Name: FlexiGRAFT® in RC Repair
Uploaded: 2016-03-01T00:00:00Z
Duration: 17 min 35 s
Channel: Arthrex

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VID1-00615-EN | A | FlexiGRAFT® in RC Repair

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FlexiGRAFT® in RC Repair

I think it's always important to remember and just put this in perspective, that our techniques have evolved considerably in cuff repair surgery. I borrowed this slide, the top left, from my mentor at Special Surgery, Russ Warren, which is a not uncommon way that we used to have to approach cuff repair. And largely because of the great work of this company and others, this is sort of now our standard of care more often than not fixing these things. Arthroscopically. As you can see here. But again, one of our challenges remain that even though we can sew this down in the operating room, nice double row technique with or without knots, we still recognize that the biology lags behind the technology. You know, our tendon bone interface still remains our weak link. Our repair site heals slowly. And for those of us who do this in the in the O.R., we're often humbled that for these large and massive tears, if you look a year or year and a half or two years later, oftentimes the structural failure meaning the cuff is no longer intact despite a somewhat satisfied patient is all too common. And that's why I think this symposium becomes so important. If you look here, all of you are probably familiar a little bit with this, but the normal insertion of the rotator cuff to bone is this really organized structure. This is a cross-section of a supraspinatus tendon inserting into the greater tuberosity. You see it transitions from tendon to unmineralized fibrocartilage to mineralized fibrocartilage to bone. And this is a so-called enthesis or normal insertion site that is really designed to allow for low transmission between soft tissue to bone. When we get the rotator cuff repair to heal, even in those circumstances where we're fortunate. This is kind of what you end up with. It's rather this sort of disorganized scar tissue that matures over time. And even this is in our best case scenario. So it really begs the question, which I think is, again, the value of this symposium and why everyone here is so fortunate to be learning about this. What are the things that can tip things in our favor? Maybe it's that we don't have the right cells there. Maybe it's that if we have the right cells, they don't get the right signal to start to form tissue and tendon interface. Maybe there's not a good enough blood supply. Or maybe the environment is more prone to breakdown than it is to tissue synthesis. And these are all the things that we need to be thinking about as surgeons, beyond just placing anchors well and placing sutures well, and doing an anatomic reduction and repair of the rotator cuff. So this is kind of a little bit of a busy slide. But again, when I was thinking about this talk, I was trying to put together what what you have on the market makes this a little bit of a special time for a surgeon like me to be practicing sports medicine and shoulder surgery. If you were looking at the ideal scaffold, it might have this list of of four things. It needs to maybe increase the thickness of the tendon, particularly in these cases, which are large or massive tears where our tissue quality is sometimes poor. We want it to improve the healing response where we know in these large and massive tears, even if we get a nice suture repair, we don't necessarily, a year or two years later, see that the tendon is healed the way we'd like. Ideally, it could even deliver biologics. We could use it as a vehicle to deliver the things that we know are favorable for tendon to bone healing. And then finally, we know that the post op forces on the rotator cuff are high. And if we can modulate those forces, it's very difficult, as we know, to immobilize the shoulder, the way we can put a cast on a wrist or, or an elbow, all of these things would tip things in our favor. And again, what are some of the unique advantages that you have here at Arthrex? When I was thinking about these different goals, certainly some things that can increase the thickness of the rotator cuff tendon. We've talked about the BioWasher and you'll hear more about it later today. The ArthroFLEX is a technology to also augment tendon tissue or use it, for example, with an SCR and couple it with margin convergent stitches. You know, what about augmenting the healing response? You've heard a lot about ACP and now bone marrow aspirate. Are these things that we can couple with a with a vehicle? And again, the one that I'm talking about this morning, FlexiGRAFT. If you couple this with bone marrow aspirate or ACP, does this offer the opportunity to be a vehicle to deliver favorable cytokines and cells at a site of healing and then again, modulating post-operative forces? And that's what all of our these products are about, whether we're using a