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BioCartilage se diseñó para ofrecer un método reproducible, simple y económico para aumentar los procedimientos tradicionales para microfracturas. Se desarrolla a partir de cartílago para aloinjerto que ha sido deshidratado y micronizado. BioCartilage contiene la matriz extracelular que es nativa del cartílago articular, incluidos componentes clave tales como colágeno tipo II, proteoglicanos y factores de crecimiento cartilaginoso adicionales. El principio de BioCartilage es actuar como matriz sobre un defecto microfracturado y ofrecer una red de tejido que potencialmente pueda ser una señal de interacciones celulares autólogas y mejorar el grado y la calidad de curación del tejido dentro de un defecto del cartílago articular preparado de forma adecuada.

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BioCartilage® Extracellular Matrix

BioCartilage® extracellular matrix provides a reproducible, simple and inexpensive method to augment marrow stimulation procedures. BioCartilage matrix is developed from allograft cartilage and contains the extracellular matrix that is native to articular cartilage. This animation shows how BioCartilage matrix may interact and potentially signal autologous cellular interactions to improve the degree and quality of tissue healing within a properly prepared articular cartilage defect.

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Following the marrow stimulation procedure and implantation of BioCartilage, marrow and progenitor cells travel through the cancellous bone and into the BioCartilage scaffold. Biocartilage contains key components such as type two collagen, proteoglycans, and cartilaginous growth factors. These components interact with the progenitor cells as they begin to filter into the BioCartilage scaffold, potentially allowing for differentiation into chondrocytes. The BioCartilage scaffold is remodeled as the chondrocytes modulate, produce, and maintain the process of new cartilaginous tissue formation.

Brian J. Cole, MD, MBA (Chicago, IL), presents recent published data on multicenter, prospective, and clinically significant outcomes of using BioCartilage® extracellular matrix to treat cartilage defects in the knee, including a two year postoperative success rate of 97.9%.1 Dr. Cole discusses how BioCartilage extracellular matrix can be used in conjunction with microfracture to improve patient outcomes and how it fits into treatment algorithms for patients with articular cartilage defects.
Reference:
1. Cole BJ, Haunschild ED, Carter T, et al. Clinically significant outcomes following the treatment of focal cartilage defects of the knee with microfracture augmentation using cartilage allograft extracellular matrix: a multicenter prospective study. Arthroscopy. 2021;37(5):1512-1521. doi:10.1016/j.arthro.2021.01.043

