Chapters Transcript Utilizing a Dehydrated Placental Allograft in Foot & Ankle Surgery Dr. Alan Ng, DPM discusses his experience using NuShield (Placental Allograft) in a variety in Foot & Ankle surgical procedures. Thank you so much for joining us tonight. My name is Jeff Martin. I'm a product manager for New Shield on the surgical side, um been been at or organogenesis for a couple of years now. And um we're just so excited to, to have you tonight and to, to get to hear from Kelly and doctor. So just wanted to go over a quick high level um agenda. So Kelly Kimerling is gonna kick it off. She is an R and D manager at Organogenesis. She's been with us for seven years. Um Kelly has a phd in biomedical engineering from Duke University and she's gonna be talking to us tonight about Science of New Shield product processing uh and some data in both in vitro and in vivo studies. And then we're so excited to have doctor Alan with us tonight. He's a pediatric surgeon specializing in foot and ankle reconstruction. Um with 22 years of experience, he's the fellowship director at Rocky Mountain, reconstructive foot and ankle fellowship. He's the past president of the American Board of Foot and ankle surgery and the current secretary and treasurer of the American College of Foot and Ankle Surgeons um And then he's gonna be going over a foot and ankle overview, talking about New Shield as a surgical barrier, some case reviews and indications, um his experience with New Shield uh in a variety of cases. And then we'll have some time for Q and A at the end. So once again, thank you so much for joining us tonight and I'm gonna turn it over to Kelly. Thanks Jeff. So like he said, I'm gonna talk first about the science of New Shield. So New Shield is a complete dehydrated placental Allegra. It retains all the native layers including the spongy layer which differentiates it from some other placental allographs on the market. Additionally, new shield also retains key proteins including growth factors, cytokines and extracellular matrix content found in native placental tissue. And at the lower right of your screen, you can see a picture of new shield. Next slide, please. So the New Shield proprietary processing method maintains key components. So if you look first at the panel under the letter A, you can see a hematoxylin Eoin or H and E staining of New shield which shows all the placental layers. Next. If you look at the immuno histochemistry staining and panel B, this is showing the presence of collagen, one collagen, three laminin and fiber nein, which are all prototypical extracellular matrix components that are retained following the new shield processing. Additionally, these components are distributed throughout the graph with laminin predominantly focused in the amnion layers and collagen, one collagen three and fibronectin concentrated in the Coron layers. Next slide please. So first looking at some in vitro data around the protective barrier function of new shield, what you see here in the images are again, hematoxylin and Eoin or A E staining of new shield, either without fibroblast added or with fibroblast added. The orientation of the product is labeled either at the epithelial or Amnon side or the chon side. And then the white arrows are indicating the presence of the seeded fibroblast cells. If we look at the panel, we can see in image A and D, there were no cells seated onto new shield and you can see um that you don't have that cellular layer on top of the epithelial or chon side. If we move next to the middle panel, panel B and E, we see the cells that were seated on the epithelial side, the white arrow is again pointing to the presence of those seeded fiberglass cells only on the epithelial side. Next, if we move to the right side of the figure panel C and F, we have the chon seated side. So again, the white arrows indicating the cells that were seated on the Coron side only. So from all these pictures, we can see that no cells were observed on the opposite side of the product, which highlights the capacity of new shell of new shell to act as a protective barrier in vitro. Next slide please. Next, we did two animal studies looking at the protective barrier function of Nhial. First, looking at a diabetic rat, achilles tendon repair model, we used a type two diabetic rat with a full thickness achilles tendon injury and repair model. In this model, tendons were um induced to an achilles tendon injury and then repairs following the repair, tendons were either wrapped with new shield or left unwrapped as a control. And these were examined at day 14 and 28. We found in the study that tendons wrapped with new shield or D AC M showed reduced failure rates and improved mechanical properties compared to the unwrapped controls along with positive changes in tendon healing biomarkers. If you look at the figure at the bottom of your screen panel, A is showing the rupture rate of the tendons that were either treated with new shield or the unwrapped tendon in the new shield treated group, we had zero ruptures over the course of the study. However, in the control group, which was not wrapped, we had 20% rupture rate. Next. If we look at panel B, this is showing the maximum 10 file load, which is essentially the maximum load that attendant can endure. We see the control group which again was unwrapped, is shown in black and then the