Any questions you have for our panelists through the app, or you can come to the mics to ask. It's hard for us to see the mics with this, but we're not frantically checking our text messages. We are checking the questions that have been submitted. So I'm gonna start with Dr. Verma, because you've received a few questions from the audience already. Dr. Verma, why did you compare spacer to partial repairs? It seems comparing to an SCR would have been a more similar group. Yeah, so that was honestly one of the biggest controversies in this study is defining what was the most appropriate comparative interval. We selected partial repair because historically that seems to be the gold standard for managing massive rotator cuff tears. And number two is we wanted to make sure that we had a fair comparison in terms of using implants in each group. So I think you can make the argument of a lot of different procedures as potential comparative options, but I think that partial repair is really the gold standard over time for this type of intervention. Thank you. And then another question from the audience. For the in-space study, what determined an irreparable repair? Fatty atrophy or intra-op determination? So it was really determined at the discretion of the surgeon. So a patient would be indicated at the time of an office visit as having a potentially irreparable tear. That could be based on either the size of the tear, the tear morphology, or the biologics as you allude to with regard to muscle atrophy. It was confirmed at the time of the surgery that the surgeon did not feel that an adequate, fully, that a complete repair could be achieved. So I can't give you any better definition other than it was at the discretion of the operating surgeon at the time of the intervention. Thank you. And then I personally have a question, but as a former biochem major back in the day, I am curious, you know, PLLA degradation in certain, we know that it can have problems in the bone. We see the ACL screws and they can sometimes cause reactions. Can you talk about the degradation of the implant? If it drops the pH, do we know? Could it potentially cause chondrolysis to the joint as a result? It's certainly a good question and one that can be a potential concern. As you just mentioned, there have been other substances that have been placed in the shoulder joint that have resulted in chondrolysis or other significant articular problems. I did not present it in this study just based on the five minute timeframe, but all of these patients underwent an MRI scan at 12 months in both groups. In more than 90% of patients, there was no evidence of any device residuals. So they're almost all gone by 12 months. They're probably functionally gone sooner in terms of deflation of the device, but resorption is almost complete by 12 months. And we saw no difference in terms of any changes to the articular surface, to the soft tissue, or to the bone that was deleterious or differential between the two groups. So I think based on the results of the study and the MRIs that were done, we can definitively say that it's a safe device. That's great. I'm also curious about the younger patients. So when you have, I noticed your inclusion criteria was 40 and up. Is there concern, you know, in my hands, I would prefer to fix that if I could, or at least do even a partial repair to get some type of force couple naturally to the patient to sustain that reverse, you know, to put it off. Is there, are there any indications in changing that age? Like maybe just 55 and up, 60 and up, are we going to keep it at 40 when the implant comes out? No, I think it's an important point. And, you know, as you know, there's a smorgasbord of options that are available to these patients. And really it becomes very difficult to determine when do we do a tendon transfer? When do we do an SCR? When do we do a bridging graft? And is there a difference between any of these procedures? We did find that when we did a subgroup analysis that patients over the age of 65 did better than the younger patients. But I would argue that that's probably likely true for most of the interventions that we were talking about. Having said that, I think that the sweet spot for this intervention is for patients that have maintained function, that have pain, that have failed a conservative course, and are really looking for rapid pain relief. So it's lower demand patients who can raise their arm but are painful. And those are the patients that get better very quickly. I don't think we have an expectation that strength is going to improve significantly other than strength that may improve from pain. But I think to your point, it really comes down to trying to choose the right patient based on what their complaints are and what their goals are after the surgery. And then I have a quick question for Jillian because we don't want to leave her out while we're getting ready and everyone can start coming up for the last video, the panel. Jillian, in a nutshell, what are your author's hypothesis on why the scores are improved? I notice you have a poster here too that maybe delves into that. Give us a little overview of what you think the reason is. Absolutely, yeah, that's one of the most common questions we get with this study. So our excellent outcomes that we saw are actually really similar to what other studies with SCR have seen. We believe that this may be secondary to a spacer effect by the graft that at the extremes of flexion that the graft may inhibit the contact of the humeral head. So almost similar to a subacromial balloon. So that's one of the hypotheses that we have. Another one may be that the SCR may have a different pain-modulating effect that we might not fully understand yet. Or it's also possible that the improvements we see in patient-reported outcomes may be a little bit more complex than just the simple abduction kinematics that we can evaluate in the lab. All right, great. Well, thank you all very much. Thank you.

spacer

partial repairs

rotator cuff tears

gold standard

implant degradation