Dr. Daniel Kapl...: Welcome to the Arthroscopy Journal podcast. I'm Dr. Daniel Kaplan from NYU Langone Medical Center in New York City. Today, I have the pleasure of speaking with Dr. John Tokish, professor in the Department of Orthopedic Surgery and director of the Orthopedic Sports Medicine Fellowship at the Mayo Clinic in Arizona. He's also the past president of AANA. Dr. Tokish was the senior author of the article titled "Compression of an Autograft Biceps Into an Augmentation Patch Does Not Cause Mechanical Damage to the Tenocyte," which is currently in press at the Arthroscopy Journal. Welcome, Dr. Tokish. It's a privilege to have you on.
Dr. John Tokish: Oh, thanks very much. I appreciate the opportunity. It'll be a fun discussion.
Dr. Daniel Kapl...: I think so too. I've been looking forward to this one. So, I first came across this biceps compression device as a fellow when I was working on a "What's New in Biologics" talk. I found this to be one of the most interesting concepts on the horizon, and also might be because the device can be called the "Biceps Smash," that's also an incredible name, so we'll see. So, to begin, can you just help us understand the scope of the problem? Why are we, as a field, looking for augmentation for rotator cuff repairs?
Dr. John Tokish: Well, that one's easy because they fail, right? I mean, even in the best of hands in the world, you get lots of risk factors, but we're not winning on this at the end of the day. There's an article that was published by Rick Madsen and his group out of Washington that took a look at the number of articles that have been done over the past since 1990, and that number goes up, just shoots up exponentially. But then compared to that, he has the outcome scores, and they're basically flat. He has the re-tear rate, is basically flat. They have the patient symptom scores, et cetera.
So, I think what that article and what many of us know is that in spite of the fact that we have gotten mechanically incredibly better, double-row repairs, self-reinforcing, compression action, et cetera, leaders like Steve Burkhart and others have taught us so much about the mechanical side such as, now that the "mousetrap" is pretty good. And so, you would think, "Well, if it was a mechanical problem, we'd have it licked by now," but unfortunately we don't. And we know now that it's not just a mechanical problem that helped us but certainly, this a problem of biology. And so, until we fix the biologic issues here, we're going to continue to struggle with these failure-to-heal rates.
Dr. Daniel Kapl...: As you mentioned in your article, there's maybe over 20 existing patch augmentations. What are some of the limitations of the existing patches, which spurred you and your team to investigate the biceps as an alternative?
Dr. John Tokish: Sure. So, there's a ton of ways to go about augmentation, if you will. And the main factors that go into it, of course are: ease of use for the orthopedic surgeon, biology, something that makes sense from a biologic standpoint to try to recreate or at least truly biologically augment something, and then of course, cost. And so if you look at across the spectrum for that, there's roughly autografts, which, of course, this an article about. There's an allograft, there is xenograft, and then there is manufactured patches and meshes and things like that that come into play. And each of them have their advantages and disadvantages.
I think of the popular ones out there today, there's a xenograft patch out there that's very positive, bovine collagen. I will say that that one, when it first came out, I was super skeptical of it because I don't love, in general, xenografts haven't performed very well, but the group that did the initial work on that, they were great. They did their due diligence, they publish good data on it, and then combine that with the fact that the implant is incredibly easy to implant into the shoulder. Now there's been other problems with that one, et cetera, but you put those two things together, easy, simple, quick, it's a little bit like catnip to us. Other allograft sources are great, but those are tricky sometimes because you have to have a tissue bank and, internationally, those are not great options.
And then ultimately, does the biology match up to work? And so, things like human dermal allograft or tensor fascia latae, or Achilles, all those are reasonable things, but they're not as easy to place, not as easy to fix into the cuff. And then, of course you have the cost of an allograft patch. So then that led us to think about what about the autograft? So in autograft situations, the patch is almost always there, but more importantly, it's free at least the patches. You don't ever have to worry about asking a patient to cover the additional $3,000 to $6,000 cost on that.
And then the other thing I love about the allograft is ultimately no matter what we're putting in the shoulder, we would love it to turn into tenocytes, well, no better sort of baseline product than tenocytes. And so from that standpoint, we think there's great advantage to working in this area.