new field or D AC M group is shown in gray. You can see here that the newel treated tendons had a a slightly higher maximum tensile load compared to the control. But this was not significant. Finally, if we move to panel C, we're looking at stiffness, which is the ability of a tendon to stretch and recoil quickly and effectively. And here you want to see an increased number. So again, looking at the control in black and then the newel treated in gray, we see that the new shield treated tendon had a significantly higher stiffness compared to the controls. Next slide, please. In our final animal study, we looked at a rat, a rat subcutaneous implantation model. So in this study, what we did was implanted new shield subcutaneously in rats for up to 84 days to evaluate the capacity to maintain a barrier function in vivo. In this model, new shd was able to be detected throughout the 84 days of implantation. And Mason's trichrome stain images of new shell are shown here on the right side. Panel A is looking at the implant after 14 days and then panel B on the bottom is looking at the implant after 84 days. As you can see, um the implant is marked by the X and you can see the presence of both of the implant in both images showing that new shield remained intact over the course of the study. Next slide. So just to summarize the key points in the science of New Shield, first, New Shield's proprietary processing method maintains all the layers of the placental membranes, key extracellular matrix components including collagen, laminin and fiber necton are all maintained throughout this processing method. In an in vitro barrier study, seeded human dermal fro blasts were maintained on the theta side of blue shield. In a diabetic achilles tendon repair model, new shield drop tendons showed reduced failure rates and improved mechanical properties compared to unwrapped controls along with positive changes in tendon healing biomarkers. And finally, in an implantation model, new shield was detected and attacked out to 84 days. So next, I would love to pass it off to doctor to talk about the clinical side of new shed use. Awesome. Thanks Kelly, a great overview on the science. You know, um it's always difficult to figure out why you want to use a product or a biologic in order to enhance your surgeries. So that kind of gives a little baseline of what we're looking at and, and the reason why we use it in certain cases. And uh so what I'll go over those, I wanna thank uh for innovate as well as organic Genesis for kind of sponsoring this webinar. So we kind of discussed kind of the cases I've been using um new shield for and indications and and why we're using it and we've been using it for now over at least 67 years uh utilizing New Shield. And before that, the, the affinity product which is primarily wounds now, which we've had some really good results. We talk about utilization, you know, for index procedures as well as vision. So let's go on to the next slide. So, you know, obviously we talked about when are you gonna, when are you gonna use an Amnon barrier? When are you gonna decide when, when and if? OK, so, you know, initially, we always think of this secondarily is when we have a patient, we do surgery on them and they come back and they say they have a neuropraxia or sniffing adhesions or scar tissues in their foot or ankle. And that's kind of thinking in retrospect, you know, well, could I have done something before the surgery or during the surgery that would help decrease my post-operative complications? And that's kind of how I looked at using Amnon and uh new shield in these procedures on patients for index procedures. So, when I started looking at my surgeries, I started thinking, all right, what's what cases did I do that historically cause a lot of scarring or have a lot of nerve entrapment. First thing that came to mind was perineal tendons. The sterile nerve always gets entrapped on that lateral side and the scar too, even if you can super meticulous and you know, you didn't touch the sterile nerve and you're doing a tendon repair, post surgical, the amount of scar tissue that forms and e forms some sort of neuropraxia. The other procedure I thought was colectomies, you know, we do a lot of helix lius and you're debriding the bone spurs off the dorsal aspect of the metal, you're cleaning up the joint. And most time the the amount of enzymatic degeneration from the synovitis and the arthritis in the joint has caught a lot, caused a lot of thickening and scarring of the capsule. And post surgically tend to, you know, at least scar up and they get tight. So I thought initially putting a new shield over the top of the colectomy and also thinking about the inherent contents of, you know, amnion and placental graphs. You know, any type of high risk procedure I look at, well, I'll probably have to use the surgical barrier uh index procedure, especially in tral tunnels. Uh post op when you think about these things in retrospect or, or after the, after the fact, we already done the surgery. A lot of these times you get this arth fros scarring. Um We know that every patient is different, some scar worse than others. Uh We don't know who's gonna be a good scar farmer, a bad scar farmer. So let's talk about this to impact, you know, on patients. Obviously, scar tissue is painful. Obviously, they can cause some scarring that