Section: CME Category: Surgery

Surgical Hardware - When to Remove

Michael Trepal, DPM

Michael Trepal, DPM discusses different hardware materials and implants that may be utilized in podiatric surgeries. Dr Trepal also discusses the durability of these materials, how, and when these implants should or should not be removed.

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Goals and Objectives
  1. List different materials of implants used in podiatric surgeries
  2. Distinguish between the biocompatibility and strength between the implants
  3. Judge when it is appropriate to remove hardware
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  • CPME (Credits: 0.5)

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    Release Date: 09/06/2018 Expiration Date: 12/31/2020

  • Author
  • Michael Trepal, DPM

    Vice President for Academic Affairs
    Dean and Professor
    Department of Surgery
    New York College of Podiatric Medicine
    New York, NY

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  • Lecture Transcript
  • TAPE STARTS – [00:00]


    Unidentified Male Speaker: We'll move into the next one. This surgical hardware went through – so I started looking through the literature on this and I kind of grew up in the philosophy that if you put it in, it's a foreign body, take it out. It wasn't meant to be, if it goes in, there's a time to come out because it's going to stress shield. But what's really surprising is as you go through the literature is the wide diversity of opinion and thought process on this. It's really mind-boggling for different centers around the world as to what is really a standard of care on this.

    For this talk, I have no disclosures on it. And if I learned anything from looking through the literature, is that there are numerous, and when I say numerous, I mean numerous opinions and practices with fairly significant differences. And there is absolutely no worldwide consensus as to what should be done. As much like the blind men and the elephant, okay. One guy holding the trunk and says it's a rope, another guy holding the ear and saying that's a tree leaf, and another one holding a leg and saying this is a tree trunk.

    You see what you want to see in many times. So I guess the bottom line is you got to kind of be like Kenny Rogers here when dealing with surgical hardwares, you got to know when to hold them and you got to know when to fold them. Now, what becomes clear in looking through it that the influences against or on one side of the other as to remove or not clearly surgeon preferences, there are country related practices. The United States is very different than you would see in some of the European countries. Patient related preferences, some patients I don't want that thing in me at all.

    [02:04]

    Opinions as to do you treat it differently in children versus adults. What about the ankle versus calcaneus versus the first metatarsal versus the syndesmosis? What about the material types of stainless steel versus the new metal alloys? There are significant as you would not be surprised to learn financially implications here as to the cost. This is not insignificant cost here and also litigation, it comes into this on here. And when I say litigation, I don't mean just in terms of Med Mal, but workers' comp. I've seen over the years many, many workers' comp patients who are motivated by maybe other factors as to what they want that screw out, or whether they want that plate out, or whether they want that hardware out.

    And it's not so much that they really believe it's in their physical health interest, but there may be other mitigating factors here that are driving them to seek that as surgeons. Now, many times surgeons are anxious to take it out because they don't like the way x-ray looks. Not necessarily because they believe it's causing any harm. Now, again think about this in a very logical fashion, whether you'd have a traumatic fracture or whether you have a surgical planned osteotomy, and you fixated. The purpose of that device, okay, is to hold the osteotomy stable or fracture or osteotomy, we've been using this into changeable here. And self-sufficient healing has occurred to allow normal loading.

    That's it, that's why you do it, no other reason, all right, just like putting a suture in a skin. Once the skin is healed that suture is no longer needed. And to get that goal, to hold the osteotomy and/or fracture stable, there's more than one way to skin a cat, we all know that. Just go to any surgical seminar and you will see 65 different companies out there with all different combinations and permutations of different screw types and different plate types and different designs.

    [04:13]

    Some of them work better than others for sure. Certainly some of them cost more than others. They got differences, but don't lose that track of the point of why you're putting it in there. I heard this given in a talk by [Allan Jacobs] [0:04:31] and so I'm giving him credit not for the quote, but I'm giving him credit for turning me on to this. And those of you who are golfers, well I'm not nor not a good one. There was a golf coach famous guru by the name of Harvey Penick and he wrote a book. And he was just kind of like the Yogi Berra of not quite as famous as Yogi Berra is.

    But Harvey Penick said, when asking when trying to teach someone how to get out of the sand trap. He says, "Before I teach you how to get out of it, I got to teach you never to get into it." And then I heard Dr. Jacob say that and it kind of really hit me. And so before we really start to talk about how to get out of a mess with surgical hardware, I think a lot of it is we need to teach and understand how not to get into the mess as much as possible in what we do. So once fracture healing has occurred an implant really has no useful function. So what you're looking at this curve is from .0 on the left hand side.