Dr. Daniel Kapl...: That's awesome, and that makes a ton of sense. That's also why I gravitated towards this when I first saw it. Moving towards the biceps specifically, your article gave a really nice history on some prior uses for the biceps tendon as a repair augment. Can you just give us, and our listeners, a brief synopsis on what existed prior to your guys' work for using the biceps?
Dr. John Tokish: Yeah, I appreciate you bringing that up because nothing's new under the sun. You always think you're thinking of something new or pushing the envelope, but somebody's thought of it before you. And I think the first example of it was actually an advisor many, many years ago, back in the '80s, that used the biceps to reinforce it. That was more of a structural autograft, which I think is wonderful. For example, I'm a big fan of biceps SCRs. If you've got an irreparable cuff tear and you need a piece of tissue to go over and reinforce that cuff, I think that is a great choice.
Larry Field has recently published his technique and results on biceps, we call it biceps SCR. There's been probably six or eight studies in the literature now on it that show this a very, very viable option as it goes. So, that's a different construct, though. That is a structural autograft, and I use that one a lot. It's my first choice if it's possible to use for an irreparable cuff tear if the muscle's alive. The advantage of that structural autograft is that, at least the way that we do it, you leave it attached at the glenoid. And so, then you bring it over like you would an SCR, just like a patch, and sew the cuff into that.
I should state, though, that there are studies that show that you can not detach it distally. You can leave it intact and just pull it over completely. We always do a tenodesis distally with it, but Dr. Field and others have shown that that may not be important in terms of the outcomes. And so, I may be learning something on this. That's never made sense to me, but there's a lot of, the bit smarter surgeons than me and better technical surgeons than me that are employing that, and it seems to be working for them. So I might be doing an unnecessary step, but those don't biologically enhance it.
And so, a lot of the credit here goes to Jeremy Mercury and Greg Colbath. Greg's an orthopedic surgeon in Spartanburg, South Carolina, and I think Greg is a real forward-thinking guy. And, I don't know, a bunch of years ago, I got thinking about Amnion and trying to put it into the shoulder. That's expensive too, but it also works. Anyway, we thought about a way, could we take some of these biceps and make them biologic?
I think Greg was the first one to have the idea to say, "Hey, let's take it and see if we can run it through a measure." He and I used to have conversations about, "Well, what about a meat tenderizer like you might use in the house, something like that, or a bit of nails to get it down?" We published on that with Jeremy and Greg a few years ago, and it was largely Greg's work on that. That was a really cool idea.
The problem with it was that the measure turned the biceps autograft into kind of just that, it's not mush. We'd like it to be a measure. It's probably better termed a "musher" because the structure of it was pretty poor. Now, we did... the tenocytes, some survived. You had 65%, or two-thirds of them, that still survived, so you did deliver that biologic stimulus to the cuff, but boy, it was a little tough to work with.
So, over the years, a couple of folks have come up with the idea of saying, "Gosh, if you put this in a press, how will that work?" The press works just beautifully. It turns it into a beautiful patch, and if you've got a long enough tendon, you can double it. You can even triple it, cut it, and then stack them, and you can get a patch that's quite thick.
Dr. Daniel Kapl...: So, yeah, that took us through a bit to our next question. I'll point listeners to the 2022 Arthroscopy article by Drs. Colbath and Tokish that showed that initial technique, and then here is now our evolution. So, you started touching on it. Can you briefly just go over the technique with us from proximal biceps stump harvest to implantation? I know you have an awesome 2022 Arthroscopy Techniques article that gets into beautiful specifics, but just for our listeners, could you run us through it?
Dr. John Tokish: Yeah, absolutely. So, most of us, when we do a cuff repair or when we do a debridement of a cuff or calcific tendonitis, one of the more common things that we do is a biceps tenodesis. And so, the way I do a biceps tenodesis an arthroscopic suprapec. So, what that means is I go down into the subdeltoid space, we find the upper border of the pectoralis major, and we either... Usually, we release it inside the shoulder before we go there. So, that's done with either a pair of scissors or, more commonly, I'll use an ablation wand.
