Chapters Transcript NUSHIELD® & PURAFORCE™: SURGICAL APPLICATIONS IN RECONSTRUCTIVE SURGERY OF THE LOWER EXTREMITY Foot Innovate Webinar with Dr. James Cottom, DPM, FACFAS Thank you so much for joining tonight. Uh My name is Jeff Martin. I'm a product manager on the surgical marketing team at Organogenesis. And uh as you can see, we're tonight, we're talking about two of our products on the surgical side, New Shield and pure Forest um applications and reconstructive surgery of the lower extremity. Um And we're super excited to have Doctor Cotham um with us tonight just trying to get advance to the next slide. There we go. Um But before we um introduce Doctor Cotham, Doctor Jay Sarin from our uh field product specialist team, he's been with the company for more than five years um with a phd in biomedical engineering um from Stony Brook and a postdoc from UN C. He is going to be reviewing the Science of New Shields as well as an introduction to Pure Force. So we're going to get a good overview of both of those products that will sort of lay the foundation for Doctor Cotham as he reviews um some Awesome New Shield and Pure Force cases as Beverly mentioned, um you know, throughout the, throughout the webinar, please feel free to add some questions into the Q and A um or chat portion so that we can get to those at the end. Um But without further ado, I'll hand it over to doctor J and um we'll start talking about New Shield. Thank you so much for joining us. Thanks Jeff and thank you all once again for being here. Uh What I wanna do over the next 10 minutes or so is the following. I will start off by introducing one of her personal tissue based products, Nesi, I'll, I'll share some preclinical studies both in vitro and vivo studies. Then I'll introduce one of our other person. Uh 11 of our other adjuncts, surgical adjuncts called a Pure Force. Then I'll hand it over to Doctor Cotham. So they can share some of his thoughts, insights uh and experience using both these products and uh in some real world cases. So let me start off with uh New Shield. The next slide, please. So what is New Shield? So New Shield is one of the most complete dehydrated Amnon chon membranes. It is derived from place little tissues. A place environment is one where a single cell grows into an eight pound baby in nine months. That environment is rich in growth factors and cytokines and many of these growth factors and cytokines get absorbed or absorbed by surrounding tissues. So, placental tissues in general are good sources of are rich sources of growth factors. Cytokines and our proprietary processing technique allows us to retain many of these ex c the matrix proteins, growth factors and cytokines. In New Shield. New Shield is uh uh a termly sterilized product. And in the surgical setting, it is used as a physical barrier. Next slide please. Now, there are several placental tissue products in the market. And all these placental tissue products start from the same raw material, donated placental tissues. But what sets them apart is what's present to them, meaning the composition, how they are processed and how they're preserved. When I say composition, we're talking about whether it's an Amnon only product, whether it's a Chon only product, whether specific sublayers within the Amnon and Chon have been removed, whether it's an umbilical cord based product or is it, or is it a combination product when we're talking about whether how it is process and how it is preserved? We're talking about whether it is an aseptically processed product, whether it is termly sterilized, whether it's a dehydrated product, a cryo preserved product, a Lioy product or a hypothermic store product, right? So all these things, all these manipulations and modifications have an impact on the final characteristics of the product. Next slide, please. So let's look at an example. So in this particular slide, what we're doing is we're comparing new shield to another commercially available uh plus all tissue based product. So essentially in this uh competitive product or uh uh commercially available product, they've specifically removed. Uh the spongy layer. And what we see is that new shield consistently has a higher concentration of growth factors and cytokines when compared to this other commercially available product. And the second graph, what we see is that new shield contains nearly six times the H A when compared to this other commercially available product. So in this particular slide, uh we're looking at histological sections on the left, we have uh new shield on the right, we have this other commercially available product and we see that new shield is consistently thicker than this other commercially available product. And how this usually translates from what I've heard is in the handling characteristics of the product. So I've generally heard that neo shield is more durable, it can be maneuvered and manipulated uh while passing maybe through a troll car and robotic procedures, for instance. OK. Uh Next one. So when we started off, I mentioned that new shield is used as a physical barrier in the surgical setting. Here, we have an in vitro study that supports the barrier properties of new shield. So in this experiment, what we did was we seeded human dermal fibroblasts either on the epithelial