for questions before we get on to the next section. I don't know if anybody wants to come up to a mic or the room's small enough you could probably just yell out. I have maybe one quick one for Dr. Bush. Now, did you guys separate out articular-sided versus bursal-sided tears and did that make a difference? We did and it did not. Thanks for the interesting presentations. I'd like to just ask a question about the bio-implant and the results that you published are kind of similar to some other results in papers where there wasn't an implant placed, either with a partial thickness repair or full thickness tears that are repaired. Have you guys looked at your data and compared to historical controls in those series? And just as a follow-up, do you have any idea what kind of power you need to be able to detect meaningful differences with the bio-implant? You go for full, I go for partial. Hello, hello. Is this thing working? Whoa. Thanks, Pete. So, you're right, yeah. So, at a year, the results are similar. We found what the real value of the implant was early on, right? So, the patients actually, by three months, were having statistically significant improvement in their pain and function. But it was happening even earlier than that because we started collecting data at two weeks. Now, there's only two studies in the literature that actually look at results before one year, and that's the Shin study in arthroscopy and the Peters study in JBJS. And they started looking even at three months, not even earlier than that. So, one of the clinical sort of impressions that we had was that the patients were feeling better sooner, especially regarding takedown and repair or in-situ repair. So, if you look at the Shin and the Peters studies, this shows significant morbidity in that first three to six months in regards to pain and stiffness, stiffness especially for in-situ repair. So, that's one of the values we felt was inherent in the implant. And to your answer about the power and all that, we didn't do any of those analyses. Yeah, I mean, right now it's just a registry study, but I would echo what Lou said that it's a very early effect in the timing, but we all know that that matters. You know, in the days of Amazon Prime, days matter. And the current study that we're doing on the, we're currently enrolling for partial thickness, we're literally taking it to that level of how much pain day one, day two, day three, day four. And I think that some of that's a problem with our historical controls, right? That how much pain you have in a year is kind of irrelevant. It's either failed or it hasn't by then. And what we're really seeing with this patch is that it makes a difference in the first few weeks. And there's just not a lot of historical data about that. But I do agree with your point that at the, and our study showed that as well, that by six months and definitely by a year, there's no difference. Lou, the ones that you took back, the revisions that you did, some of the failures, any comments on what the tissue looked like? Did you do those revisions? And a question, curious if you know anything. Not necessarily in this study, I've got probably 300 under my belt personally. And we've had a couple where we've gone back and it's literally integrated. You can't tell the difference. And if it's failed, I had one, totally end of one, level five evidence here, but the tissue had healed under the implant and there was a space right behind it where it hadn't. And you could see based on the tendon anchor where that margin was. And that was kind of cool. We've had a couple that were probably P. Acnes infections where the tissue obviously looked terrible. And I think that there's probably some level of hypersensitivity that some patients have in one of the very earliest studies on this implant. That was their only complication, but it was in a patient who had a history of adhesive capsulitis on the other shoulder. So I think in some patients there's a predisposition for that. You ever see little amendments of the staples floating around at all? I've seen that in traumatic repair. I've seen that in, or traumatic cases of failure. But the few times I've gone back, it's looked pretty good. There's some feeling that there are some synovities, brucidities that can occur at about the three month period after implantation of the implant. The hypothesis was that perhaps that was related to dissolution of the PLA staples, which are of course absorbable. There has been at least one report I know that the peak staples, there have been loose peak staples too. So the peak staples obviously are for fixation to the bone. But if you go in after these, after say three months, you really can't discern that the implant was there. Yeah, and there's a... Oh, that's rice bloodies. Right, yeah. And we've looked into that. There was a paper I think three years ago on that. And it's just extremely hard to control for other things that can cause rice bloodies. We haven't seen it in the IBR group. We haven't seen that yet. It may be underpowered to Peter's question about how many do you need. Because when you do this overlying a repair, we're not controlling for number of implants, type of implants, manufacturer, any of that. So probably your best look at that is your IBR group. And we just really haven't seen it yet in that. More to come. So we'll have Dr. Rodeo come up and talk more about patches.

bio-implant

effectiveness

tears

pain and function

Dr. Rodeo