Innovative and Minimally Invasive Technique for Fracture Fixation
Tuesday, November 14, 2023 at 6:00 pm EST
Describe a technique for pathologic and osteoporotic Fractures
Recognize the criteria for use of the technology
Good evening everybody. I'm Sarah Lowe with Baptist Health. I am here to thank uh to introduce Doctor Roy Cardoso. He's here to present on innovative and minimally invasive technique for fracture fixation. Doctor Cardoso is an orthopedic surgeon at Baptist Health orthopedic care in South Florida. He specializes in conditions of the hand and upper extremity. Doctor Cardoso completed his medical school at George Washington University School of Medicine and he completed his residencies at Tulane and UC Davis. His fellowship was completed at Wake Forest University. We will be taking questions throughout the uh presentation but we'll answer them at the end. So please feel free to pop in and ask questions. Doctor Cardozo, please take it away. Thank you, Tara. It's a pleasure to speak with you all tonight. Thank you for taking some time out of your evening. Uh to learn a little bit more about what we're gonna talk about. So the talk is uh purposely slightly vague, innovative, minimal invasive technique for fracture fixation. Um I am a consultant for a company called Lumino that does have some relevance to the talk. Um And what I'm talking about is a intramedullary implant. It's a patient conforming intramedullary implant. And what what is done is AAA thick balloon similar to an angioplasty is placed into a bone and that bone is injected with this photodynamic monomer um as a liquid and then a light is shined into the into the liquid tube and that turns the uh the liquid into a solid. Um and there's a, a light box that emits this um UV type light through the implant for approximately 10 minutes and it turns this uh balloon filled with liquid into a solid which facilitates uh stabilizing uh bones. So the procedural steps. So the first step is you make a small perforation in the bone and you place this uh little implant in. So it kind of looks like that inside an intramedullary canal. And then you take uh the liquid that we mentioned and you fill it into the tube, which it, it blows it up such as that and then you shine the light into the balloon and then it turns that liquid into a, a solid and when it's done, then you cut the, the tip of it and then it's completely encapsulated within the bone. So here's a quick sort of video of what that kind of looks like. Oh, sorry. Yeah, you see the balloons slowly start to inflate until it fills the uh the space of the canal. We're gonna talk about that a little bit more. So the balloons have predefined shapes depending on what the uh what we're using them for which bone we're using them for. And they maintain dimensional shape both in terms of length and diameter. Uh irrespective of how much pressure or how much fluid you fill them with. Um They have relatively thin walls though. So they do conform to the shape of the canal that you put them in and then you shine this light into the balloon and it does heat up the polymer to some degree, but certainly a lot less than uh methylmethacrylate. So much less than um cement as it were. So, about 62 °C and it's only for about four minutes at that temperature. So it's, it's fairly osteo safee. It's quite osteo safee, in fact. So, indications for use, it can be used by itself in stand-alone fracture care. It can be used to fill up metastatic bone voids. And also it can be used um as supplementation because you can uh apply it to a bone to add stability and then still add traditional plate and screws uh into the bone as well. So, one of the benefits of, of this technology for geriatric bone is that there's 360 degree cortical contact around the area. So it, it provides significant support throughout the contact area and then it, it conforms to irregular shapes of canals. It doesn't have to be specifically de designed for individual bones, it fills the canals. And so there's rotational stability and no need for screws if you don't want to use screws. And then the nice thing is it can be easily drilled once the device is hardened. Um It, it is uh easily drilled into and it can also increase the holding pla uh power of plate and screws by 3 to 5 times. Um And there's flexibility in terms of, of how you wanna place your screws or where you wanna place your screws. It's not like a, a traditional intermedial bone device where you have to utilize the screw holes that were previously placed. Um And it uh this, this slide simply shows that it increases the pull out strength of uh screws, especially through osteoporotic bone. And then of course, you're able to go around curved bones, which is tremendously helpful or around implants. As you see in the, in the uh right side of the screen there, you can traverse implants, which is of course helpful with per prosthetic fractures. So I'm gonna present some of my cases. I'm a hand and upper extremity surgeon. Um And I uh have used this device um maybe about 30 times. Uh I started using this device in uh 2021. The device has been approved for the in, for use in the United States by the FDA since I believe 2018, but it's been used in Europe uh for much longer than that, I think since 2012 or 2014. Um And I use it mostly in um patients with osteoporosis, uh 55 and older and in um fragility fractures, particularly distal radius and ulnar fractures and uh and the electron fractures. So this is a typical case, this is a an extraarticular distal radius fracture. Um and a patient in their sixties and the fracture displacement was such that the patient wanted it to have it corrected. She also was not interested in in