    The red line being the bone strength, so at .0 the bone strength has nothing, and it's going to go back up ultimately or hopefully to 100%. And the yellow line, which you may not be able to see so good there, starts off. The implant strength at the time of insertion is 100% and ideally you want to get into a situation where the bone regains its normal strength and the implant loses it. Hence, the development of absorbable implants, which were not so commonly used for a number of reasons and now as they once were 10, 15 years ago, absorbable screws were with range.

    [06:15]

    Or just look at the cable wire as a splint. Okay, once that bone has healed, I'm not saying that's an ideal fixation. Believe me that's not – the point I'm making is that once that bone is healed that implant is no longer needed. So percutaneous device K-wire or X fix or whatever it is that's removed, okay? The implant is not needed and it's gone. Where in the case of an absorbable implant, the implant is not needed and it resorbs. Decision making, a lot of it depends upon the materials that are used. Traditional implant materials were made out of stainless steel.

    Stainless steel is an alloy, okay, it is strong, it's economical, but it's an alloy. So one of the components of there is nickel and a [indecipherable] [00:07:04] and it can theoretically be corrosive. And it was always thought that and back in the day when the only implants available was stainless steel that they could corrode, that they could rust, that you could have an adverse reaction to the nickel components and that all of that is true. Hence, some of the newer metals or alloys that are the most notable will be the titanium alloys.

    You have a commercially pure, which is rare or some degree of odd mixture or titanium alloy. Thing with the titanium is it's not a strong, it's softer, it has excellent biocompatibility, but the price you pay for that is in cost, it's significantly more expensive. And of course the hardest, but most expensive would be the alloys of cobalt-chrome, very strong, very biocompatible, but very, very expensive. The traditional stainless steel was the iron can oxidize, it can what was a fear of metallosis.

    [08:07]

    A fear that maybe is most of you are probably a little bit too young, but those of us who have a little more gray hair on remember about 15, 20 years ago the scare that these implants will cause anogenic and particularly in total hips that this created osteogenic sarcomas and soft tissues sarcomas from the metal. Much of that has been proven to be not true and more of a fear, but hence this is how back in the '80s and that that fear of causing anagenesis drove people to say that this is a foreign body, get it out, okay, because of the metallosis, and you can see metallosis is real. That's the first MTPJ implant that was removed.

    Look at that, that's metallosis in that first MTPJ, all right. Fear of allergies, okay. So that leaving the implant in there, the older metals could be injurious to the patient's health, even internals are allergic reactions in terms of metallosis, and in worst case scenario causing anagenesis. All of that has really been on the way so I didn't and shouldn't do it. On the other side, titanium alloys as you see on the right-hand side very biocompatible. And something about it that's almost biologic in nature that bone grows into titanium and so titanium stems and titanium implant.

    Now, that's very good for healing, for stability, but a triage, as you'll see very shortly, other problems down the line. So what about cases like this? All of these where you have fusion, osseous fusion in various different procedures, calcaneal osteotomy, calf fractures, ankle fractures, Lapidus procedures, digital procedures, various combinations and permit. Do these all need to be taken out? Is it acceptable to leave these in? So when? What are the indications? What are the benefits and what are the drawbacks of it?

    [10:15]

    So indications for it, certainly patient's preference, indications with a causing pain, indications with a causing instability. There are other reasons such as patient's fear of setting off, how many have had patients like might going to set off a metal detector? When I go, right, I mean that happens – if you ask that question once, you've been asked a hundred times. And there's also a downside for a second operation. Infection, nerve damage, impaired wound healing, all right, sometimes the cure is worse than the disease in this.

    And not to mention the cost associated with implant removal, so there's certainly a downside. Generally, when the implants are in there because and the patient complained of pain, okay. A survey of this have shown pain indication, not any other reasons, the patients has insurmountable and not perceived pain because sometimes you know darn well that screw was in good position and it's buried and it's not prominent and that's really not the proximate cause of the patient's pain.

    But in cases where you can demonstrably show that that fixation device is the proximate cause of the patient's pain. And you remove it, pretty much the patients are happy and the pain goes away. And again, looking at various articles and this you can see is a whole variety of different anatomic… most of these are procedures that we don't normally do. There's just a few that are down there towards the bottom of the list involving the foot and ankle. So it is not a very high-powered study.

