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PushLock® SP

Der 4.5 mm PushLock&nbsp;SP wurde entwickelt, um die Durchführung einer Rotatorenmanschettenrekonstruktion im SutureBridge-Verfahren zu beschleunigen und ein präziseres Fixierungsergebnis zu erzielen.&nbsp;Der PushLock&nbsp;SP besteht aus einer kleinen Titanspitze mit einem Ankerkörper aus PLLA, BioComposite oder PEEK.&nbsp;Dank der Titanspitze ist das Ankörnen des Knochens für die laterale Reihe bei Double Row-Rotatorenmanschettenrekonstruktionen, wo Weichgewebe die Sicht verdecken kann, nicht erforderlich.&nbsp;Dadurch wird das teils schwierige Auffinden des Vorgestanzten Loches, das bei einem Standard-PushLock-Anker nötig ist, hinfällig.&nbsp;Die selbststanzende Funktion sorgt zudem für eine korrekte axiale Ausrichtung des Ankers beim endgültigen Einbringen in den Knochen.

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Shoulder and Elbow - Next Generation in Repair and Reconstruction 2024

A scientific report from the Arthrex Orthopedic Research Department stating an objective, methods and materials, results, and discussion and conclusion.

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Relatório científico do Departamento de Pesquisa Ortopédica da Arthrex declarando um objetivo, métodos e materiais, resultados, discussão e conclusão.

Informe científico del Departamento de Investigación Ortopédica de Arthrex que establece un objetivo, métodos y materiales, resultados, discusión y conclusión.

Arthrex® Bio and Biocomposite Implants: Post-op Complaint Analysis by Product Family

Neal ElAttrache, MD, (Los Angeles, CA) presents his principles to achieve successful outcomes for arthroscopic rotator cuff repair. Dr. ElAttrache describes the natural history of cuff tears, biological and biomechanical elements that affect the success or contribute to the failure of cuff repair, a summary of the published biomedical testing, and his practical techniques and tips to achieve the best rotator cuff repair possible.

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My Approach to Rotator Cuff Repair

