Thank you very much for being here. I'm going to talk today about Hallux Rigidus and MTP implant procedures versus fusion, what is best. I want to thank the AOFAS staff and everybody who's worked hard to help us put on this course. I don't have any disclosures to relate it to this presentation. Presented with a 55-year-old former collegiate athlete with grade 3 for Hallux Rigidus. How are you going to handle that? In general, your options are to tell a patient to continue to live with it, though in many cases they're in your office because they are sick of living with it. Consider doing just a chiolectomy by itself and interpositional arthroplasty, a fusion or possibly an MTP implant device, whether it be a total joint replacement or a hemi joint replacement or a resurfacing type procedure. In general, what are the key diagnostic findings that occur in my algorithm? Well, number one, is there any motion to save? Clearly, if the patient has little to no motion and they've been functioning for quite some time with that scenario, then in many cases they're there due to pain and not necessarily lack of motion. Oftentimes, if that's the case, fusion may be just fine for that patient. Is there pain with mid-range of motion? Yes or no? That's key in my algorithm. If a patient does not have pain with mid-range motion, then I can consider just procedures without resurfacing. On the other hand, if you have pain with mid-range of motion, in my estimation or in my experience, I've not found that just chiolectomy alone is going to satisfactorily take care of that patient's symptoms. Then what is the patient's demeanor and expectations? Are they expecting to have a normal toe? How much motion do they want? Is this a person who wants to wear high heels? Is this a person who plays tennis or is this a person who just wants to walk around and hike on basic flat surfaces? All those play a role in terms of what decisions I make in regards to whether to salvage the joint or to do a fusion-type procedure. What about fusion? We know through many published studies that there's an extremely high fusion rate whenever you perform fusion, upwards of 95% or so in most studies. I can tell you in my practice, it's probably closer to 98%. It does restore the weight bearing to the first ray in multiple studies that show that the medial column and first ray, now you can actually put weight on those. In my experience, it also decreases lateral foot pain because many of these patients are ambulating in a supinated-type position in order to relieve pain from their first ray. Once you restore that weight bearing to the first ray, oftentimes a lot of their lateral foot pain will also improve. There's high clinical satisfaction. Again, here's a study showing long-term outcomes in the International Orthopedic Journal from 2016, long-term outcomes of first MTP fusion for severe hallux rigidus. They had a 93% success and 6.7% of the cases that had a pseudoarthrosis had a painless pseudoarthrosis. Essentially, upwards of 100% patients requiring no additional surgery and functioning well, substantially improving their postoperative outcome scores. Interestingly, though, 70% of the patients were very satisfied, 18% satisfied. In the range of, again, 90% being satisfied or very satisfied with their procedure. In general, these patients do well and are very functional. What makes it unsuccessful? It's easy to know that it can be a very good operation, but what makes it unsuccessful? Well, pseudoarthrosis in some cases, not always as that last study indicated, but that can be an issue. Most patients, if they have a pseudoarthrosis, at some point will start to get symptoms. Sometimes they're manageable, sometimes not. How do we prevent pseudoarthrosis? Well, I use a cup and cone joint preparation. I think that's really standard for most situations as opposed to flat cuts. Adequate fixation. I personally use an MTP plate. It's a locking plate. I realized there is some evidence out there early on with locking plates that that might decrease fusion, but I think that's only if you keep the joint distracted. I think that as long as you have good bony apposition, it works well. Then I add a plantar half of the joint kind of screw. I prefer a fully threaded screw across this area. What this does is it prevents the plantar gapping with weight bearing. If patients early weight bear with this, they do have that locked construct on top, but there still can be some opening on the tension side of the construct. You can also use cross screws. You just need to make sure if you use cross screws, you don't cross them at the apex of the joint. If you cross them at the apex of the joint, then you're basically creating a fulcrum that there can be motion through. Ideally, you want to cross those either proximal or distal to the joint surface apex itself. Then, of course, the other things you need to do for pseudoarthrosis is optimize your patient medically. Hemoglobin A1C less than seven and a half preferably, no tobacco use, good vascular supply, all those sorts of things. Make sure their vitamin D isn't super low. I'm not sure it makes a difference if it's mildly low, but if their vitamin D is less than 12 or 10, then you may have some issues healing. This is my construct, my preference. The type of hardware can change in terms of companies. This actually combines two different companies, but by the same token, either way is reasonable. I prefer stability more than compression. I don't think you need compression in these as long as there's bony apposition. As I tell people all the time when I'm confronted with this question, we don't compress spine fusions. We stabilize the bone. As long as there's good bony