We'll do the same. We'll take… We've got just a few minutes for a couple of questions. If you go to the mic, that's easy. We'll try to keep an eye on the app too. Yeah. Hi. Kitty Stabile out of Lancaster, Pennsylvania. Question for Dr. Tokish. With regard to the biceps that you're taking, it's already from a diseased tendon. These are chronic rotator cuff tears. We've all seen these tendons. That tissue is not normal. Those tenocytes are already compromised. What are your comments on that? That's a great point. The study that I mentioned in the first talk this morning, we sent biceps that were consecutive, and many of those look like those biceps that you and I would go, oh, I don't love those. At least from a macroscopic standpoint, the tenocytes are still pretty good. The extracellular matrix is… looks terrible, but the tenocytes themselves still look healthy in those… in 93% of the patients. I don't know, though, because we'd certainly like to look… to use a better-looking tendon in that situation than a worse one. The real question, of course, comes down to the idea that we're not looking for a mechanical graft here. We're looking for the tenocyte stimulation of the biology, and if the tenocytes are intact, and we need further study to know that, but if the tenocytes are intact, that may solve our purpose. Yeah. I mean, if they're already loaded with all these interleukins and all these destructive, you know, growth factors, I think that could be very problematic. That's a very fair point. Yeah. Thank you. In the back? Verma, have you had to… sorry, have you had to… have you revised some of your balloon spacers to a reverse yet? How's it looked? Yeah. Anecdotally, I've done two in the last five years, and it honestly looks fairly native. There is very little residual remnant of the balloon remaining. I haven't had the issue with the adhesions that you sometimes see in more complex rotator cuff repairs, so I would say anecdotally, it's been much closer to a native procedure in comparison to when you're doing it after a more complex rotator cuff procedure. Okay. And then, Dr. Verma, further along those lines, any concerns with regard to taking down the CA ligament for an acromioplasty in terms of being able to contain that balloon? Yeah. So, we haven't seen that device displacement was a significant factor. It certainly wasn't in the study, and anecdotally, from the patients that I've done after that. I do think that you want to avoid overzealous resection within the subacomial space in general. The biggest risk is that it goes to the front or to the side, so I stay away from resecting the bursa in the front or the side. I think if you do a release but not a resection of the CA and just a smoothing, I don't think it's a clinical problem. And remember, these have intact subscapularis too. Question for Nick Verma, Peter McDonald from Canada. The subacromial smoothing and the tuberoplasty, how much does that contribute to your long-term pain relief versus the balloon? Yeah. That's a great question, Peter. Right. And we can ask that question about SCR. We can ask that question about tendon transfer. You know, what is the actual benefit here? Is it all the other stuff we're doing, or is it the balloon or whatever procedure it may be? The answer is we don't know. I think that it makes sense to me because at the end of the day, the balloon is designed to go away over time. So at some point, you are going to have recurrent contact between the humeral head and the acromioplasty. I will tell you that I think the balloon aspect of it is real. In the study, we had a number of patients that have had primary rotator cuff on one side and then were enrolled into the study on the other side. And they unequivocally could tell you, even being randomized, I know I had the balloon on this side because my recovery is just so much different. So I think it may have some value in the long-term setting. I don't have any data to suggest that. But it's a good question in terms of where's the benefit coming from. Thank you. Allison, can you help us sort out, you know, SCR data and information is very dominated by a very small number of surgeons and what the results are. And we have thick, we have thin, and we've had recent information that may be just covering the tuberosity and or acromion, i.e. maybe making a bit of a biologic balloon sort of situation, if you will. How do we sort all that out? I mean, we sort of, and is there a role still for interposition as opposed to putting it over the glenoid? Now thanks for the question. I think that this idea of an interposition effect, and so we say a spacer, let's call it that just because interposition can mean just a graft on the tendon. So as a spacer effect, I think the study that we saw that I presented where you had a six millimeter graft like a fasciolata versus human dermal allograft, if it was six millimeters, the patients had, and have equal results in terms of pain relief or, you know, or resisting biomechanical translation. And as you said, there's a small group, especially fasciolata, that the early literature here and the literature that's now five and ten years out is completely dominated by the fasciolata group and one author. And that does make it hard to sort out, but I think J.T. could comment as well on putting a graft or an allograft on the acromion, and then one also on the