immobilization for a long period of time. So the steps of the case, the fracture is uh reduced and held in place with a little wire. And then we start to uh open the canal similar to how you place any intermedial device. So we start with a little wire. Um And then this is augmented with a reamer. I tried to go as media as possible with a reamer in order to support the medial column of the device. And then there's a flexible guide wire that goes down the shaft of the canal. And then this is the, the little spirals are the deflated implant. And I'm using a little joker uh instrument. It's called the joker to push it over immediately. So it supports the the radius the way I want it to. And then this is you see the the coils start to open as I start to inflate the device in this image. And then finally, this is the device after it's it's placed and hardened and the end of it has been cut So it's flushed with the bone. So you can see that the reduction of the fracture is, is pretty good uh in all planes. So I was very happy with the uh the fracture reduction and this is all done through pretty minimally uh minimal incisions. There's a couple of other cases. Here's another case, this is a much more displaced fracture. And this patient came to me by the time we were able to, to attend to them, they were almost um three weeks out from this fracture. So it had reset to some degree in this mal united position. And so in order to reduce this, I needed to approach it from the front. So I made a carpal tunnel incision. I, I use an endoscopic carpal tunnel incision. I widened it just a little bit so I could get a little freer elevator through the front so that I could uh reduce the fracture more easily through the volar aspect or the palmer aspect. And then from there, I put in a wire in the back to hold the reduction while I did the procedure as I previously showed you. And so this is when the device is implanted into position. And here's another case, once again, a similar case that displaced this radius fracture. Um And once again, once the device is implant, implanted and inflated into place, you can see that the um the length of the radius is an atomic and that the articular surface uh in both planes is in good position. And so the one of the beauties of this um device is that it's done through very, very minimally invasive incisions. And so uh patients who are older, who have multiple medical problems, who have diabetes or healing issues, this becomes less of an issue because the implant is so stable, they don't require casting afterwards. I put them in a removable brace and they start moving pretty soon afterwards. This is a video of a patient who is uh about three days after the surgery. You can see she still has her stitches in. Oh, sorry about that. Let's go back and watch that again. Um You can see she has minimal bruising and she's able to move her wrist pretty well. This is again, three days later, we're gonna put her in a brace and so we start her in some therapy. So the patients love it because they can get back to activities right away. So there's multiple other applications um for the device. Uh this is these are not my cases. Um This is in a uh proximal humerus fracture. Once again, you can uh for those of you, those orthopedic surgeons who take care of you with intramedullary nails, you know that going through the rotator cuff can be difficult um or problematic. And with this device because number one, the implant is the, the application site is so small. And number two, because you can curve around tissues, you can get this into small spaces fairly well without so much damage to the soft tissues. This one is utilized again, in conjunction with an intramedullary nail, the person who did this case uh decided this patient needed some extra um bone stock or strength. Uh I guess so they added this to that. This is used in conjunction with a plate similar to what you'd use a fibular strut for uh in a patient with pretty severe osteoporosis. This was just the technique that that person used to to uh apply the plate after the nail had uh after the intramedullary balloon had been placed. And then this is for uh paraprosthetic fractures. This would be, this fracture would be uh difficult to augment um excuse me, this is for a, a very distal fracture, not a per prosthetic fracture, difficult to augment with anything. Uh But this uh device because you have such little fixation um so close to the knee. This is with the, this is the case with the per prosthetic fracture. Again, you can curve around the device um that was in place. You can supplement this without cabling cable grafting, you can use it in the pelvis, uh in curved bones, I can see here and then this is once again utilized in the acetabulum uh in a curved portion of the pelvis. Once again, this is in a tumor case in a in a metastatic tumor case to supplement a a hip replacement. This case is uh utilized in a, in a proximal tibia tibial plateau case where you can see that there's quite a bit of depression uh along the lateral column of the tibia. And they're utilizing it in addition to plate to a plate just to support that uh that bone better. And finally, in an ankle case, in a fibular case. So uh a question that I get a lot is how does one remove the device and it is removable. Hopefully, you don't have to remove it. And unless perhaps in the case of an infection, um because if you had a, if you had the device by itself and it broke you, you broke that bone, for example, you can, you don't have to remove it. You could just plate around it but say you did have to remove the device, you can drill into it and remove it that way or you can extract it. So once the device sets there is a, a