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Listen to the inaugural Joint Ventures podcast to hear renowned surgeons dive into the world of bioinductive augmentation with the REGENETEN◊ Implant. In a vibrant discussion, they share extensive experiences with this innovative implant and its associated technique, the strength of supporting data and impressive outcomes they’ve observed. Featuring: Dr Ian Lo, Dr Michael O’Brien, and Dr Scott Trenhaile.
Creators and Guests
Host
Dr. Ian Lo
Orthopedic Surgeon, Calgary, Canada
Guest
Dr. Michael O’Brien
Orthopedic Surgeon, New Orleans, Louisiana, USA
Guest
Dr. Scott Trenhaile
Orthopedic Surgeon, Chicago, Illinois, USA
What is Joint Ventures – A Sports Medicine Podcast?
Progress occurs when thought leaders share insights and knowledge at the cutting edge of sports medicine...so we’re inviting renowned surgeons and industry experts to lead the conversation. The Joint Ventures podcast series puts the hot topics center stage, so stay tuned to explore evolving trends, shifting perceptions and emerging procedural technologies.
DISCLAIMER:
Smith+Nephew is a medical device manufacturer and does not provide medical advice. This material may contain information related to Smith+Nephew products, educational content, and/or demonstrate certain techniques used by the presenter(s) and is intended for informational and educational purposes for healthcare professionals only. This material is not intended as a substitute for the assessment, guidance, or judgement of a healthcare professional. Any procedures featured should only be performed by a suitable healthcare professional, and clinical decisions made by such a healthcare professional. Presenters featured in this material may include employees of Smith+Nephew and external healthcare professionals, as indicated in the material content. The healthcare professional presenter(s) featured are paid consultant(s) of Smith+Nephew. Please note that sources of some images and references may not be identified and/or may constitute copyrighted material. For information presented by any healthcare professional presenter(s) featured in this material, such presenter(s) are presenting their own clinical experience except where stated otherwise. Opinions expressed by such presenter(s) are those of the presenter(s) only and may not reflect the opinions of any other person, institution, association, or manufacturer, including Smith+Nephew. This material is not intended to endorse any named institution. Selection of appropriate products and techniques for each patient is the responsibility of the treating healthcare professional, using their clinical judgement. Product performance and information featured in this material may not represent typical outcomes. Each procedure and patient represent a unique set of circumstances, and therefore results may vary. For more information on the application of any products featured in this material, as well as indications for use, contraindications, and product safety information, please consult the Instructions for Use (IFU) and Drug Package Insert for the relevant product, as applicable. The information presented in this material may not be appropriate for all markets. Products featured may not be available due to regulatory and/or medical practices in individual markets, or as a result of being withdrawn or replaced. Please contact your Smith+Nephew representative if you have questions about availability of Smith+Nephew products in your area.
Hello everybody. Welcome to Joint Ventures by Smith and Nephew Sport Medicine. I'm your host Ian Lowe and today we have two guests with us, Doctor. Michael O'Brien, Tulane University and Doctor. Scott Trenhill, Ortho Illinois.
Speaker 1:Thanks for joining me guys. Today I think we're going to talk a little bit about rotator cuff rotator cuff tears, how your practice has changed really over the last ten years or so, and really about the REGENETEN implant how that has changed the outcomes for your patients. Now Scott, I know you were involved with this implant really for a number of years. Tell me about your experience initially before you had this implant. How were your rotator cuff patients doing?
Speaker 2:I mean, always think that our patients are doing fantastic until we really start to look at our results critically. There was always a gap or a void in my treatment armamentarium where I just wanted to do better and thought I could do better with these patients. And I actually started my whole experience on the large to massive rotator cuff conundrum.
Speaker 1:Right.
Speaker 2:Not the partials side of things. And I explored every patch, so to speak, that was out there trying to find something to do better for my patients and and make make the outcomes better and and Injectables and Everything. RP. Yes. Yeah.
