Dr. Thorsten Seyler reviews RI.HIP MODELER and discusses key features and benefits of using CORI™ Surgical Sytem for computer-guided THA procedures.
Good morning, good afternoon, good evening. Um From wherever you join us for this webinar. Uh My name is I'm from Duke University in North Carolina United States and I will be talking to you about addressing current hip arthroplasty challenges with hip enabling technologies in my disclosures and the relevant disclaimers for this, that we will only talk about unlabeled stuff tonight. A little bit about my background and my personal technology journey. When it comes to enabling technologies. If you look at this, there's robotics in it, navigation as well as uh patient specific instrumentation. So it's fair to state that over the past 10 years, I've dabbled around in different technologies. Uh And um I'm excited to share some of the this with you tonight. I want to talk a little bit about the coin in a ecosystem and, and part of the presentation or the majority of the presentation will be around components of this ecosystem that I'm personally very excited about. And obviously I'm using this. So I want you to consider this technology as I think it's a step forward and then what we're doing in Hypoplasty. I start off my presentation with a case. This is unfortunately one of my patients is a 66 year old female that I revised for metal metal failure uh and she dislocated shortly after the revision. So this is not an uncommon event. As most of you guys know this, the dislocation rate of a revision of a failed melo metal can be as high as 25%. So not an uncommon uh scenario that we encountered clinically. So if you look at the clinical need for this, and I love this t-shirt taking each day one dislocation at a time. That is true. Uh As in particular for me, working at an academic tertiary referral center. Uh This is not an uncommon scenario if you look at this total hypothyrosis and we know this, it's one of the most successful surgeries in all of medicine with really low failure rates. If you look at this less than 10% in the 1st 15 years, um the dislocation rate unfortunately is the second most common cause for implant failure. And that can be as high as 21%. And the majority of these dislocations occur within what we considered a safe zone published by uh Levine. And, and that, that has been considered a gold standard for for over 40 years at this point. And one of the reasons that dislocation can occur is implant impingement and there's easy ways to address this. So if you look at this, the predominance of early dislocation in this study, um Almost 1800 patients primary had total hip dislocation. The rate was 3.4%. This is significant amount of dislocations in this series. But 34% of these occurred in the first four weeks and then 64% actually occurred within the first three months. Uh They also looked at revision total hip dislocations and that rate was not surprisingly significantly higher as high as 8.1% and 65 of these was in the first two months and 87, almost so almost 90% within the first three months. So, early dislocation is the predominant thing that we find and that probably goes back to uh implant malposition at that point. And there's another study looking at recurrent dislocation. So a study of 6554 primate total hips, almost 70% redis located even with an abduction price and 69% red dislocated without a price. So questioning the the validity of even using an abduction price. But the number that is is really interesting and daunting is the 69% here in a study of 91 revision total rates very similar 24 and 27% v dislocation after the first uh with and without a price. So why are total hips unstable? What are the factors that lead to these dislocations? Well, obviously, one is component malposition surgical approach certainly plays a role in their implant impingement, their head neck ratio, abductive deficiency, which we often see in metal metal failures. And then finally, the spinal pelvic relationship, which I think we're more and more exploring as data becomes available. If you look at component position. And I talked about this briefly in one of the earlier slides, the gold standard really was levi safe zone that, that looked at this location, right? It's based on, on x-rays and they looked at or defined the safe zone as a cup incarnation of 40 degrees plus minus 10 degrees and an an a version of 15 plus minus 10 degrees. But if you truly look in the literature, is this an accurate safe zone? Well, probably not. And this isn't a concept we shouldn't apply in, in 2021, the vast majority of dislocated total hips are in fact, within this proposed levi safe zone. So this is probably not the answer and shouldn't be the target for what we're doing in 2021. And I alluded to this as well. What about the spine? I think this is one of the most interesting or intriguing things that we're looking uh to in in total hip arthroplasty. If you look at the relationship between the spine and the pelvis, in particular, in patients that have undergone spinal surgery or um uh spinal fusion, the odds for dislocation after a total hip and a patient underwent spinal fusion is 340 times higher. So there is a need for us to address this and really look at component positioning in these patients. So the inner play of the coexisting hip spinal pathology really demands attention. And I think that is one of the areas that Smith and Nephew specifically is looking at to, to um guide us with and and and really looking at how we can solve this issue and reduce the uh dislocation rate. So coming to the main purpose of this uh talk tonight is looking at enabling technology, looking at the Real Intelligence hi platform. And if you look at this, it consists of three separate components. The first component trauma