fine area around the device, the device shrinks slightly. And so it it it doesn't uh conform to the bone to such a degree that the bone grows into it like a um like a porous coding, for example, like a total, total joint coding. And so the device can be fairly easily extracted. The center portion has a remember when you put in the wire, there's a central portion that has a hole. So you can put a KK wire into it and then pull the device out so that is possible to do. Um So those are all my slides. Um I love to talk relatively short so that there's time for questions or, or discussions and I'd love to hear all of your thoughts um on what I talked about. Thank you. Hi, thank you. I appreciate uh everything you had to say. Doctor Cardoso. Um If anybody has any questions, please make sure to submit your questions and then we, I can provide them to Doctor Cardoso to answer. But um I'm thinking just to start off Doctor Cardoso while everybody's kinda thinking, you know, what's the history of this particular device? You know, how long has it been around? How long have you used the device? So, um you know, as I had mentioned before in the United States, it's, I think it got um FDA approval around 2018. Um and uh it had a specific indication for um you know, os bone and for uh pathologic fractures, but it can the the indications have broadened in Europe. It's been used safely since 2014. I think they got approval in 2014 to use it. So they, they have a larger track record than we do and they have a, a large body of research around this device and they've used it for much longer the um safety. Some people had some safety concerns in terms of what the liquid is but it's been proven to be completely inert and has no um untoward effects on the body. And it's also very uh osteopor uh friendly. It doesn't cause osteonecrosis, even even with the warming period that it takes to set the, to set the device. Wonderful. Uh We have a question here. Are there any absolute or relative contraindications for this technique? So I, I think it depends on how you utilize it. I use it um for extra articular fractures, I think if you're gonna use it for fractures that go into the joint, you would have to supplement that with additional plate and or screws. Um In young people, I really don't use it. I haven't placed it in anybody younger than um 50. Um One of the reasons is um potentially for having to remove it at a later time. And also um it relies on a fairly capacious canal. And so, you know, you, you'd have to ream it out quite a the canal quite a bit to have enough space. So I tend to use it for, for kind of older folks for 50 above. Thank you. Um Another question. There is another contraindication that in the, in the, in the setting of infection, I would not use this device. OK. Thank you. Um Anybody else have any questions, please pop, pop them into um in and uh we'll read them, read them to Doctor Cardoso. Um Another question I think that I have Doctor Cardoso, is, is there any other devices like this in the United States? Is this um or you know, is this the one of the first of its kind that's really being utilized? And how widely used is it in the United States right now? So it's uh it's pretty unique. I haven't heard of anything even close to, to this. There have been other metal cages and other things that try to conform but nothing, nothing like this that um is a conforming sort of balloon. Um So it's pretty unique. Um There is use throughout the country. Um But there's still many, many people who don't know about the device, including many orthopedic surgeons who who have not been exposed to the device. So uh in terms of exposure, it's pretty new. I noticed that there were a lot of different parts of the body with bones and stuff that you can use it. Now, you, you mainly use hands. Is there a specific group of uh orthopedic surgeons? You feel like it's being used on more um like is it more cancers style patients or do you think the hand or just I'm curious as to where, you know, you we we're the predominant use right now. So I have seen uh lots of use in the, in the upper extremities. So, wrist fractures and uh humerus fractures. Um However, my trauma colleagues tend to use it on long bones. So tibia. Um and then it's used quite a, a lot as you had mentioned in among uh musculoskeletal oncologists. So, so docs who uh deal with bone tumors. Um It, it has pretty wide use in, in, in uh among patients who have uh me metastatic or primary tumors of the bone. Mhm. Ok. Wonderful. Thank you. Is there, is there anything else that we should know about the product or, I mean, or, but this procedure, I would just, I would say as a whole, not necessarily the product. So is there anything else any research, research being done or anything else that you know that we could talk about? There's, there's quite a bit of research being done around safety and around um multiple a wider applications of use and, and stability, et cetera and all of them have been very, very promising. Um I would say that if you're interested in the device, um there's a pretty small learning curve if you're an orthopedic surgeon and, and you do and you, and you work with in intermedial devices, it's not a technically demanding um procedure. However, uh the company is quite um accommodating in terms of setting up a cadaver lab or if you're interested in coming down and seeing what we do down here, we're happy to accommodate that as well. Um So I'm pretty excited about it again. It's, it's not for every patient, every fracture. It's uh it's a small part of my practice, but the patients who do get it, who qualify and who do receive the procedure. Love it. Um There's a lot of satisfaction around it cause