causes anger malalignment. Uh Perfect example is predi location syndrome. One of the worst procedures I would rather not do if I could avoid it, but unfortunately, we see a lot of it and these patients lose range of motion, they were very stiff. So if there's ways we can stop the stiffness or decrease adhesions, decrease the malign it. I think it's worthwhile in the as an index procedure. So what is scar tissue? Obviously, it's cross link collagen fibers that form stress to the extracellular matrix. These these fibers are overproduced. The collagen becomes more dense and it's very inelastic. So it doesn't stretch like normal collagen tissue does or healthy collagen tissue. And the fibroblasts proliferates and contracts the tissue makes it tighter, makes it stiffer, makes it harder to, to manage. So, next slide. So thought process. What is new to dehydrated amnion corea membrane surgical barrier to support adhesion prevention, we know it does retain some of its inherent properties of growth factors and cytokines uh and supports healing and repair of nerve soft tissue and cartilage. And we've done some looks in the past using some amnion for osteochondral defect repairs even in the past, which have had some good success. Next slide. So orientation is important. You know, we talk about new shield, it is notched in the upper corner. Um And on the right side, if the notch corner is the right the upper side towards use, epithelial and the other side is facing down is the Coron, that's very important because the anti adhesive part part of it is epithelial facing you. So orientation is important. Next slide. So let's talk about some cases and I'll talk about my experience with, with New Shield and what I use it for in my cases. Um So number one worst procedure, this is close to predis loc location syndrome uh with tsun decompressions. Um I use all my index cars tunnel decompressions because the fact the only thing worse than doing a primary cars tunnel is a secondary revision cars, tunnel. So anything I can do to avoid doing a revision on this, I will So I use it, use the initial as a barrier to the posterior te bone nerve. After release, the lisin ligament, obviously, you gotta be very meticulous in that area. There's a lot of dangerous um an atomic structures in that area you really want to avoid. So you have to be very careful and then I usually place the new shield from above the transected lisin ligament all the way down to the doctor hiatus most of the time, if I'm really wanna make sure it's released, I wanna make sure that doctor hiatus is preventing from scarring. So when I've seen on these revision cases, that's where the scars back in and the nerve gets irritated uh next slide. So in this case here, this is the surgical pictures of, of my, one of my cases, you can see that in the medial aspect, we have the hemostats uh underneath the lisin ligament and we transect lacin ligament. Next slide as being kind of exposed like on the upper picture, I call it the finger test. Um I put my finger up above and below the area of the tarsal tunnel. If I can slide my index finger, uh up that area without much, much constriction to that area. I know I've released it enough. Um, and also dissect and the bottom which you dissect down to the area of the doctor hiatus where the nerves go into the foot and I make sure that uh that circular little constricted area is released and I can slide my pinky down into the bottom of the foot without significant, you know, tightness in that area. Next slide. All right. Next slide, Jeff, there you go. So again, this is uh this is when the older new shield that had a backing that doesn't even have a backing. Now. So you had to be very meticulous with the new shield slide up behind the nerve. And this, in this case here, I wrap it like a little burrito and sew it with 50 Monocryl. You can also just, you don't really truly have to make a burrito out of it. You can actually lay the new shield over the nerve nerve vascular structures on the metatarsal tunnel, making sure it's covering from superior to inferior. We want to keep that space open and prevent as much scar tissue in that area as possible. Next slide. And that's just showing the representation after the backing is off sewing up the fiber monocryl, making sure it's freed up of all the adhesions in the tarsal tunnel, whether it's Venus, whether it's scar tissue, whether it's lisin ligament, ensuring that area is freed up and now protected from new scar tissues forming onto the nerve. Next slide. So again, in conjunction with soft tissue releases or neurolysis, and I use this as a barrier for nerves that have a decompressing, whether it's a sterile nerve where it's a perineal nerve, whatever it may be utilizing also in joint capsule adhesions in prec location repair, uh poster neuropraxia and general scar tissue causing nerve impingement or capsular impingement. Next slide, there's a case here of a cranial nerve in the ankle that was entrapped causing the patient a lot of discomfort we opened up, found out there was essentially a neuroma in that area. Next slide to breathe the area and then place the new shield around the nerve itself to prevent it from adhering after we freed it up from the scar tissue in the area. Next slide and this is wrapping the nerve and sewing around it, making sure no further adhesions occur. So that nerve is kind