Knotless Suture Implant System

Transcription

1 Knotless Suture Implant System Northwestern Memorial Hospital Chicago, IL August 12, 2009 Welcome to this OR Live webcast presentation, brought to you by ArthroCare. Good afternoon, everyone. Sorry for the short delay, but we do appreciate you joining us here today at Northwestern Memorial Hospital in Chicago. I m Nick Rupnow [PH], joined by Doctor Armen Kelikian, professor of clinical orthopedic surgery here at Northwestern University s Feinberg School of Medicine, and also head, foot, and, ankle surgeon at Northwestern Memorial Hospital. Dr. Kelikian, thank you for coming today. Hi. Good afternoon. We ll be showing a procedure performed by Dr. Kelikian where he does an intra-substance Achilles repair, also with an FHO transfer using the Opus system, which is a knotless suture anchoring system. We will show the footage narrated by Dr. Kelikian, and then you have the chance to do a question and answering session afterwards. Please feel free to your questions in via the website. Dr. Kelikian, is there anything you would like to add before we show the footage? No. This is about a 48 year-old gentleman with a delay in diagnosis in an Achilles rupture. He s diabetic. It s about 4 months old. He came in with weakness, inability to push off, go down stairs. He doesn t remember what happened. He doesn t remember an injury. And he was undiagnosed prior. So it wasn t like an acute rupture where you do a direct repair. We had to augment this and bring the gap back together and use a flexor hallucis longus tendon, his own tendon, to augment the graft, give him more power, and add vasculary to a diseased tendon. And the operation is going to start with the exposure. We re going to put some stitches in each end of the tendon. We also do a Strayer Procedure. People in foot and ankle are very familiar with that. It s proximal lengthening of the gastrocnemius fascia to bring the proximal end down so we can dock the two together so there s not tension on the repair. Now, we augment that with the flexor transfer. It s a short harvest; it goes into the bone directly. We don t go into the fore foot to dissect it out, and it gives us more than what we need. As far as a fixation, it s usually the Opus Magnum 2, the large Opus anchor. Sorry. Yeah. No problem. And that s basically at the end of the procedure. Perfect. So if we could roll the footage. Yeah. So right now, what I m doing is the Thompson test. And I m just squeezing his calf to show you that it doesn t respond. Negative test, positive response. And you can see he has markedly increased dorsi flexion because there s no tendon there. I m putting my finger on the gap, which is called a hatchet sign. Now this is done through a straight posterior incision, rather than medial or lateral, and that s a surgeon s preference, but it s better circulation, better angiosomes

2 for wound healing. And this has been more of a trend to go through the straight posterior incision. The other incision I m marking more proximal right now is where I m going to do the gastroc recession. And right now we re going through the central skin of the Achilles incision. He s prone. He s upside down. This is the left leg. We re not using a tourniquet. It s really not that necessary. We re exposing small vessels. This is called a confusion stitch, it s just a retraction stitch, you put it through the skin on each side, and we take a loop out. It pulls the skin apart without using metallic or tractors and putting in necessary tension; something I learned years ago from my dad, and something easy for a lot of foot surgery. At this point, after the skin has been exposed, we re going to cut the paratenon, or the superficial fascia, which we will repair later. And right now I have a small mixture underneath that, and we re cutting that, and we re exposing the rupture site, which is about we thought it was more distal, but it s about two centimeters from the insertion of the Achilles. So in this case we had to do a delayed repair. And the graft, it wasn t an avulsion, which we suspected it might be, off the calcaneous. And right there you see a big gap; I ve opened what was the sheath or lining of the tendon, there s a big gap or missing space, and at each end of that we re going to find the proximal, where we are now, and distal stumps of the Achilles tendon. And I decide I had to go a little bit higher up and get more exposure to get the proximal end of the tendon, which has migrated up the calf about three centimeters. I m just doing some blunt dissection now. And, again, we re opening up the paratenon, or posterior superficial fascia, and, again, staying straight in the midline. And we want to preserve this fascia later for our closure over the repair. This is a double action instrument that I m going to grab the tendon with. It s a tendon instrument, and it allows us to pull down the proximal end. Right now I m just trying to feel my boundaries. See, I had this big tube, and the tube s hollow, and that s the patient s attempt to heal this naturally, which obviously is nice tissue, but it didn t