Speaker 1:Yeah. Mean, have been so many biologics out there really haven't stood the test of time. And, you know, when they first come out, you're like, oh, this could be the next thing best thing since sliced bread.
Speaker 2:Mhmm. Right.
Speaker 1:Critical appraisal, I think the outcomes are very different.
Speaker 2:Agreed. Yeah. So I started on the on the massive cuff tear side.
Speaker 1:And you started augmenting those with different types of implants?
Speaker 2:Yeah. You know, I I, of course, was augmenting everything that was in danger of retear, radiographic retear is where it's at. Right. Just the the outcomes weren't predictable. And so I that's when I gave her Jenna actually, back then, it was under a different name, but Yeah.
Speaker 2:I gave it a try, I was like, this is different. Right. That was my start.
Speaker 1:So what's your early experience?
Speaker 3:Very similar. And so Buddy Savoy is my boss, and he was an early adopter of the implant, and actually helped, I think, design the arthroscopic implementation tool with Jeff Abrams. And similar to Scott, where you have these large and massive tears, and when you really follow them critically, you realize more fail than we want or that we want to accept.
Speaker 1:Right.
Speaker 3:And we follow ours with ultrasound, so then you can see at that three, four month mark that it's failed even if your patient's doing well. So then what do you do? So Regenetin became available, and I started, like Scott, using it as an augment on top of large and massive tears. And I had tried other things too, different forms of biologics, you know, but wasn't getting good results with that. And when I first started using it, I was super skeptical.
Speaker 3:I didn't think it would work. But I had heard people like Rick Rioux and Jeff Abrams present their data and Buddy Savoy and see their MRI outcome studies and show that they were getting these tears to heal. So I started using it. And following them long term, we could see it, like, in their range of motion, in their strength, following it on ultrasound. We could see the implant on top of the rotator cuff, and then between three and four months, you can see it kind of disappear so you know it's integrating into the Right, yes.
Speaker 1:So this is interesting. So you routinely follow your rotator cuff repairs on serial ultrasound like with every Every one. Follow-up visit?
Speaker 3:Four weeks, eight weeks, twelve weeks, and then their last visit, whenever that is.
Speaker 1:So just tell me then anecdotally, what do you see on these ultrasound with that implant, the interface, maybe the tendon thickness? What are you looking at?
Speaker 3:What do you That's, yeah, all of those things. So if you get someone to put their hand on their hip, it brings the greater tuberosity forward from under the acromion. And so then you can see the greater tuberosity, and you can see where your anchors are, so you know exactly where your repair is.
Speaker 1:Oh,
Speaker 3:interesting. And early on, you can see a space between the implant and the tendon. And early on, it's about two millimeters, so you can measure the thickness of your tendon and then the thickness with the implant, which adds about two millimeters as the implant swells a little bit. And then I think it's around four months that the implant completely integrates, and then it just looks like one tendon. And so we follow that over time initially just to kind of show that they were healing and not re tearing.
Speaker 3:And we also kind of used that to guide their therapy. So if their repair looks kind of thin, we might not start strengthening right away. If the repair's looking good, we might start strengthening a little sooner, like ten weeks versus twelve weeks or fifteen weeks. But that was one thing that really led me to believe in the utility of this implant.
Speaker 1:So who do you feel like you know, REGENETEN's probably not gonna help this particular patient or repair? I
Speaker 2:certainly, you've got patients who are arthritic.
Speaker 1:Okay. Yep.
Speaker 2:You know, more on the their their their joint is just a little too far gone.
Speaker 1:Like a cuff arthropathy patient.
Speaker 2:Yeah. Pre cuff arthropathy patient with a really large tear.
Speaker 1:Yes.
Speaker 2:Probably north of 70 to 75 years old, and I can't prove that, but I just my clinical suspicion with with tendon healing in general and how you add all those factors together, there's there's only so much this can do. Right? There's guardrails, and I think those are some of the big factors where you'd say, this this doesn't make sense.