side or on the chorionic side of new shield. What we found was that very few cells attached and more importantly, even fewer cells actually penetrated or infiltrated through the matrix. This suggests that new shield is an excellent physical barrier. And in vitro pats, another question that usually comes up is how long does new shield last at the implantation site? Next slide, please to answer this particular question, what we did was we implanted new Shield subcutaneously in male and female lois rats. And what we found was that the total product area of New Shield did not change over the course of 84 days uh in a patient. However, you know, the dwell time of New Shield might probably vary from patient to patient. And it might also depend on the underlying pathology of the implant patient side itself. So with that, let me wrap up the new shield portion of this talk and give a brief overview of pure force. So what is pure force care force is an eight layered cross-link native collagen matrix intended to be used as attendant reinforcement matrix. The matrix is 10, it is between 0.25 and 0.4 millimeters in thickness, but it provides excellent mechanical strength. It is intended to be used to reinforce a tendon after primary repair has been completed. Um It is not really intended to be used as a spanning ground next slide, please. So we once again wanted to look at how long perforce would last and and in vivo setting. So once again, the in this experiment, what we did was perforce was implanted, subcutaneously and male and female Lewis Ranch again, and we found that the total product area of pure force did not change drastically. Over the course of 84 days. With that, let me provide a quick summary of both new shield and pure force. New shield is one of the most complete dehydrated amnion poon membranes. Our proprietary processing allows us to retain many growth factors. Cytic these present in native place tissues are in vitro. Studies suggest that new shield is an excellent physical barrier. While our invivo experiments suggest that new shield lasts at least for 84 days in an animal mob, there is an eight layered cross-link native collagen matrix intended as attendant reinforcement matrix. And in and and in vivo studies suggest that pair of force lasts at least 84 days in a rap model with this. Let me wrap up the science portion of the talk. And I'll also like to take this opportunity to welcome and introduce Doctor Cotton. Doctor Cotham is an orthopedic fellowship trained foot and ankle surgeon from Sarasota Florida. He specializes in trauma and reconstructive surgery. He is the fellowship director of the Florida orthopedic Foot and Ankle Center and he has authored over 60 peer-reviewed manuscripts and book chapters. Doctor Cotham. Thank you, Doctor J. Um Thanks guys. I appreciate you guys taking a little time out on your Monday evening uh to, to talk about this. So I just wanted to kind of go through um my experience with New Shield and Pure Force. Uh I've been utilizing these uh started in 2019, 2018 or 19. So we've got some experience with it and, um, show you some of the case as we used them in, we've had uh really, really excellent outcomes uh, up to this point. So, first off, why New Shield, why, why do I want to use this graft or why do I like this graft? Well, it's actually helping protect the repair site, especially in our lower extremity uh surgery. It's got a very ease of handling. It's very easy. So that's one thing when this is hydrated when we're in the operating room and we uh this gets wet with either you hydrated or it touches body fluids. It doesn't like booger up like some of the other grafts in there. And so it's actually got a pretty, pretty robust uh handling characteristics. It's off the shelf use, um application. There's numerous applications for this. Basically any open procedure you're doing. Uh this would be a great application to place even sub Q for things which will go over inconvenience. It's basically, it's off the shelf and uh basically it's opened up, uh your rep opens it up for you and you, you can hydrate it up and it's ready to go. So there's not a lot to it next slide, please. So this is one of the first cases. Um I actually used the product and, and so this is what kind of got me um very, very interested. So this is actually a 17 year old male in a stage two posterior tibial tendon dysfunction uh which are really interfering with the sports. Uh We did obtain an MRI um basically showed a very attenuated and thickened posterior tibial tendon, no issues with the ankle and no signs of a coalition with them. So, next slide, please. So in particular for this uh individual, um our surgical plan going in was a partial open gastronomia recession. And what I mean by that, we've been uh uh for years now resecting just uh the medial or lateral half of the gastro um and, and depending on what we're trying to correct with the hind foot, um we've had very good results with that, that's also maintaining some of that muscle tone uh in the gastric is complex. Uh Evans uh Calcaneal opening uh wedge uh procedure possible uh Calcaneal osteotomy if needed an FDL transfer possibly. And uh at the end of the case plus or minus a cotton osteotomy just depending on our alignment. So, um next slide. So you can see already the uh