work. And we re going to use this. We re not going to put in some artificial tissue such as graft jackets and things like that. A lot of people use that. I don t find much use for it. They easily get infected and spit out. And I m going to take this tissue and use it later in my repair. So right now, I m just trying to get my boundaries. I m on the medial side of the Achilles, the distal stump. You can see the gap; it s about four to five centimeters. And I ve got that loose, redundant connective tissue. And I m measuring that for you there; I believe it s four to five centimeters again. And that s unhealthy tissue, we re going to use that to wrap around like an anchovy later on, or a roman sandal, but we re not going to use that for our direct repair. The direct tissue I just picked up proximally. And then this is showing the distal tissue. Now, at this point I ve decided, look, I have a lot of tension on this thing, and I should do a Strayer Procedure or a gastrocnemius recession. There s a lot of ways to do it. Some people do it endoscopically, but at this point, we re making about a three to four centimeter incision, just medial from the midline. This is superficial fascia which we got distally, and you want to get that out of the way and protect it because the sural nerve and the short saphenous vein are right here, and you really don t want to cut those, it s not good for them. So right now we re cutting the white fascia. And when we see red, we stop. Red is the muscle. And we have to get all the way medial. We re working on the medial side. My head s in the way there. Right there we re getting more central. These are some thyroid-type retractors. You can see now, I can easily pull my tendon down, I ve done the gastroc recession. There s about three centimeters of length I just got back, and that really doesn t weaken the patient that much at all. It s not like doing an Achilles lengthen. So I m going to get this back so I can have the right, proper resting length. 2

3 Now after I ve done the Strayer, we re closing this with subcutaneous tissue and then skin. And here s my tube, my redundant tissue that s probably a remnant of the plantaris that you see hanging like a little worm here. It s not a nerve, it s the plantaris. And that could be used in the augmentation. It really has not structural integrity. Now right now, I ve moved my Achilles out of the way, I m in the deep posterior fascia, and I m cutting that to harvest my FHL, flexor hallucis longus tendon. That s a muscle and it goes form lateral to medial. The tendon comes here and it s just posterior to the neurovascular bundle. Now I ve just got my right angle around the muscle and I m going to find it s tendinous portion, I m going to take it distally, and do what s called a short harvest. I think Doctor Sig Hansen popularized that out of Seattle. And we re going to cut the tunnels around the FHL tendon. This is a Penrose drain, just so we can put tension on it. We re well away from a neurovascular bundle. And, again, we re not going to dissect in the foot because I don t need it with this anchor system. I don t have to use a drill hole or anything like that. Here s more just soft tissue that s got to be dissected away. A little vein that s crossing over, so I m going to go ahead and cauterize that, I believe. And this is called a groove director. It s an old instrument. It just lets you cut right on the gutter, which we re going to do after the cautery. And then I m going to watch the tendon. Now, again, here s the heel. I ve got my Kocher dissector in there. I ve got a groove director, same device, and we re cutting. Nerve and artery are more medial and deep. They re a little anterior to where we are. I just want to cut my tunnels so I can go ahead and harvest my tendon. And I m pulling on the tendon. It pulls on the great toe. We re proximal to the master knot Henry here, and we re cutting this with a Pott scissors. It s used for chest surgery by, first of all, Pott, you know, we talked about tuberculosis and stuff, and we ve cut the tendon, proximal master knot Henry. So the patient could still flex all his toes. He will just have decreased power of the FHL of the big toe, which shouldn t cause much of a functional deficit unless he was a ballerina. Right now I m taking my number-two suture, and we re doing a modified Krakow stitch for about a centimeter or two into the harvested FHL. We re locking this as we go. Just about three or four whips through it. And this is what I m going to pull down, and later on, at the end of the case, I m going to use the ArthroCare anchor for the Opus system. Now what we re doing here now we re going back to our proximal segment. We re using the same suture, but we re going to do a modified Krakow stitch. Krakow described this for lateral ligament repair after total knees. He s not a hand surgeon, not a foot surgeon, he s not a sports doctor. He s a total joint surgeon, which is kind of ironic. This is more used by sports and foot and ankle people now, but it s still orthopedics. And we re doing a single loop, single suture proximally and a single suture