care, digital templating has been around for a long time. Um The last component hip seven is the navigation portion is the uh patient specific implant placement. And then the in my opinion, the most exciting and intriguing portion of this trio is the Real Intelligence hip modeler, right? Currently, it's awaiting uh FDA approval but it it it should come soon. So we're very excited to get our hands on this. But I think that the trio of these applications is what is exciting for me as a hip surgeon. So if you look at this in a in a little bit more detailed uh real intelligence hit platform, it it's a suite of planning applications, right? Trauma K is a digital uh platform for templating. Um The images can be can be stored in the cloud and can be used for collaboration can be imported in other applications, right? It can be imported into the model which is a life mod technology um run or powered simulation software that then simulates implant, impingement and potential areas of impingement in dislocation. And then finally, the plan can be executed using uh H P seven through the navigation platform. So for me, if you look at hip seven and I have done hip navigation um for a long time, the the exciting part is just sim the simplified registration. If you go back all the registration software platforms that looked at hip navigation, um it's fair to state or I will submit to you that there was some pain involved in the registration of the patient, in particular, the pelvis. Uh Hi P seven has a very simplified registration process that got uh got validated and it really consists of four steps to register the acetal, two steps to register the femur and it's an automated software workflow. So there's no repositioning that we know from older platforms. You start in supine or sloppy lateral and then go in your lateral position. This, this really doesn't require repositioning which is great. So what cup placement or position decreases the risk of impingement during activities of daily living when we're counting for the spinal pelvic mot uh mobility, right? That, that what I think is the most important factor at this point when it comes to this location. Well, the thing that we need to consider is truly the pelvic tilt, right? And why is this so difficult for us to get a grasp on the pelvic tilt? Well, first of all, the acid have component orientation is usually reference to the interior pelvic plane. When we do intraoperative fluoroscopy or x-rays, these x-rays or these imaging modalities are not in line or parallel to the entry of pelvic plan which makes it very difficult. So, implant visualization usually leads to significant discrepancy between the cup orientation measured intro and post, right. And then if the cup implant positions uh is out of what we consider a norm stability in where really becomes an issue there at this point. So when you look at the pelvic tilt, how much does it matter? And what are the implications? If you look at this for one degree of entry of pelvic tilt, the functional tilt of the pelvis changes by roughly 1.7 degrees, right? Inclination changes are roughly 0.1 per one degree of entry of pelvic tilt. So the entry of pelvic tilt really has implication on your implant positioning, which you need to look at in particular inclination and and and and to some degree and a version of the cup. So the hip navigation portion hip seven really is a way for us to execute a patient specific specific cup placement. We compensate for pelvic tilt. We simulate the post-op x-ray with the real-time cup orientation. As you can see on that screen and it provides us with the confidence and feedback that we don't need interoperate imaging and we can control for outliers and hopefully reduce the dislocation risk. Now, if you look at this, the navigation portion not only helps us with navigating or optimizing cup placement, it also helps us control the leg length in an offset. This is done with a simple registration, two points, two steps to register and it will allow us for more accurate measurement of leg length and offset changes. Right? I think this is a very important thing because leg length differences are still one of the most common reasons for lawsuits, at least in the United States. And this is this is the final puzzle piece of the trio when we're talking about enabling technologies around the hip, it's the real intelligence hip model or application which truly brings the simulation to life. What it does at the end of the day, it simulates certain activities of life and where potentially implant uh impingement occurs. So it's designed around a simplified x-ray landmarking process. And then the patient gets classified based on spinal pelvic classification. In in his stiffness. The plan then gets simulated and we can perform live range of motion analysis in light, in light of the spine classification and how stiff and how positioned the spine is. And we can provide a target inclination and a version that then can be executed with hip seven the Real intelligence, hip navigation software. So if you look at this, we know the limitation spinal pic motor has been linked to a higher risk of dislocation. There is no doubt about it. Everybody talks about the standing and the sitting position of the pelvis and the relationship to it. And then ultimately leading to potential dislocation events, the sp pelvic mobility can be assessed with simple lateral standing and setting x-rays. It's not something that cannot be done in a regular office. It's very, very simple to assess and then can be classified in a similar fashion. If you look at this, there's a classification system that has been published back in 2000 17. Looking at the delta, the change in sa called slope defining these patients as normal stiff fused or hypermobile, right? This classification