Treatment of Cartilage Defects in the Knee Using BioCartilage® Allograft

Hello, I'm Doctor Brian Cole, professor and vice chairman of the department of orthopedic surgery at Rush University Medical Center. And I'm going to speak to you about the outcomes of BioCartilage for the treatment of congenital defects of the knee, and also provide some background to you on how BioCartilage may fit into your treatment algorithm when managing patients with articular cartilage disease. I think it's important to understand that there's more than one right answer to manage our patients, said. Another way, we can get it right by applying different technologies based upon different location, size, patient and organic patient specific factors. What we see, however, is that there's over 100,000 procedures performed to date that involve marrow stimulation, with or without BioCartilage or AutoCart. As we speak today, microfracture has a long history of providing good outcomes when performed correctly with responsible adherence to the rehabilitation. In fact, many studies show a return to sport rates in excess of 80% at one year. However, one of the challenges with marrow stimulation is, if not performed correctly, if patients weight bear early, they have changes in the subchondral bone developing subchondral, edema and other as well as clinical outcomes may deteriorate over time. So we're always looking to do better with this treatment option. We've largely gravitated away from the microfracture all towards drilling. We've learned that creating vascular access channels using a drill a traumatically at a depth of 6 to 9mm, can provide access to MSCs and improve upon the host response without creating a fracture environment at the level of the subchondral plate. We've also looked at this clinically in 68 patients, comparing 34 of those who had an awl compared to a 34 who had a drill at three years. We showed that at six months, the drill was better than the Awl in terms of patient reported outcomes, including the Icdc and SF 12. What was equally stunning is that the revision rate when we compared the Awl versus drilling was 41% in the Awl group, and only 17% in the drilling group. Biocartilage is an adjunct to Neurostimulation. It involves the use of particulated allogeneic cartilage that's aseptically processed with a five year shelf life. We mix it into a paste with autologous fluid. We have shown, in collaboration with Lisa Fortier at Cornell University, that there is retention of extracellular matrix, including type two collagen and growth factors. In our first robust pivotal animal study, we looked at five horses with two defects in each knee, and we compared microfracture with or without the addition of BioCartilage second look. Arthroscopy was performed at two, six and 13 months. We also looked at gross MRI, micro-ct and histology at serial follow up. This is a representative second look arthroscopy in an animal that underwent microfracture, compared to a second animal who underwent BioCartilage augmentation of that microfracture. And you can see improved macroscopic appearance as we go from two to 6 to 13 months. Objectively, when we looked at our data, we showed that the overall repair scores at 13 months were superior in the BioCartilage group compared to microfracture alone. We also showed that our MRI was superior, in addition to the fact that patients with BioCartilage had improved type two collagen staining. The technique itself is relatively straightforward. It involves a dual syringe system that allows us to mix the autologous fluid with the BioCartilage, and then inject it using the ArthroPaddle delivery system. This is an open case example of a patella. We create vertical walls. We violate the calcified layer using a 15 blade followed by a sharp curette. And then we place our holes sequentially around the lesion, spaced 2 to 3mm apart using the PowerPick. The defect is then filled just below the surface, and we augment over the fill with fibrin glue. Preferably we like autologous fibrin glue. We know that the adherence is excellent. We also know that it can provide autologous growth factors. This is a different example of a femoral condyle lesion showing that this technique can be performed arthroscopically. This is an arthroscopic view showing implantation, followed by a second look at 12 months with excellent highland light cartilage formation. So how do these patients do clinically? We recently in arthroscopy published the clinically significant outcomes following the treatment of focal cartilage defects of the knee with microfracture that was augmented with BioCartilage. The purpose of this study was to determine the early term outcomes following microfracture that was augmented with cartilage allograft extracellular matrix, otherwise known as BioCartilage, to treat our patients who had symptomatic focal cartilage defects. It's a level three prospective cohort study. It involved 48 patients. There were eight surgeons at 80 institutions. The follow up was at three, six, 12 and 24 months. We looked at traditional pros. We looked at clinically significant outcomes, failures and complications. And the MRI was offered at two years. We included patients with Outerbridge. Grade 3 or 4 defects greater than one square centimeter was stable ligament exam and menisci and age less than 55 and BMI less than 35. There were a number of traditional exclusion criteria, as you see here bipolar defects, workers compensation status. They could not be malaligned. They could not have failed a previous cartilage resurfacing procedure. They have to be realigned within six months or more. They cannot have an active joint infection or chronic disease. The age at the time of surgery was in the neighborhood of 31 plus or minus ten. 77% of these patients were male. Better than half of the defects treated were the patellofemoral joint, although clearly we included femoral condyle lesions medially and laterally and even the tibial plateau. Our poor oral compliance at six months was 81%, at 12 months was 73%, and a two years was 48%. We determined that all joint specific and function related ProEAS significantly improved compared to baseline at three, six, 12, 18, and 24 months. We showed that the marks activity scale showed a significant decline at two years, although our POS remained consistently high even at 24 month follow up. We also showed that the percentage of patients achieving the clinically significant outcome as defined for microfracture at two years was 90% for MRD, or the minimally clinically important difference in 85% for Pass or the patient acceptable symptomatic state. Patient factors including age, sex, BMI, symptom duration, smoking, meniscal, tear, lesion size, location were not associated with the achievement of a clinically significant outcome at two years. Our two year postoperative MRI demonstrated a mean of 40 in terms of our Moca 2.0 score. As you see here, two examples one of the femoral condyle, one of the patella showing excellent fill with quiet subchondral bone. Only one patient failed with graft delamination at 9.5 months. That patient required arthroscopic treatment and actually did well after that debridement. There was an additional patient who complained of clicking and grinding and crepitus at 15 months. Now, there are a number of limitations to this study. It is a relatively small sample size. We did have limited pro compliance at two years. There was some heterogeneity across the board in terms of patient age and lesion location. And we only had ten patients with two year postoperative MRI which was elective. But we did show significant improvement in all functional outcomes. We showed high rates of clinically significant outcomes at two years. There was a low failure rate and a low complication rate. Thank you very much.

Imaging and Resection

Jack Farr II, MD, (Indianapolis, IN) and Brian Cole, MD, MBA, (Chicago, IL) review the treatment options for small articular cartilage lesions. The available treatment options include debridement, marrow stimulation with the PowerPick™ instrument, Osteochondral Autograft Transplantation (OATS® technique) and BioCartilage® Cartilage Extracellular Matrix to augment a traditional microfracture or marrow stimulation procedure.