    [12:00]

    But generally again, where the patient complained of pain can be reasonably and reliably attributed to the fixation device removing it is a generally a good thing. So the decisions are remove, there are certain absolute indications. Perforating material, it's herniated through which is sticking through, it's demonstrably cause/source of pain, or it's the source of some instability into the osteotomy or the fracture construct. Relative indications, okay, where it's not half caught and clear as it should be removed, patient request, I don't like it, I don't want it.

    I was going to set off the metal or other reasons that might be driving because as I mentioned workers' comp or the other issues. The potential to serve as a stretch riser, this was a big fear at one point, not so much anymore. Loosening to an extent, I mean if it's popping through the skin then that's the indication to take it out, or even a broken implant. If you have a broken screw and that's sitting around there, minding its own business, I mean that's not hard and fast evidence that that ought to come out. You have indications where if your intention from the get go to take it out, right.

    And these X-fixes, or percutaneous K-wires, the plan was to take those out from the beginning, all right. So that's it, the patient knows we're going to leave that in six to eight weeks and then it's going to come out. And then you have complications, which clearly Anthony, you see, I'm going to use your slides there, okay? [Dr. Juniper] [0:13:39] got me one of those slides those week. Actually, his wife got it so I don't know, not him. But here you see screws popping out, you see a stable for the metatarsal phalangeal joint, protruding screws, unstable constructs where the osteon dislocated and the screw was holding up there and maintaining the instability.

    [14:02]

    A broken plate for an MPJ fusion that is preventing normal osseous integration and healing it, so these are complications where I think any reasonable person will say that's got to go. All right, other examples, implants. So we're talking about not only screws in plates, but we're talking about fracture, the top left and that was a Lapidus on the post-operative x-ray, the screws ended up in the wrong joint, okay. Honest mistake in this particular case, but in that particular case, surgeon went back in to get those out.

    Dislocated implants, destructive osteotomies, failure of the fixation device creating worse deformity are all indications that these need to come out. Synthes modex screws, okay back in the day again synthes modex screws, they were out, okay. Before you have the patient, well there's a lot of discrepancy in the literature right now on it and there's some decent literature in here on it. And looking at the difference between a super synthes modex screw and a transcended modex screw, big difference in terms of the outcome, in terms of reduction loss.

    As it turns out, the higher the screw, the less chance of a reduction loss, and statistically significant as well as the size of the screw diameter, and whether looking at the penetration of the distal corticy or not. Some of these things are statistically significant and others are not. As best as I could see looking through and this is about where the literature is the best that you're going to see is I guess the statement, which is the result of systematic review and not the removal of synthes modex screws is advisably mainly in cases of patient complaints related to the other implanted perimalleolar hardware or malreduction of the syndesmosis after at least eight weeks post-operatively.

    [16:15]

    Broken or loose screw should not be removed. So this patient was entirely happy, did not have a complaint in the world on it and you look at that and certainly you see that probably was not the desired of that particular screw and even the angulation that it was put in. So usually it's an eight-week weight and if it's not causing a problem, leave it in. Interesting literature on calcaneal screws, okay.

    And here is significant statistically different values for the screw size and the insertion technique going to the removal rates, okay. Clearly and there's two good articles on this, utilizing two small screws is better than using one large screw, okay. Statistically significant that using two small screws okay, has a much lower need for hardware excision than using one larger screw, okay. So the conclusion is fixation of osteotomies with two full point five screws is advantageous over using one large screw.

    A lot of that had to deal with this size of the screw head, there was another article that really wasn't – it was a retrospective, not high powered, but it showed that possibility that could be ameliorated by using headless screws where the screw head wasn't as prominent. Lapidus, okay. This was a fairly well-powered study, 165 patients looked at retrospective repair of the first tarsal metatarsal arthrodesis with a plate, not cross screws.

    [18:03]

    Only 15% of clinical fear and we're not talking about complications where didn't fuse or dislocated. If that joint fused, okay and it was good evidence of clinical fusion of the tarsal and metatarsal joint, only 15% of the patients had prominence of the hardware that required excision of it, okay, interesting. So there's really no rush to do it. Of course this takes out those patients who had none unions or dislocated unions or over complications.

    Infections, okay, this I think the literature pretty much is coming to some consensus on infections. The film obviously is implant as a foreign body. Foreign bodies have biofilm, which adheres to it. The biofilm with that like okay, legs, that protects the bacteria, they go not only does it protect them from getting antibiotics penetration, but their metabolic rate decreases, they're not sessile, they're not mobile, they're more sessile. They're kind of almost in hibernation.