So now you've released it. Then, you go up into the subacromial space, and then you go into the subdeltoid space, which is a space that many surgeons are not so comfortable with. So, that's a little bit of a learning curve. I teach this in a video called "The Three Bumps." There are three bumps. One of them's lateral, and that's always the bone. One of them's really medial, and that's the conjoined tendon. And then the middle one is a soft, ballottable one, and that's the biceps. Once you learn the anatomy there, it is actually very, very fast, and you can do a biceps tenodesis in 5 to 10 minutes. It's a very quick operation.
So, once I find the biceps and release that area in the groove, then I simply grab the biceps from the anterior superior portal, and I pull on it to put on physiologic tension on that. I used to think that we could over-tension it. I'm in the lateral position, by the way, so the arm is straight, so you really can't over-tension it. In the bent position, if you're a beach chair person, you do have to be careful a little bit because you probably could over-tension it, but in the lateral position, you don't have to worry about it.
So, once we've got this physiologic tension on that biceps, I put a simple, and I've done it a thousand different ways, but our current way is a 1.8-millimeter knotless anchor that goes right into the lateral to the tendon just above the pectoralis major. Then, we take a scorpion and we throw two stitches, a locking stitch and another locking stitch through it. It's knotless, you zip it down, and then you cut it above that. That gives you your tendon, and that comes out of the shoulder, and that is somewhere, usually around 40 millimeters to 45 millimeters. You need, for this technique, the plate is built so that you need 27 millimeters. So you're always cutting off a little bit of that, which is kind of nice because the tendon proximally is sometimes a little junky, and the tendon distally is a little funky. So, you can trim that up, and that gives you a nice one.
Those that do open subpecs, you'll get 70 millimeters of tendon out of there. We've recently developed an all-arthroscopic subpec that's coming out in ATECH. So, we go actually the same way below the pectoralis major, and then we can get that. If we want longer tendon, then we can get 70, 80, or even 90 millimeters of tendon in that regard.
Once you have that, you then stick it into the press. Some people just stack it in something heavy, so you don't necessarily have to have a commercial press, although it's kind of convenient. You can actually just stack it between two things, an instrument tray with something on top of it, it'll flatten it out.
Once you do that, then it sits. And the way we use it, there's a tray, it fills the tray perfectly, and then it'll fill the space in that void. So it comes out to be a perfect rectangular patch. Now, if the patient is really small, sometimes that patch is a little thin, but please remember, we're not trying to get structural fixation here, we're looking for biology.
So, then the patch is created, you put stitches in the corners, then we have a device where you can deliver it, and then you fix it in situ, much like many of the other systems out there.
Dr. Daniel Kapl...: Yeah. You mentioned a lot of great pearls right there. I also do a suprapec arthroscopic tenodesis taught to me by my mentor, Dr. Verma, but I love that three-bumps technique for figuring out because that is definitely the hardest part of that procedure, finding that biceps, no question.
Dr. John Tokish: Yeah, I agree with you.
Dr. Daniel Kapl...: And then something else you mentioned, when you have extra biceps, have you found value in doubling it up? You mentioned that earlier, where you can essentially repeat the process to get a couple of patches together. Is that valuable?
Dr. John Tokish: I think so. When we first started out, I thought, "Oh, this will be great." One of the reasons we developed this arthroscopic subpec technique is I thought, "Gosh, if I could double or triple this, we can get a five-millimeter thick patch," which is about as thick as the biggest of the dermal allografts. So, do you need it? I don't know. Because none of them are structural, right? None of them are mechanical. But why wouldn't you, right?
So I will say this: the patches, originally, I'd smash one, then I'd put another one in, smash it, and then we'd stack them. And originally, I thought they'd all stick together. They don't. So they will shear off of each other. That's one little pro tip. However, I love the five-millimeter patch. So if you are going to use three of them stacked, or two of them stacked because you want a thicker patch, then just go ahead and stick a little stitch through it.
And then, we have one of the plates that comes out that'll allow you, it's almost got multiple hole options, so you can just send it down, send it up, send it down, send it up. Or, you can just use a free needle and pass those things and then kind of treat it. Much like Tiru Mejada does with his SCRs. He takes that big tensor fascia latae, then he puts stitches all the way around. So that's a little more time-consuming.