of protected from the surrounding scar tissue. Next, slide, pernial tender repair, uh probably one of the most common uh areas where I use new shield. And you know, when you get that scar tissue formation, after you do the perineal tendon repair, a lot of times you get that adhesions and the stroll nerve and patient relates is numb and a lot outside of their foot. If you look at the imaging there, that's my typical incisional approach. Uh Rec my leader coursing along the course of perineal tendons. Next slide, uh debris in opening up that nerve, that area of the tendon and doing essentially a rein tation of the perineal tendon. Uh as you can see in the area just inferior to the tendon itself is where your soil nerve is gonna run. And a lot of times it even being uh not even seeing the nerve and not violating the nerve, you still end up scarring in that area. And sometimes that can affect the ability of that nerve to conduct properly. Next slide. So after repair, obviously, logical rep repair, in this case here again, wrapping the new shield around the perineal tenant and sewing it in place. Uh using essentially the path side has to be facing out stromal side or Coron side down. And I use either 40 or 50 MOOC to sew that into the uh repair site. Next slide and post hip tendon repair. This is a patient that had a long tear distally um was symptomatic. Uh Luckily, it was a more of acute injury was no signs of any biomechanical or mechanical abnormality. It did not have to do an osteo repair with this one. next line, expose the perineal and then repair uh and sew around the tendon itself after we do the launch split tear repair, next slide. So again, uh when looking at this here, soft tissue impacting, you know, post surgical, when, when you done an index procedure and you know, you come back, patient comes back, they're scarred, they're painful. So any what time you have that scarred tissue you're releasing, whether it's an MP J, whether it's an ankle, you know, when you cut through that thick scarred hyper tissue and you cut out that tissue, you don't want that tissue to grow back in that area. So I pretty much placed an issue where you wherever I see that thickened um non elastic scar tissue. Again, this is a failed pre dislocation syndrome. When in excised, all the scar tissue exposed to joint released a joint took the hard route. Next slide and then placing the new shield in the interface of the joint. I tend to try to take the new shield and slide underneath the metatarsal head and then wrap it over the top and then close the capsule over the top. Uh ideally, that would not form any further arthro fibrosis in the area, at least for it at the time while the new shield is in there. Uh Next slide, uh sometimes in these cases, when you have really contracted tissue or contracted cicatrix or scar, you may have to size that scar into advancement. Z plasty or V to y this patient here had a significant amount of dorsal contractual or toe So we released the extensive compartment, laid the new shield in the joint and also laid it along the scar exci excision site dorsally and then a Z plasty over the top to try to lengthen the skin. Uh next slide how some of this we've done more and more of this lately. I know Chris hired, published um a article on this uh years past on utilizing amnion uh correal tissue. And this is a perfect example of that case here for you to breed the first MP J clean up a joint and trying to prevent the arthro fros post uh post resection. The next slide in your classic example, uh MRI showing in this case, first MP J showing metatarsal seismo arthritis uh which is one of the most uh difficult um things you deal with with how it limits in this case here. Um MRI is just verifying what we have there next slide uh classic uh Helix and mis rids as we release the first MP J, the susman apparatus, we see the first metros head. So in Century state, late stage two, early stage three Helix and rids what are we gonna do with this? You know, obviously, first MP J fusion is an option. Many patients don't want to do that. They wanna try to collect me first. Uh In these cases here, I'll go ahead and debris the joint. Um I'll clean up any loose cartilage and I'll do an abrasion Konop plasty or do a little micro fracture with this 035 K wire and kind of and then lay the new shield over the top. So again to breed and then you see here this one case here, I did micro fracture a little bit, which I don't usually do in the ankle. But in the first, every day, not many other options. Uh In this case here, laying the in the middle picture, you can see laying the new shield over the top of the joint and sliding underneath. Again, more cases of helix limits. You can see this here. This is a pretty late stage uh on radiograph showing a large oral spur and significant joint space, narrowing. Next slide and same thing here, open up the joint. This is what we see, obviously a pretty rotted joint with large spurring. Um in case looking at the right, you know, that area is pretty damaged. Again, you're gonna need a clicking, you're gonna get a kind of irritation area if it's not uh regenerating fiber cartilage. And also after the scar, he's in dose after you resect off the spur. So again, we tried to um decrease adhesion post surgically. Again, this is some examples of ones we've done um to breathing it. And you can see the