Have We Missed Something? with Tom Cutler

Have we missed something?  In this episode we go back to the basics.  Actually we go before the basics and that is surgery.  Does the quality of surgery affect outcomes?  What makes a good amputation? What makes a good outcome?  Are prosthetists asked to do miracles? What is the role of the IT band in normal gait?

We cover this and more with Tom Cutler.  If you listen to this episode and have not been challenged to think and consider what we have learned well....I did not do my job. 

This episode is brought to you by Advanced 3D.

Resources:

Here's the video clip of femur vs IT band hip action: Link. 

Here's the animation showing how large the horizontal force is at the hip vs at the ground: Link. 

Here's the theory about the IT band being 30% of hip power:  Link.

Here's the article about TF amputees missing 30% of hip power. Link. 

This has amputees at up to 40% deficient. Link. 

Here's Gottschalk's article about amputation surgery:  Link. Page 19 shows the sharp edge, open bone marrow, and the text about moving the tensor fasciae latae. 

Here's Gottschalk's article (Link) about TFL being the most important hip muscle in gait (page 184) and the gluteus medius being inactive during stance while TFL shows intense activity (pg 182). 

Here's Pohl 2015 about a gluteus medius nerve block followed by... NOTHING! Link. There's no trendelenburg gait... no changes...  

What about increased cardiovascular morbidity after amputation? 

Here's an article about a 10 year old dying of fat embolism syndrome after TF amputation. Link. 

Here's a spike in cardiovascular mortality in traumatic amputees (amazing data, very sound). Link.

What about the validity of the "adductor myodesis" technique? Link. According to this article surveying surgeons, "it is not possible to stitch the muscles to the bone due to the lack of fasciae structures." and a very telling statement "I have been a surgeon for 40 years and have learned by bitter experience. The information provided in the literature is miserable and I often
disagree with the arguments." 

To all of the above, consider this:  there's no skeletal support. End of discussion, right? Until we provide amputees with skeletal support, everything else is moot.

Transcript

Prosthetics and Orthotics Podcast Season Opener

Speaker 1 0:00

Welcome to Season 9 of the Prosthetics and Orthotics Podcast. This is where we chat with experts in the field, patients who use these devices, physical therapists and the vendors who make it all happen. Our goal To share stories, tips and insights that ultimately help our patients get the best possible outcomes. Tune in and join the conversation. We are thrilled you are here and hope it is the highlight of your day. Hello everyone, this is the Prosthetics and Orthotics Podcast with Brent Wright and Yoris Peels. However, yoris is not with us today, so I have another co-host and a co-worker and a co-designer, and her name is Katie Richmond. She works with me at Advanced 3D, doing some super cool things and super talented, and we'll get to hear from her a little bit later on as well as well. And speaking of Advanced 3D, though, advanced 3D is the sponsor of this show for this season. So, katie, do you know anything about Advanced 3D?

Speaker 2 1:16

Yes, having joined just coming up on three months ago, I've really enjoyed getting to work on multiple different projects, from concept design, patient specific to much broader. If there's a problem that you need help trying to work through the digital workflow, whether that's something you want us to handle from start to finish, or you want to learn free form and you know kind of take things into your own hands, we will help you figure out how to do that.

Speaker 1 1:53

That's awesome, yeah, and I think one of the cool things about Advanced 3D is that we meet you where you are, you know. If you have never scanned before, we can help you choose how to scan. If you want to start designing, you can do that. You want to do FDM 3D printing? We can help you choose how to scan. If you want to start designing, you can do that. If you want to do FDM 3D printing, we can help you with that. Really, anywhere in your journey along the way, we can help with that.

Speaker 1 2:12

And Katie has the heart of a teacher. She's also a certified prosthetist and orthotist and a technician Been doing this for a while and so really seeing the whole gamut of traditional fabrication versus additive manufacturing where it makes sense. Where it may not make sense, advanced 3D can help you there. So I'm really looking forward to the show. Today We've got Tom Cutler on and this is going to be a fun and entertaining uh podcast.

Speaker 1 2:52

But uh, one of the things that I really appreciate about tom and he's uh owned his own company for a while now. He does a lot of stuff in research. He's a certified prosthetist, biomechanist. Most of the stuff that Tom says goes over my head, but I know that I like it, and so one of the ways that we got to know each other was really talking around not only some of the flexible sockets that we're doing, but then some of the history of transfemoral prostheses what is right, what is not right and I think one of the things that we agree on is that everybody has a responsibility and a good outcome for patients, and that includes the surgeon, the physical therapist and obviously us surgeon, the physical therapist and obviously us, and so we have a great discussion around how that kind of team can create great patient outcomes. So, tom, thanks for coming on the show and, as you know, we always ask the question how did you get involved in prosthetics and orthotics?