graft has been placed in for the uh Evans uh procedure and that did uh wonderful as far as our hind foot and osseous correction. So, uh we did not need to do any slide on the calcaneus for this one. And um you can see the guide wire in place in the navicular for the FDL tendon transfer. Next slide. So here you can see, I tagged my FDL tendon and harvest it the um on the picture on the left, right below. Here, you can see how thick and that posterior tibial tendon is. And I've got my guide wire in place, the navicular for where I'm gonna transfer the tendon. So uh we basically uh thick uh d uh d um thicken the tendon if you will. So I made a longitudinal split and the poster tibial tendon removed all degenerated tissue in there. So I get good healthy tendon back together. I imbricated the uh FDL uh tendon into the posterior tibial, almost a pulver TF weave type technique and then transfer that into the uh navicular next slide. So for this particular case, what I really want to do with this is is see how this would just, this is how this would work with this patient. So I wanted to place it sub Q and see if I noticed anything postoperatively in regards to supporting the prevention of adhesion swelling. I, I just wanted to see the outcomes. And so um a little pearl for you guys too is if you're gonna use the graph, it's often very easy uh cut the graft. As you can see the picture on the far left inside the little sheet it comes in, it just makes handling easier. I I cut it before I I rehydrate it. And the far picture on the right, what I'm showing is just where this graph is gonna be placed sub Q um in that incision site. And then the middle picture here is actually after the raft has been placed. And with it, as soon as it touched the patient's body fluids, it just starts to fall right into place where you want. It's easy to handle. I just use the back of a pickup to kind of tuck it in the corners. You do have the option. You could get a, a small absorbable suture in there if you want to tag it in there that can be done as well. Uh This also works quite nice. Next slide, please. And here we're just showing the incision for the Evans and that was the graph that we were going to put in uh before we put it in next slide. So this was this patient uh his first post op visit. This is about 10 to 14 days after the procedure picture on the left. Uh My fellow that particular day decided to suture uh the medial side and staple laterally. But uh the point here is I was very impressed with the uh overall disc condition of the incision sites, the really lack of uh swelling. Um And next slide, please at eight weeks post op I mean, this this this guy healed wonderfully again, granted he was 17 years old, he was young, but this was accelerated healing anecdotally in, in my practice. This is what I've seen in almost all the cases we're utilizing this. And so I guess as a first line, you know, introduction to the, if you haven't used it, a good application may be sub Q, especially in the 4 ft where you've got uh extensive tendons if you're doing a plan or plate repair. Um first MTP fusion, things like that and maybe an, an area you wanna go ahead and uh initiate yourself with it. So, um I was pleased with this and so next case, So this took on uh as we started doing more here. Uh We do a lot of uh total ankles uh down here in Sarasota. Um This particular patient was 72 years old. She traveled down to Michigan uh for uh from Michigan uh for the implant. Uh She had a Hinderman series two implants. And when I do these, there's not a lot of bony resection in the gutters uh anymore when we do these procedures, uh there is a little bit but I don't go out, I don't make real wide gutter puts as much as I used to uh 1012 years ago. And so I, I found it really advantageous and there's some um some reports in the knee uh literature for arthroplasty about packing um these type of graphs if you will uh around the implant. So I, I placed new shield in both the media and lateral gutter. And also there's some studies and anecdotally I like actually actually placing this right over the, the metal on the implant. You ever have to go back and scope somebody out uh with uh adhesions after an ankle replacement, it, they can, they can really grow in there. And it's uh uh sometimes it's just a mess of adhesions in there and maintain a good, adequate range of motion is something that I think is a win, win. So, next slide, so I wanna show you here. So this was the patient, this left picture again, this is the the new shield on top of the incision site before I closed it. So this was placed subcutaneously uh right over there over the extensive retinaculum as it was repaired, this particular patient's stitches, um This was her first post op visit back in the middle and she went on to heal uneventfully. And what I'm showing here on the far right is a different patient. We did around the same time as as this one and we did not use any new shield uh with us, any type of supplementation on this. And so you can see this is about six weeks out from her procedure, but she's got that superficial um incision um kind of deh it's just kind of, the incision is kind of looking funny there. And um next slide, I've done so many uh we've done so many ankles over the years. My threshold for going back