Speaker 3:Yeah. Similar. You know? Because I my current algorithm now is I put it on every large and massive tear, even somebody young, because if they fall skiing and tear their whole cuff Right. You need that to heal.
Speaker 3:So even a young person without medical comorbidities, you need that to heal. Every revision case, I have now started using it on the partial thickness tears. That's where I'm not really sure what is the cutoff, you know? So in my mind, if it's fifty percent or less partial tear that I use Regenetin for, if it's over 50% or 80%, then that's where I'm not sure if that is enough to get that to heal. Then I still add an anchor in those high grade partial thickness So the one I don't use it is the arthritic patient.
Speaker 3:Sometimes if the tendon quality, if you can get a repair, but the tendon quality is really, really poor, where you almost realize in there, like, maybe I should be doing something else than a rotator cuff repair right now. And I don't use it on one centimeter tears because I don't think it needs it. You know? The healing rates are so high Right. With one centimeter tears.
Speaker 3:Yep. But, I mean, there's data that supports putting it on every single tendon.
Speaker 1:Okay. So have been using it for partial tear. Have you been using it for partial tears as well, Scott? Yes. So what's your experience been with partial thickness tears?
Speaker 2:Well, first and foremost, it's a when you look at how patients do with that over a takedown and repair
Speaker 1:Yes. Or a transcend repair.
Speaker 2:Yeah. Which I really don't do at all anymore. K. But when you look at those patients clinically, they are so much happier just out of the box. You know, they're less narcotics.
Speaker 2:They drive sooner. They go back to work sooner. They do all these things in their life. They're get they're out of the slinging couple of weeks. You know, they're they're they're just returning back to life much sooner than a takedown or repair.
Speaker 2:And so there's that patient, and then there's the patient that and maybe it it was a patient who was getting an acromioplasty, but their cuff really didn't look good. Looked tendinopic. Very sick looking tendon. And that patient even, they seemed to do clinically better early on with less pain, more motion, activity levels,
Speaker 3:all of I love that indication because before this implant, we would see those where you're going in there and you're doing an acromioplasty. They're having rotator cuff pain. But then when you look at it arthroscopically, the tendon doesn't it's not torn, but it doesn't look healthy. Right. It's all kind of beat up and frayed, which now I think we recognize is just early rotator cuff disease.
Speaker 3:Right. And that's one indication that I think is great because I think it kind of halts the progression of that, you know? And you're bringing in blood supply and you're adding collagen to the bursal surface and you're helping that sick tendon heal before it becomes a tear.
Speaker 1:I mean, at least you feel like you're doing something biologic. Totally. You're doing a chromoplasty, that's like a mechanical thing almost, like decreasing the impingement, but I feel You kind of
Speaker 3:feel like you're not doing anything with just an acromoplasty.
Speaker 1:Yeah. I mean, sometimes I feel when not often, but you're doing an acromioplasty for that disease. I'm like, are they just really doing rehab again? Or what are what are we really doing for this person? Yeah.
Speaker 1:I wanted to book that myself. So are you doing this in all types of partial tears, like bursal surface, in substance tears, articular surface tears?
Speaker 3:Intra substance, yes. I think it's a great indication for an intra substance tear. It'll trephinate the tendon with a needle, and then I might take the gold ball and micro fracture the tuberosity a little bit and then put regenerative on top. If it's articular sided, less than 50%, I'm using regenerative and accelerated rehab protocol, like Scott mentioned. If it's 50% bursal sided, I usually use an anchor.
Speaker 3:But then I still might add regenerative if the remaining tendon quality looks really bad. Right.
Speaker 1:So there is this concern, though, I think, with the rehab protocols and developing stiffness after the use of the REGENETEN implant. What's been your experience with stiffness and REGENETEN?
Speaker 2:Yeah. I think the thing, in my experience, that you have to understand is this device really accelerates healing. And with healing, you can get accelerated inflammation, good inflammation. There's good and bad inflammation, of course.