apposition and you stabilize it well, you can get a good solid fusion across that joint. The key is if you don't have good enough fixation or if you keep it distracted and you don't have good bone on bone contact, then you will end up with a higher risk of pseudoarthrosis. Poor great toe positioning at the time of fusion can also create some problems for patients postoperatively. How do you do that? Well, number one, I think you have to incest the entire foot for the correct MTP joint position. I use an intraoperative foot plate to simulate weight bearing. The reality is that every foot is different. There are some feet that have more cavus position. Some feet have more of a metatarsus adductus or their lesser toes are wind swept into varus. Other patients are wind swept into valgus. As we've heard in some of the talks about metatarsus adductus, sometimes that plays a role. Basically, I use an intraoperative foot plate to simulate the weight bearing position. I position the great toe where it needs to go based upon the weight bearing of the foot in a neutral 90-90 position. That allows me to assess. I try to put it so that the tuft of the toe on the plantar surface is just barely touching the ground. You may need, if it's a patient with lesser metatarsal wind swept varus, you may need to place it in slightly more varus. Otherwise, you have to correct all the lesser toes. On the other hand, if it's a patient who has a significant hallux interphalangeus, you also may need to put the MTP joint in slight varus so that when the IP joint is in valgus, the toe is essentially straight relative to the other toes. Additionally, dorsiflexion and plantarflexion can change. If you have a very cavus foot, then the patient's toe relative to the first metatarsal has to be a little bit more dorsiflexed. Whereas if it's more of a pest planus, it's more of a neutral type angle. Again, using an intraoperative foot plate, I think is key to getting the right position. Then I pin that. I hold the rotation. You always want to pay attention to the rotation or hold the rotation as I'm putting the plate on. Then I put my cross screw in afterward because my cross screw, as I said, is really more of a rebar type situation, not a compression type scenario. Then for patient selection, what are the things that you need to talk about with patients before surgery as far as outcomes? What are the expectations that they have? Are they expecting to have motion? Are they expecting to have pain relief? Are they expecting to wear high heels, things of that nature? Then what is their socioeconomic situation? We heard a little bit from Dr. Hines last night about making sure when she was doing complex hindfoot fusions, making sure patients have adequate support systems postoperatively. Same thing here. If you've got a patient who has a poor socioeconomic situation and they basically can't have to go back to work right away, can't stay off of it, or at least treat it in a kind manner, you may end up with more issues of infections and wound healing problems along with pseudoarthrosis. Again, the OR is the time for doing, the clinic is the time for thinking, as Dr. Samarka used to tell me. That's the time in clinic when you want to be assessing, is this a good patient for this procedure or not? Why not an implant for this patient? In general, implants have not had consistent results in the literature. There are certainly many case cohorts and case control studies and retrospective studies saying, hey, this does okay. In general, my experience with these is they're just unreliable. Some patients do okay. There are patients who show up in my office who had this done 20 years ago and are still doing okay. Many of them don't get great motion. Many of them have either mild consistent pain and they've just put up with it because now they know that they've done what they've done. They've had this operation and then they just put up with it. Unfortunately, with silicone implants, you can get significant synovitis and local bone loss, which when and if it fails, which it usually does at some point, then now you have a situation where you're trying to reconstruct this. Then metal loosening does occur with the scarring. You essentially have a fusion with an implant. Then again, if you have to revise this, there's significant bone loss. There are landmark studies comparing fusion to MTP arthroplasty back in 2005 and 2017, which basically showed that those who underwent arthrodesis had less pain and were more satisfied in a statistically significant manner than those who underwent arthroplasty. In general, I lean away from complete arthroplasty for these patients. I don't think it works very well. However, is this really comparing apples to apples? There are no major double-blind and randomized controlled studies for previous MTP implants that I can really find. Most are all retrospective studies showing these findings, but the original cohort was studied prior to this option of a synthetic cartilage replacement implant being available. There is a new player on the market or a new player that I think does open up some opportunities. Do we have to fuse to get satisfactory results? Well, again, fusion is a very predictable outcome, but at the same time, oftentimes, it's a four-letter word to the lay public. Once you mention fusion, they start to freak out. They think they're not going to be able to do things. Although I do a large number of fusions in my practice, probably 50 to 75 a year, in general, I typically have to talk patients a little bit into it because they are so reluctant having heard that they think a fusion is going to cause them to be able to do less rather than be able to do more. There is