in, even if I see a little wound or something starting to develop my threshold is extremely low. I don't ever ever wanna see exposed tendon implant or bones. So, anything I can do to prevent those things I will do. And so I'm real up front with my patients about this. So, uh this patient was worked up for an infection. She did not have an infection. So we ran in the operating room uh very quickly after this and you can see this is the wound in the operating room. Um We'll just go ahead and, and debriding it, uh kinda uh preparing the wound for a graft placement here, next slide. And this is something uh I like to do and I've done a lot with some of these de his surgical incisions. I call it my, my hot dog if you will. And what I mean by that is I'll take a small sample of the new shield. Uh I'll basically, I'll cut a little landing strip down and what I'll do is I'll place it directly in the wound and I'll kind of fold it in half upon itself. And then what I'm doing here on the picture on the right is I'm actually incorporating or sewing the new shield as again, it's folded in between the skin edges and I'll run that right up the incision. So here uh this was post op this, this patient, this was 55 days after and this was this particular patient at four weeks after. And so I was very, very impressed with the hot dog uh type technique um with this and so next slide, this particular patient uh this is a neglected calcaneal fracture. So, this young man presented them to Florida um from Wisconsin, he subsequently had this calcaneal fracture. He had it no if actually performed on it and his hardware was removed. Um And he was still having continued pain within his hind foot. Um You can see the male uh positioning of the calcaneus. Um We've got some issues with the uh Taylor subsiding into the Calcaneus and our bowler's angle and gasson angle are are off on this one. So the plan for him uh was um after his hardware is removed in a painful sub tailor joint, um He was having our plan was for him to uh reconstruct that next slide. And so we did this with a posterior lateral approach uh just next to the achilles tendon. And with this, basically, we're dissecting down, you can see with the Galp in place on the right. I'm looking deep down into the um posterior aspect of the sub tailor joint there. Peroneal tendons have all been retracted uh to the left or laterally. Next slide. Then under fluoroscopic imaging, uh I took a pin distractor opened up uh the back of the joint where we needed it to be. I took a small sagittal saw and just removed the little remaining cartilage that was inside the uh sub tailor joints and I was able to prop it up and find the appropriate sized uh graft to utilize uh to bring that tailor height back up and, and where we want it. So, next slide, so the graft was placed uh back in the back end of the sub tailor joint from posterior. Um that tonight's talk is not about uh a bone graft product, but organogenesis also has fibro um which I did pack in there and that uh that's for another talk another day, but that works quite well. So these are x rays. Uh pretty much inter op here. We've got our fixation in place. I'm happy with the restoration of the height of the talus next slide. And then when we were in there, uh also laterally found a small split tear in the uh coronial longest tendon. And that's what I've got the uh the pickup underneath right there. And so uh this was a case where you can see on the right picture on the left there, excuse me, just uh trimming up a new shield graft. And again, basically with this, just wrapping it right around the tendon. And the nice thing with this is actually it's in a technique and I have a video, but I don't have it in this uh particular talk right here. But you can place the new shield right on the uh on a malleable and you can wet it a couple times. So what I'll do is I'll take a uh a bulb syringe put a couple drops of saline on it and then what I'll do is I'll pull the pickup out or whatever I'm using a malleable out laterally and it'll actually help wrap the tendon, right? Uh That, excuse me, the graft right around the tendon. So this picture on the right, it's hard to see here, but either is your Peroneal tendon and the new show of grafts been wrapped totally around it just with that maneuver. Uh In this particular case, I did not uh sew it in I I or it stayed right where we needed to. So you're happy with that. And uh this is one way you can get this done very easy. Next slide, these are x rays uh post op down the road, next slide and then this was this patient at six weeks and then at 12 weeks out or three months out. Um You can see it at his picture on the on the right 1212 weeks out just how little swelling he has in there on top of this. Remember he had a previous Calcaneal oif. And so that tissue is, you know, not so much where I went through, but that, that part of the anatomy, lateral hind foot and ankle has already been gone through. And so, you know, there's gonna be scar and other things down there. Um And you know, by doing this and we all do this, we know how long it takes for all these uh the swelling and scar tissue to dissipate in the lower extremity. So, um these are the things I was starting to see when we first started using it. And so I was just very, very