we can get them back to doing what they want relatively soon. The um healing rate and everything else is a lot faster in terms of the skin envelope and the soft tissue envelope. Um So I've been very pleased with, with, with the device. Is there any therapy or anything that's needed? Um Or, or if there is, is there anything that therapist should be aware of? Um Sometimes, sometimes the, um sometimes the patients become stiff and require therapy. Um We send them at at least initially for an evaluation in a few sessions just to make sure they're on track. Um I would say that the patients still need to understand that even though the wrist feels really good that they have to be cautious and they still have a fracture. Um Sometimes we have to hold folks back because they, they see a tiny little incision that heals quickly and the hand and the wrist feel uh good relatively quickly. Um But I still have them avoid heavy lifting for, for until the fracture itself heals. That's the one caution that the therapist also have to have, I'd say. And then you said that the, the, the um how long does it usually take for it to heal? I'm sorry, I may have missed that in your discussion. No, no. I mean, the sa the same time period, it takes any, any bone to heal. Um, you know, it takes about, I'd say 1010 weeks or so before the bone is at least the upper extremity bone and a healthy person uh, heals that said though, you know, the skin envelope is healed by about two or three weeks and they're usually, they usually have very good range of motion by the first month in most wonderful. Um If anybody would like to reach out, would you be, is it ok if we share your information with the, the attendees today? Absolutely. That'd be great. Wonderful. Um Any one last call for questions. So if anybody has any questions, please feel free to go ahead and post and uh while we're at it, Doctor Cardoso um can while we're waiting to see if we have uh we have a question, actually, I'll take that back. Um Have you had any complications with this? Luckily, I have not. Um I've done about 30 as I had mentioned in the last two years. I have not had a complication with this. Um Part of that I think has to do with that. I'm I'm pretty careful with the indications of which patients II I put this in. Um Most of them are similar to the cases that you guys have seen. I've done some ulnas as well. Um I had one patient who I was going to use this on uh uh the patient had an electron on fracture. It was a fairly straightforward electron no fracture. And I was going to use the device on this patient. But as I approached the bone and I was getting used uh getting ready to use the device, I saw that the bone was pretty fragile. Uh And so we, we just switched to using a traditional plate and screws. Um but some complications that I've heard of are if, if you're not careful with whom you chosen, if you're not careful with how you inflate the balloon, you could potentially propagate a fracture. You know, these are patients who have osteoporosis. So you have to be, there is some, there is some skill to, to using the device and, and some gestal to how you wanna do that. But uh if you are a little un carere, then that is a potential problem. Ok. Um Another question here is um how does one decide when extra fixation is required and when no further fix fixation is required? So I would say for the average patient who, so these are not um cancer patients, these are just fracture patients. Um if you have an extra articular fracture, um and you have reasonable fixation around the fracture. Um You typically don't require any additional fixation for those humerus fractures or, or distal radius fractures or even dis long the fractures after you place the device though, if you're happy with the reduction, you can test. I mean, it's very stable immediately. So you can test and see how you feel. Now, if you're gonna push the envelope and say do an ex an an intra articular fracture and you want to supplement that, then you probably do need to, to add that. Um I think there's two ways of thinking about this. One of them is you're going into this surgery with the idea of using this principally as a primary device. And then if you feel at the end of the case that you just don't have the fixation you're comfortable with, then you need to supplement the device versus going into the case with the idea that this is gonna be your supplement and that this is gonna supplement the plate and screws. And I think if you, if you go in with that sort of mindset, then, then you, you'll have a clear idea about when you're gonna supplement and when you're not wonderful. Thank you very much. Um Well, I think I'm not seeing any further questions right now, Doctor Cardoso. Um, if anybody does just let us know if not, um, Doctor Card Cardoso, is there anything else you'd like to add before we wrap up our session today? I think we covered everything. Like I said, I'm, I'm, I'm more than happy to answer any other questions offline. Um And again, if you would like to help to, if you would like to be part of a training group or if you'd like to learn more about the device. Um We'd be happy to, I'd be happy to help facilitate that as well. Wonderful. Well, at this point, um I wanna thank everybody that has joined and we will be sending out hopefully some information. Uh maybe uh Doctor Curto. So you said you're ok if we send your email, is that correct? Ok. We will send out his contact information and if you have any questions, feel free to reach out to him. I wanna thank everybody for taking um some time on their Tuesday evening and um just have a wonderful week and a blessed uh Thanksgiving week next week as well. Thank you. Thank you.