SpeedBridge construct or FiberTape, and we're augmenting it with ArthroFLEX or BioWasher. All of these are hopefully mitigating those forces. So you can see, I think you guys are very fortunate to have already a fairly impressive profile of different products that might help us here to accomplish this goal. I took this slide out. This is from a recent paper in the Journal of Shoulder and Elbow Surgery, about different scaffolds that have been used for large and massive rotator cuff tears. And again, these are perhaps more for the irreparable cuff tear. But you can see the vast majority of these of these different brands are based on kind of xenografts from pigs or cows or even equine pericardium. And while all of these aim to address number four on that previous slide, you know, augmenting mechanically, one of the things that these don't do is act as a delivery vehicle for the biologics, right? So we need to be able to deliver the growth factors. We need to be able to deliver the cells, because we recognize that just having the soft tissue there alone or the scaffold alone may not be enough. And that's maybe why I think FlexiGRAFT or this Demineralized sponge offers some advantages and some things to think about. What are the features and benefits here? This is 100% Demineralized Cancellous matrix. It has a few advantages, which we'll talk about here on the next few slides. One of the critical ones, of course, is that it is Osteoconductive. I know everyone in this room knows the difference between conductive and inductive, but it certainly is a scaffold that supports bone formation. But very importantly, it naturally absorbs PRP and bone marrow aspirate. So in this regard, it not only acts as a scaffold that bone can grow into, but it actually offers a vehicle of delivery for other biologic agents. And in this regard, it offers a lot of advantages it can handle, similar to a sponge. So it has a a ability to change shape and be relatively easily delivered into voids or defects. And again, very, very importantly and not to be underestimated, its ability to be kept on the shelf and have a good shelf life is an advantage for surgeons who might find a need for this, sometimes in an unanticipated way. So it can be kept on the shelf and and used rather than a fresh graft, for example. Now, as I just mentioned, we said this scaffold is osteoconductive. But this is I think what distinguishes it a lot from the rest is it's also osteoinductive. And that means that it actually promotes bone formation and retains some biologic properties to promote osteoblastic activity. And that is unique. It's not just something that like a calcium phosphate matrix that supports bone formation, it actually promotes it. This is some data from a study and the references at the end of the talk where they actually delivered this into muscle, which is a good environment to see whether you can support ectopic bone formation. And you can see here after 28 days, you're starting to form what looks like the like the trabeculae of bone. You're promoting osteoblastic cells that are laying down osteoid and matrix. So again, pointing out that this has the advantage of not only supporting bone formation, but inducing it. And for all of us who do these surgeries, whether it be ACL repairs or rotator cuff repairs, we recognize at the tendon bone interface, much of the healing is from the bony side. So things we can do to promote bone formation and bone ingrowth into the tendon interface is super helpful for us. So again, it comes in lots of different sizes here, anywhere between 1 to 10 cc's, which is advantageous in terms of whether we're filling a void or defect or placing this on the greater tuberosity. Again, as I mentioned here, this critical thing, it's not just conductive, but it's also inductive. And because of its relative flexibility, allows you to deliver it in an easy way. Again, in cases where you think that there's a abnormal or adverse healing environment, a chronic tear or revision setting, it can actually hold PRP or bone marrow aspirate. And in this regard not only becomes something that promotes bone formation but can actually become a delivery for biologics. I think this is hugely advantageous, really for the future. As we learn more about which growth factors are more important, at which location and which location we need aspirate and cells, which ones, we need just cytokines. We can use this as the delivery vehicle to get our unique or individualized mixture of cells and cytokines, or both to the right location. You don't need an additional carrier. It offers the opportunity for both. And again, as we mentioned, a good shelf life and a good assured sterility. So where have we learned about this? These are publications that have shown that FlexiGRAFT works here in a in a setting of bone formation. All of us know that for spine surgery, our goal is spinal fusion, something that's sometimes difficult to accomplish despite the best of instrumentation here, you can see in