Speaker 3:I mean,
Speaker 1:all healing starts with inflammation.
Speaker 2:Right. And so patients you'll see patients that are doing fantastic, and then between nine and eleven weeks, they start to get sore. They're they may lose a little bit of range of motion. And it's all about counseling those patients and kinda weathering the storm because there's a there's a lot of good inflammation going on. Sometimes it's too good.
Speaker 1:And I think it's important for them to also understand the rehabilitation protocol, particularly for treatment of partial tears. Yes. Because if they've had a traditional rotator cuff repair before, that patient might think that's the rehabilitation protocol that's appropriate, but you've got to move them early, right?
Speaker 3:Yeah. And I think the physical therapists as well. So when this first came out and we were using it for partial tears on the physical therapy order, I would send a protocol, but then the therapist looks at it and says, Wait, you just had a rotator cuff repair. You should be in a sling. You can't be raising your arm up yet.
Speaker 3:So I think educating the patients that it's okay to move your arm because we didn't have to reattach anything. This implant is on the top, it's stable, it's not going anywhere. And then also educating the physical therapist that it's okay to push these patients a little harder and start strengthening at six weeks.
Speaker 1:I totally agree with that because I used to write just rotated cuff repair with graft, but traditionally if
Speaker 2:we would
Speaker 1:use a different type of graft, it was super slow, super mobilized, I was like, this is a huge mistake. I should have never wrote that.
Speaker 3:And I think that's what they think when they see that. Yeah. And so they're thinking, oh, sling for six weeks, no strengthening till twelve weeks. And so sometimes I'll try and send the protocol with them.
Speaker 1:Yes.
Speaker 3:Say, like, sling for a week. Out of the sling at one week, start using your arms, start active motion, start strengthening at week six. Hopefully, by educating patients and physical therapists, that'll help that.
Speaker 2:It's interesting because when this came out and we got into all those kind of miscommunications about all this, we ended up developing small cuff protocol, large cuff protocol Same. Bio inductive implant protocol, sub scap precautions, all of these layers, and everybody got smarter. You know? Everyone everyone involved through the continuum of care. It got better.
Speaker 1:So with that now, is stiffness a problem?
Speaker 2:No. Because we anticipate it, and we don't make the mistake of locking people up in a sling too long. You know, I've got cases of people where I was really concerned early on with these large to massive tears. I put the device on, locked them up in a sling like I always do, and next thing I know, I got a stiff shoulder because I waited too long.
Speaker 3:Right. I think stiffness is really rare, and I think probably we all have seen a couple where using Regenitin on the bursal surface for a partial tear where some stiffness develops, and I don't know if that's the inflammatory response. I don't know if it's the patient being extra cautious, but kinda like Scott said, for me, it's that eight to ten week time point where they're doing okay and then they start getting a little stiff. That's pretty rare. It's pretty rare.
Speaker 3:It's pretty rare. I don't see it in using it as an augment for the large and massive tears. They don't get stiff. Right. You know?
Speaker 3:And that's a traditional rehab protocol where they're still in the sling for six weeks and start strengthening at week twelve. They don't get stiff.
Speaker 2:You know, I this is just kind of a sidebar, but I always try to point out to people, like, we have to make sure that we're treating rotator cuff disease and not treating impingement, which may also be early early onset frozen shoulder. Because those can present similarly. And is this is this a cuff problem or something else? And you don't wanna get thrown into that category by mistake, that's why we don't rush into surgery right away. We try to rehabilitate people and avoid surgery if we can.
Speaker 3:Yeah, absolutely. If you have somebody that is getting a little stiff, and they have a regenerative implant in, will you put a cortisone injection in the subacromial space and at what time frame?
Speaker 2:That's eleven week. Yes. And it's it's later.
Speaker 3:Me too. Twelve weeks.
Speaker 1:Like, three a month or yeah.
Speaker 2:Yeah. Mean, like, three a month or I'm usually eleven because by then, they're in my office and, you know, they're worried.