Speaker 3 4:04

Well, it was part of a work release program from rehab no, I'm kidding, I was a geologist, but I'm really more of a people person because I'm not joking around and I wasn't happy. So it was really dumb luck. And a phone call from my mom and she had been a muralist at an orthotist's house. And I get this call and she goes, tommy, and I'm like, yes, and she says I found a perfect career for you. See, as a kid my dad was known for breaking your toys just trying to put the batteries in. So at six years old, if I wanted to play with my big wheel instead of just the box, I had to put it together myself. At six, and my mom goes I found a perfect career for you. What is it? And my mom you know she's like I forget what it's called. I'm like it's adorable, 'm like this is adorable. And I go what is it? He goes well, I met this man and I don't know what it's called, but he makes paralyzed people walk. I go, mom, that's called a faith healing, you know. So, um, but that was uh, he was worked with rGOs Reciprocating Gait, orthosis and Spinal, and I got into the field that way, ended up going to the Linguids for my orthotics program this was before they had the Masters and then, after going there, did my residency and then went to Northwestern for prosthetics Absolutely loved prosthetics and uh and orthotics I did. But um, then when I got back and opened my eye here in the middle of nowhere, california, um, bakersfield and Fresno are kind of the you know armpits of LA, so I guess I'm the sternum because I'm right in the middle in Visalia. So that was kind of it. I opened up in 2003, and then the rest is history. As they say.

Speaker 1 6:21

So that's on the prosthetic side of things. When did you really start with the biomechanics sort of thing?

Speaker 3 6:28

Oh, 2014. I had a patient that I fit him with the leg but he was about to blow out his other knee, so I put him in the pool. After one month in the pool, this guy went from walking five minutes to 45 minutes Just by putting him in the pool. After one month in the pool, this guy went from walking five minutes to 45 minutes. Just by putting him in the pool he worked out a contracture from 45 to 20 degrees. He went from walking 100 feet to 400 feet.

Speaker 3 6:57

Everything changed and I decided to write a journal article about combining skeletal capture. So, with the hi-fi socket really grabbed the femur. So I thought, oh, you grab the femur, you can rely less on the brim, whatever. And I didn't know to start my journal article, so I started it at the surgery. Because that's, I mean, mean, where else do you start?

Speaker 3 7:27

And when I went and looked at the surgery after being in practice for 15 years, um, my, uh, I'm still shocked to this day because they intentionally weaken the hip abductors. And I go why? Why are you taking away the power that I need to support body? And I go, oh, we need to balance the hip, but it's not functional balance. Functional balance is is one, you know, one side, one leg muscles against the other leg muscles, and they were balancing the outer leg versus the inner leg. And so they, they removed the it band from the outside of your leg and put it on the inner thigh and I finally, after being in clinic for 15 years, go wait, that's wrong. And they said Joe, tom, shut up. And I mean that's the first time I've been told to shut up. But I said no, no, no, no, no, no. I'm already shocked by the results I got from my patient. So I was like no, I want an answer. And the more I asked and I was like what am I missing? They didn't have any answers. And finally, six months later, the American Academy of Orthopedic Surgeons admitted that I was right about something I found in their model of the hip.

Speaker 3 9:04

It doesn't have a horizontal force, they only have vertical. I said wait, what about the snow angel? If you move your leg laterally like a snow angel, I don't see that in your model. And so they go, it's fine. But then I said oh wait, actually look mathematically. Mathematically, your model of the hip violates fundamental math because your muscle attaches to the femur. But if it's a teeter-totter, the pivot is the femur and you're not allowed in the math I mean, this is all the math you know you're not allowed to separate them out. So when you combine them, the distance of that kid on the teeter-totter is zero, and anything times zero equals zero.

Speaker 3 10:00

And then I go, oh, turn your hip model sideways 90 degrees and it changes from a teeter-totter to a different type of lever. And then you combine them with a pulley, which is a different machine. And then, when I'm trying to explain it, I went back to the biomechanics book and they didn't include pulleys or wedges or anything except levers. So biomechanics is like a, is like a five year old that has a hammer. And you go, buddy, you know, buddy, you need a screwdriver for this. No, hammer, buddy, come on, come on, you need a screwdriver for this. No, hammer, buddy, come on, come on, you need a wrench. I got a hammer and what I found is that because biomechanics, from the very beginning, only use levers, everything is a lever.

Speaker 3 11:01

And then so I was like, wait, you guys have the wrong hip model and you don't include the IT band in your model and you don't have anything. And then I went look so now, and the best way I explain it is let's say that you're everybody had that bad relationship growing up and that one moment when you're like, wait a second, he's not a sweetheart, he's a jerk. Right, everything changes and you see everything with a whole different set of assumptions. I always assumed that biomechanics had all the answers. All I did was I stopped and stepped back and said wait a second. This word on the Princess Bride, it was inconceivable. I don't know that. It means what you think it means. And so when they talk about the rockers of the foot, I just went back and looked at the. Where did you come up with rocker? And it was in 1974 with Jacqueline Perry. She used it as a metaphor. But there's no such thing as a rocker, it's not one of the mechanisms.

