch the femoral neck with the reamer. That could elad to a potential fracture with the prosthesis. 00:31:04 SCOTT COOK, MD: That is absolutely correct. And this gentleman—I will point out his neck, and this is one of the keys to this procedure. I think the exposure is number one, and then the second key is defining neck versus osteophyte, or bone spur. And sometimes it can be very, very difficult. I think we’re looking good there, as long as we proceed very carefully. Okay. All right. Now what we’ll do now, because we really want to—another one of the problems that’s been established with hip replacement surgery is something called heterotopic ossification, and that’s where extra bone can form in the tissues. Let me have one more. To be honest with you, Linda, I don’t think I need it this time. We had such a good exposure. And obviously, part of the reason why we picked this patient is because he would have such good exposure. Now let’s—I don’t think I can fit that smaller one on there, so what I’m going to do is hand this to Linda so she can protect me from doing the notching into the neck. 46. And we will proceed very carefully with this particular reamer. Actually, let me see the pickups. And Mark, I got off concentrating on this again. Did I finish what I was talking about? 00:32:55 MARK RASMUSSEN, MD: Yeah, I think you did, Dr. Cook. There’s been several questions on how long can we expect a Birmingham hip resurfacing to last. And I think, and correct me if I’m wrong, we haven’t had it out long enough to get longterm follow-up studies. The short-term follow-up studies look very promising. 00:33:17 SCOTT COOK, MD: They look very promising. And so in the short-term, it looks very promising, even in comparison to total hip replacement. But we just don’t have the long-term studies. What we do know is we’re preserving bone, we’re loading bone in a more physiologic manner, and—I’m going to keep going—and that we’re recreating the anatomy of the hip in a much more favorable fashion. In other words, I’m replacing what I’m taking off, and that philosophically is very similar to what we do with knee replacement surgery. And so it’s very appealing. Now let me see a rongeur. And here what I’m doing is jut making sure that I can visualize exactly where I’m going with that cylindrical reamer. Okay. 00:34:41 MARK RASMUSSEN, MD: While Dr. Cook is continuing with that, we have a slide that talks about what’s the process of evaluation. And one of the things you should look at is recognize where your pain is coming from. And typically, pain from arthritis in the hip will be a groin-oriented pain and not pain in the low back or buttocks region. The next step, if that is a concern, is consultation with a surgeon. Often the initial treatment, especially for a young individual, is to try conservative measures, which include anti-inflammatories, physical therapy, weight loss for people that are obese, as well as activity modification. And then the last option then obviously for a younger

person would then be considering some type of surgery, whether they would be a candidate for resurfacing or a total hip replacement. And that’s where the surgeon would be the best to evaluate whether you would be that sort of a candidate. 00:35:40 SCOTT COOK, MD: Mark, we’re getting there with this reamer. I’m just proceeding very cautiously because of these osteophytes. Now let me put it on hand. 00:35:53 MARK RASMUSSEN, MD: So you can see how he’s reamed around the head and has turned that more into a cylinder at this stage. And he’s going very slow and careful so that we don’t get any type of notching of the femoral neck. And as we talked about before, that’s just in an effort to help prevent any type of fracture from a stress rise or from a notch. 00:36:17 SCOTT COOK, MD: Absolutely. That’s critical. That has been the one thing that has been linked to these postoperative femoral neck fractures. And I don’t know if you can see this on the film. Let me see that rongeur. 00:36:35 MARK RASMUSSEN, MD: We got a real good look at the cylinder there in the cancellous bone, Scott. 00:36:38 SCOTT COOK, MD: You know the other thing I would point out with this one is that the neck, you know, like we talked about, Mark, it’s very hard to define that headneck juncture and what is actually supposed to be there and what is not supposed to be there. And the neck actually starts—the head-neck juncture is actually right here, and so we know that this is all osteophyte out here and we’ll very gently debried that away. We try to save as much soft tissue to the femoral neck as possible because we want to maintain as much of a blood supply. 