Speaker 3:Right? Yeah. So but it's it's it's really rare. Agreed.
Speaker 1:But you have to remember too, like, you know, even though there's this incidence of stiffness per se, you know, if you were to do a traditional takedown and repair, small parts of those ones used to get stiff all the time.
Speaker 2:They get way worse.
Speaker 1:They're like worse. Those are actually I find them my my angriest patients.
Speaker 3:Oh, angry. And it's usually young males. You know, they're in their forties. They're super stiff. They're unhappy because they still hurt.
Speaker 3:Yes. They can't raise their arm up. And I think it's just by doing a takedown and repair, you're shortening the tendon. So you're changing the natural length of that tendon than it was meant to be. And so it makes sense that that would lead to lead to stiffness.
Speaker 3:Stiffness.
Speaker 1:Yeah. Yep. And those are the ones you wanted to get back early. Like, those are the young people who are like, oh, yeah. Sorry.
Speaker 1:You still can't work now because that thing bloody hurts.
Speaker 3:And they're so unhappy. And that's where Regenetin has been a game changer Yeah. In those patients. Right. Because you can move them faster, and at three months, they're feeling pretty good.
Speaker 3:I've had some folks partial tear with Regenetin in three or four months being back to everything pickleball and tennis.
Speaker 1:I remember this distinct patient probably just about six months ago. Operated on him partial thickness tear, bursal surface. Maybe I broke protocol a little bit, it was probably 80 to 90% of the way through I was like, that's a little dicey, like don't get me wrong. I treponated the bone, I put the, regenetin on top just to kind of extend it out. This guy, I saw him at three months.
Speaker 1:He's like, oh, that's fantastic. Full range of motion. He's curling 40 pounds dumbbells either side and 80 pounds single hand overhead. I'm like Wow. That is crazy.
Speaker 3:I thought he meant he was actually curling like the sport up in Canada, but dumbbells.
Speaker 1:Well, I mean, partly, I mean, he was curling like, you know, curling stones.
Speaker 3:Curling Yeah. Those are with curling stones.
Speaker 1:Thing. And
Speaker 3:I mean, that's that's a good outcome right there.
Speaker 1:I was crazy 80 pound dumbbell press I'm like, what? Like, there's normal people who can't do that. This is not a big dude. I mean, he wasn't as big as Scott, obviously.
Speaker 3:Few are.
Speaker 1:Yeah, few are. Here we go. Okay. Okay, so when you're introducing this implant to patients, you know, there's been some concern related to the source material, which of course, as we know, is bovine. And you know, industry wise, we know this term xenograft has been utilized for other implants.
Speaker 1:And so, when you first saw this, and it was, you know, bovine sourced, what did you think?
Speaker 2:I thought I wanted to know more, obviously. I wanted to know where it came from, how it was made, how it was processed, what's in it, what all the ins and outs. And, you know, some of that information is proprietary, so we didn't know all of it. But I knew enough to know that this was basically a highly purified collagen graft, or implant rather, that was derived from an Achilles tendon of a cow. The way I explained so once I started to understand that, I I basically just tell people exactly what it is.
Speaker 2:You know? This is a this is an Achilles tendon of a cow. It's broken down into its finite element elements. It's actually broken down into a powder made back into a slurry, and then it's like a wet potato chip when we put it in. And it's essentially a man made product with very little to no DNA.
Speaker 2:I mean, it's hard to trace. Once I kinda walk people through that, they seem pretty okay with it, because it's a it's an engineered product.
Speaker 3:Yeah. I feel like I, yeah, knew way less about it when I first started using it. I knew it came from a cow Achilles tendon, and that was it. I didn't know how it was bioengineered. And learning that, especially in the last six months, that the source DNA is removed as this is highly bioengineered and this is a pure collagen implant, helped me understand how it works a little bit better.