I don't know. We don't have any data yet on single-layer patch versus double-layer patch. My guess is that it may not matter because, again, we've got lots of tenocytes in a single-layer patch, and that's what we're trying to deliver to the site of the biology. So, I don't know that the double patch will help us, but eventually, we may get to a point where we use this structurally and involve combo patches and things like that.
Dr. Daniel Kapl...: You've been alluding to it, and your article does an awesome job sort of explaining this, but can you educate us a little bit why this more of a biological approach versus a mechanical times-zero augmentation?
Dr. John Tokish: Yeah, so everybody loves the idea, "Oh, let's make this mechanical." But here's the thing, when you tie any of these patches, we are always tying the medial side of them to the muscle. So, there's no possible way that now if the thing heals and it thickens up, and you put the two ends in an MTS machine and pull on them, okay, maybe the tendon becomes robust and gets better. Okay, I'll buy that with any of them. But when people say, "Oh, I'm going to put a patch in and it's going to give me mechanical strength on that," that can't fly because all of us are attaching that on the medial side. On the lateral side, fine, it's going to bone. But on the medial side, no matter which patch I use: allograft, xenograft, autograft patches, whatever, if it goes into the muscle, then when that cuff starts to undergo stress and strain under load, well, the failure point is just going to be either the patch is going to pull out of the muscle. That's the weak link in all rotator cuff repairs. So, it can't work that way.
The only way to make that work is to do an SCR concept where you bring the patch over and attach it to the glenoid. But the problem with that is that you can't have it both ways. You can't take a static structure and attach it to something dynamic like the cuff without having it have an elastic portion into the patch. And as of yet, although I've been arguing for this, I mean, there's probably people listening who have heard me on a soapbox about this. We need the biologic bungee where we get some sort of material that will remain in the elastic range of the stress-strain curve with the arm going through a normal range of motion. So, it will take up load, but then won't permanently deform. And as of yet, we have no option for that.
So that's why the internal brace, for example, won't work in a cuff repair scenario because you either have to put it in with the arm in abduction and make it tight, in which case your arm can never go back into adduction, or you put it into adduction, and then as soon as you move the arm into abduction, it's off tension and doesn't work for either way. You can't have it both ways yet.
Dr. Daniel Kapl...: Got it. No, that's super enlightening. Thank you for that awesome discussion. Related to that, is that desired biologic activity, ultimately, what the impetus for this study was, to demonstrate that the tenocytes for the bicep smash?
Dr. John Tokish: Yeah. So, one of the things we found when we did the measure was that we did have a significant amount of tenocyte death. And while you can argue, does that matter, how important is it? Is it the extracellular matrix? What is it that stimulates it? I would say we don't know the answer to that. But if I'm going to do an ideal patch, we certainly want those tenocytes alive if we can get them alive.
So, originally, I think we said, "Hey, are they still viable?" But the challenge with viability is, that requires some basic science work, like Jeremy Mercury's lab at Clemson had, that we were able to look at. And at our lab here, we didn't choose to measure viability. I just wanted to make sure that at time-zero, I wasn't destroying the tenocyte. And so, that was the impetus behind the study design.
Now, you could argue, and I might argue, that no matter what we do, when you put it into the shoulder, that tenocyte or the graft itself is now separated from its blood supply, and it may die, you see. So, it may be that all of these die, and that may be true. For example, you take a hamstring or patellar tendon graft and you put it into a knee as an ACL reconstruction, those tenocytes in those things die.
I will say this, though, that we've seen in our lab, there is evidence of the tenocyte actually, they almost develop these little pseudopod feet. And depending on the chemical or whatever the milieu that they're in, sometimes you can see those things kind of crawl out of the patch toward the native tendon. The other thing is, while they're alive, those tenocytes may well signal, have a paracrine signal to signal the local satellite cells to come into the area. And that, we think, is one of the most potent potential bonuses of this.
Now, that'll take some more basic science work, but if you put tenocytes into the area and they are releasing their signals, even if temporarily, you may set up the chain that's necessary to bringing those things that are tenogenic into play.
Dr. Daniel Kapl...: Got it. Now, with that background, can you tell us a little bit about the actual study design and what you guys did?