this animal model laying FlexiGRAFT not just as a bone graft extender, but also with its osteoinductive potential can promote this bone formation and really get this nice fusion mass. Here again. Where does this apply for us? In shoulder surgery and sports medicine? Lots of different places. This is one example here shown. This is a ladder. We all know that we're placing cortical bone here from the coracoid to the anterior cortex of the glenoid, or sometimes with allograft for example, plafond grafts, which I use not infrequently to get fresh cartilage. Here you can see using the FlexiGRAFT not only to promote bone formation and to support bone growth, but also to deliver biologics, can offer something particularly advantageous. Oftentimes, we can't control the contour of the coracoid process. There is a void or space here between the created area of bone loss, and the coracoid can offer something to fill there to potentially augment healing. Certainly, for those doing foot and ankle surgery areas which are sometimes hard to fuze, this offers a vehicle to augment fusion, promote bone formation, but also to fill a void. And this is again some data that says this is not just for bone to bone healing, but it can have a role in tendon to bone healing. This was an interesting study that was done. So the tendon was detached. It was repaired like a suture anchor to bone. And this actually is a very, very good model that simulates the rotator cuff repair because rather than tendon healing in a tunnel like what we see in an ACL surgery, this is tendon healing to the bone surface like we see at a greater tuberosity. And again, pretty impressive results here. When you compared repairing with or without this matrix, we found a zero failure rate compared to 33% failure rate increased amounts of fibrocartilage and mineralized fibrocartilage. And if you think back to the first couple of slides of the talk, remember the normal tendon to bone interface has that fibrocartilage and mineralized fibrocartilage to allow for low transmission. So again, it's starting to make it look more like the normal in thesis. Maybe not quite completely normal, but certainly headed in that direction. And that's a really favorable for us. Now Jimmy Cook and his lab at Mizzou has helped us to look at this specifically in rotator cuff repair. They did this great work in our typical established model. You know, the gold standard, the ovine infraspinatus model, in this case in dogs. They released the tendon. They used a typical construct for rotator cuff repair, a modified bridge configuration, and then at 12 weeks or three months, looked at all our parameters of healing. And their results paralleled what was seen in that sheet in the patellar tendon repair model. Here you can see with your standard repair when you don't have the FlexiGRAFT here, just like we showed in those early slides. Fibrous intervascular interposed scar tissue there versus here with the FlexiGRAFT the appearance of this more typical enthesis transition from tendon to form of fibrocartilage to bone. And again, perhaps it reflects the FlexiGRAFT here which is promoting bone formation, but also bone ingrowth into the tendon to get that metachromasia, which is a classic finding of that tendon bone interface. It panned out also with biomechanics when they tested those that had the FlexiGRAFT versus those that didn't. Things looked better in terms of load to failure and stiffness correspondingly when they looked at the appearance of the enthesis on MRI or directly. Histologically. Lower is better. So scores with the FlexiGRAFT were better in both parameters. So again, lots of optimism here that in the right setting this may be helpful for us. This is a video. This is Matt Smith a courteously providing this from Mizzou Columbia. Just showing how this can be done. It's really very easy to deliver regardless of which construct you use. Here you can see the SwiveLock anchors are placed along the medial margin of the greater tuberosity. Pass through just in a routine fashion like any rotator cuff repair. Here he's working from anterior in the footprint to posterior in the footprint. And then once you've passed those sutures through, you can really incorporate the graft very easily as part of your second row or your lateral row. The graft can be loaded right onto the sutures or onto the tape outside of the cannula, and then it can be shuttled through the cannula, through the passport here underneath the tendon, in between the greater tuberosity and tendon interface. That really seems to be the best place to deliver that. So it has contact with the prepared greater tuberosity and then with the underside of the tendon and rotator cuff that allows you to then simply secure it as you secure your lateral row and interpose it, trap it between the tendon and the bone. There it is coming in. You can see you can customize the size of that and the volume that you want to deliver. Because of its easy handling properties, it doesn't need a