Treatment Options for Small Articular Cartilage Lesions

Hi, I'm Jack Farr. I'm here with Brian Cole. We're going to talk about how we've changed our thought process on cartilage algorithms over the past 20 years. Brian, I want to start off about small lesions. Have things changed much? I think they have, because. Well, the first thing that's interesting is that if you look at sort of clinical adoption, small lesions are often not treated that aggressively. So the good news is I think that people tolerate small lesions, small lesions incredibly well. So what do we define small to to us small is a little different. So yeah. So I think the thing that's interesting is that we talk about size. But size is often dictated by how relevant they are and often by the technology that we have available to us. So we've typically tried to say, well, these are 1 to 2cm². That's sort of our small range. 2 to 4cm² is our intermediate range and greater than four is our large range. Embedded in that concept though is our outcomes. In other words small lesions. If they do hurt, they are often amenable to sometimes very simple things. Even debridement can remedy some of these individuals to be less or asymptomatic for periods of time, whereas that may not be effective for for intermediate sized lesions and intermediate sized lesions. As you approach say, 4 to 6 may not do as well with neural stimulation and so forth. So it's very difficult to just drop them into buckets. But suffice it to say, if we want to have an overview to help guide people on how to think about managing these lesions, I think we can at least use that as a discussion point. Small, medium and large. I think something we've been talking about for the last ten years is size. Absolute size is important, but relative size and how much of the actual condyle? For example, if you have a ballerina with a size one femur and you have me with a size six, right, ten millimeter lesion is going to be much different on her. Yeah, absolutely. And that and we have some really interesting research that looks at how these can be load shielded small lesion relative to a small condyle as you're saying is a lot different than a large lesion relative to the same size condyle, which is why they tolerate it. And we basically see the more normal cartilage they have remaining relative to the size of the defect. That may manifest in how load bearing leads to the onset of symptoms or the absence of symptoms. So I think for for me, a small lesion, I have to respect them. And if I find it incidentally, then I think to treat it as somewhat overly aggressive in most cases. So most of those small lesions so maybe less than 1.5cm I'm going to evaluate them, stabilize the margins, take away anything that could be a mechanical irritant. But then basically just measure it and grade it and observe the patient. Many of these people will become asymptomatic with short duration. I would agree so that so what you alluded to is the relatively asymptomatic or incidental lesion that may have a very innocuous natural history. Most of us who see a number of these patients will tend to just stabilize them and and watch them going forward, sort of benign neglect. So those that do become symptomatic, say 1.5 to 2cm. What's your. Personal. Algorithm? So I think there are several options. And and obviously there's other nuances Athletes in season and so forth. Mechanical symptoms. You know, if you have that rare patient, that one, you can still treat the same way you just described and render them less or asymptomatic. But definitive treatment, I think, ranges from either an autographed maybe in our more higher demand level patient, which has excellent outcomes when you look at return to sport versus microfracture or marrow stimulation. And I think advances that we've had there allow us to treat those lesions pretty predictably. And I'll typically use as an adjunct anything bigger than 1.5cm². I'll typically add bio cartilage to that as well. But I would suffice to say the buckets for small lesions, if I'm not going to simply to breed them, will either be for their intermediate to high level patient stimulation, adjunct bio cartilage with ACP or Osteochondral Autograft. If it's a very high level individual who has an 11 millimeter defect or smaller in in circumference, because I prefer to use a small number, maybe just one osteochondral autograph plug. I think the literature looks fantastic for osteochondral autograft for the small lesions, the return to sport, the early return to sport. But for me, it's hard to find those small lesions that are symptomatic. I agree. I think you touched on another point on an in-season athlete, or maybe they're trying to get ready for next year. The Andrews group came out and they showed their results much better with just simple stabilization control compared to. I mean, you generally don't get long term if they have been symptomatic once, they often will become symptomatic again if they remain highly active. But it fits within the confines of getting an athlete back to play within their timeline horizon, whether it's a contract or what have you. So it's a great option that doesn't take them out of the sport for any prolonged period of time. Just can't forget about it as a good option. Well, I think that pretty well summarizes my thoughts on small lesions. Do you have anything to add? Very good. Brian, that was great. Thank you. Thank you.

Asheesh Bedi, MD, (Ann Arbor, MI) demonstrates the use of BioCartilage® extracellular matrix to treat acetabular cartilage defects. Several technical pearls are demonstrated including the ideal portals and approach, intraoperative surgical planning, as well as implantation techniques of BioCartilage extracellular matrix.