one on the far left is a pretty significant amount of pre aggressive colectomy did and then placing the new shield over the top and the sliding underneath again, same thing with this one here. More of a lateral uh portion of the joint eroded uh and laying the new suit over top. And luckily when it gets a little wet, it does cling very well. I have tried to sew this in the past the bone. It doesn't do well. It lays in there. It holds its place pretty easily. We close the capsule over it. Now, one of the questions I was posed by one of the attendees was when suing the new shield. Are you suing it to itself or are you wrapping the membrane and suing, suing it to the repaired or at least structure? So, when suturing new shield, I do. If I'm in tub beating it around a tendon, I'll go ahead and suture through the tendon through the new shield to hold it together when I make a burrito type of repair and when doing it around the nerve, obviously, I don't wanna skewer the nerve. So I wrap it around the nerve and then I'll sew the new shield to itself. Um A lot of times with these nerves will lay it on top and same thing, the first MP J will lay it on top and let it sit, you know, kind of sticks to its place and then taking the soft tissue and pulling it over the top and kind of holding it in is what we usually do. Um So one other question while we're still on that topic. Have you used new Shield on achilles repair? Yes, we have. And usually we do that at the area of the repair site on the open repair. I do the majority of my achilles repairs, percutaneous or more of a pars technique. So there's not a lot of uh placement area for the New Shield in those cases. But if we do an open repair, I laid over the repair site itself. So these are pictures of the how some are doing a lot of this now and trying to do something to enhance the ability for these patients not to go to a joint destructive procedure. And so far we're doing pretty well with this uh utilize this as an adjunct towards primary chom. Next, next slide. Now this is a patient. The unique patient had a acute first MP J dislocation and just afterwards got really stiff. And I think the traumatic dislocation caused the ses metatarsal sesin apparatus to become scarred and damaged. So when he opened up his joint, his cartilage is beautiful pristine, no spurring. I got to his metatarsal seismo apparatus. It was all fibrosis. As we know with this locations, you damage the inner met, inner, inner ses modal ligament as well as some of the um ligaments between the metatarsal and smo I think those were traumatized when he dislocated his toe. So in that case, here, we just slid the new shield between the seso and the metatarsal. After we released it and slid it underneath and pulled it underneath the uh mears itself. It does give you less neuropraxia Charal tunnel. At least in my hands. I've seen some better results in my index procedures. I do use them in my revision Charal tunnels as well. Uh But if I can avoid doing a revision tarsal tunnel, I'll do that every day. I mean, it's just something that it's not a fun procedure to do. Um index for um use for Arthro fros index for revision. You have a patient that has history of scarring. I'm gonna use that in their index procedure in revision surgeries. I mean, you don't have much of a choice. You kind of have to do something to address that scar tissue. And in that case there, uh we do use it for most of our revision type of surgeries, how some of this has been more and more using more and more having better results. That's something that is, makes sense to me. Um Other things we've used in the past to kind of interpose tissue between there. A lot of times it can be a little too bulky and may actually cause a foreign body reaction and, and knock on wood. I haven't seen that very much with the New Shield. I haven't seen any foreign body or any spitting of the, of the New Shield itself. Pre dislocation syndrome. Might one of the worst surgeries I I don't like doing, but I have to do them ankle arthroplasty. I'll sometimes put that over the tibial anterior tendon sheet. When you do a total ankle, you know that's always exposed and then scar tissue removal, we obviously want to um after we remove scars, we don't want to come back. So using that uh does tend to help. Um I'm gonna go over a couple more questions you guys have asked for a poster teal tendon, uh repairs specifically using a running technique or simple interrupted when doing your burrito or do you ever take bites of the tissue in surrounding areas to hold it in place? So I find that sewing it um, to other structures around the area, especially in a tendon. We want it to glide. I don't want it to adhese in that area. Uh I could see sewing into the tissue if you're just doing an onlay, but I usually don't, I usually lay it on there when I'm doing a, when I'm suing the new shield on there, sometimes I'll tack one stitch in, uh, proximal and distal and then I'll run the center and when I run it, um, I usually do take a little bit of the tendon with the new shield to kind of hold it in place. Obviously a nerve, we don't want to sew it in the nerves. We usually wrap it and then sew the new shield to itself, making kind of a tube out of it. So that's one of the ways I do it with the nerve versus um, poster tubal tendon injuries or, or tears. If it's something I'm doing like an