Going to talk briefly. Just setting the stage for what I do and why I do it with regard to the cuff. And these are what I call the rotator cuff repair facts of life. There traditionally was high persistent tear rates with our traditional repairs. And this had been shown no matter who the author. And and this was it was questionable as to if we really were going to be able to approach the results that were being reported with open repairs. We found that healed cuffs definitely have better function, but the cuff is slow to heal and the tendon is relatively avascular for a long period of time after a repair. The vascular response for healing comes from the bone, so the biologic factors come from bone marrow elements that then creep into the repair interface. Face, and these biologic factors for healing are impeded by the synovial environment. The repaired tendon has to sit still for a long period of time over as large an area of. The healing zone the anatomic area of healing on the greater tuberosity. In the face of motion. And it's in that face of motion that that even in the addition, the initial biomechanical studies, we didn't consider we just looked at tension and, and what the cuff would do. But in real life, this cuff has to sit still for a long time while the shoulder is moving. We know that tissue compression, as was mentioned earlier this morning, does enhance healing. We've seen that in soft tissue to bone healing areas of in the, elsewhere in the body. And a lot of this stuff was done with regard to ACL surgery. When we look at screws put in against the semitendinosus or soft tissue grafts in bony tunnels, and compression does enhance this healing. So therefore you want a strong, broad, GAP resistant repair that has some compression element in the repair that contains and protects the industrial healing factors. And we felt that the modified double row repairs that then evolved into the osseous equivalent SutureBridge type repairs would perform significantly better both mechanically and providing the biologic factors for healing. Let's take a look at why then. We were failing with our our other repairs. And quite frankly, if we look critically at the open repairs some of the same failures existed with open rotator cuff surgery as well. These causes of failure I think we can divide up into technical failures. I'd like to think those are mainly historical but inadequate technique, inadequate implants. Then we failed to reproduce the normal anatomy and we would, over tension tissue, put tissue where it wasn't supposed to be. Mechanical failure of our repairs. We were doing repairs that couldn't hold up to the strength necessary and the stresses necessary that, that they'd be exposed to. And the failure of biology you know, just to go back to the mechanical failure Steve was the first one to really show what kind of stresses a repair would be exposed to just by by extrapolating data that would tell us how how much force a supraspinatus tendon would apply to a repair zone. And if you look at, you know, his work, you know, there's a lot of hidden pearls in what he what he does. But if you looked at that data, it was about 275 to 300 newtons would be generated by the supraspinatus. Well, if you looked at our repairs that we were doing, our repairs were holding up to about 275 newtons of of strength. And so one, one pull of the supraspinatus would tax the repair almost maximally. Mentioned briefly, tension overload over reduction of the tendon on the tuberosity can be a problem. Malposition of the tendon on tuberosity. This is probably the biggest part of the learning curve of doing arthroscopic rotator cuff surgery. If you did open surgery, you open up the shoulder, you could grab the rotator cuff and you could yank it and pull it wherever it wanted. And so that led to a lot of failures in probably in the recovery room. Well, the same thing holds true for for arthroscopic management. Now, now we have we have better instruments. We can grab that tissue and put put it where we want it. The biggest part of the learning curve is deciding and learning where it's supposed to go. And so this malposition of the sutures and the most, most dangerous part to where to put sutures is medial to the rotator cuff cable, all those what they call type two failures, where where you end up with a failure at the Musculotendinous junction, that is almost an unrecoverable problem, is because of bad positioning of, of sutures through or medial to the rotator cuff cable. This is the study I was I was telling you about, that really taught me a lot about how strong these repairs need to be and where to reinforce the repairs. You see, the 302 newtons applied by the supraspinatus infraspinatus forces can exceed 600 newtons, and our single row repairs were holding up to about 275 Newtons is barely sufficient in that situation. What wasn't considered that at that time was that there was differential strain within the rotator cuff with rotation. This was our initial comparison. And what spurred me on to look at this was I was at a meeting in in Dublin, Ireland, with Steve Burkhart and Joe de beer, and de beer was telling Steve and I was standing like a fly on the wall, listening to Joe talk to Steve about what he was doing with with double row repairs. And we had a brief conversation about it, and I came home and started to study it. Well, certainly it makes sense. Biomechanically it improved the strength by about 48% compared to single row repairs. Stiffness by 46%, it decreased gap formation by 42% and the strain over the footprint by two thirds. But what about healing? Double row footprint repairs was superior in the lab and in the early clinical studies, but you also wanted a construct that would enhance the healing to a greater degree. So our goal was to