impressed with uh the outcomes I was seeing with my, my patients uh with New Shield. So, next slide. So that's the some cases on New Shield. Um Maybe what I'll do now is I'll, I'll just go through a couple of cases with uh Pure Force and then uh we can go through any questions at that point. So, um this first Pure Force case was actually a 36 year old male. He presented to me. Uh He uh worked as a long range uh truck driver. Um He had an achilles rupture uh about eight weeks before presenting to me, he said he felt a pop in the back of his leg when he was getting out of his semi. Uh He followed up with a, a local uh surgeon in our area. Um He was given a boot and told to go to physical therapy as first line treatment. So again, he showed up at our office about two months later, he wasn't getting much better, still having continued swelling. He was doing therapy, the therapy therapist recommended possibly another opinion. So uh we saw him and uh an MRI was performed as he never had an MRI uh up to this point and showed a complete rupture of the achilles with about three centimeter retraction, which you can see things just don't look good there. Uh Next slide. So we talked treatment options with this patient. He's young, he's got a family to take care of. Um And with that being said, his, his achilles um was attenuated. So we took him in for a a repair with this. And so when we got in there here, I can see it straight posterior midline incision. Um where on the picture on the right where my thumb and fingers are on the tendon, that's all basically scar tissue that's filled in there. And there's a pretty large sections of scar tissue. So I actually resected that out next slide and this is what we were left with there. So we've got a big gap in between the achilles from that proximal to distal stump there. So in this case, what you're looking at in the left, I dissected down through the post, your fashion the leg to the, if that's the FHL muscle belly that you're seeing there and the picture on the right harvested the FHL uh tendon for transfer and augmentation uh with our repair next slide. So here, I'm sizing the tendon for our transfer. Um And then we've tagged the tendon here and the picture on the right next slide, we then go ahead under fluoroscopic imaging. We'll find the appropriate position where I want to uh place my FHL for my transfer which uh was in this location in this patient. Um The pictures on the right are actually showing and I like this technique. This is actually a percutaneous achilles repair technique. Uh But we've uh published several biomechanical studies on just the strength of this type of repair compared to others. And so uh we did this percutaneous type type repair open with this uh with this little jig here, you can go to the next slide. Once that was complete, we'll go ahead and we will then uh we will pass down the um sutures into the distal stump of the achilles. And so what you're seeing here on the picture on the left, the proximal stump has had our sutures placed distally, this yellow handled thing as a suture passer. This is going through the um lateral side of the achilles tendon. I wanna get this in midsubstance tendon and then I bring the tip of that um pass her out and I actually penetrate the proximal uh aspect of, of the proximal stump just a little bit. And I'm gonna go ahead and pull those sutures through which you can see on the picture on the right. In this case, the FHL transfer has already been completed. I utilized a cortical button attention slide technique on the inferior aspect of the Calcaneus with a bio Tenis screw, almost a belt and suspenders type technique. So, next slide. So what we're seeing here is I've got my uh ends of my uh sutures already placed distally at the distal aspect of the achilles. You can see them in the picture on the left where they're uh threaded right into the proximal stump. And basically, as we plan or flex the patient's foot, I was able to bring the stump. Basically the achilles back together with that gapping. I had patient consented for an open gastronomic recession as well, but I wound up not even have to perform that. So, and all I was trying to do here is get the ends of the tendon back together. We're not trying to overlap them or under lap them. If you will, you can get a big nice or a bulbous area in there. So I just wanna try provide appropriate tension on that to get that back, which is what we did. And then in this particular case, just because the next slide, please, the tendon was so damaged. What I did is you're looking at the FHL muscle belly right here. So what I did was I first I took a uh ruler if you will and I placed this right under the FHL just the muscle belly. Now, the tendon is gonna be incorporated and transferred behind the distal stump of the achilles. So you can't see that on the picture on the left and the video on the right. I've actually just put some small vicryl, uh some old vicryl through the ends of the tendon here. Excuse me, the muscle belly here because what I wanna do here is incorporate all this into the repair site. So next slide. So what I did was I took the pure force and utilizing that malleable, I placed the pure force right directly underneath the FHL muscle belly, incorporating the muscle belly and the achilles tendon. So