Sustainable Aspects of TO Tunneling for RCR

Speaker 1So, um, with that, I'll hand it over to, um, our next speaker, uh, Doctor S Sukumaran.

Speaker 1Who is an academic, uh, Shoulder surgeon at Johns Hopkins, and he's done a lot of basic science and clinical Research on transosseous techniques.

Speaker 1So

Speaker 1Uma, if you wanna take

Speaker 2it. All right, perfect. Thanks, uh, Brett, and thanks for organizing this and, uh, inviting me to share our experience with this. It's a great opportunity to learn from others who have, uh, taken on this Approach and, uh, appreciate your efforts in this, uh, area. So I'm gonna talk about this, uh, as, as Brett mentioned, uh, from a green perspective and what that means, uh, for, for all of us.

Speaker 2So, um, I don't have any disclosures, uh, related to transosseous Technology. Uh, in fact, uh, some of my disclosures are actually with anchor companies. So just take that, uh, as you listen to this talk. Our objectives, as Brett's already outlined, the evolution of Rotator cuff repair. So we specifically look at this according to

Speaker 2transosseous Technology and comparing it to what's considered to be the gold standard in anchored approaches, which is that transosseous uh equivalent, and then spend a little bit of time on the biomechanical concepts and I'll review our latest uh clinical outcomes and I'll try to show it to you from a green perspective. So why should you care about this green Approach?

Speaker 2You know, maybe it's just that, uh, you know, you hug trees, it's OK to be an environmentalist. That's great. It's a way to reduce, uh, recycle or reuse things, and maybe you just don't like to waste, and that's always a, a, a nice Approach. Or maybe you just hug money. Maybe the green is about the money that, uh, Brett's referencing to. But really I think green is about value and, uh, uh, Doctor Mattson, uh, speaks about this really well and

Speaker 2Regards to all kinds of different technologies in Orthopedics, and I think transosseous fits the bill perfectly.

Speaker 2Um, as Brett mentioned, the evolution from both our Approach perspective as well as the constructs that we use, anchors were great to get us to a fully arthroscopic Approach, and as that's evolved, the question really becomes, can we get back to an transosseous Approach done fully arthroscopically? I mean, there haven't been any studies that have demonstrated that an arthroscopic technique is better than an open.

Speaker 2Techniques. So it's just really a patient-driven thing that they want the, the Surgery performed arthroscopically. So can we do it in a fully transosseous manner? And how do we get there? So this is my preferred uh Approach or technique. It's very similar to

Speaker 2Uh, doing these Rotator Cuff repairs, uh, with anchors. You place a, a pilot hole in the same fashion, and then you can use an instrument. Instead of inserting the anchor, you can insert this hook device and, uh, connect it to a lateral tunnel, and you have a passing suture which you can then apply any number of sutures to or different types of sutures, tapes, for example. You complete your construct in a very similar fashion. So, if taught this way, I think, uh, it is accessible to uh residents and fellows.

Speaker 2Without a, without a problem. And then as Brett also referenced, this circlage sort of compression of the Rotator Cuff is ideal in many ways. So let's review that from a biomechanical perspective.

Speaker 2So some of the literature would suggest that a transosseous equivalent with the anchors, as you can see on the left, has extremely high failure loads, and which is why it's so popular. Um, but even transosseous technologies can have extremely high, uh, failure loads, uh, as well as low gap formation and achieve larger footprints than we can expect from anchor points, as Brett was also mentioning, single anchor brings you down to one area. How can you spread that out?

Speaker 2So, a lot of the studies will suggest the transosseous equivalent has high type 2 failure rates or muscle tendon junction failures, compared to transosseous approaches that have a much lower rate of uh muscle tendon junction failures. And if they do fail, they're gonna be tendon from bone again, which is much easier to revise.

Speaker 2So in this study that we performed with matched pairs, you can see the, the highest percentage of type 2 failures were in the transosseous equivalent or anchored Approach compared to uh the tunnels. And that's uh exists with Other literature as well. Kim et al. in 2016, again, finding type one failures.

Speaker 2But what about, uh, sorry, type 2 failures mostly in the transosseous equivalent group. But what about tissue perfusion, the Other side of this, that, that what you get with excessive compression may be sacrificing the profusion of the tissue, and this was demonstrated in a rapid study by Kim in 2017. So the initial conclusions from some of this biomechanics, uh, work would suggest that anchor TOE constructs do demonstrate higher failure loads than TO.

Speaker 2But, uh, the transosseous constructs are quite high themselves, maybe not in absolute terms, but we're gonna show you why this may not be correct. And then the failure mechanisms pretty well established, uh, individual studies, um, as well as large reviews.

Speaker 2So how can we assess some of this work and what Other factors are associated with construct strength? So when we did a systematic review and a metal regression of over 40 separate papers about the biomechanics, specifically Rotator cuff repair constructs, we identified some independent covariates. So suture type, number of sutures, number of suture limbs, the number of mattress stitches, um.

Speaker 2And a number of anchors and finally construct types. So, is it a double row, uh, transosseous equivalent, a single row or, uh, standard double row constructs. And then we looked at failure load and failure mode. And really what we find, it's really all about the suture. So the strongest predictors of repair strength relate to, one, the number of sutures that are used, and actually the number of sutured limbs that are passed through the actual tendon.