distally. You can see I ve got this in a normal tendon, and now I m going to do a Z-lengthening of that excess of tissue, that healing response he made, just you do a Z of an Achilles, and I m going to use this later as a wraparound to augment my repair because, I told you I m not going to use some porous and pig graft or anything like that. And I ll finish my Krakow stitch in a proximal loop, and then I m going to go on to the distal loop. And so we re done with the proximal. And we can still it s a nice strong suture. You can yank on this or pull on it to get a little more of that gastroc recession going for you. We re going to do the same thing. I m going to ignore plantaris. We re doing the same thing right now in the distal end, the same suture, a single suture going from anterior to posterior, locking it at both ends. Now I m not going to do my suture repair here at the site of the rupture. I m going to do what s called a gift box technique. I think the guy that just described this at an international foot and ankle meeting wrote this up. His name is Rolph. I believe he presented it in Brazil about a year ago. 3

4 And instead of doing our suture here, we pass the suture from the proximal end, distally, and the suture from the distal end, proximally, and tie it away from the repair and it s amazing. I ve been doing this for about six months now. It s amazing how much more tension you can get and your sutures away from the repair site. And biomechanical studies have shown that this is actually stronger for acute repairs as well, to keep it away from the site. Now I ve got my I m doing a Pulvertaft weave. Pulvertaft described this for tendon transfers in the hand and we re I want to suture once through the Achilles, and I m going to tag it down. So I ve gone from posterior to anterior. Now I m going to go over lateral, and I m putting my new suture used from the Magnum 2 Magnum wire, we call it number two suture. And you can see I ve kept the limbs about 12 inches long on each one because I m going to use this later for my -- excuse me, my Opus anchor, which is right here. Now the first thing we re doing here is we re drawing a hole into the calcaneous right about here. I m lateral and posterior, this is the same ankle, and we re drilling right here. You can see the drill hole right here. I think it s the 3/2 drill bit, and it locks out, it stops on it s own. Then there s a pathfinder, which is what I have in my hand, and we re putting the pathfinder into the hole just so we don t lose our hole. And now we re going to go ahead and take our suture and we re going to tension it tension a Magnum wire through the Magnum number-two Opus. I call it a fishing reel. It s a lot like troll fishing when you tighten it. So first thing I m doing, I m passing the suture through the little wire loop about two inches, and then I m going to pull my, what I call a plunger out, toilet plunger, that s what I call it. And then we re going to bring it back to two inches. And now we re at two inches, we have equal limbs, we re going to start reeling this thing in single-handed on these little black knobs at the end of the instrumentation device. I imagine it just to be, you know, a purist, two inches, five centimeters. So now we re going to start reeling our fishing rod or our line all the way to two inches again. And you don t put a lot of tension. You re not pulling real hard. It s going to come to it. I ll measure it for you again. You don t have to do this, but about two inches. And then we re going to put the anchor facing towards the tendon, the black line you see there, those little dots, that should be towards the tendon you re working on. Here it s the FHL, so it s going anterior, and I ve engaged it in the hole, it s pushing the hole, and now I have to lock it in the hole. I m going to pull my trigger once and I m going to pull back, and you can see, when I pull back, it s anchored in there. But the tendon hasn t been tensioned. Now we re going to tighten it with both hands all the way down. Just keep you can feel the tension. You can really get a good idea about it. And you can see it going into the hole right here. There s the FHL. And when I ve got to that point, then I go ahead and lock the system. There s a button on the side we haven t pushed yet. I m feeling my tension, making sure I like it because, you know, I want to be able to sleep good that night. I don t want to do a half operation or a mediocre job. Now I ll go ahead and after I ve tensioned it or locked it, I do two and a half clicks to release the suture, you can pull it out with a needle holder from the fishing rod, as I call it, fishing reel, and it s good. I did this in a little plantar flexion so there was tension. This is an end-phase transfer. It s a plantar flexor. It s got the right length. It s got the right tension. I m taking the remainder of my suture now and just, again, as security thing, I don t know that this is necessary, just taking an atraumatic needle and passing it into the Achilles just have another anchor source, even though the anchor in the bone is my strongest anchor. But this, again, a little extra security; the suture is there, why not use it. And we tie that end. And that s the end of the repair. That s the end of the transfer. I m going to go ahead and augment that remaining tissue, which I already did, but wrap around the stuff that was left over that I saved, and now I m going to put sutures sequentially in the 4