Dr. John Tokish: Sure. So we had to figure out, how do we test to see if we're killing or if we're destroying the tenocytes? So, we talked to our pathologist, we said, "How would you view this?" And they said, "Well, that's easy, just an H&E stain. Because if you're killing the tenocyte, what you'll see is, you'll see these broken apart, destroyed, smashed, if you will, tenocytes in parts and pieces." And so, the H&E stain is certainly reasonable for mechanical damage to the tenocyte. We said, "Okay, that's the first question. Okay, we're good."
So, then what we did is, remember with a superpec biceps tenodesis, you get about 40 millimeters of tendon, of which 27, we're going to use for our bicep smash. That leaves you about 13, let's call it an even centimeter, of tendon that is going to usually in the garbage. So, what we did was we took that centimeter's worth of tendon that we were going to throw away, and then we longitudinally split that, such that the proximal, but you still had a proximal and a distal portion that were identical. It's just that the medial and lateral portion of the tendon was split, and then we flipped it each time to make sure that we were mixing them up, to randomize, if you will.
And then we sent... one of those two split samples, we threw back into the smasher, and we smashed it, and we sent that to pathology, and said, "Please evaluate the tenocytes." The other one, we didn't touch. So it was not smashed. So, exactly the same tendon region, and we re-smashed one of them, and the other half of it we didn't smash. We sent them both to pathology, they were blinded to which one was which, and then they came back and said, "Yeah, this is what we found," and they were able to read that.
Dr. Daniel Kapl...: So what were some of the key findings you guys had?
Dr. John Tokish: So, the biggest finding was that, almost always, there was no tenocyte damage. So, better than 90%, 93% or something we had, we had live tenocytes in both samples with no evidence of tenocyte necrosis, tenocyte death, tenocyte mechanical damage. In the samples that we did find that had tenocyte damage, there was no statistical difference between those that were smashed and those that were not.
So, some of our patients had proximal biceps tendon that wasn't in very good shape. And so, I think some of those were undergoing natural senescence anyway, and so we caught a few of those. But we did not see a statistical difference between the smashed group and the unsmashed group. So, we concluded from that. Therefore, the main finding was that when you do the smash, you're at least placing a viable patch inside the shoulder for this reconstruction technique.
Dr. Daniel Kapl...: One thing I did notice that I was interested that you sort of brought up, was it seems like the act of compression didn't cause any serious mechanical damage. But a handful of samples just had damage, like you alluded to. Is that something you have a sense for when you're looking in arthroscopically that you can you see, this tendon is pretty beat up? Or would you be comfortable putting a patch for any biceps tendon you come across?
Dr. John Tokish: Yeah, sometimes you get those biceps and they'll be kind of shredded, you'll see that kind of longitudinal split. And I will tell you, when you smash those, they're a little stringy, they're not as beautiful as the others. I will also say that we have plenty of those that we noted when we checked, I'd look and I made a little note that was a little vulgar, but I might make some comment as to whether I thought that patch looked good or didn't look good. And what we found was, even the ones that didn't look good, the majority of them still had very viable tenocytes in it.
The one little pro tip here is if you are going to smash those and they're kind of have that little shredding on the one side, put that side down because it's a little prettier on the other side when you put those guys in. So, just saying, don't ask me how I know that.
Dr. Daniel Kapl...: So given the viability of the patch, can you share with us a little bit how it fits into your cuff repair augmentation algorithm? So, are you doing this on every patient you do a tenodesis on? Is it only some patients? How are you using this one versus other grafts? Can you teach us a little bit?
Dr. John Tokish: Sure. I'm a big fan of rotator cuff scores to help us get there. The most popular one right now, of course, is the RoHe score, and I do a RoHe score on everybody that we have. But the only challenge is we don't... we do a modified one because we don't have bone mineral densities on everybody, but if you're an older female, and this may be incorrect, but if you're an older osteoporotic-looking female, maybe we might give a couple of points. And if you're a really young, robust 45-year-old male, probably don't give points for that. But again, it's a gestalt in that regard.
But then, we're looking at age, and we're looking at retraction, and we're looking at size of tendon, if you will, and then an eyeball of bone mineral density, if you will, and then of course, cutalia changes. But then, when you take a look at it, the magic number's been bantered about back and forth. But I wonder about that sometimes because if you've got a RoHe score of two, you've got a re-tear rate in that series of about 12%. Now that's not exactly right. If you go each number up the scale, there's a couple of the numbers that actually are lower than the number below it, but it generally is linear.
