Name: Augment® Bone Graft Compared to the Treatment Options Offered by Arthrex
Uploaded: 2018-05-02T00:00:00Z
Duration: 10 min 8 s
Channel: Arthrex

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VPT1-00969-EN | A | Augment® Bone Graft Compared to the Treatment Options Offered by Arthrex

Anish R. Kadakia

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Augment® Bone Graft Compared to the Treatment Options Offered by Arthrex

Hi, my name is Anish Kadakia from Northwestern University. We're going to review augment the studies that they have out there, the pros and the cons, and then look at Arthrex options to compete. And actually in some ways be superior to augment so that we can offer the best options for the surgeons. So what's the fuss about augment? Obviously, at every meeting that's out there, it's plastered everywhere. I'm going to review the studies, why they are flawed and how Arthrex can actually benefit from their research, because there are some things from it that actually help any biologic company in general. This is one of their big studies. It's the biggest one. This is it's recombinant human platelet derived growth factor combined with beta tricalcium phosphate as the carrier. So that's what augment is when you put it together. They did a prospective, randomized, controlled, multicenter, non-inferiority clinical trial. The reason why I said that whole thing is they will use that to kind of dazzle with words for the surgeons to say, this is a phenomenal type of study. And it is. It was a well done study, but it's a non-inferiority study, which means their main goal was to prove that it's no worse than Autogenous bone. That's it. Not that it's better, that it's no worse. What Pdgf is, is a mitogenic and chemotactic effect on mesenchymal stem cells and pro-angiogenic properties. So the two most important things we want are mesenchymal cells that can differentiate into bone forming cells and then pro-angiogenic to get the vascular supply in there to get things to heal. It also mobilizes the stem cells to stabilize the new vessels, so that the angiogenic properties cause vessels that are permanent. They had two groups, a 2 to 1 study where two times of the patients went into the AugMend group and one group in ratio to one who went to the Autograft group. They had 260 patients in the AugMend group. And you have to keep in mind it's 3 to $4000 per use for the small size on average. Again, it varies to hospital. It's hard for me to find the cost for every hospital, but it is not cheap. It is not allowed in my institution because of the cost. Then an autograph, which obviously is free to the hospital is 137 patients technically free. We all know there's cost involved and time. However, when you say autographed, we know by data that Iliac crest by far has the most stem cells per cc than any other part of the body. So the assumption is when the reps from Rite Medical will tell the surgeons when they told me they're comparing it to iliac crest versus AugMend, they don't mention the fact that iliac crest is only 11% of the cases. Distal tibia is 16%, proximal tibia about half, calcaneus 14 and then other, which obviously is very curious because there's really no other place to get bone graft for the lower extremity. So I don't know where that's coming from. It may just be local. This is very important because it's less quality in the in the calcaneus and the tibia. And they have limited osteoinductive capacity. That's been proven in multiple articles. And that's important to know. So when you review the radiographic results The rate of fusion comparing all joints with this autograft versus Pdgf was approximately two thirds 66 to 62%, and what they were looking at is more than 50% fusion based on a CT. So with that rigid criteria, only two thirds were able to fuze with autograft or augment. It's not a magical substance that guarantees a fusion. They spin the quality of the study by not really focusing on the fact that only about two thirds of the patients were able to heal a fusion. They focus on the fact that is a well designed study. A well designed study does not mean you can make up a conclusion. Augmend is similar, not superior to calcaneal tibial autograft. This is very important and they never show that the graph was even required to get a 60% fusion rate, which means there was no group that had no graft. If you understand the fact that calcaneal autograft and tibial autograft is more of a bone void filler versus an osteoinductive capacity type graft, you may not even need graft to get a fusion. We're going to use this to our advantage. There was a follow up study looking at this, and this is the original one on the left that we just talked about. The follow up study then suddenly had a change in the fusion rate. So how is it this is the same data, same patients in a different result. What they did was because that data of 62% is kind of sad actually. They changed the data instead of looking at CT and 50% bony union being the criteria. They then said the surgeons get to decide what the fusion rate is based on clinical and radiographic outcome at one year. So suddenly now it's 95% rate of fusion with AugMend. And that's what they're going to tell you. Augmend gives you 95% rate of fusion. They literally just massaged the numbers change criteria. And it's a huge bias in the study, the fusion rate. Because as a surgeon, if I'm looking for a nonunion, I get a CT scan. And if it's less than 50% healed, it's a nonunion, it's only 60%. There's nothing changed with this, just how they measure. They took that same data and