5 paratenon or the superficial it s really the superficial posterior fascia, because you want something good to cover your repair. And we re going to put a bunch of sutures in and tie them one by one after they ve all been placed. Almost like you do a calcaneous fracture with the flap. And you can see we re patching the sutures, clamping them as we go. And you look at this, and you go, God, are we going to be able to close this, but, again, the fascia s been open posterior, that thing will fall right in, and it closes very nice. And you need to have a good fascial closure here any time you do an Achilles surgery. After this is put in, we do a sub-cu closure and an interrupted nylon closure, and you can see we re tying it now. My assistant is pulling up on one while the other one of us is tying, and we ll cut them all at the ends. Now we re in a sub-cu closure and then our skin closure. It s just simple interrupted suture. We re both closing together. Now, look, we got the Thompson test back. I m happy. I m smiling, but you can t see it. I m hiding it. And we re going to put a compression dressing on and a neutral cast, and all our wounds are closed and there s good circulation to the flaps. Wow, Dr, Kelikian, that was great. Thank you for talking us through that very detailed. I m sure everyone learned a lot so far. We do have a number of questions that have been ed in. We re going to get to those at this time. The first question that came in here, Dr. Kelikian, is, What other indications can you use for the Opus system besides for an FHL transfer, Achilles repair? Well I just did one today. It s not a very common one. It was a patient, a young boy that had a tib/fib instability after an ankle fracture and lax deltoid ligaments. And what we did was took the superficial and deep delta, we used the mini-anchor, the number one, and we were on the medial side of the skin sorry about my phone. We were on the medial side of the skin, and I used this just to tighten my superficial and deep deltoid. So we put our drill holes in after we took the redundant deltoid off. We, of course, did work laterally. We had to redo the fracture and all that stuff, but I re-embrocated the deltoid ligament. Conversely, you can use it laterally as an anchor for a modified Brostrom procedure. It works really nice. The thing I like about it there is you don t have the knots right under the skin with some of the other systems, and it s very subcutaneous there. And people complain about the knot bothering them. So I ve used it lateral and medial. A very good indication for a larger one is when you have a distal Achilles avulsion, which it was not this case, or a chronic Achilles tendonosis, where you re detaching part of your Achilles and you re going to put it back, and you have to get the right tension and right length, and good secure fixation. So I d say modified Brostrom, medial side, lateral side; FHL transfer like we just showed; a reattachment of the Achilles tendon, whether it s acute or chronic. And another indication would be for posterior tibial dysfunction. If there s a complete posterior tib rupture and you re not going to suture back into the tendon with your FDL, usually do an FDL transfer, flux (INAUDIBLE) to augment it. You could put it into the first cuneiform or the navicular with a simple anchor system like this. The other thing you can do is drill holes, but the problem with the drill holes is you need more length, and you have to harvest longer and go more distal. So the anchor works really well for the medial side as well. I haven t used it for anything in the forefoot, nor do I have any experience with that. Like bunion surgery, I wouldn t probably use it for that personally. But more mid-front and hind-foot type procedures. Great. Great. Thank you for that. Obviously, you re a great surgeon and you like to use some of the best products around, so what advantages do you find with the Opus system? 5

6 Well I don t think it s lying to me. I can feel the tension is great. I want the right tension for wherever I m repairing, like a ligament, or what I m transferring, like a primary tendon or a secondary tendon. If you don t have the right tension it s not going to work. And I like the tension. I like the knotless feature because in the foot and ankle, everything is subcutaneous, there s not a lot of fat down there in most people, and they re going to feel it, and they re going to complain about it later on of the knots and things like that. So I like it for that reason too. Great. Great. And it comes in two sizes, so that s good. Perfect. The next question that came in here, and this is more of a more of a surgery question versus a product question, but, Is there any damage to the leg or foot caused by dissecting