00:37:!5 MARK RASMUSSEN, MD: And that’s important because with the resurfacing, we’re not removing the head. With a total hip replacement, that head’s removed, so the blood supply obviously to the head is no longer important. In this procedure, Dr. Cook is trying to preserve the soft tissues around the neck so that we can maintain a blood supply to the portion of the femoral head that he is going to be cementing the component onto. 00:37:38 SCOTT COOK, MD: And we are about ready to move forward. 00:37:41 MARK RASMUSSEN, MD: For the lay people, when Dr. Cook is talking about the osteophytes around the head, we’re talking about the spurs that have formed from arthritis. 00:37:48 SCOTT COOK, MD: Bone spurs. Exactly. 00:38:11 MARK RASMUSSEN, MD: Dr. Cook, there was a question, “Who does this procedure in Southern California?” 00:38:17 SCOTT COOK, MD: One is the hotbed of hip resurfacing, and Dr. Harlan Amstutz, Dr. Tom Schmalzried are both in Los Angeles, California. And they both run fellowships for hip replacement surgery. And they really have been, on the American side, the pioneers with this particular procedure. You know, and that’s one thing that I think should be pointed out, Mark, is that, you know, who does this procedure? And right now I think it needs to be somebody who has some specific interest in hip replacement, and even probably more importantly, revision hip replacement because

of the exposure required to expose out that cup. It’s very similar to doing a revision surgery. What I’m doing now is marking where the top of my component will be, and I’m going right down to the bottom of the juncture between the femoral head and the femoral neck. Let me just put one more mark on there. 00:39:43 MARK RASMUSSEN, MD: To answer that viewer’s question, also, there’s a website called the www.birminghamhipresurfacing.com website, and that does have a surgeon locator for those around the country. That should give you some information on surgeons that are performing that procedure in your neck of the woods. 00:40:02 SCOTT COOK, MD: Let me see a new lap, Sergio. Fold it up like this last one. That’s perfect. And one more. I just want to protect these tissues. All right. Thank you. Okay. 00:40:29 MARK RASMUSSEN, MD: Dr. Cook’s now reaming the very top portion of the thermal head. Though this hip is cemented in place, it’s a line-to-line fit, so he’s very technical about making sure that this is reamed just to his complete satisfaction. So that’s why he’s taking his time doing this part of the procedure. 00:41:17 SCOTT COOK, MD: And this just finishes shaping off that head. 00:41:24 MARK RASMUSSEN, MD: You’ve got an excellent view on there for the audience. 00:41:28 SCOTT COOK, MD: Great. Okay. 00:41:37 MARK RASMUSSEN, MD: That matches the—the rounding of that head matches the fit of the internal dimensions of the prosthesis. Now in cleaning all of the bony surfaces, ultimately when he cements this in place, he’ll clean any of the blood out of the cancellous bone there so that the cement interdigitates very well with the bone. 00:42:20 SCOTT COOK, MD: Ann, let me see that rongeur for just a second. Okay, and let me see the Rabluski [sp?] drill. This will just allow for some extra cement fill into the head. 00:42:59 MARK RASMUSSEN, MD: We have an email from a viewer tonight who had this procedure done that’s in Ann Arbor, Michigan—had it done in South Carolina six months ago. And she’s extremely pleased, said her recovery was easy. She walked unaided at about three weeks and was swimming at four weeks. 00:43:16 SCOTT COOK, MD: That is fantastic. 00:43:18 MARK RASMUSSEN, MD: She’s back to teaching dance and has a wonderful range of motion with no pain, and it gets even better every day. 00:43:24 SCOTT COOK, MD: That is fantastic, and I would say that you know, you’re always going to have people on both ends of the spectrum. With this procedure or hip replacement surgery, I’ve had people that have left the hospital in two days and have done great, gone back to work. And that sounds like she’s just doing wonderful. And I would imagine that’s Dr Tom Groves down in South Carolina that did that procedure. And that is another person that I’ve studied with on this, and he’s truly an excellent hip surgeon. 00:43:59