system or the classification system. These groups are extremely helpful when planning for a target to execute. So we gonna take control of an x-ray. We take an A P pelvis, we determine the tilt on this with a single preop x-ray and we, we have only a handful of landmarks that we have to do to calculate pelvic tilt to click on it. It automatically does it. You don't have to worry about it. At that point, we use the cloud based software and import it into the hip modeler software portion of this at this point. This is the landmarking screen very similar to what we did in in the the landmarking in trauma kit to determine pelvic tilt. Now we landmark um salo and, and, and pelvic tilt and in this right, and uh at this point, we have everything we need to start. So the slope, land marking is very similar and you take the poster aspect of the S one N plate, right, the entry aspect of the S one N plate and make it parallel to the floor to do this. And then you also do the len marking for, for the, for the pelvic tilt using the midpoint between the left and the right A SI S and then the pubic synthesis and we're ready to go. And this is, in my opinion, is the the easiest portion of it. And the most fascinating, this is the evaluation screen of the hip model. You see the implant screen. So you can compare different implants, you have two colors, so you can compare them side by side. You can choose your constructs, you wanna see do a mobility, a large head, a smaller head, you can go through this and look at it, the implant positioning, you can play around with it, you can set the, the functional plane or the A P P as a reference plane. And then you can play in abduction and an aversion and play around. Now, if you go through the 0D model, you see a range of motion there. But for me, the most interesting and most valuable information is are the impingement panels. The activity wheel on the right lower end of that screen, it's gonna be an animation too. But the activity wheel is where I think the meat of this application is. Now, if you go to the next the summary screen of this, you have the three model of the selected implants that you decided the selected implants are gonna be listed there as well. And there's a table cup angles for different uh reference plane. So you can see it side by side and into your pelvic plane versus the functional plane. You see the summary of the impingement screen as well as the summary of your um activity wheel. And then obviously uh a copy of the the landmarked x-rays uh if you need to, but that this is the summary screen for this before you import your plan into hip seven, right? But I want to talk a little bit about the activity wheel because in my opinion, this this is really the fan fantastic portion of it, right? So if you look at this, the activities of daily living are really covered in this wheel of activities gate, pivot, left pivot ride upstairs downstairs, step over chair, bend forward, sit low and it will simulate based on the implant, the cup, an aversion inclination, you pick, it will simulate these activities. And the closer um the closer this gets to the outer rim of this activity wheel, the the the smaller is the distance before impingement and potential dislocation in each of these activities. So keep this in mind. So if you look at this, this is the step over activity, if you look at this. So when you click on this, you can simulate it. This is a computational model that simulates the sitting down. And you see and you follow this, remember what we looked at is the the model of the range of motion. Then you have your impingement screen. And then in the activity wheel, you see how, what happened with this hip kinematics and how close they come to the outer skirt of this this circle, which means the minimal distance before impingement and potential dislocation. Now, at this point, you can adjust the plan, choose different implants or more inversion, more inclination to adjust the plan to find the optimal implant positioning before you save it and then use it to execute this plan. But I think the activity wheel is is the fantastic portion of this this tree of applications that will help us improve patient care and reduce dislocation risk. Because now we have the patient classified based on the spin and pelvic uh motion and we have the x-rays imported and simulate this through life mod simulations. Again, this this these are the two screens that I think are the most important ones is the the planning screen where you can compare implants, you have the activity wheel where you can look at this and then your summary screen, which ultimately leads to the navigation screen, which puts the plan in place, right? And here it is, you have your plan in place. You, you navigate the cup placement, using the impactor and put it right where you want it, you can adjust for orientation as level a cup as well and you can make last minute changes if you want. So it's it's a really helpful uh tree of applications. So in conclusion, if you look at this hip and knee arthroplasty are truly high value surgeries, right? There's no doubt to uh to believe that we're doing a great job already, but we can improve the quality even further utilization of robotic computer assistance is increasing and based on my own uh practice, patients really demand it. It's something that they want. So the increased usage I believed uh of this technology will improve patient outcomes further, particularly when when it comes to to dislocation. And I think the Real Intelligence e ecosystem has the potential to provide a much higher value, especially that, that tree of applications that we see. So, in my personal opinion or definition, the Real Intelligence platform is a real opportunity for orthopedic surgeons to improve patient care. Thank you.