Speaker 3:And with the high porosity, that helps you understand how that can bring in blood flow and the tenocytes can start growing into the implant. I would first tell patients, when I first started using it, I had the brochure provided by Smith and Nephew, and I would show them a picture of it and say, This is a collagen implant that comes from a cow Achilles tendon. It's FDA approved for this purpose. It's the size of a postage stamp. We're going to fix your tendon, and then we're going to slide it in and insert it over the top, and it should help the tendon heal, and it should integrate into the tendon within six months.
Speaker 3:I had two patients. Oh, here, yeah, when to not use it. One lady told me, I have a beef allergy. Yeah. I was like, what?
Speaker 3:I'm allergic to beef. So I called the engineers, and they said, I wouldn't use it. So we didn't.
Speaker 1:Right.
Speaker 3:And then I had a man who was a vegan. And so when I said cow Achilles tendon, he said, I'm a vegan. And I said, that's great. And he goes, I don't want that in my body. And I was like, oh, okay.
Speaker 3:Yeah. So he chose not to go that route.
Speaker 1:And there are, of course, certain religions where that may be looked down upon, but I've actually had people of that religion, some are acceptable to it Mhmm. And some are not acceptable to it. So I just explain exactly where it's from Yep. It's processed and how it's made, some of them are still agreeable to it. Yeah.
Speaker 1:Some of them are like, if you feel like this will make my You're welcome. Better Yeah. Then I'm still okay.
Speaker 3:I trust you.
Speaker 1:Yeah.
Speaker 3:And now, you guys have probably had a similar experience. Some people will come in asking for it. So they've heard from friends or acquaintances that they got this collagen implant, and so they'll come for a second opinion and say, Can I get that implant? Because I've heard it helps with healing. So I've had some people come in asking for it.
Speaker 1:And in fact, I find that if I talk to the patient about the implant, but I don't put it in, they're so disappointed.
Speaker 3:Oh, yes. Yes. They're like, Why did you put
Speaker 1:that in? Oh, what?
Speaker 3:And you're like, Well, I don't think it needed it. You said it would make it better, so I learned that the hard way too.
Speaker 2:Mean, hurt
Speaker 3:feelings, and then I felt like an idiot, and
Speaker 2:I'm already an We're having trouble enrolling patients. You know, we're always studying this, right? We're always doing research, and the patients don't wanna be enrolled because they're fearful of being randomized to one arm over the other. They want the device. Yes.
Speaker 1:They the device.
Speaker 2:And that's that's our problem. Yep. Is that the the the population has become a lot more savvy to what this is and what it can do.
Speaker 1:Okay, so if you have somebody who's thinking about maybe using a regenerative, what are your kind of tips and tricks for that first case? Who's the best patient to try it on, maybe the easiest person to put it in? How would you approach that? I think, and I guess
Speaker 3:it depends, if a user wants to start with a partial tear or an Augment on a full thickness tear. But on a partial tear, I think my best tips are you don't want to put it over the rotator interval because if that creates thickening of the rotator interval, that might lead to some stiffness. And so when I'm intra articular, I drop a spinal needle down at the anterior aspect of supraspinatus, right behind the biceps, and I leave it there. So then when I go up subacromial, I see that spinal needle, and it's a runway of where to put the implant. And I have found I do this in beach chair position, and so my lateral portal to bring in the implant is lower than my standard lateral portal because I'm trying to bring it in parallel with the rotator.
Speaker 2:Land it like an airplane. Land it like an airplane. That's you gotta come in flat.
Speaker 3:Yep. That's and so I get that angle with a spinal needle. I put it in through a cannula. I bring it in. I make sure it stays posterior to that spinal needle
Speaker 1:Yes.
Speaker 3:Marking the rotator interval. And I do I like the peak bone staples. So I use three soft tissue staples, medial, one or two anterior, two posterior, and I usually use one peak bone staple. Scott, you don't use the bone staples?
Speaker 2:No. I do about the same. Okay. You end up getting one bone staple at that corner Mhmm. Where you run out of tendon, and yet you want it's all about coverage, right?