MARK RASMUSSEN, MD: There’s been several questions of patients that have LeggCalve-Perthes disease, which is a disease in childhood that often leads to a very deformed femoral head, which I presume, Dr. Cook, is probably not a good candidate for a Birmingham. 00:44:17 SCOTT COOK, MD: Most likely not. Large deformities are not good candidates. The thing is, is in order to—oftentimes with that disease you have a flattened head, and in order to make this cylinder can be quite difficult. Another one that makes it extremely difficult—let me see that rongeur—would be congenital hip dysplasia, although it has been done, but it is a more difficult procedure. Large cysts that you see with some arthritis and large areas of avascular necrosis are also not good candidates. Let me see that horseshoe back for a second and we’ll re-mark that. I think we’re just about done. Let me see that rongeur. He’s got circumferential osteophytes. The other thing is I want to get these bone spurs down as much as possible because it will interfere with his range of motion. 00:45:45 MARK RASMUSSEN, MD: We have a very interesting question from a patient here in the United States who is going to be having this procedure done in India, apparently because his insurance has considered this experimental and won’t pay for it here in the United States. Have you run into any problems with that, Dr. Cook, currently? 00:46:08 SCOTT COOK, MD: I have, and I can’t name names, but I have. 00:46:15 MARK RASMUSSEN, MD: [laughs] So with any procedures, that’s always a potential. Hopefully as the operation becomes more well known, then hopefully viewers won’t have the same problem here down the road. 00:46:34 SCOTT COOK, MD: Let me see the marking pen. Yeah, and that was one of the main reasons that I became very interested in this technology is that people were having to go to Belgium and India to have this procedure done, and hopefully we can avoid that from here on out. All right. Now at this point we’re ready to mix the cement. And this is critical for the surgeons out there: we want to cement this component when the cement has been mixed for one minute exactly. Now let me just put a lap down in the cup. 00:47:34 MARK RASMUSSEN, MD: We had a question on the different sizes of this prosthesis, and there are six different head sizes that correlate with the different socket sizes, so there was a question whether there was different size prosthesis for male and females, and it really depends on the sizing. As you saw Dr. Cook up there at the beginning of the procedure, you have to determine what size best fits the patient. 00:48:03 SCOTT COOK, MD: Absolutely, and-00:48:05 MARK RASMUSSEN, MD: We do have pre-op templates that Dr. Cook can get an idea of what he’s going to be doing, but the final decision is really made at that meticulous process you saw him doing trying to decide whether the appropriate size was done so they wouldn’t get a notch into the femoral neck of the hip joint. 00:48:23 SCOTT COOK, MD: Exactly, and a lot of that sizing—we do template it, but we also do, just like Mark said, a fair amount of sizing as we’re going in to determine what size of cut we can put in and then what our choices of head size are. 00:48:44

MARK RASMUSSEN, MD: Those holes you can see in the head on that view are little holes that allow the cement to interdigitate better into the head also that Dr. Cook had drilled a little earlier. 00:48:58 SCOTT COOK, MD: You ready, sir? And you will watch this tubing, you’ll see a fair amount of fat and blood products right there that we’re saving from the patient’s circulatory system by just having that tubing there. 00:49:20 MARK RASMUSSEN, MD: That’s what’s called a vent tube that Dr. Cook had placed just below where he’s implanting this so that as he’s impacting that prosthesis, the increased pressure from impacting that, that vent tube has suction on it and sucks out any cement particles or any bone marrow particles that may go into your system. We know with standard hip replacements, you can get particles into your venous system which we then see in the heart when we do transesophygeal echos of the heart. Now he holds that prosthesis in place while the cement’s setting up so that there’s no chance for that to back up. 00:50:08 SCOTT COOK, MD: And we think that’s probably unlikely, but with this being in the early stages in the United States, I don’t want to take any chances. We actually have a couple minutes. What else haven’t we talked about at this point? 