veins that are in the way? Not really. I mean the angiosomes really that posterior approach that we just showed, you re cutting minimal amount of veins. If you went more anterior or medial or lateral, you re going to get into more important angiosomes, which are the small veins and small arteries. So in a straight posterior, like in the case we just did, less likely to do that, but you have to cut what s in the way on some of these exposures. Right. And obviously you ve had good success. Yes. I mean, if you re cutting nerves, there s damage, but not small veins. Absolutely. Okay. Great. Thank you. Next question coming in here, How are your patients doing after the cases you have done using the Opus system? I ve got a handful, I d say about 15, 16 patients, and so far nothing no problems with failure that I ve seen or anything like that. It s a small number. Okay. Great. Dr. Kelikian, when you are thinking about using an anchor, what materials do you prefer to use? I don t really personally care if it s biodegradable or not. That really doesn t matter to me. I mean, it sounds nice and cute and all that, but as far as the biodegradables, I don t know that much difference between this PLLA and Peak (INAUDIBLE) now is stronger. It s just coming out. I ve seen some studies that say the Peak is stronger than the PLLA. I want to find minimal reactivities, soft tissue reaction, which I haven t seen with the PGA from 10, 15, 20 years ago, we saw that a lot. With the PLLA, that wasn t really an issue. So I just want something mechanically strong that s not going to cut out. And whether it s biodegradable or not, it really doesn t affect me. Okay. Do you ever feel like a metal anchor gives you an advantage just because you can X-ray it right afterwards to see where it s been placed? Some people really don t want to see where they put stuff. Okay. So I don t know that that s really an advantage. Okay. Okay. Great. Thank you. Next question we have here, Dr. Kelikian, Was this one of the simpler procedures that you have done or that you continually do? With the Opus thing? 6

7 With the, you know, intra-substance Achilles repair with an FHL transfer, how would you rank that against as far as difficulty? I know it s kind of an awkward question. I mean once you ve done a few of them it s not that hard. Okay. I mean, once you ve harvested three, four, five of them, it s fairly straight forward. Every time I harvest one you have to be really careful, and you worry about the neurovascular bundle, which is anterior to you, but all in all it s I mean, if you ve done enough of them, it s fairly simple. The first few it s a little rough. Yeah. But it becomes pretty routine. You have to know your anatomy. And if you know your anatomy, it s pretty easy. Well, how would I mean, would you rank it any more difficult than doing a Brostrom procedure? Is it all Oh, a Brostrom procedure is brainless. I mean it s really easy. Come on. That s simple. The FHL, you ve heard of what they call tiger country, there s big stuff there? Yeah. This is two times, three times more difficult than a primary Achilles repair, you know, harvesting and graft, augmenting and putting back. On a one to ten on a foot and ankle, which you know, we re not spine surgeons. We re not doing big scary stuff. But I d say it s about a six. About a six. Okay. Great. Great. Thank you. All right. Again, I know you talked a little bit about what kind of stitch you were throwing when you did your intra-substance repair, but can you again explain maybe the gift box technique that you were talking about? The gift box, again, it might be Rolph is the name. I can t remember what country he s from, but he presented this at a combined International Foot and Ankle Society in October in Brazil. And it was recently written up. Instead of taking your ends of your sutures and bringing the two ends together and tying it where the tear is, he takes a needle on the distal suture and brings it up a couple I go through twice, but don t lock it proximately, and then take the needles from the proximal and then go distal. And you pull one, tie it, and then you pull the other. And it s called a gift box because it s like trying a ribbon. I see. And it s biomechanically stronger, proven in the lab. When you do your suture like that then at the repair site. Plus if you have a wound healing problem at the repair site and you ve got this big knot of a foreign substance in there, I think it s a little less worrisome. And I ve been really impressed how easy it is to bring the ends together, and you re not fighting yourself, and you don t have to go and clamp it so the knot might slip and all that. It s very simple and it s almost ingenious. I can t believe I don t know why I didn t figure it out. Maybe I m not smart enough, but I wish it was called the Kelikian gift box, but it s not. Yeah. That would great. Thank you. Next question here, Doc, What is the recovery time with the Opus Magnum 2 system or the Opus knotless system? Well it depends on what operation you re doing. I mean it s not going to change. This patient here, I m going to go non-weight bearing for about he s in a cast right now. I m going to see him 7