FDL transfer, um, say for a flat foot reconstruction of post tendon, you know, it, it's dealer's choice but a lot of times you don't want adhesion in that area, I would lay it over the top epithelial side out. Um If you're just doing a primary pair of a tendon that's split and you're just sewing that tendon together. That's when I use a Burrito technique again, with the perineal tendons as well, I'll wrap it to try to circumferentially surround that tendon. So, uh one question from Lee, have you gone back in after using new shield was new shield still acting as a protective barrier. There have been times that I have gone back in there, say a perennial tendon or a tarsal tunnel. Usually that's a little longer than the 8490 days that they state that, you know, they still there in the, in the rat model. Uh Sometimes you'll still see some of the um new shield in there. Uh The Brito technique, uh Sometimes you'll still see in the tenant if you're going back and do a secondary tender repair, which is very rare that you're going back in there at that sort of a period if the new shield is still there. So, uh any other questions, feel free to put them in the Q and a uh oh, there's more here. Awesome. So how does NIA compare to some of the competitive products? That is always a fun question to address. Um, so I've used multiple different products and I'm not gonna name names of the competitors. Um, in my hands, New Shield has worked very well for me. Um, I haven't had any reactions thus far and I've used it for multiple years, uh, and it does handle it sometimes tough to handle, but it does work very well. So it, you know, obviously I wouldn't use a product if I didn't believe in it and I didn't think I got good results of it. So some of the other product in the past I may have had some issues with and in those cases I've switched and I've been using new sh with organogenesis for over 56 years, at least at this stage. So, uh I based all my utilization based on my results and I've had good results with it so far. Um Another question, do you moisten the new shield prior to placement or is it easier to place the membrane hydrate in place? Do not moisten the new shield before you put it in a foot or ankle? It will turn into sticky tissue paper and it is almost impossible to get it to put it in place, especially if you're gonna wrap a tendon or a nerve. Do not let it put it in dry, let the blood and the patient's fluids kind of hydrate it and allow you to place it in place if you wet it beforehand, um, to get it to wrap around something, you might also open another uh another unit because it is gonna be extremely difficult to utilize. Um, once it's wet. All right. Any other questions for me or, or for Kelly on the science side of it? Um You know, there, there's a lot of science that goes into this. Um ah another question. So here we go. Have you had any experience using new shield with deltoid ligament repairs or have you used any form of ankle fracture with any success? So most ankle fractures, I'm not using um the new shooter amnion barriers because most times, I mean, they're fixing, you know, traumatically dislocated ankle and, you know, honestly, be 100% honesty. A lot of times you don't think of that when you're trying to put something back together like that. Um As far as deltoid ligament repairs, yes. Um As we all know, deltoid ligament repairs are extremely difficult. There doesn't seem to be really a good answer or a good solution. In my opinion, I've tried all graft tendons. I've tried no stretch tape. Um You know, the key obviously to deltoid reconstruction is mechanical realignment, placing the heel back into the leg and hopefully tightening up the medial deltoid to uh tighten up the medial deltoid structure. But if you have a mechanical problem that's still stressing the deltoid, it's not gonna do any good. So you have to address the mechanical side of it first and then utilizing the uh deltoid which will repair whether it's allograph, whether it's no stretch tape, whether it's a flexible type of synthetic are all options. So, uh between skin and subcutaneous tissue in the shirt, that might be a bad place for it. But as far as directly on my deltoid repair, I don't tend to use it for that. Um Sometimes I use it like a sending gutters for ankle arthroplasty. Uh Those are kind of the way the where I will use the uh new shield. But in traumatic ankle fractures, I don't tend to use that in my index procedures most of the time, I'm just trying to get the bone to heal and get it realigned. Something to think about. Maybe an appeal on uh that has a little more trauma, that more more inflammatory tissues that kind of form from that amount of trauma. So, um any questions or follow up questions to that, all you guys are making it easier tonight. Let's see here. Oh, another one from Cameron, what would you say? My number one application for, for New Shield is uh right now it's probably how it's limited. Uh I do a lot of uh joint attempt to call collect me to not fuse MP J. Every patient is consented that they know that if the Ky fails or getting a fusion. They want me to try. And some of these are kind of pushing the limit. They're in stage three, that most likely should have been fuse. But sometimes I'll wrap a new shield around it and try to buy them some time. They know that if it fails, they may end up with, um, a first