BioCartilage® Extracellular Matrix Mixing and Delivery Advancements in the Hip

All right. So we're going to have the opportunity to show a little bit about BioCartilage in the hip and where it can be an advantage if you look here just to orient you to this hip, this is a right hip. We're under traction in the central compartment. The camera is in our typical proximal anterolateral portal. We've made a mid anterior portal here just to show you. That's the typical portal that we would work through for instrumenting the labrum. In this particular case we've gone ahead and already treated on the rim side. You would expose just deep to your indirect head of the rectus. There you would do your rim decompression. And then here we've performed our labor repair and labral refixation. You can see here this is our typical zone that you would have for cam delamination. This of course is variable based on the morphology of the cam and the size of the cam. But in general it tends to be in this anterior-superior location here just around the anterior to 12:00, where the indirect head here is coming together with the the margin of the acetabulum. And here as we're moving anterior-superior anteriorly and then medially. This is your typical location often as we've seen that flap. And in this case you can see grade four exposed bone. You often see this best only after you've done your labor repair because the labrum is somewhat subluxed into the joint. So I always recommend that you treat your rim and then do your labor refixation step first so you can fully expose that area, and then debride your flap and get a sense of how large and how prominent your lesion is at this step would be where you'd want to now start to prep this lesion. So you would want to scrape the calcified cartilage layer off just as you would for a marrow stem procedure anywhere. We've started that here. But just to show you how you can do that, the Arthrex kit has a number of different curettes that you can use with various angles to get at this joint. You can try it from either the mid anterior portal or from your Dallah portal. The dallah portal often ends up being best to give you this kind of angle that works right on the face of the acetabulum here and here. You can kind of scrape the key, as you know, is to create these well shouldered margins. So if any of these flaps are loose or looser, unstable on the edges here. You're going to want to remove those to sort of create a sharp margin. And again remember the key here is our goal is to have a nicely adhered clot. So we're going to scrape all of that away and have well shouldered margins there. You want to work that prep all the way laterally as well as you can see there. Scrape all of that down just as you would for your standard microfracture type of procedure. Again, depending on where this lesion is located, your angles could be better from the mid anterior or dala portal. But in general, the dala portal is going to give you this best trajectory to work underneath your labrum and right up towards the cam delamination flap like we're doing here. Once we've prepped this out, then we'll be prepared to go ahead and do our drilling. I recommend to go ahead and do that right, while you're doing the rest of your work in the central compartment. And the reason for that is you can get that done now under traction, and then your time coming back into traction after treating the peripheral compartment is really only restricted to delivering your BioCartilage and sealing your BioCartilage. So there we are there. Having prepped this, now we can use our PowerPick here again, the angle of that pic will depend on the lesion, but I think probably the simplest one again is to come from your Dalla portal here and deliver that distally. So now we're ready kind of for that drilling step here. As you can see we've brought our PowerPick in. We can try to get as perpendicular as we can to the lesion. It depends on the angle for our joint here. But here we are. So here we are preparing this lesion with the PowerPick drill. Here you can see you can make these drill holes throughout the lesion like this. So you've prepared your calcified cartilage layer and scraped it. And here you've prepared the bed of the lesion with multiple drill holes to allow for placing your BioCartilage. At this step you would go back now having completed your central compartment work, treating the labrum, treating the acetabular defect. And now you'd switch to work on your periphery, on the femoral side and perform your cam resection. After you've performed your cam resection, then the end of the case is really when the BioCartilage gets delivered and brought into the to the field, traction is reapplied and we dry up the field to allow for delivery of the BioCartilage. Just note that we've actually replaced our stitches here for our capsular closure. So as you finish your peripheral compartment work, you can have your inner portal or t capsulotomy stitches already loaded. So all you're doing at the end of the procedure is delivering your BioCartilage, sealing it with ACP or fibrin glue, and then can come out of the joint and be done with the case. Let's go ahead and dry this up now. So usually at this step the first part of the drying can just simply be with the shaver and suction. We'll simply pull off all the fluid from the hip as best you can. So now once you come back in the central compartment after doing your cam work, you can see there's your lesion, the flow is off, and to further dry the lesion you can bring in these suction swabs. They can go right up against your defect. And then you can apply the suction directly to them to get some additional drying right in and adjacent to your lesion. They can either come in from your mid anterior portal or sometimes from your distal anterolateral portal, just to dry off any additional fluid adjacent to your lesion. So as you guys can see, this is your standard access cannula. That what comes in your kit is also this particular adapter here. You can actually thread this adapter right onto the end here. And then you can use that to go ahead and dry your joint. In this case as you saw we brought this in through the distal portal here. It allows you to remove any additional fluid that's in the joint all the way down to the fossa and just adjacent to your cartilage lesion. Here you have this attachment which you can hook to your suction. You can see after you've completed all your central and peripheral compartment work, you can dry out the joint in addition to the suction swab. A combination of these two tools will get the bed quite dry to allow for application of your BioCartilage. So to show you now as you're getting ready to deliver your BioCartilage, here's your delivery needle for the hip from that 1001 L kit. You can see here it has this obturator that goes down the center of the of the needle and back. This will become useful as you want to deliver the BioCartilage to the tip of the needle here. And then here's your mixed and prepped BioCartilage at that point 8 to 1.0 ratio. With ACP, you can see that this has been pre-mixed. And now at this step, usually it's easier before you deliver this into the hip, to go ahead and attach that to your needle, and you want to have most of the BioCartilage delivered down the tip of the needle to the end. So when you introduce that into the joint, you don't have to introduce all of that air. So you can preload that, if you will, to deliver most of that right to the tip of the needle. So here we're showing that here as we'll advance that through. It's kind of a homogeneous paste as that comes down. And you'll want to advance that. Seeing it come right to the tip of the needle, you can see it should be about that consistency of a thick paste as it delivers its way down. And the backside, as you can see, has this nice bevel or curve that you can subsequently use to flatten and deliver it on your prepared surface in the joint. So if you see there now you're looking at your dried lesion here. Now from the Dalla portal we can deliver that BioCartilage needle. Right here. You can see the flat surface can allow you to deliver that right into the joint. And then I'll usually have an assistant kind of gradually just deploy or push on that obturator as they start to deliver some of that cartilage from the back. As you can see, you can just sort of fill the lesion here. And then now again, you can use the back of this needle here to deliver that flush to the surface of the lesion. And the extra edges here are extra material we can scrape off here gently with a small curette. But the key is to fill that into all the spaces there. So here you can use for example like an elevator tool here to help flatten that out here coming from the Dalla portal. And come in and right along the edges here. Work to make sure we've smoothed that right into all the spaces here. Our goal is to have that flush right at that cartilage junction. And then we'll just remove this excess material here. You can see how that can fill quite nicely right next to your chondrolabral junction. So as you can see here now with our BioCartilage, we're nicely filled right along the margin right up to the labral junction. A nice paste, good consistency. You can see here. Now you're prepared to go ahead and repair and tie your pre-placed inner portal stitches and remove traction. After this lesion is sealed, either with your ACP or fibrin glue. So to me, this is a much better approach for these grade four lesions, which historically we've left or just excised the flap where now we can drill behind them with the PowerPick prepare them, but now have a good chance for lesion fill with that with that matrix. So rehab for these lesions at least in my hands fortunately has not been changed too much by the BioCartilage initially in our in our experience this is quite stable. The concentric nature of the hip joint and range of motion does not shear this this lesion or material off. Our initial plan has been for early motion. Usually the patient is protected for weight bearing related to their cam lesion, usually 20 to 30 pounds foot flat for the first 2 to 3 weeks. After that, we progress with weight bearing and standard rehab. The labral refixation and healing of that is actually usually our rate limiter, but typically by 2 to 3 months the patient is beginning to progress to walking and running, and soon thereafter more agility work with typical return to play after surgery at 5 to 6 months.