Speaker 2:Right. So this it doesn't it doesn't propagate beyond what you've covered, so you need to get the implant over the diseased tendon. Right. And, you know, if you've got a flap or an edge that's hanging over and it's on bone, then use the use it. Use the staple.
Speaker 2:It's
Speaker 3:okay. Yeah.
Speaker 2:But it's it's it's just purposeful that way, not because you're trying to bear load immediately with it because we know that's not the point.
Speaker 3:Right? On revisions, I've brought it in both ways too, from bringing it in lateral, in line with the tendon fibers, or posterior, perpendicular to the tendon fibers, and it doesn't seem to matter. It doesn't seem to affect the healing rates of the implant. And so I think it's kinda dealer's choice.
Speaker 2:By ultrasound, you mean? Yep. So why would you bring it in lateral or posterior, rather?
Speaker 3:So in certain instances where if I'm able to get it's a revision, and I can only get a single row repair, and I don't wanna bring it in over a big knot stack because it's not gonna integrate over a big knot stack. So then I bring it in from posterior, and I put it a little bit more medial and use all soft tissue staples. Yep. If I can get a good double row repair, then I bring it in from lateral because I I believe in covering that bone tendon junction as a possible source of failure.
Speaker 1:The other thing I find is if you are bringing in it from lateral to medial, there's a tendency to push the graft.
Speaker 3:Oh, yes. Right?
Speaker 1:Great tip. So what are your what are your tricks on that?
Speaker 3:What I've seen is training residents and fellows, the first couple times they use it, they think they have to push really hard.
Speaker 2:Yeah.
Speaker 3:And so I'm holding the implant and I'm holding the scope, and they might push too hard medial and then see the whole thing shift medial. Yep. So I try and teach them ahead of time, get your starting point, bring your hand up, and then straight down, and you can really feel two pops. You can feel it pop through the implant, then pop through the tendon. Yep.
Speaker 3:And I tell them they don't have to push hard. But, I definitely made that mistake early on where I pushed it more medial than I wanted it
Speaker 1:to I find if if I put the middle staples in as opposed to the medial staples in, it kind of stabilizes a little bit easier. Where if you have the medial ones first, especially if they're slightly oblique, it tends to push it a little bit medial, so I try to stabilize it in the middle first and then go medial
Speaker 3:and then go lateral. It's brilliant. I just Well, your angle is better. It's
Speaker 1:more perpendicular. Yeah.
Speaker 2:More perpendicular. Makes sense.
Speaker 3:Yeah. That makes great sense.
Speaker 1:Okay. So previously, we only really had anecdotal information to go off of as far as how your patients are doing. They seem to be doing better. But now we really have some level one clinical data. What do you think about those recent results, Mike?
Speaker 3:I think it's outstanding. And so prospective level one randomized, triple blinded, controlled trial, you know, out of Madrid, Hundred And Twenty patients, all one to four centimeter tears, so medium and large tears, randomized, all with a transosseous equivalent, randomized where half get regenerative and half don't, and to show a one third retear rate at twelve months on MRI, and much lower type two show failure rate. I think that's outstanding. It's great because I think that validates what we've all been seeing and feeling and knowing that this has benefited our patients, and this study actually proves it, in a much stronger way than the previous studies did, retrospective reviews and even the studies that you and Bushnell did, are good But this one, it's the holy grail of orthopedic research.
Speaker 2:It's liquid gold. It's what it is, because it just helps us get this device in our hands to help our patients.
Speaker 1:Right. It really gives data, you know, when you talk to patients now, you can talk to them about the trial, actually. Actually, it's been proven in the literature now that this can help you, can help heal your tendon. Right. And I mean, it's really funny, like, you know, if you talk to Resy Bond, I mean, when he was first designing this trial, right, he was like, I don't believe in this technology.