then looked at the amount of graft fill and how they defined this is that they stated that 50% of the area occupied by graft at nine weeks, based on CT, was required to get a fusion if it's adequate, which means if on a CT scan you had bone to bone touching more than half of the fusion site, you had an 81% rate of fusion based on CT. This is rigid criteria, at least if it's inadequate, which means you had a larger void only 60% healed. The other way to look at that from a surgeon standpoint is that if you do a good job with your bone preparation, you have bone on bone apposition. So this may not be the fact that it's graft fill. It may just be better preparation. But again a company that has biologics, you take this data and say you need to have some sort of graft to get a fusion. And clinically that's what their conclusion was. And so Jbj's article that you have to have graft to get a fusion. That's a big deal. So every Hindfoot fusion really should have grafts. You have to take this to your advantage. When you look at the three studies that have been published on augment, Graft is needed for a fusion is the end conclusion. It's not exact, as one could argue that the nonunions may just be from bad preparation, but that's not the job A of the company, nor was it the conclusions of the authors. So we'll take it at face value for our advantage and say that graft is needed for a fusion. Augmend has no superiority over poor quality tibia or autograft. This is important to educate the surgeons so that they know they're not paying for anything. That magical graft is important. Augmend is not an Arthrex has multiple substitutes to avoid the complications from iliac crest harvest or proximal tibia harvest, etc. and that's important for the hospital administrators. Not to say you should bypass the surgeon because that may cause conflicts, but it's important to know when you deal with the administrators in the hospital that if you have a graph that is efficacious and cost effective, they're going to want to use that over a $4,000 loss. What are the options you have? Angel BMA with in combination with StimuBlast is a very, very effective. And I'll explain why in a second. We have Arthrex Quickset. But that may be best for bone Bon Voyage. It's not really for augmentation of fusion, so different usage. Arthrocell allograft is the best competitor flat out to augment, and it's actually superior in the fact that the mesenchymal stem cells that you're trying to attract with augment are already there with ArthroCell, and the Osteoprogenitor and Multilineage inducible cells are there as well. So the difference is augment is trying to pull the cells into place where ArthroCell will put them there. And that's important. We have a smoker, a diabetic or an elderly patient who we know has poor quality tissue. It will put the high quality tissue in there for you, and it's osteoconductive as well. The Angel technology we know, I think everybody's familiar with, can spin down the stem cells and concentrate them to a very high amount. It's sterile. You can precisely do the spin parameters, where sometimes with other systems it's more visual based on the technician. So the Angel system is very, very accurate. What does bone marrow offer that blood doesn't like. Why not PRP? Well, there's multiple things. You have progenitor cells, the stem cells, the mesenchymal stem cells. Endothelial progenitor cells for angiogenesis which we talked about how that's important. And then concentrated bone marrow. This is something that surgeons may say well why should I pay money for this. Well, it's clear when you look at the data, the cost for Angel is important. What they've proven is that if you have increased colony forming units, that's associated with healing of a nonunion directly injecting concentrated bone marrow into a nonunion will cause it to heal. Nothing else is required. And that's been proven in this article. And Jbj's 2005. And not just one study. These are four different studies showing that bone marrow that's concentrated will heal a nonunion or delayed union. So you have multiple studies more than that by AugMend. And this is for non-unions is what really we want to do when we have our tough cases. So bone marrow concentrate is extremely effective. When you look at concentrated bone marrow here you can see the colonies they form and then they just kind of die. They don't really keep growing. When you concentrate the bone marrow, the colony forming units are present in higher concentration and they blend together. So they're continuing to grow. And that's why we concentrate the bone marrow. When we look at Arthrex Biologics for fusion, we know that biologic augmentation is quote unquote required. So you should take the work that's been done by right medical and use it to our advantage and say that a fusion is required. But take their data critically and show that augment. And we know augment is not better than poor quality bone graft. The value of the cost is not there. The Angel BMA has multiple articles that shows just concentrated BMA will heal a nonunion. So you have actual data there. And if you have a poor quality host, a smoker or an elderly patient where their cells are no good, where augment is probably of very little value. Where Angel BMA may not be as useful. You have ArthroCell, which is a perfect allograft which has stem cells in it is osteoconductive. It's cost competitive to augment, and that is probably the most effective option. And you can justify the cost of the surgeon with that, because nothing else really will give you the same effect.