another option out there that has come on the market. It's a synthetic cartilage replacement. It's gotten some good press and bad press. This device acts to resurface the worn-out cartilage and provide gliding surface to allow for range of motion at the MTP joint. It's a polymer-based viscoelastic hydrogel implant composed of polyvinyl alcohol and saline, very similar to what's used in soft contact lenses. As I said, there have been some studies and there's been a lot of scuttlebutt about the fact that, quote, this device really doesn't work well and it's really no better than a chiolectomy itself. I'm going to push back on that a little bit. I think in many cases, it's a patient selection issue. The question is, let's look at real data. If we're going to be an evidence-based medicine society, if we're going to say that we want to follow evidence-based medicine, then we have to believe evidence-based medicine. Evidence-based medicine is out there. There's many different types, whether it be everything from expert opinion to double-blind and randomized controlled studies. We know that in a double-blinded and randomized controlled study that was done initially and published in 2016, this was a type one study. The best type of study you can do, it was for FDA purposes. Basically, at 24 months, the synthetic cartilage implant outcomes with pain relief, function, and safety were equivalent to those of arthrodesis, while improving the additional benefit of maintaining and often improving first MTP motion. Again, the results speak for themselves in this study, but yet many people, once they started to use this, said, oh, I can't repeat this. Let's look at maybe why that is the case. The key inclusion criteria were degenerative or post-traumatic arthritis of the MTP joint with those types of grades, two, three, or four, a pain scale of greater than 40. Key element, presence of good bone stock with less than one centimeter of an osteochondral cyst and without need for bone graft, greater than 18 years of age. Again, presence of good bone stock, important. What were the key exclusion criteria? I think those are even more important. If you look at the candidates that were grade zero to one, interestingly, if they had ipsilateral lower limb pathology requiring active treatment, if they had bilateral that would require simultaneous treatment of both joints, if they had had previous chylectomy, if they had an inflammatory arthropathy, if they had significant bone loss or a cyst greater than a centimeter, if they had lesions greater than 10 millimeters in size, if they had any hallux varus, and if they had any physical condition that could possibly cause the implant to not have adequate support, so metabolic bone diseases, things of that. I think if we look, this list is longer than the inclusion list. I think a big key with this is really patient selection. If you look at evidence-based medicine, the time in the OR was in general less than the synthetic implant. The overall anesthesia time and the overall procedure time was less. The subsequent secondary surgeries required were equal percentages between synthetic implant infusion. Even though the overall numbers were greater for the synthetic implant, the percentages were the same. The conversion to fusion was about 10% of the patients who had the synthetic implant had conversion to MTP fusion. Revision for pseudoarthrosis in MTP fusion placements was about 6% of patients. That kind of correlates with some of the studies we've seen that about 5% to 7% of patients may get a pseudoarthrosis. Now, not everybody's symptomatic, but in this particular case and in this particular study, 6% of patients prior to subsequent operation for revision arthrodesis. Whether you're revising it first to a fusion or revising it second, those results are pretty similar. The overall pain scales decreased with time by year one to year two, and they continued to decrease over time with both of the procedures. The FAM scores for activities of daily living and sports both increased over time. The VAST scores overall continued to go down. Then published in 2019 was a further follow-up with these at five years, a minimum of five years follow-up. Additional results were shown basically that they maintained those same FAM and range of motion findings over the VAST scores were the same. The FAM scores were essentially the same. Once they got to two years, they maintained them over the next five years. Range of motion, the same. They maintained that. What you got by two years, you had by five years. The reality is if you get out a year or two from the procedure, it usually works. That's probably consistent with what we know about cholectomy. Cholectomy in general, if it fails, it fails early. It doesn't usually fail late. Similarly, with these type procedures of the synthetic implant, if they fail early, they fail. Otherwise, once they get through that period of time, if they haven't, they usually do well. In general, they had slightly superior physical function scores preoperatively than the arthrodesis group, but there was no difference found for pain interference or complication rates between the two treatment groups over about a five to seven-year follow-up period of time. This is, again, published now in 2021. This was a different set of patients in the FDA study and used PROMIS scores for physical function and pain interference. If you look at these results, they show that the baseline to six months and then at final follow-up, all of these patients overall did better. They actually did better than arthrodesis in terms of physical function scores. They also had less pain interference than arthrodesis at six months and at final