humeral head, and then you have six millimeters or more. And I've switched to a thicker graft myself, feeling like that spacer effect is important. I think there's still a role for interposition, and where I think that's most important is when you've got the lower grade guttale in a younger patient that still, if you're hoping to hook the tendon up and still get some function, I think that's important. And lastly, I emphasized subscapularis a couple of times in my talk, and I know Nick just mentioned the same thing. I think we really need to pay attention to the subscapularis when we're doing operations and not thinking we're going to reverse pseudoparalysis and all if we have a subscapularis, especially upper and lower subscap out like a massive tear, including that. I think you need to be careful of SCR and what you think you're going to accomplish. I think in the United States, we've done a really good job bastardizing a procedure with a really thin allograft, and that's the thicker graft that we've shown has proven a little bit better biomechanically, and so rethinking potentially some of these grafts that we use for SCR. And as you mentioned, patient selection is extremely important, but it can be a very good operation in the right person. So Nick, do you have any plans to randomize me? We have some pretty good literature that in some of the patients you've described, a biceps tenotomy solves everything. And so cheap, fast, easy rehab, whatnot, I mean, I guess you'd say no harm with Bloom, but there's an expense with the Bloom. So if those results turned out to be equal, that you're just reproducing tenotomy effect in that right patient, do you have plans to look at that or evaluate that the cleanup or something else like Peter talked about as opposed to the Bloom or not? Yeah, it's an interesting question, Bob, and actually when we were designing the study, you know, one of the questions that came up is what's the right comparative group? Is it debridement? Is it partial repair? Is it reverse? At the time, you know, this was seven or eight years ago, SCR was being proposed as the appropriate comparative. We chose partial repair in part because the FDA wanted another implant to be used against an implant, but also because in large part, we just had a hard time convincing surgeons to say, just do a debridement. They weren't willing to do that. But I think for any of these procedures that we're discussing, I think the big issues are is your patient looking for strength or pain relief? We may be able to get away with some of the things you're talking about. And I'm not sure that we know the answer in terms of whether debridement alone would work, but I think it would be interesting to look at each of these categories versus simple debridement to see if that's all we need to do. As I said, I do think that there's that temporary reduction in contact between the humeral head and the acromion that provides some value, but that's just my level five evidence at this point. And then I guess one last question for Dr. Verma as well. Have you expanded the use of this? You alluded to it a little bit in terms of using this to offload cuff repairs and other things and what are your thoughts on that? Yeah. So I think my thoughts are that there's probably two groups where we could expand this. The first group is what you're talking about, which is over the top of the repair. And then we really have to ask ourselves, what's our goal there? Is our goal to improve healing? I'm not sure that that's really going to do that. We're going to add an expense to the procedure. Is our goal to be able to accelerate rehabilitation because we're providing some internal splint? Maybe there's an opportunity to do that there. But really, what's our goal of putting a balloon over the top of a repair, particularly given the cost considerations that may be associated with that? And I think that's going to be a hard win from a scientific standpoint just because we know that, as Bob pointed out, even when these fail, they do very well. So I think the bigger strength here is what we saw with the balloon was earlier improvements and better range of motion. So patients lost less motion than a repair group and they gained more motion than a repair group. So it's a very friendly range of motion operation. So maybe what we look at is these lower demand patients that are trying to achieve pain relief and they've got a three or four centimeter tear that's probably repairable, may have a 50% or 60% failure rate, but all they really need is a balloon because they're not looking for the strength recovery that a 40-year-old is looking for. They're looking for functional activities and they can already do that. They just do that with pain. So to me, that's the bigger role of expanding this is to get away from this concept that we as shoulder surgeons and sports surgeons think we've got to repair it if it's repairable. Maybe we don't need to because you don't necessarily need the cuff to achieve the pain relief component. So you kind of like to say we're just getting started, but we're getting the hook from Dr. Brockmeyer. So no, we're okay. You guys go ahead and thank you, presenters, appreciate it. Always learn something. JT, I'm going to be a cream puff right now, so sorry.

Q&A session

medical conference

surgical procedures

rotator cuff tears

shoulder injuries