00:50:23 MARK RASMUSSEN, MD: Well, I think we covered—we have another question from one of our email viewers, and I think we talked about a little earlier, does this procedure preclude you from having a standard total hip replacement? And I think, as Dr. Cook had said earlier, this actually is a conservative measure that down the road, should you need to be converted to a total hip replacement that the hope would be that you could be converted to a standard total hip replacement and not the revision total hip replacement that we have to use after a standard hip has failed. So this should hopefully not preclude you from having a standard total hip replacement, if necessary down the road. 00:51:03 SCOTT COOK, MD: Absolutely, and one thing I would add to that is that the cup—we will have large-size metal implants, hopefully, by the time any of these things need to be revised, so that they can fit into the patient’s cup. So most likely, the cup won’t have to be revised, and that the way that we’ll revise the femoral side is just by doing a standard cut and doing a total hip replacement, like we would with anyone else. So from a revision joint surgeon standpoint, that’s very attractive. 00:51:39 MARK RASMUSSEN, MD: There’s been a question too, Scott, on what the Birmingham hip replacement is made out of, what sort of metal. 00:51:45 SCOTT COOK, MD: It’s made out of cobalt chrome as cast. And that’s important. In the early stages of this, they tried some heat treatments after creation of the implants, and that seemed to disrupt the molecular structure of the metal. And so that as-cast portion is how Mr. McMinn has been able to get his good results with no osteolisis in his entire series except for those hips with the isostatic pressing or the heat treatments. 00:52:26 MARK RASMUSSEN, MD: I believe the heat treatments were designed to hopefully decrease the porosity of the metal, but it actually led to a significant change in the quality of the metal that led to those problems, so that’s why the hip is made the way it is today. And like Dr. Cook said, hopefully decreasing the potential for metal debris.

00:52:46 SCOTT COOK, MD: Absolutely. Let me take a look underneath. 00:53:00 MARK RASMUSSEN, MD: I’m empty on questions. While Dr. Cook’s cleaning up around that femoral head, I just want to show a picture of Dr. Cook on the right and Mr. McMinn, and as Dr. Cook mentioned earlier, in England, physicians are not referred to as doctor as a prefix, they’re referred to as Mr. So that isn’t a typo, that’s just the appropriate acknowledgement in England. But Mr. McMinn, as Dr. Cook has said, has been the physician that has been the one that has done all the more recent work on the current prosthesis that Dr. Cook is using tonight. 00:54:01 SCOTT COOK, MD: For the Birmingham. Absolutely. The surgeons in England way back were called barbers. They were not considered physicians because they were doing the really dirty work at that point, and so that tradition has lived on and that’s how that came about. And now I’m just removing some of this cement from around the neck. It’s got nice and hard. And in a second, we’ll reduce this hip after we clean it up really well and show you how it moves. How much time do we have? 00:54:45 MARK RASMUSSEN, MD: About five minutes. 00:54:48 SCOTT COOK, MD: Five minutes. Perfect. 00:54:58 MARK RASMUSSEN, MD: One of the questions, Scott, is this procedure, and I think you mentioned a little earlier about Dr. Amstutz, had been done a number of years ago that had some pitfalls, and what has allowed us to do this today as compared to then? 00:55:15 SCOTT COOK, MD: That’s very critical. Actually, another surgeon asked me today, why do we think this is going to work now when it’s been tried 30 years ago and then again 20 years ago. And so, what is the difference? And I think there’s a couple major differences. The biggest difference is the difference in what the bearing surface is. So, in other words, where the ball meets the shell. Back 20 and 30 years ago, it was a big, large-size metal ball on a plastic shell that was implanted into a metal shell. So the plastic was exceedingly thin, very brittle, and would lead to plastic particles that would wear off, get into the joint and cause the bone to dissolve. And so now, really, we have three excellent bearing surfaces for young people. Number one, and not in any particular order, but metal-on-metal, ceramicon-ceramic, and metal-on-highly crosslinked polyethylene. And each one has its own set of downsides. I do use every single one. But now we think with this metal-onmetal articulation that we’re not going to get the kind of osteolisis that we saw before with that metal on the very thin polyethylene, which we’ve seen time and time again in orthopedics just simply does not work. Okay, let me see that pliers. 