that when I bring the tendon back together the thought process, this is so I'm gonna have the muscle belly underneath to provide good vascularization of this tendon. And then we're gonna almost make a AAA wrap if you will or or AAA Hammock, if you will in order to go ahead and secure all that into place next slide. So here's where we're transfer or actually docking if you will the sutures into the calcaneus, um which again, we published a study showing the increased biomechanical strength with his technique and that's why we utilized it. Next slide, please. And here was the patient here and a picture on the left. You can see the marking for the gastro recession which wasn't done uh suturing the purer force in, in position. And then you can see here the calf compression squeeze test and we've got things back together and he's planter flexing nicely in the or next slide. So this was the patient here directly in the operating room. Um That middle picture is actually a video um hopefully it'll play. Um But this was about 64 to 6 weeks after his index procedure. And so, um, my protocol for these are three weeks, three weeks nonweightbearing and then I get him walking in a walking cast for two weeks. And at five weeks they go into a boot and I think this was a five week mark and we were gonna get ready to start some physical therapy. Uh The photo on the, the image on the far right was just the patient's first post op visit. You can see he's got that scar back there. Uh But he went up and healed and he did, he did awesome, he's back driving cross country uh without uh problems. And he's now four, I believe, four years out from this and we still see him yearly. Um But he's doing, he's doing very well. So next slide uh this case is just a simple uh Peroneal tendon repair. This is a 48 year old female. Uh She had uh chronic lateral length instability uh for over five years. She worked as a nurse in, in one of my hospitals and on top of a peroneal tendon tear, she also is having subluxation occurring as well. Um Next slide. So we took her in for an arthroscopic brochure uh which we did basically all through the scope uh this Peroneal subluxation repair. Uh I can't do, I, I can't do through a scope. So we did have to open this. And what I'm doing here, the picture on the left is just exploring uh the peroneal tendon there. She did have a lowline muscle belly, which we resected. And then the picture on the right um you, that's where she's subluxing uh from the uh posterior aspect of the fibula edge of that bone is very sharp as we all know. And so when patients are ranging their, their foot up and down, these tendons can basically just uh sever on that uh that bone back there. And so we did actually next slide, a groove deepening with her. And so what I did at first was I went ahead and just uh took a 25 drill bit, the distal tip of the fibula. I drill this up just uh sub cortically near the posterior aspect of the um fibula. And then I'm just impacting it with a little uh bone impact or staple impactor here. I'm just trying to deepen that groove a little bit. Um So that's what we're accomplishing here with this uh with this video. Next slide, please. Uh Next, the uh coronial tendon was first tized again, just utilizing a non absorbable uh uh stitch in this, in this situation. This was just some old vic here, but go ahead and uh wrapping the entire tendon uh through the incision site. Here, we are repairing the superior pero retinaculum, I think in the subluxing cases, um We always make sure that the tendons are staying nicely behind the retromalleolar groove with uh Dorsey flexion and Planar flexion as well as circumferential range of motion of the ankle joint. Uh but just for an insurance policy, I like to do this as well. So a couple of knotless anchors just placed in a, in the fibula and we'll grab the uh superior Proia retinaculum and really cinch that over next slide, you get a good, nice solid repair on her. So this is the patient immediately in the operating room, uh post uh the repair and the scope and this is the picture on the right. Excuse me, it's her first visit, about two weeks of status, post the procedure. Again, minimal swelling. Uh She's doing quite well at this point. With that uh next slide, I use the same protocol for these. Um At this point, I keep them three weeks nonweightbearing. Uh two weeks in a uh excuse me, three weeks nonweightbearing. And then I let them start uh physical therapy with their walking boot at three weeks. Um I take them out of their walking boot after two weeks in therapy. So about um five weeks out, they're out of the boot. And then this is his patient. Six weeks out from surgery, no pain. She's still obviously doing her therapy, very minimal swelling. But overall, she was quite happy with us. And again, uh I was as well because again, these are some of our first cases where we're utilizing these graphs. I should also note that the pure force was utilized around the tenant and subcutaneously, I also use the new shield as well. And again, I'm utilizing both these products to enhance uh our outcomes. This one was an 80 year old male uh who presented to me um he has end stage ankle arthritis and he actually uh was uh presented as a second opinion. Uh He had an arthroscopic debridement of his ankle joint