BioCartilage® extracellular matrix was designed to provide a reproducible, simple, and inexpensive method to augment traditional microfracture procedures. It is developed from allograft cartilage that has been dehydrated and micronized. BioCartilage matrix contains the extracellular matrix that is native to articular cartilage, including key components such as type II collagen, proteoglycans, and additional cartilaginous growth factors. The principle of BioCartilage matrix is to serve as a scaffold over a microfractured defect, providing a tissue network that can potentially signal autologous cellular interactions and improve the degree and quality of tissue healing within a properly prepared articular cartilage defect.

BioCartilage® Allograft Repair of the Ankle

Biocartilage extracellular matrix is derived from allograft articular cartilage and serves as a scaffold following marrow stimulation procedures to prepare for implantation. Utilize the tissue retractor to improve visualization of the joint. Then debride the defect. Remove the unstable cartilage layer and establish stable perpendicular margins. Utilize the PowerPick to create bone marrow access channels to complete the microfracture procedure. Dry the joint and defect thoroughly using suction in the cannulated swabs. Then utilize the delivery needle to deliver BioCartilage extracellular matrix into the defect. The ArthroPaddle delivery device can then be used to deliver and smooth the BioCartilage extracellular matrix into the articular cartilage defect, leaving the mixture slightly recessed to the surrounding cartilage. Apply a thin layer of fibrin over the construct, and allow it to sit for five minutes before manipulating the joint.

BioCartilage®: matriz de cartílago micronizado

BioCartilage^®: matriz de cartílago micronizado