00:56:44 MARK RASMUSSEN, MD: We’re getting down to about three minutes or so, Scott. 00:56:48 SCOTT COOK, MD: Three minutes. Yeah, let’s see if you can pull it out that way, Sergio. It twists, so I know it’s loose in there. There you go. Good man. 00:56:58 MARK RASMUSSEN, MD: One more question, Scott. Is there any restrictions in your post-op protocol as far as hip precautions or things like that for the patient? 00:57:10 SCOTT COOK, MD: I still am using—let me see the pickups—posterior hip precautions for the first six weeks, currently. I’m letting patients wait there as

tolerated, directly following their surgery, but I do have them use a walker. And then, after they’re ready to convert from the walker to the cane, which is usually at about a week to 10 days, they switch to a cane. Then they can come off the cane once their limp goes away. But I do maintain those precautions for six weeks, and then after that, we basically don’t use any precaution. 00:57:52 MARK RASMUSSEN, MD: And for those that haven’t had a hip replacement, often we’ll put restrictions on total hip replacements, as far as how far they can flex their knee and what position they can get in with their knee, in an effort to avoid a dislocation. One of the benefits of this large femoral head is that the risk of a dislocation is decreased because of the size of that ball going into the size of that socket. It’s much more difficult to get that to dislocate. 00:58:22 SCOTT COOK, MD: That is the main reason. It’s all about the jump out distance. Because the other thing we look at is the impingement of the neck against the outside rim of the acetabulum. And obviously in a normal hip, you have a much less distance between the periphery of the head and the neck, and so the ability to impinge, or the propensity to impinge, is much more. 00:58:48 MARK RASMUSSEN, MD: You may show them—we’re getting low on time, Scott—you might show them if you’ve relocated the hip now. 00:58:53 SCOTT COOK, MD: I did. Let’s just take it through a range of motion. And I think what’s most satisfying about—if you would have seen this gentleman before we started, even while he was under an anesthetic, was how stiff he was. And he has an excellent range of motion now. It moves much more fluidly, like you would expect a good hip to move. And he’s stable at that point. 00:59:19 MARK RASMUSSEN, MD: No tendency to dislocate. 00:59:20 SCOTT COOK, MD: No tendency to dislocate. I think it feels great. 00:59:25 MARK RASMUSSEN, MD: Excellent. Well, we’ve got just about 45 seconds. I’d like to take this time to really thank all of you for participating in the broadcast with us tonight. An archive of this program will be posted later this evening on the website. This has been a demonstration of a Birmingham hip resurfacing technique from Shawnee Mission Medical Center in Shawnee Mission, Kansas. Please join us on November 2, 2006 where Dr. David Emmett will perform a robotic prostatectomy. Any further things you have to add, Dr. Cook, before we sign off? 01:00:03 SCOTT COOK, MD: I just want to say one thing real quick. One of my other fellows that I went through fellowship with in Manhattan, New York, is very sick and courageously battling cancer in Virginia Beach, and I’m thinking about you, Lou. 01:00:18 MARK RASMUSSEN, MD: Great. I’m Dr. Mark Rasmussen, and for Dr. Scott Cook and the rest of the OR staff here at Shawnee Mission Medical Center, we’d like to thank you for participating tonight and hope you have a good evening. Thank you. 01:00:33 NARRATOR: This has been a Birmingham Hip Resurfacing performed live at Shawnee Mission Medical Center in Shawnee Mission, Kansas. For more information, to make a referral or make an appointment, click on the buttons on the screen. 01:01:07 END OF BROADCAST

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