and uh he was in physical therapy in about three weeks in the, the uh he felt a pop at the anterior aspect of his ankle. Um His therapist then uh refer or uh recommended a second opinion. So, uh we went ahead and saw him, he came in and uh we did that for him. We actually ordered an MRI and what the MRI demonstrated was a complete severance of the EHL tendon right near the ankle joint or capsule region. Um Next slide. So I, I try to usually, as we all do, do our due diligence before we go in and, and do a procedure like this. So I had the uh the tendon. Um I had my MRI results. Uh I looked at the MRI had MS K radiologist looked at it, the proximal stump or the tendon when the MRI was performed was right at the joint level is what I was told. And so I was planning on, on the picture on the left, just a real small incision because I'm just gonna get that tendon. I'm gonna bring it back together some pure force and we're gonna go home. Well, we got in there and first of all, the tendon was completely shredded the joint capsule. I believe these, the scope went through the anterior joint capsule and just basically uh ate this tendon up if you will or just really um debrided down this tendon to nothing. So I went proximal with this guy. Um As far and I told him at the beginning of the case, I don't want to chase this thing up your leg and that's why we wanted to get this done sooner than later. I think he had some issues with staying off it in between time, we saw him and actually getting it done. Uh So we wound up with this big whack right here. So the picture on the right is actually showing uh that's the t A tenant underneath the uh little ruler there and I've got the EHL in the pick up. So, um I didn't have a backup draft in the operating room. He wasn't even consented for that. And so we kind of had to make a call on the fly with us. So next slide. So what I did did in this situation was I took the EHL Tendon and I basically did a pulver TF weave through the tibial an interior tendon uh several times obviously with the foot in neutral position. And what I Mike's trying to accomplish here was just keeping his great toe in a rectus position, just basically keeping it up from uh plantar flexing. I just wanted to keep it up uh in that level uh next slide. So that's what we were able to do. We had really good tension on this. And so once I did that, I asked him or I basically um tubize the uh tendon transfer with a pure force graft which you can see in the middle there. And I ran that all the way down through the two tendons next slide. And then you can see on that on that slide on the left, the picture on the left there, I mean, I could have done a total ankle easily through that on this guy. And that's really kind of what he needed. Um He just, he did not want to go there. So, um the middle picture, you can see the new shield that I'm applying once the retin a has been repaired. So this is very similar to my, my total ankle repair protocol and again, cutting up the new shield on the back table or, or before hydrating it again, do it in the package. It will make your life a lot easier next uh slide. So this was the patient uh inter operatively on the left first post op visit, uh two weeks later in the middle pitch and that far right pitcher was about 5.5 weeks out from surgery and he's 81 years old, I mean, he was pretty good health for 81 and everything, but the way that healed up front and if those of you out there are are doing, you know, pelon fracture, open pelon fractures, anything anterior, an uh total ankles, things like this. We know how difficult it is to heal these anterior, you know, flexion point incisions and everything. And so this is really where I started really adapting uh this practice. And, and, and for me, this is pretty much uh done in all my my cases these days as far as closure goes um with these patients, I've just seen great results over the year and I've been extremely happy next slide. So in summary, again, we've got many options for graphs uh for all sorts of different situations in the lower extremity. Um I think it's really important to you to do your homework with these graphs because we're all bombarded, you know, as physicians, we get reps coming in and telling us um all these different things about their graphs. But I would, I would implore you to do a little bit of research on your own and do your homework. One of the, the things I really like about uh organogenesis is the amount of data they have in house. And so I would ask your local rep if you have any questions, they can supply that data for you. And data is important. Uh at least with how we're trying to treat our patients. Um The grafts, ba basically the new shield helps support the prevention of adhesions as we discussed. And again, I've seen better outcomes with my patients, happy patients. And I've been quite pleased uh ever since utilizing this, this technology in my practice. So I'm happy to answer any, any questions or comments uh about the talk cases, application. And again, thanks for uh spending some time with us tonight. Thank you, Doctor Collin. Those are some really great cases. Um Yeah, we're open for questions. So please type in your questions in the Q and A box. Um That being said, uh I do see a few questions that have come up. So, uh