develop a construct with that would provide increase in contact and compression over the entire footprint. And that was then the birth of the interlinked double row repair that came to be known as the SutureBridge. When we failed biologically, we were failing because we primarily were not being able to take advantage of where these healing healing factors were coming from. We weren't able to contain them, we weren't able to protect them, and we weren't able to improve the mechanics of compression. And these elderly patients that sometimes we deal with have a questionable biologic wherewithal for healing anyway. And so what that was what I considered something that we needed to try to pay attention to when we were deciding on what technique to to do. We already talked about the pressure effect and this footprint compression. We knew that there were open techniques that were able to do it by passing suture through bone and then tying suture over the top of the tendon. But could this be reproduced? Arthroscopically. And that's what then we set out to do with the bridging repairs. This was our first study that Steve had mentioned. This looked at this was a pressurized film study to see how much of the footprint we could compress in contact with the bridging repairs and the Fujifilm that you see on your on the far left is with the double crossing repair that it looks very familiar as the typical SutureBridge. The Fujifilm in the in the middle is a V shaped linked repair, and then the one on the far right is the double row repair. And what you see there is just simple spot welding of the tendon down onto the bone, so you can contact and compress much more with the simple bridging type of repair. But can these be maintained? So what was the biomechanics of this. And what we saw was that the double row repair, as I showed you before, was very strong compared to single row repairs. And the and we were able to reproduce that strength with just interlinking the bridges. But I'll show you how that the by interlinking the the anchor points is even more beneficial. This is one of the things I learned in doing these studies. And this was a cadaveric study where we just simply looked at where are the strains in the cuff when you move the cuff. And we found something that now looking at it, you see, says, well, that should have been intuitive, but it really wasn't. And what we saw was that the anterior part of the supraspinatus, where that Steve has coined the anterior rotator cuff cable that is under enormously larger forces, under motion and with external rotation. All of the stress and strain goes right to that part of the rotator cuff. So that deserves a lot of attention when that part of the cuff is torn. So how did we account for that? We looked at how the bridging type repairs would hold up to motion, especially with tears in that location compared to our single and double row repairs. And we found that the bridging repairs had a higher yield load than the double row repair when allowing for external rotation. So you see when when the shoulder would rotate if you had unlinked double row repairs, whatever anchor it was that was getting rotated into the axis of of pull was left to fend for itself. It was like you had done a single row repair at that ankle anchor point. And so by interlinking and self-reinforcing. That's another term that Steve coined, the self-reinforcing repairs. You were able to protect that anchor point under motion. Likewise, in abduction, when you abduct the shoulder, the entire medial footprint of the tendon peels off. And so the double row, and especially the linked double row repair will will limit that gapping away and allow the tendon to stay on the bone to promote healing. So what are the advantages of the osseous equivalent technique. They are improved footprint contact improved strength which provides a more favorable tension angle. Minimal gap formation. The tissue can only settle under cycling. It doesn't pull off. It simply slides on on the footprint of a millimeter or even less, rather than actually separating away. It doesn't rely on the most lateral tissue. The interconnectivity is very important because of these repairs being exposed to motion. It facilitates revision repairs. So when your entire tuberosity is filled with shrapnel from previous operations, where do you go? What you do is you bridge over that and you apply the tendon down onto the onto the area for healing. The medial row provides a barrier between the synovial environment and the healing zone. It contains healing factors and allows for biologic manipulation in the future. Potentially. So what does this look like? This is a this is a very sneaky tear. This is one where the entire enter cable is off. If you can see the bicep with no tissue posterior to the bicep tendon, your anterior rotator cuff cable is off. So this is a video that I did maybe four years ago using the the you'll note the anchors that we're using. These are not biocomposite. This is a SwiveLock that was put And so that's the medial row. And what I've done is I've passed the sutures together in a mattress fashion. Now, because the anchor cable is off, I thought that that deserved individual fixation. So I went ahead and put a biocomposite Corkscrew anchor right there and fixed the cable directly with simple sutures. That reduces the repair nicely. And then simply then tie one knot per anchor medially. For large tears. I would, even though it's attractive to do knotless technique for for large tears, I would still suggest that you might want to consider tying one knot per anchor. So that was that was basically the First or second generation of of the bridging repair in that type of tear. That is sort of a lazy crescent. A lazy crescent, meaning that the anchor cable is off, the biceps