Name: FlexiGRAFT® Demineralized Bone Graft in Rotator Cuff Repair
Uploaded: 2016-01-22T00:00:00Z
Duration: 8 min 46 s
Channel: Arthrex

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VPT1-00369-EN | B | FlexiGRAFT® Demineralized Bone Graft in Rotator Cuff Repair

Alan M. Hirahara

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FlexiGRAFT® Demineralized Bone Graft in Rotator Cuff Repair

So the first thing we talk about is FlexiGRAFT dbm sponges. Now I'm know by now most of you probably know what this is already. It's just the demineralized cancellous sponges. They come as ground cubes, strips, demineralized cortical fibers, and the use is going to be based on its actual form that you choose to use. I'm sure some of you have already seen this, that the DBM has produced significantly more fibrocartilage and mineralized fibrocartilage at 12 weeks, and it showed a more mature, organized tendon bone interface. And this this was by Sundar. And this was actually the specific article that really got me interested in this because and some of you may have heard me talk about this a couple years ago at national sales meeting. This has the potential to significantly improve and hasten healing, which in my opinion, is one of the only things that I've found so far that actually can actually do that, meaning make healing occur faster. So we know that people like Rodeo Aronofsky have talked about that tendon to bone healing. That it has to increase the strength of the interface would be proportional to the amount of associated growth. So if we can somehow strengthen our interface, get a better interface, we have a chance to get a better actual ingrowth there. And improving the osteoconductive and inductive environment will help improve that tendon to bone healing. So remember that when we're talking about tendon bone healing, that you're trying to get a tendon to attach on to bone and remodel. Because if you remember your basic science, the actual tendon to bone interface is not just tendon and bone. It's a subtle change into one to the other, and it has different layers and levels. Keep that in mind as we go through this. So the DBM did produce more fibrocartilage mineralized fibrocartilage as shown earlier. And now recently Jimmy Cook and in Missouri did this study, which has been pretty much confirming what we've all been thinking. After taking ten dogs, doing bilateral shoulders, releasing the tendon, repairing after four weeks, comparing FlexiGRAFT and PRP versus just a direct repair. Then 12 weeks sacrifice and looking at outcome measurements of MRI, histology and biomechanical testing. What was found essentially was that the standard had more fibrous tissue at the interface and was more diminished compared to the FlexiGRAFT analog that was on the MRIs. And then we look at the histology. You're seeing a much more normal zonal insertion with the FlexiGRAFT use in a much earlier stage. So we know that over time, using just a standard reattachment, you're going to eventually get that normal zonal insertion. It's going to be recruited over time. But what we're seeing with FlexiGRAFT is that zonal interface is being created much faster, much sooner, which is basically the The translation. It's going to heal faster. And if you take the MRI score, the histology score and look at all the biomechanical testing, essentially we are seeing a significant improvement with the actual healing of the actual rotator cuff with that FlexiGRAFT strip as opposed to just standard repair. Now we kind of extrapolate that into use with my pasta bridge. So with the pasta bridge we go ahead. And actually originally the original way we came up with this was actually to suture it into place. And we found that it was very technically hard and challenging for people to do. So we started realizing that we didn't need to actually use the FlexiGRAFT on very low, low grade lesions. So anything that was 50% or greater, we started saying, okay, well, it's a big lesion. Let's go ahead and just take that graft and stuff it behind the sutures, which is a much easier way to do this. So you do your standard pasta bridge repair. And before you go put in the sutures on the bursal side. Once you have your sutures into the articular side, we're just shoving that graft right behind into the lesion. So naturally, if it's a 50% or greater lesion, there's plenty of space back there. So getting that FlexiGRAFT back there is really easy. And you saw how fast that went in. So it takes no extra major time and no extra major effort. And then of course, once we get that FlexiGRAFT into place, going ahead and putting that that ACP into position is really simple to do. You saw I just cut right through the tendon right into our graft. And what it does is it creates an intercalation. Remember I talked about in situ activation where here we go. Same thing. We're getting that ACP to actually incite to activate and attach and adhere into that FlexiGRAFT DBM sponge. And at that point then when we do our repair and tie it all back down, you've now squished that sponge and ACP into your repair, and it's now sandwiched between the Between the tendon and the bone right where you want it. We've taken a look at this, and I will admit that this surprised the heck out of me. I started doing this about two years ago, and the first I had a couple patients that did not do stellar, and I was like oh, this is not going to work. But then I started actually looking at the data and started realizing, oh my goodness, it actually is doing what we expected. We're actually seeing diminished pain scores a lot faster and better scores much faster. And this really did surprise me because at first I thought this was not going to happen. And it did. And so we've gone back to this and we started doing this more and more again. Now here's an example of what we saw. So here's the same patient in 2012. We had to do a second look in 2013 for some some scarring. And we found it. It healed in really marvelously. And you can see how well that looks. And it looks almost normal actually in this attachment. And this is something that's been quite consistent for these patients having these FlexiGRAFT grafts. Well, we took that one step further. We said, okay, let's do it. Actually now for SpeedBridge for full thickness cuff tears. And this was the original technique we came up with trying to attach the FlexiGRAFT. And we had a lot of trouble with this because we got some, some BreakThrough on these FlexiGRAFT sponges and had the FiberTape, which was, as you know, quite a large piece of material. And as we were trying to introduce it, we'd have a couple of things actually break on us. And when we got it in, it was it was fabulous and it looked really good. And as you'll see with the the results, actually we were seeing some very good results. And so once the graft was in place and we were just doing a standard SpeedBridge augmentation, this was quite simple, but the hard part was getting it to stay fixed into place because as I said, that FiberTape is quite large and as you can see going in there, even though the FlexiGRAFT is quite robust, it would in fact rip through on occasion. And so at this point, you can see this is just pretty much standard repair and standard SpeedBridge at this point, but you can see how we've got those graphs in the position quite nicely. And then of course, putting the PRP into the into that graph and have it interpolate is really nice because it actually has a nice area for it to hold on to, and it creates a nice graph inside to. We can also put some more back in underneath the graph. So we've now come up with a better way. And what we found is that all we really need to do is just like with the speed with the with the pasta bridge is get that graph into position and have it stay there and not have it move around. So what we did was we are able to now take just a simple FiberWire and loop it through the graph, and we go ahead and place our medial row anchors for the SpeedBridge as you would normally. So nothing different at this point when we already have our anchors in position and you've already passed your FiberTape through that medial rotator cuff tendon. All you have to do now is take your Scorpion and pass these FiberWire sutures through your graft where you want it. You're done. So all you do is you introduce the graft in, you pull the sutures, and it's going to set that that FlexiGRAFT under the tendon and keep it there. At this point it's standard SpeedBridge just to your standard SpeedBridge. And then at this point you just pull the FiberWire suture out and it's done. It's set in position because by doing the SpeedBridge, it's going to actually by mechanics hold that graft into position. And so it's a much easier way. You don't have to worry about things tearing and ripping out. And again, like before, if it doesn't work out you've done nothing to harm your repair. So this is a way that the surgeon can feel comfortable, that they don't have to mess around, and it's not going to actually go south on them. And even if it does, it's no harm, no big deal. Just take the graft out. No problem. But the SpeedBridge can I mean, the, the the SpeedBridge will continue as before.