one of the first questions is, how do you choose between new shield and pure force? All right, that's a good question. So, pure force I am going to use basically to augment or support a tendon repair. That, that's what that's for. Um what I'm doing with that. It just, it depends on what kind of tendon repair I'm doing. Um If it's a small, if it's a, it's a primary achilles rupture, I may want some more uh bulk in there if you will. So that's why I'd go with pure for something like that. But remember, pure force is not designed to help bridge gaps or anything. It's just designed to help supplement the repair um on a small tear, something smaller. Um not as extensive, I think New shield is a great, a great way to go with that as well. Awesome. Thank you. Uh I think you've answered the, the next question already, which was uh can P force be used as a weight bearing or bridging material? It cannot be used as a weight bearing or bridging material that's not the intended use of the product. Um So the next uh question that we have here is since using these products, have you seen a change in your post op protocol? Actually, I have uh I do a lot of arthroscopic work. A lot of minimally invasive type um trauma and uh reconstructive surgeries. And so it, it's really, it's with me or at least where I am. I, I live in Florida. I practice in Florida and I'm originally from the Midwest, from Michigan. I practiced up there. I was in Ohio for my orthopedic fellowship and um something down here, I don't think it's the humidity or where we're at, but people's incisions, wounds seem to heal a lot, lot slower. And so this is really, this was a game changer in my practice because what I'm seeing with it as I showed you guys with some of these cases, I'm seeing a lot less swelling with these patients. I'm seeing a lot less overall, just scar tissue uh with these patients made me happy. It's made my patients happy. So I've been able to decrease my nonweightbearing times and I, I've been become more aggressive by getting people up and moving cause I'm, I'm confident and overdo these for so many years uh that this, these are gonna help our patients. And so it's been uh a game changer from my practice. Awesome. Um I do have like two other questions. I'm, I'm reading one so anecdotally with the amount of total ankle replacements you've done. Have you seen the incidents our need for revisions or even fusions after T RT A R failure go down after starting to utilize the products. The way you have, I have seen, I've had it very few um revisions since we, we started using it. And that was 2018 or 19. And so most of my revisions are coming back from 1012 years ago, things like that. So one, I think it's a little bit still too early out to see those coming in. And so for me, it's, it's basically, it's, it's every, every total that we're doing now. Um This is what we're doing with them. And I've got good data also comparing when I started to, when I didn't, when I didn't use it. So I've got some comparison, data, retrospective data um that we're still working on with this. We've got pretty high numbers with that. So that, that data is pretty impressive and we look forward to publishing that. That's great. So, so your top process, it's not just the, the surgical aspect, the, the incision site also seems to have and, you know, there's an impact even on the incision side, the healing of the incision itself, there's uh multiple benefits in these particular cases. Yes. Uh So, so, so, uh do you have any specific sutures you usually use for New Shield? And what about pure force? Like are the sutures different? Have you? I, I use a lot of it just absorbed monocryl a lot of times I think you saw like a 30 Monory um with New Shield um as well as the material is a little bit thinner, but you can still, you can still get a stitch through there. Some of the slides I showed, I think we were using 30 Vicryl uh pops, you can use those, but I, I use a lot of monochrome uh with them. It just seems to work, work real well if I'm gonna actually uh suture them in and adhere them to attend and pa force I always do that. Always gets uh uh incorporated in, in attendant repair. Oh um So what other cases are you utilizing your shield? NTMA S amputations? So, really um yeah, first of all, yes. Um but virtually, you know, with this application with the new shield and what, what we do, you know, foot and ankle and again, I referred to hand earlier but to prevent, you know, and help support the prevention of adhesions, you know, I think this could be used and we we use it in almost all of our cases. Sub Q and I've got other cases and slides. I can show you with a lot of 4 ft surgery, a lot of 4 ft cases. You know, that's one way you can kind of t, uh, t, uh, tiptoe into it if you're a little bit, you know, on the fence and you just wanna try something that, that's where I would try it if you can just, and just watch those patients and see how they do in your own practice. Well, thank you so very much. Uh If, if there are any more questions, please type it in the Q and A box. But for now I'm gonna hand it over back to uh Jeff Martin. Thanks everyone so much for um joining us tonight, Doctor Cotham. The cases were awesome. So thank you so much for sharing those with us. Published August 19, 2025 Created by