is exposed, and so that that deserves a bit more reinforcement. This is a more recent technique. We're looking we're intra-articular right now looking at the bicep. Full thickness, large rotator cuff tear that you'll see in a second. Now we're in the bursal space. So the initial thing is once again, determine your orientation of the tear. See what goes where. The initial step here is to fix the biceps. So I pass a FiberTape suture through the bicep tendon. Then I my technique then is I take a the FiberTape pass it over the top, reach underneath. So now I'm through and around the bicep. I punch this is a nice flat rasp that is very good, not only for the acromion, but for the tuberosity. Then you can pull up on your stitches and get underneath the bicep so you get a bleeding bed. Then we punch a hole there in the in the top of the groove. Fix the free ends of the. See what I did? I already estimated the depth of my tunnel, so I slid the eyelet on the sutures about a centimeter and a half. Gave myself a little slack, then applied the anchor into the bony socket. We cut those sutures, then reset the intra-articular portion of the biceps tendon. Don't forget to do that. Then we go ahead and fix our our tear as we did previously. Steve, this is the that technique where I mentioned to bring the sutures through in a horizontal mattress fashion. Then then tying the tying the FiberWire sutures first and then passing the FiberTape from medial to that horizontal mattress over to give what you call the the rip stop. So I'll move forward on this. This is you've seen the steps for that on the previous video. And don't forget what we've been taught about broad based U-shaped tiers and L-shaped tiers. So we want to turn those tears into crescent shaped tiers. And then you can do your interlinking, bridging type repairs that that we just showed. Let's talk very briefly about the results, because I want to talk about some of the misinformation that's being put out right now about whether it's worth it to do these or not. This is a busy slide, but I'm in press right now is a study for jbj's that is an invited review that looks at it's a big meta analysis of of the current literature. And what we see is these level one and two studies all have a they all show a statistical tendency, statistical tendency towards better performance of the bridging double row repairs. But these studies are that are in the literature currently are all underpowered. It was shown by De Haan that in in JSM that in order to show a reduction in complete tear rate by half, you have to have 247 patients needed per comparison group to show a reduction in tear rate by a quarter, you need over a thousand. And the current published studies don't even come close to this. But still, even in the current published studies, you see a statistical tendency to better performance of the repairs that that we're doing with the linking repairs. But that's not what's being presented on the podium. This this slide is it summarizes something else very important. If that blue triangle there crosses the vertical bar, that means that there's there's no statistical significance. What we see is the relative risk of all returns was statistically higher in single row returns than double row returns. If you look at full thickness returns, you didn't see any statistical difference. But if you look at the deep partial thickness returns, you see again a statistically higher rate in the single row returns. Now, if you look at the follow up length of time of the studies in the meta analysis across the worldwide literature, it's little less than two years. These returns, these partial thickness returns are occurring in less than two years. And we know from the current literature that these tears get bigger over time and that once they develop a full thickness tear or retear, they perform significantly more poorly. So the reason that I think that the double row and the linked double row repairs are performing better, and we clinicians know it. It's just that these guys on the podium aren't. It's a problem with the with the way they're doing the studies. They're not they're not following them out long enough because this will reflect itself in poor outcomes. This is a study that Steve has since published since I put this slide in my talk. And it shows the long term outcome of arthroscopic repair of massive tears. And certainly the patients do better. They're stronger and they're much more satisfied considering to have a good an excellent outcome with the repairs. So when do I use the double row repair? Whenever I can and when I can't do anything else. And this is one of those cases that I told you about with the whole tuberosity was filled with shrapnel. So my observations and I'm going to close here shortly. Most tears benefit from and are amenable to footprint compression constructs as part or all of the repair include margin convergence for large U-shaped and L-shaped tears, as necessary for large tears where the head can't be covered. Consider interval slides as described by by Steve, and my personal preference is to either do interval slides or balanced partial repairs. Tears involving the rotator interval usually mobilize adequately by releasing the coracohumeral ligament and the order of repair of torn subscapularis from intra-articular aspect. First anterior cable attachment. Next, post your cable attachment if it's torn. Third margin convergence if necessary. So we're gradually closing this down to a crescent shape. And then a central SutureBridge grafts to bridge gaps are of questionable benefit over balanced partial repairs or interval slides, in my opinion. So why did we fail? We didn't restore anatomy. We provided suboptimal biomechanics and we couldn't optimize the biology for healing. Thank you.