Speaker 2As well as the type of suture, so dimensions of the suture, whether it's a wide bore or like a tape versus a, a cord type suture. So when you control for these factors for suture material, there's no difference in Rotator Cuff strength between any of the construct types. So single row, double row, TOE or transosseous techniques. So you can achieve any strength you want in terms of load failure based on your use of sutures and the fixation points that Brett mentioned.

Speaker 2So, the Other findings again confirm that TOE repairs are associated with high type 2 failures, uh, as referenced to either uh concentration of force along the medial row.

Speaker 2That might be too high. So when we consider this contact area and compression, which we're trying to achieve with any, any technique, uh, the TOEs have shown favorable compression areas compared to Other anchored, uh, approaches, but not compared to a transosseous Approach. It does have the best contact area when you do a fully, uh, transosseous technique where all the pressure is down evenly across the cuff tendon into the tuberosity.

Speaker 2But with compressive ability that goes hand in hand with tying the medial row for anchors, and that leads to the type 2 failures that we're, we're talking about. So the best balance really comes with respect to contact area and compression, uh, is with the transosseous repair. You can achieve this large contact area, a favorable compression pattern with high contact pressure, all things you need for high, uh, healing rates.

Speaker 2So this, you can get this compressive pattern without uh using that medial row compression and getting that stress riser and therefore avoid that type 2 muscle tendon junction failure.

Speaker 2So moving on to our clinical experience, this was, uh, recently published our, our matched cohort of Rotator Cuff repairs, uh, in core. We basically looked at the gold standard in an anchored Approach, which is the TOE versus fully anchorless transosseous technique, and compared both clinical as well as Patient-reported outcomes with, uh, Ultrasound followup. And we had a minimum 2 years of follow up. So this was retrospective but matched for sex, age, tear size, smoking status, all the important confounders for Rotator Cuff healing.

Speaker 2And our Primary outcome was the ASCS score, and we powered it to detect the minimal clinical important difference of 12 points.

Speaker 2And then the Ultrasound was performed at one year by separately by a blinded, um, uh, the interpretations by a blinded radiologist as to the surgical technique. So, as you'd expect, the results are equivalent, uh, regardless of 1 year or 2 year follow up, uh, ASCS score, the subjective Shoulder value, were similar across groups, and Pain scores also at 1 and 2 years were equivalent. The

Speaker 2A range of motion and functional outcomes were also similar, and the Ultrasound evaluation was equivalent. We broke it down by size, of course, that's the biggest predictor of your healing rates. This is equivalent across transosseous as well as transosseous equivalent, uh, approaches.

Speaker 2So conclusions here are that both groups can achieve clinically meaningful outcomes, as Brett also mentioned, this is a bit of a surgical sealing and Rotator cuff repair. We have a lot of good techniques to get healing to happen and clinical outcomes to improve with respect to our PROs. There's no significant difference in procedure duration, uh, or retear rates and any clinical outcomes. Of course, this is still a retrospective review in a single, you know, institutional experience in terms of our limitations.

Speaker 2But this was our first adequately powered study to detect the MCID for the ASCS score with clinical outcomes beyond 2 years, which were equivalent retear rates again equivalent with equivalent resources in terms of operating room resources, but significant Cost Savings if you look at the implants themselves. So takeaway points are that the biomechanics, uh, can be, can achieve similar strength, and it's really about the number of sutures and how you place them.

Speaker 2And the suture type, uh, as well. Clinically speaking,

Speaker 2Uh, we can achieve equivalent outcomes. So if your costs are similar, it's a very, uh, simple cost minimization, um, analysis. So, your value is going to be much higher, uh, should your costs be lower and your outcomes are equivalent. So this represents much greater value. So can we go green? So, speaking to the point of adoption, it's an additional tool and it helps if you can teach it in a way that's very similar to anchors because they dominate the market.

Speaker 2But it is also an opportunity to disrupt this market and really drive the cost of anchors down and also further innovate in the transosseous space and make it easier and simpler for everyone to achieve, uh, these types of outcomes.

Speaker 2We've talked about this surgical sealing and finding the most affordable way to allow us to shift more to the biologics, which are going to be expensive, especially initially. So this opens up that opportunity for even cost restrained restrained or bundled environments to start looking at those things. So really being green is about less waste, especially plastic, all these disposable anchors and each handle is thrown away, being less expensive in general, having a higher margin if you own your ASC or have any involvement with that, it's important.

Speaker 2And finally, most importantly, you're achieving an equal or improved patient benefit.

Speaker 2Thank you.

Speaker 1Um, Uma, did you, did you, uh, I, I may have missed it. Did you show any difference in the ASCS scores of the anchor versus transosseous?

Speaker 1It, it seems like the Transoia have very high ASCS scores because of the Pain, you know, slightly higher, it seems than, than anchors. I don't know if you've noticed that or not.

Speaker 2So we, we only, not in this study because we're looking at it at 1 year and 2 years. So by then, everything kind of washes out. Everything's going to be the same. I think if you measure it at, you know, 6 weeks and 3 months, in that time frame, you'll detect that, uh, Pain benefit that a lot of folks have, uh, um, demonstrated or know anecdotally from their own experience that the transosseous Technology seems to have less Pain. So that'll, that gets reflected in ASCS score early. But at the end, at the end of the day, by a year, they're all the same.