follow-up. Final follow-up was similar, but at six months, they were better with the synthetic implant. There are some recent studies that state that there's no difference between cholectomy and synthetic implant. This was a comparison of patients using the polyvinyl alcohol implant versus cholectomy. There were significant improvements in both of these procedures when compared to pre- and post-op scores within each group. They found that cholectomy had higher post-op scores for pain intensity or better scores. I shouldn't say higher, better scores for pain intensity and physical function. There were persistent pain in a similar number of percentage patients in both cohorts, about 11% in the polyvinyl alcohol group and another 11% in the cholectomy group. There were three revisions in one conversion in the synthetic implant group to arthrodesis. There was one conversion in the cholectomy group. Essentially, they said there was no difference comparing the two cohorts. They were equal in populations. I'm not sure they were equal populations. I couldn't find that data as to what stage each one of them were done for. It was basically a comparison of a group at this particular hospital and this particular academic center where for a long time they had been doing cholectomy. Then they converted over to the synthetic implant. Then after about 60 of these on one side, they compared them to the 73 before that. I don't know that they were all exactly the same. Certainly, I think that's a big part of what you have to identify is what stage were these patients. Were these patients really at stage three or stage four? Did this patient have pain at the mid-range of motion? The question I always ask myself is do I really want to proceed with a routine regular cholectomy in a patient with pain at mid-range of motion? If they have significant pain with only 10 to 15 degrees of motion, how is a cholectomy going to help that if I don't do something to the joint surface? While fusion can be successful, there are some patients who just don't want a fusion. In my experience, the studies that have been done, the FDA double-blinded randomized controlled studies, which are I think the quote best evidence-based medicine we have out there, my success rate is consistent with that. It's about 85 to 90 percent successful. It's for patients who desire this maintaining of motion. It doesn't increase range of motion, and I think that's pretty important to tell people. You're not necessarily going to get dramatically more motion, but I can maintain the motion that they have as opposed to sacrificing the motion. Again, if I have a patient who has a stage three or four, how it's rigidous, but has less than 10 degrees of motion, I'm probably not going to consider doing a synthetic implant in that patient because as I said earlier in the talk, that patient's had a stiff foot for a long, long time at this point in time, and they oftentimes have dealt with that for many years and are able to function with it, but they just now have gotten to the point where it hurts. I think a fusion works well for that. On the other hand, I saw a patient the other day who has 35 to 40 degrees range of motion and has pain, has significant cartilage loss, has very limited spurring dorsally, but has significant pain with mid-range of motion. That patient, I'm sure, is going to have an articular surface defect and I think would do better to have a synthetic implant type device than to do a fusion and restrict her motion to that extent. So which do you choose when you have this option? Do you choose a joint salvage type synthetic implant? Do you choose to do a fusion? Well, in many cases, the conversation I have with my patients is predictability versus less predictability. That is the question I present to them. It's not that one is good and one is bad, or one is necessarily better than the other, but for that particular patient situation, that individual patient, a fusion is highly predictable. You know exactly what you're going to get. You're going to have a stiff big toe that has a very high chance of not having pain and functioning pretty well. Patients with a fusion do very, very well, but they don't have motion. And in order to gain that predictability, you give up motion. If the patient wants to maintain motion and still have the option to have some motion there at that location, while at the same time preserving, if you need to do a fusion down the line, it can be converted without, you haven't lost a lot of bone length. Unlike the metal implants and the silastic implants, you still have length available to you. Then I think it's a reasonable option for the patient. It just has about an 80% success rate. So you have about a 20% chance that your procedure won't work. And if that's acceptable to the patient, then I think it's reasonable to do. So in conclusion, you have to have a detailed conversation with your patient. You have to remember. And I think what the reason we've seen so many quote failures with this synthetic implant over the first several years afterwards was because in many cases, they didn't, they did not follow the exclusion criteria. Remember the wrong patient for the wrong and the wrong surgery equals a bad outcome. If you're not getting good patient selection, if you're just putting it in everybody and you're doing it in a manner that's difficult to do or in the wrong circumstances, you're going to have a bad outcome no matter what you do. So choose your patients carefully for either procedure. And both of these operations can be successful for you and your practice. Thank you very much.

Hallux Rigidus

treatment options

MTP implant procedures

fusion

chilectomy

diagnostic findings