lot of machining or contouring. And here, just before you can see, the lateral sutures are tightened. It's opposed nicely against the greater tuberosity footprint and secured down to to the repair. This is just another video. This was actually courtesy of Allen, who I think is here or I know was here yesterday. He's done a lot of good work in this area as well as with the CRx, but this is just showing that same technique here where the graft is delivered. In this case, he actually had passed a few of the sutures, I believe, through the medial row anchors as well to secure the graft there immediately. And again, same concept here. You can see now that the graft has been interposed nicely. It simply is secured as you bring your lateral row stitches down. Again, the key thing here is recognizing just how easy that is to deliver and shuttle down the cannula. And then you can just bring that into your interface. I found this to be, I think, particularly valuable in settings where you've already had a previous failure, where it's no longer an issue of the of the biomechanical construct you use, but rather an issue, potentially, of biology. You can see here he had actually even placed a few holes into the greater tuberosity footprint to to promote stem cells, to even seed into the graft from the marrow. So, well, what about cell based approaches? And I know this isn't the topic of mine. That's a topic related to bone marrow aspirate and others, but I wanted to mention it here because we're all familiar with these different types of cells, whether they're coming from bone marrow, they're coming from fat, they're coming from embryos. I think the key thing to recognize here is that FlexiGRAFT offers an opportunity to couple with things that we're learning more about in the future, which is cell delivery and what kind of cells. And I just put this slide in here to mention this was a paper from HHS by Larry Galata, a colleague of mine, where he showed, you know, in a rat model, if you detach the supraspinatus and all you did was deliver stem cells through a single injection, no delivery vehicle. So no, no scaffold to load the cells on and no signal for those cells. Things really didn't improve. Things didn't look better in histology and the biomechanics didn't look better. But on the other hand, if you did the same study and you delivered it with something that allowed those cells to to know what to do. So in this case, scleraxis, which is a known promoter of tendon formation or delivered it with a vehicle which could keep the cells at the localized at the tendon bone interface. All of a sudden things looked different. So I would argue here that any one of these things in isolation, whether we do a bone marrow aspirate and inject it at the interface or we place a scaffold and inject it at the interface, may in and of themselves not be the Holy Grail, but when you have this nice portfolio of product that may allow you to combine things to deliver things, localize them, and deliver biologics to tell cells what to do may change the game. So kind of in summary for me, what are the take home points of FlexiGRAFT for cuff repair? But really beyond cuff repair for a sports surgeon like me, all the different places where you may consider using it. Certainly it's osteoconductive like many scaffolds out there, ACL tunnels, particularly in revision settings where we're trying to fill bone voids. Staged surgery where we're hoping to come back to have a completely incorporated tunnel, I think certainly advantageous there. Like we showed in this talk at the Greater Tuberosity or for glenoid reconstruction with a ladder or plafond graft. But don't forget about these other areas which are prone to not heal anyway. For example, an osteochondral defect where we're having trouble getting it to heal like a nonunion placing graft here, particularly loaded with biologics, may be an advantage. And toe or high tibial osteotomy where we've created a big correction, a big void with an opening wedge, maybe in addition to our typical allograft or osteochondral matrices. Something here that delivers biologics but is also inductive and conductive may be a huge advantage. Don't forget it's off the shelf. So it's there. It's easily deliverable. It can be handled easily. And as I just mentioned and really emphasized, I think the advantage here is don't forget it's not just good for bone formation. It's a delivery vehicle. So we can link with our other product products with the Angel system, bone marrow aspirate or ACP to really to really act as something to localize these favorable healing products to, to the site that we're really trying to maximize the effect and preliminary data at least suggests from Jimmy Cook and others that this might help to knock down that rate of structural failure and cuff repair. So in those settings where you know you're a large or massive tear and potentially at high risk for a retear, maybe we should consider this, particularly if we're considering biologics.