I fusion down the road, but I will try that. It's probably my number one application right now behind. That's probably perineal tendon repairs. And after that is uh tarsal tunnel or dealer's choice, whatever comes about that, I think it's in the scar predi lo location syndrome. I do as much as I can avoid to do that surgery. I just don't like decompression, osteotomies. I don't like direct pion or plate repairs and no matter what you do, they always are the fibros afterwards. So that's not my favorite surgery. So I try not to use that as my number one application of this at this stage. All right. Anything else, Kelly, any of the comments on your side? Science wise, I think I'm good. Awesome. Jay asked a question. Is there a specific patient population where you use it in? I don't really think of it. No, I don't think so. It's not something that I kind of look at as a, you know, patient's demographics or, or, you know, if they're immunocompromised, if they have, you know, history of, you know, ster arthropathy without push me to use it more. I, I guess I'm more procedural on that the patient has like is, is doing, let's say I'm doing a, you know, a cy on a patient who is diabetic. Sure, I'll probably use it. I use it anyway as an index procedure. So I don't really have a specific population tend to use that, use it and whenever I think it's gonna be necessary, uh, and I don't know the reason why some patients just scar more than others. So, uh I am tending to use it more on index procedures versus just using them for revision type procedures. Uh Do you ever place it between hardware and soft tissue, like over a plate? I don't, but that's a good point. Um So you have a patient who's very skinny and, you know, may have, um, you know, a thin envelope to sew together. I don't tend to use it between hardware and soft tissue and maybe something I need to start considering thinking about and I primarily use it for the indication I discussed tonight and have a really good results of that. So, you know, with hardware, you know, I've always been out of the thought. I don't like putting other stuff and I don't need to or don't want to um in an area that could possibly cause reaction. But like I said, with the New Shield, I don't, haven't had any reaction issues in my patients so far. Oh, another question uh when you have to go back to fuse a new shield patient, how is it, how does the tissue look versus Casey referred to fuse without new shield? So fusion from a failed chom, I'm assuming that's what we're talking about when you have to go back in and um do a first time. A fusion is what I'm assuming you're referring to. Um Honestly, it's not that much different, you know, by the time you have a pect toy, you're bone on bone. And most of those patients are a few years out from their colectomy. And the new shield essentially is gone. I guess the ones that, um did well with the new shield maybe didn't come back for the fusion. Who knows? But with the ones we have gone into and did a fusion after a colectomy with a new shield placement, it just looks like any other bad end-stage arthritic joint. There's just nothing there anymore. So there isn't much of a difference between one that's had new shield and one that did not have new shield at the end stage fusion procedure because it's so worn out and so painful in the flame. All the new shields gone in those cases or the or the patient without, it just has end stage arthritis. So it's not a huge amount of difference in those in those, in that case. Um Cameron uh in cases where you have to go back in, are there visual improvements to adhesive tissues as compared to your experience in cases where it wasn't used more natural tissue planes. Um, honestly, I would say no. Um, when you go back in there, a lot of times you go back in when you have used New Shield in the past, which is a very limited amount in my hands. It's years. It's not necessarily within the 1st 3 to 4 months after you've done the index procedure. You're talking a year or two years out, we're kind of scarred up or you're taking the hard route. So it's maybe something that I haven't seen specifically or something I don't really pay attention to if I'm going in there to do something else for that patient. Um As far as natural tissue planes, et cetera, if it scars back up again, it scars back up. There's no good tissue planes. So I haven't noticed a huge amount of difference on those patients where I've had to go back in. So I hope that answers the question. It's kind of vague in a way because sometimes you just don't remember, you know, your patients miserable scarred. They wanted you to go back there and take care of things. You're not really, you're going in and just take care of what you need to do. You're not necessarily paying as much attention to like, oh, this treats you playing slightly better than one that doesn't have it. I just don't remember looking at that specifically. All right, some good questions. Any other questions from the guys in the audience out there? Awesome, Jeff, I'll hand it back to you. Um And the questions I'm more than happy to answer them. Thank you all for your time and attention and thanks to foot innovate for helping to educate um all of us foot and ankle surgeons and uh pediatric physicians. And thanks for getting a genesis to allow us to do this. Published December 11, 2023 Created by