In this study presented by Dr. Bryan Hanypsiak under the guidance of Dr. Stephen Burkhart, the knots of more than 70 accomplished shoulder surgeons are tested against Arthrex knotless suture constructs. Knotless sutures consistently provided a more dependable strength, while the knots tied by surgeons seemed to produce less consistent load to failure.

Presentation Videos

Knot Tying Studies

We're going to talk about our knot tying studies. We recently did two studies which I think will help you overcome some of the anchor debate that's out there. I think this is particularly applicable to the juggernaut and the single row versus double row arguments. So I'm just going to take a little bit of time and and go through what we found in our research. So the first one is entitled knot strength varies widely among expert arthroscopies. It's been submitted for publication and includes Steven Burkhart and Walt Lowe as authors on it. Our hypothesis was the first that skilled arthroscopic surgeons would be able to tie arthroscopic knots of similar strength. We also thought that surgeons who are less than ten years in practice, would achieve more consistent results because they were trained during their residency and fellowship programs in arthroscopic surgery. So the guys who are just coming out have had the advantage of being able to practice and learn from their mentors, whereas the guys who've been out more than ten years had to learn during their practice. And I think that's often less successful. And we felt that surgeons who performed more than 200 arthroscopic shoulder cases per year would outperform those who perform fewer arthroscopic cases. So those are the things we're going to look at. So for our methods, we took 73 independent expert orthopedic orthopedic arthroscopies. These were all of our master shoulder instructors. And we had each surgeon tie five of their favorite knot. The one they use in the operating room, the one they're most comfortable and familiar with. We didn't want to test knots, different types of knots against different types of knots, because Steve Burkhart has already published a landmark paper in arthroscopy, which has already done that. So what we wanted to look at is the ability to make all the knots, whichever one you use, the same strength. So we tied five consecutive knots. We photographed, labeled them and numbered them one through five, and then tested each mechanically on an instrument for maximum load to failure and clinical failure for clinical failure. We identified that as being three millimeters of construct slippage. And I think it would be fair to say that if you did a bankart reconstruction and it was loose by three millimeters, that that would be a failure and you wouldn't expect it to work. So that was an arbitrary number which we picked. And I want to show you what we got. These are some of the knots that were tied. And we took a picture of every night. And you can see that there's a tremendous variation in the appearance of the knots. And then when we look at the sets of five it's almost like a which one doesn't belong. But if you look some of the knots that these were all tied by the same surgeon in the same setting back to back, and I would challenge you to tell me that any of these look alike. So there's a there's a tremendous variation in even the appearance of the knots. So what happened when we put them on the instron? Well, the first thing we did was look at maximum load to failure, which was to put the knots on the instron and pull them. And as the construct slipped three millimeters, we generated the clinical failure number. And then as it finally broke and gave in, we got the maximum load. So when we looked at first group surgeons who were less than ten years in practice, we found that those surgeons tied statistically significant, better knots than those who were more than ten years in practice. But when we looked at maximum load for those doing more or less than 200 cuff repairs per year, we found that it didn't matter. So it didn't matter how many surgeries you did. If you tied a knot, you tied a good knot. If you didn't, you didn't. You just tied that bad knot more times that year. So then when we looked at clinical failure, which was three millimeter of slippage. We looked at more or less than ten years in practice. And we found that there was no statistical difference in whether or not your construct failed clinically. And that was true also for more or less than 200 rotator cuffs. Now the interesting thing comes in when you look at variation. So we looked at the distribution of maximum load and we looked first at individual surgeons. So out of the 73 surgeons that participated in the study, only 27 of them or 37%, were able to tie the knots within 20% of the mean. So basically, it's a huge bell shaped curve, and there was tremendous variation in large standard deviation. We noticed that there was no significant difference from not one to not five. So doctors weren't getting tired as they tied the five knots. They were all the same. Then when we looked at the individual knots, the 365, only 18% were within 20% of the mean. So again, a tremendous variation in the strength of the knots. When we looked at clinical failure, we found the identical picture. Most of the knots fell outside of the average knot strength in the study. Then when we looked at knot stack height, we found something very interesting. Out of the 365 knots, the average knot stack height was 5.6mm. That's over half a centimeter. I don't know how much room there is between the rotator cuff and the acromion on an average patient, but I don't think it's more than a centimeter, and it certainly might be half a centimeter. So these knots take up a significant amount of room in the subacromial space. And I would challenge anyone to say that you're not celebrating the undersurface of the acromion is a problem. Isn't the problem. Excuse me. Okay, so then we looked at the Enstrom charts for consistency, and we found that some surgeons were able to consistently tie great knots straight across the spectrum. So the top two are good examples of consistently well tied knots. The bottom chart is one of our surgeons who was great at tying bad knots. These had the lowest standard deviation of anyone, and they were all equally bad. So there's consistent charts in both spectrums. Looking at inconsistency. When you look at the standard deviation, the numbers are very high here. And you can see that these charts are all over the map. One knot to the next is completely different. And then we found something really interesting. There were some that if you just looked at the numbers, they