And so if you start getting up into the four and five region, you're starting to get up into the 40%, 50% chance of re-tear rate above five or above six for sure. So if you start getting into those, and I think it's important to do it, but then you could ask yourself, look, if you have a RoHe zero and a RoHe one, those re-tear rates were zero. So maybe not in those, but anything above that, so that means anybody above 65, I think 70 was the cutoff in that study. But if you're older or if you have any good talia kind of early changes, I can't think of a reason not to.
Dr. Daniel Kapl...: Yeah. And then are you pretty much only using the biceps now, or are you ever using any of those other graft options?
Dr. John Tokish: Well, sometimes we're doing revisions, and revision is another reason. That's not something that's in the RoHe score, but maybe should be. So, I actually think there's a modification to risk factors that we're maybe not taking into account that I think, eventually, we're going to build on that score and we'll come up with an even better score. But I really think the authors deserve great credit for bringing that concept to our attention.
But things like smokers, and things like revision surgery and stuff like that where people with high cholesterol and triglycerides, we know those are risk factors as well. So when you get to one that you say, "Hey, that's important," and that's most of them because of the problem that's in front of us, then I would say, "Consider doing it." I mostly do the biceps smash. I would say that if you don't have a biceps left over, then we can't do a biceps smash in those patients, then I would switch to whatever my second choice is.
Dr. Daniel Kapl...: Got it. And then you alluded to this earlier, it's something that there's a million different names for, but I really like some version of the biceps SCR anterior cable reconstruction, leaving it attached to the glenoid. Is your decision point there really just about if you need to occupy space for missing tendon versus just reinforcing a repair? Is that how you think about it?
Dr. John Tokish: Yeah, it's a great question because it is one of the things that I think is maybe a little misunderstood for many of the people that I talk to about this. The bicep smash cannot cover a hole. It's not designed, and it's a mistake to try to use it to cover or bridge a gap. It's just not strong enough for that. So if you have a hole or a gap you're trying to cover, this not your operation.
This is your operation, I think, if you've got somebody with... but we all run into these significant partial tears and you go, "Well, maybe I could do a debridement, but I'm getting close to that 50%. What about the patient with calcific tendonitis that I'll take out the calcium?" And then the patient's got kind of a little bit of a hole. This is an awesome technique for that. What about the single and double row repair that you do on the small and medium and even large size tendons? These are great for that. But if you've got a gap that you can't fill, this is not your choice. So then, I think that's where the structural biceps, biceps SCR, or traditional SCR, or whatever your procedure of choice is for trying to get that gap closed is better.
Dr. Daniel Kapl...: Got it. Yeah, no, that makes a lot of sense. And that's sort of how I've started looking at it, too, because I really like that anterior cable reconstruction when we need it. What about other settings? So, I don't have evidence for this, but the only thing I kept thinking of when I saw this was how great it would be to use this in shoulder replacements for the subscap, and I've been incorporating it mostly in anatomics. What are your thoughts on something like that? Do you ever do that? I know data might not exist yet, but it seems like it would follow the same principles.
Dr. John Tokish: Yeah. So I do a lot of shoulder arthroplasty, and I repair the subscap, obviously, on every anatomic that I do. And every anatomic that I do a subscap repair on, gets a bicep smash. And we've been doing that for a while now. It's probably not reasonable to talk too much about it because it hasn't met peer-reviewed yet. But we wanted to see our first, I think we have 28, so we wanted to see our first 25, and we've ultrasound at each of the 25. And I don't want to get too far ahead of myself because, again, it hasn't been peer-reviewed yet, but we have a 0% re-tear rate in that group.
Dr. Daniel Kapl...: That's awesome.
Dr. John Tokish: Yeah, and then Philip Moroder, who's a good friend and, I think, one of the most brilliant shoulder surgeons in the world and in Europe, kind of thought about making a little bit of a longer biceps plate. And so, we're kind of fiddling with combining data so that you could not only reinforce the subscap repair but maybe go up into the rotator interval and reinforce that as well. And that's in the process now, and we'll probably collaborate on something along those lines.