Speaker 1:I'm gonna prove that this technology doesn't work. So he said, What's the most robust thing I can do? Multi standard, prospective, randomized, triple blinded study. And now, with his results, he's a believer.
Speaker 3:I love it. And I found that so compelling to find out that he set up a set out on this study to prove that it didn't work. And then he believes his own data, of course, and now he is a believer and a big user. I find that so compelling, you know?
Speaker 1:And I do think that, you know, some people will say, well, you know, my retear rate's not that high. But I'm like, no, no, no, no, no, no, no, no, no, that's not what we're talking about. Because all of these patients were, in quotes, asymptomatic meat tears. Everybody got an MRI. Yep.
Speaker 1:And if you MRI ed every single patient in your clinic, you might be sorely disappointed what your true healing rate is. One hundred percent.
Speaker 3:That's what I say to everyone too, that my patients do
Speaker 2:find out of We as clinicians have actually been lived through that.
Speaker 3:Right?
Speaker 1:Right.
Speaker 3:I have. I know you have. Yes.
Speaker 2:We've done research on how things were going. That was actually a segue for trying the Regenotin back in the day was we we started MRIing people, and I was like, they're telling me they're doing great early on, and they get the MRI back, and they're like, oh, boy. This is not
Speaker 3:Retear rates much higher than we thought. Yeah.
Speaker 2:They get worse as they, you know, five years, seven years, ten
Speaker 1:years. Midterms. Yeah. That's when everything starts falling apart.
Speaker 3:Yeah. Yep. I think that's what's so great about the Ruiz Iban study, because early on they're doing great, but now we know that long term they're gonna do great. Because we know all outcome studies show that a healed cuff performs much better long term than a retorn cuff, even if they feel better initially.
Speaker 2:For joint preservation and Yeah. Everything. I mean, it just opens up. It protects the joint to continue to do what it's supposed to do rather than just progression of disease and reversal later. Absolutely.
Speaker 3:Yeah. You know? Reversing reversal mania.
Speaker 2:Yeah. So There you go.
Speaker 1:And it's a funny thing, you know. I used to think about this implant, like, Oh, don't want to do it in my older patients and that type of idea because presumably they have a compromised healing environment. But I'm kind of like a little bit reversed now. Like in the younger patient with a medium sized tear, we still know there's a known failure rate. And if that patient re tears in that young population, it's like a disaster.
Speaker 3:Disaster.
Speaker 1:Because you have I truly believe you've got one chance to heal this thing. The first chance is your best chance.
Speaker 3:Absolutely.
Speaker 1:And so I'm like, I know you're young, but I think you should just have this.
Speaker 3:Oh, absolutely. I agree. Like, I had a guy that fell skiing and he had a four centimeter full tear of super infra. He was 48. Yeah.
Speaker 3:And I put a REGENETEN on. Because I agree with you. This is our best shot to get this right and get this guy to heal. Especially with that size tear.
Speaker 2:Yeah. It's that's the bad actor. Yep. Right? That's that's the one that statistically is could very well have a bad outcome.
Speaker 3:Totally. Because then when those do re tear, the tear is huge. Yeah. And your tendon looks like garbage.
Speaker 1:And you might be thinking about a different operation now. Big time. It's like, oh Transfer or yeah. It's like, disaster time for this person.
Speaker 3:Exactly. Dermal allograft, which hates me as much as I hate it. I
Speaker 2:could get on board with that.
Speaker 1:Very good, guys. Well, Michael, thank you for joining me today. Scott, thank you for joining me today.
Speaker 3:Thanks Ian.
Speaker 2:Certainly. I think this
Speaker 1:has been a very interesting discussion about Regenetin and how it's really changed your practice related to rotated cuff tears.
Speaker 3:How it's changed our patients' lives. I think we're really making our patients better. I agree.
Speaker 1:But there's actually even more information coming out. Another prospective randomized level one study showing REGENETEN improving patient's outcome again. But thanks for joining me today on Joint Ventures by Smith and Nephew Sport Medicine.