looked consistent and And consistently good. There were others that when you looked at the charts, you said, wow, these numbers don't match up with what we're seeing. So let me show you the one on the bottom first. This was the guy who tied what we thought were the best knots. We wanted to study what he was doing that made his not so good look at the max load 339 Newtons with a standard deviation of six. These are all consistently strong, but we went back and looked at this window here, which was the clinical failure. He tied some of the worst knots. So it was 88 newtons of total strength with a large standard deviation. So what we found was that he wasn't actually a good not tire. He was good at tying knots that functioned like Chinese finger traps. The harder that instrument pulled, the tighter those knots got, the higher the maximum load. But in reality, his knots were going to fail clinically much faster than anyone else's. Again, here you look here. This is tight standard deviation in clinical failure and max load. There's a wide deviation. Again here you see the same construct. So even within the not pictures themselves the numbers don't always tell the whole story. So then we looked at anchor pullout. And I wanted to look and see how those knots did against the anchors. Because everyone knows the anchors generally don't pull out anymore. When something fails, particularly in the cuff, they cut through the tissue. Right? Well, what I wanted to do is see what happened when you added the clinical variance in knot strength to this. And what we found for SwiveLock Corkscrew all of the most popular anchors out there that on average, only 66% of the knots tied exceeded the pull out strength of the anchor, which meant that one third of the anchors placed were at risk for clinical failure just from pulling on the anchor. Now, we don't know the force that they see exactly, so it's only Conjecture, but I would tell you that it's quite possible that if you do a three anchor bankart repair, you've done a two anchor Bankart repair, unless you've done knotless fixation, because there's concern about that not failing. So in conclusion, there's considerable variation in knot strength between arthroscopic knots of the same type tied by the same surgeon. This variation has the potential to affect the integrity of arthroscopic repairs, and I would suggest that independent, objective testing of knots should be part of a surgeon's training. I learned how to tie knots as a resident and again as a fellow, but no one ever checked to see if I was actually good at it or tied good knots. So my suggestion is maybe our clinical programs and our fellowships should test their residents, test their fellows to make sure they're doing the right thing. So that was the study one we wanted. And we suspected that using Knotless fixation would be more consistent than tying anchors, but we couldn't really say that because we didn't test Knotless fixation. So the next logical step would be to put Knotless fixation head to head against tied suture anchors. And our hypotheses were that the pull out strengths of knotless anchors would be more consistent than knotted anchors. The time to complete a knotless construct would be significantly shorter than for knotless anchors, and that knotless anchors would have less slippage of the construct prior to failure than knotted anchors. So we repeated our methods. What we did is we took 71 independent expert orthopedic arthroscopies, and we had them tie three anchors in foam block, tying their knots or placing their knotless fixation over the steel bar, which coincidentally matched the instron. And what we did then is we had them tie the three knots and we timed them on every knot, and we had them place the swivel locks and we time them on each knot. We also measured the knot stack, and then we tested for clinical failure and maximum load to failure, just like we did in the previous study. This is what the station looked like. Again, we went in order and photographed all of them until they were complete. We did those for both the tied anchors and for SwiveLock. In looking at the results, when we looked at clinical failure, which was three millimeters, knotless fixation and knotted anchors were equivalent. That is the only condition which is still arguable of what the what that means three millimeters of failure where these were equivalent in all other aspects. Knotless fixation was superior to tied. Suture anchors. When we looked at maximum load to failure and we looked at standard deviation, the p or theoretically f values. Looking at. Variation between the standard deviations were statistically significant. Even though the tide suture anchors were slightly stronger, the variation. Was much greater, so these were more likely to fail because of a poorly tied. Not if you could tie consistently five knots. These anchors were slightly stronger. But we know from our previous study that you can't. Looking at extension and slippage. The tied suture anchors for maximum load stretched twice as far as the knotless. Construct before maximum load was achieved, and that was statistically significant. When we looked at time, it took 82 seconds to put in a tied anchor and 40s to. Put in a SwiveLock twice as long, and that was statistically significant. Look at those. P values, not stack height 5.35. Nearly identical to the number we got on our other study. Swivelock essentially zero. There was no not stack. So in conclusion, our SwiveLock and tied anchor performance was equivalent at conditions set for clinical failure. At all other conditions, the SwiveLock was superior. The SwiveLock was five times more consistent than a tied anchor at maximum load to failure. The SwiveLock was two times faster than a tied anchor to be placed, so it improves your operating time. And the SwiveLock had a nod stack that was zero and half a centimeter smaller than any tied anchor. So I would take that information out, get it out there, because not less fixation is faster. It's more consistent. It is just as strong. And it doesn't leave a not stack behind to cause problems later inside the patient's shoulder intra-articular or in the subacromial space.

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Shoulder and Elbow - Next Generation in Repair and Reconstruction 2024

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Knot Tying Studies

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My Approach to Rotator Cuff Repair

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Arthrex® Bio and Biocomposite Implants: Post-op Complaint Analysis by Product Family

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