    So biofilm is not a good thing, and the fact that by activation of the RANKL gene, there's some evidence that bacteria may actually slow down callous formation, all right. On the converse side, if you go in and remove the implant, okay and it's unstable and by removing that implant the construct which you made now becomes unstable. There may be need for a new implant that you have to put in. There could be further bone loss and further surgical side if you're flexing around there and playing around, you can actually see it will spread the infection further.

    So a lot of the consensus that's coming out in the later is that the negative impact of the bacterial contamination may well be at least mitigated, not completely eliminated by proper use of wound washouts and wound debridements, and judicious use of proper antibiotics. Again, it's not going to totally alleviate the biofilm of negative effects, but can significantly mitigate it and you're getting a balancing act here.

    [20:26]

    This is a paper that just came out of Italy and just very recently published in 2018, earlier this year. And it's kind of a synopsis of many of the thought processes that incorporates of both for the European and the American orthopedic community. And they've talked about the ICS classification of infected hardware. The I for infection, C for callous progression, and S for stability. And it classifies infected osteosynthesis as being a type one, type two, or type three.

    Type one infection is that you have stability. You have infection at the side and callous progression. Type two is infection, it's still stable, but you're not seeing any radiographic progression of the callous and a type three is where you have infection, no callous, and instability. And based upon that, they recommended a treatment paradigm base, okay.

    Basically for a type one and a type two where there's stability is maintained to leave the implant in place and manage the infection as best you possibly can. In cases where the construct has lost its mechanical stability advantage and that would be the recommendation for removable. And in following that and looking retrospectively overtime across the board following this paradigm, an 89% good outcome, okay.

    [22:11]

    And again, we don't have time to go into what exactly that means, but basically bone healing and elimination of the early infection following this paradigm led to an 89% good result. Taking out fixation devices too early in cases where it doesn't, can lead to something like this. Here was Austin and this happens all too frequently, okay. Austin ended up with some cellulitis, went to the local other practitioner down the block who ordered the bone scan.

    And guess what in the first lesson, what's going to happen with the bone scan? You're going to see increased uptake. So what's the radiologist going to say? Increased Uptake, consistent with osteomy – if the diagnosis is ruled as osteomyelitis, you're going to get a bone scan, he's going to say consistent with osteomyelitis, usually suggest clinical correlation. So the subsequent provider rushed and took out that pin, total loss of stability, collapse of it, and guess what, this patient never had osteomyelitis at all so be careful.

    Also, with the new materials with lacking plates, titanium alloys, they're real good, but boy they can get rock solid and what we're seeing now again latest 2017 report is that the complication rate, which is both screw complication, plate complication, soft tissue complication is significantly higher, significantly higher when taking out a lacking plate as opposed to taking out a non-lacking plate, okay.

    [24:10]

    Those screws because of the titanium alloys, because of the lacking nature of it, they can be significantly more difficult to remove and subjected to much greater sharing loss of the screw head because of the soft material, breakage when taking it out, chipping away at the bone to try to get that plate or that hardware out of there. So not everything is what is made out to be. This is a patient I'm struggling with right now had the procedure as you see here. This patient was about as non-compliant as you possible can imagine.

    He did everything except pole vaulting on that foot immediately from day one post-operatively and dislocated this osteotomy and in spite of that you can still see there is progressive bone healing and bridging across there. And so you ask yourself, in cases – if you just treat the x-ray you say yeah, those screws need to come out. And that needs to be re-fixated across there, but I don't think I have then the sagittal. In the sagittal plane that's perfect sagittal plain position, transverse plain, relatively straight, that's what the foot looks like clinically, not complaining of any pain over there.

    So one needs to say is it worth it going in there to try. I guarantee you those screws will not come out easy, I mean you'd have to go because there's going to be all kind of bone callous overlying that so you're going to have to chip away possibly fracture the bone. Then, what are you going to put back together again even if you do get it back together in great alignment that the patient is going to be non-compliant all over again.

    [26:03]

    So the decision in these things is again, I'm still wrestling if it's long as he remains to get progressive healing and it looks clinically good. It's actually the joint range of motion is pretty darn good. Hopefully it stays that, but these are the actual real life clinical decisions that you have to make in treating a patient. So you don't want to burn your bridges when it comes to hardware and in doing it, sometimes the enemy of good is perfection.

    And so except in specific instances, robust evidence and clearly definable in the literature for guidelines for removal of implants is just not there. Currently, the indications for removal where pretty much we'll agree are basically relative and patient driven such as pain or prominence of the implant. So stay tuned, I'm sure there's going to be much more as technology evolves, you get new problems that come along.

    TAPE ENDS - [27:09]