8 in two weeks, take the sutures out if the wound looks good, it should, I don t want to jinx it, and then I ll put him in a cast. At about week four to five, I ll take the cast off, put him on a CAM walker, and let him start plantar flexing, physical therapy. I won t let him dorsiflex past zero degrees. So he ll be about five weeks behind a routine four to five weeks behind a routine primary Achilles repair. He ll be full weight bearing at five or six weeks. He ll be protected for about ten to twelve weeks with a removable AFO type device CAM walker. Okay. So for that case it s a little prolonged. For a Brostrom procedure it doesn t matter what I m using, whether it s suture or anchors, we go two weeks non-weight bearing, then three to four weeks full weight bearing in a cast, some people use a CAM walker. So it really depends on the operation, not the device that much. Okay. Great. Several questions had came in. We answered most of them. Is there anything else you d like to add? No. I think it s something I had to use it four or five times and, to be honest with you, I felt more comfortable going over this before with one of the sales reps or whatever, trying it out on little saw bones. And just because of the little steps, there are so many small steps, it s nice, at least for the first couple cases, to have somebody from the company around in the room. And, again, passing the suture through; pulling out the toilet plunger, as I call it; you got the two inches exposed; and, you know, there s about seven or eight steps and you look at them and you go, God, I don t want to remember all that stuff, but after about five, six times, even a person with an IQ of 80 like me can get it down. So you go ahead and tighten this up, and after you get it tight, you know, you ve already tested it; you ve tightened it up; and then you lock the device. This one I can t lock, I m sorry. And then you go ahead and push this two and half times; but you ve got to remember all the steps in order. You don t want to deviate. And remember this black line here, it s toward the tendon you re transferring. So in this case it was going more anterior because the FHL is more anterior. If it was a Brostrom ligament, a lateral ligament, it would be more anterior, more superficial as well. So it really just you ve got to remember this thing. And when you put this in the hole, you don t turn it, you have it in the hole in the right direction before you employ these little wings over here. I call them fish hooks. Everything is a fishing rod, I m not a big fisherman, but, you know, the little I know, it reminds me of. Great. Thank you. Now you talked about a couple of the advantages being knotless, building tension; has it saved you time in the OR at all? Well, I think it takes but a minute to tie a knot, so that s not going to save you a lot. No. I just think it s just that secure feeling you have the right tension. Because if you don t have the right length, a strong muscle that has a good motor, the right tension, and something that s not endphase, cortical control, it s not going to work. And for the FHL, the FDL, this is beautiful. It s real easy. Great. Great. All right. I think we ve got one more question here. This is I know you ve had a little bit of experience with the bears. Is this or will this be utilized in NFL and other high-impact sports injuries? Well whether you re in the NFL or just someone simple like you or me, I wouldn t Do anything different? 8

9 -- do anything different, right. I d treat you the same. Of course, if health care changes now, maybe we can only afford to do it on those kind of patients, but, you know, reimbursement and all that. But, no, I wouldn t I d use it for sports injuries, but not specifically a bias with that over a regular patient. Perfect. Perfect. Okay. We ve got another coming in here and this will be the last question today. Are there times you use a bone tunnel with interfering screw to fix a FHL transfer? Yes. I ve done that. And it s a great question, and I ve been looking at the literature. I haven t there s no good double-blind studies compared with some lab studies where a bone anchor might be a little bit stronger. I don t know if it s an academic question or not, but, yes, I ve used bone anchors when I ve put tension on I ve manually put tension on my tendon and then put the screw in, so I ve done it both ways. I don t have a good answer of whether ones better than the other. And I think it would be a great categoric study for someone to work on in the lab and compare it one to the other and see what s really better. I agree. Great. Thank you. Well, again, we d like to thank everybody for dialing in today. We appreciate your time. Again, thank Doctor Kelikian for being here with all his knowledge and everything he s done. Please contact your local sales rep or customer service for any questions you may have. Again, thank you for joining us today. We really appreciate it. Thank you for watching this OR Live webcast presentation brought to you by ArthroCare. 9