So that's one of the clinical studies. And then, we also have our first full-thickness rotator cuff tear data that is coming soon. That's very promising too. We'll, again, have to go through peer review, finish it up, and make sure the numbers make sense. But from a healing standpoint, asking it to do what it's supposed to do, we're optimistic, shall we say.
Dr. Daniel Kapl...: That's great. Well, that makes me feel a lot better about doing it so far. And then, just as we finish up, you mentioned those studies. What's next for you and your team regarding the bicep smash? You guys alluded to some biologic evaluation maybe as a next step. Is that what's coming down the pike?
Dr. John Tokish: I think so. I think... I don't know that we want to spend too much energy on the biologic assessment of it because the answer is, who cares? You can do a beautiful biologic evaluation. We have pals that are just geniuses at this, and I'm interested, but the truth is, people care about, "Does this lower your re-tear rate or not?"
So, ultimately, I think for us, we will certainly go into those lines. Those studies are expensive and they're hard, and you wonder if they move the needle. So, I think we're better off spending our time looking at where the problem lies. Now that it's reasonable, and we've worked out the insertion device and making that work, I think we'll probably spend most of our time on clinical stuff.
And I think the next one is to take a look at a prospective study, or even a prospective randomized study, that will compare cuffs with similar RoHe scores that are fixed with biceps smash and those that are not. And then, eventually, I think you can get into questions about, well, comparing one patch to another in that regard to see with like ones.
The challenge, as you well know, is rotator cuff studies are hard to do because there are so many confounders, and it's difficult to get reasonable groups together because you've got age, size, comorbidities, tension on the cuff, and all those different things that you have to try to control for, which are pretty tough. But we do plenty of rotator cuffs, so we'd need a multi-center trial. But everybody's welcome. Let's go.
Dr. Daniel Kapl...: Give us a call at NYU. I'm sure we'd love to do it.
Dr. John Tokish: Yeah, man.
Dr. Daniel Kapl...: As we wrap up, do you just have any closing thoughts to share with our listeners about this stuff?
Dr. John Tokish: Well, I think I would say this, one of the things is that most of us don't follow our data, technically. And I will say that it's humbling to follow your data. And you can say, well, maybe the cuffs are healing, or even if they're not, patients are doing okay. But I think this a race worth running.
I don't know if this is... Well, this certainly not the final answer. I can imagine things where maybe it's mesh down the road, or, as I talked about, the biologic bungee as I call it, or something down the road where we can get a combination of mechanical load sharing and then smash up biology to put on the inside of it.
But I think this a pursuit worth running for all of us because that patient who's 45, that's failed their cuff twice, they don't have a great solution beyond reverse. And man, as you know, that's taken over the world, and I love the operation, but if we can get a... I mean, there's nothing better for a torn cuff than a healed cuff.
And I think we need to continue trying to stimulate research and try to pursue funding in this area to see if we can't answer some of these questions together.
Dr. Daniel Kapl...: That's great. Dr. Tokish, thank you so much again for your time and your insights. It was an absolute pleasure speaking with you.
Dr. John Tokish: Listen, man, I'm available to you anytime, buddy, and thanks for taking over the helm on the podcast. I'll just say this, you guys can print this, but many of our listeners aren't aware.
But this podcast, we looked at the data numbers last year, and the views and the hits are in the millions. I'm not kidding. It was one of the most shocking because I'm an old guy, and so a little bit of a dinosaur admittedly. But to have the number of hits that where our A-Tech and the podcast and AANA's educational offerings to be getting the kind of hit levels that people are actually going to and opening is clearly that you guys are just doing a beautiful job.
So, thanks for being with us, and I hope you keep asking hard questions and highlighting the work of all of the AANA people out there that are just making a difference. So, thanks very much for having me in my small part.
Dr. Daniel Kapl...: Of course. Thanks again. Dr. Tokish's article titled, "Compression of an Autograft Biceps Into an Augmentation Patch Does Not Cause Mechanical Damage to the Tenocyte" is currently in press and available at the Arthroscopy Journal website at www.arthroscopyjournal.org.
Thank you for joining us. This concludes this edition of the Arthroscopy Journal podcast. The views expressed in this podcast do not necessarily represent the views of the Arthroscopy Association or the Arthroscopy Journal. Thank you for listening. Please join us again next time.
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