Speaker 3 12:14

But if you and I was like I was talking so this is what I did was I was told that that there's a problem with the socket. If a patient is struggling, now, imagine 15 years later, I find out it's not the socket, it's the surgery. I spent 15 years being the scapegoat anytime there was a problem. Nobody's comfortable pointing at somebody else, but everybody is comfortable pointing at this, this leg, and I put my heart and soul into that. So I mean, granted, if, if there's a problem, we're going to make money by replacing it. So I mean you don't feel too badly for us.

Speaker 3 13:02

But I was like I did everything I could. I was furious because I said you can't hurt my patients and then blame me. And then I started looking at the background and I realized that Frank got shot and I emailed him eight times. I was like dude, I got like one sentence response. So I tried to include him and I said now that you're retired, can we talk? I want you part of taking this to the next level. I got nothing, so I'm okay.

Speaker 3 13:34

He ignored an amputee orthopedic surgeon by the name of Perry Rogers who said oh, oh, weight bearing is the benefit of being a knee disarticulation amputee. Because he's an amputee perry rogers. And and if you look and I have the book I'm showing you the visual lower extremity amputation he talks about all the benefits and Frank gotcha plane ignored the orthopedic surgeon amputee. And he goes no, it's the attachment of the adductors which don't even fire. And and then he everything about amputation surgery is wrong. Now when I say everything is wrong, wrong. Now when I say everything is wrong, there's no skeletal support.

Speaker 3 14:35

Now what other surgery or condition in medicine allows patients not to stand on bones? Nobody. Now where else do they go? Well, I'm just they. They started leaving the bone marrow open, which bone marrow is um 80 fat. So you would get fat embolism syndrome, which causes a huge spike in cardiovascular mortality. So where else are you just allowed to leave a bone open like a sewage pipe in the body? But the final straw was a weak in my chest.

Speaker 3 15:22

Now I'm going to do one thing. Okay, can I I don't know if you've ever had we're going to do a group activity. Okay, can I have you guys stand up? Can I have both of you stand up on one leg? Okay, all right, so I'm one leg. Good. Now bend your hip and knee 15 degrees Ready. Can you feel the difference? Can you stand up again? Okay, kind of relax. Now bend it and you feel that 15 degrees is your IT band turning off? Okay, I found out from an article in 1947 in the journal of bone and joint surgery that there are two separate hip configurations and in fact I'll make this relevant to the prosthetists.

Speaker 3 16:29

If you give your patients a half inch to three quarter inch heel, you will relax a typical gastroc contracture and your patient will be able to double their standing time. Diabetics have gastrocnemius contractures. It tightens up. We all know gastrocnemius gets tight and it buckles the knee. The gastrocontracture will buckle the knee and I found it in the liver. Buckling the knee removes your patient's ability to stand for casting your patient's ability to stand for casting. So what I found is your IT band and tensor fasciae latae is actually the primary muscle for walking on flat ground which were moved from every one of our patients.

Speaker 1 17:16

Yeah, yeah, okay. So I mean we've covered a lot there. So I'd love to take some of those points because I mean, obviously there's a rewind to the podcast stuff and there's a lot there. But so let's go back to you had the patient and it was in the pool and then let's just take it one at a time. So you've got the IT band and they cut the IT band off, but what does that do for the prosthetist and what does that do for the people wearing the socket?

Speaker 3 17:54

So it turns out and I'll show you this here you see your IT band. Okay, your IT band is actually an abductor of the tibia. Do you see that If it attaches below the knee, it abducts the hip below the knee? So what is 30% of the hip doing down here? When we look at the hip, the only thing we look at is where the femur and those connect. But if 30% of your hip is down here and that's where the abduction occurs, then you have a counterforce of holding it in. When you cut the IT band, I had to do arts and crafts. This is funny because I really did have to do this before the orthopedic surgeons believed me and the people that are listening. I apologize, you can't see it.

Speaker 1 18:55

We're going to have to get some pictures, so we'll put this in the show notes.

Speaker 3 18:58

Okay, great found as I'm trying to attach my my abductors to my hip model is I had to do a.

Speaker 1 19:13

let me get a rubber band we haven't even got started, have we Tom? I haven't said oh, tom, I should have actually I haven't said that.

Speaker 3 19:24

Oh, tom, I should have. Actually I haven't said that enough yet, I know right. So, katie, okay, katie, do you see this? That right there, the femur moving sideways? Yep, this is just a picture of the light and we have this big horizontal force that all of us see.

Speaker 3 19:50

What I found is that it's actually the it band that pushes, holds the. The it band is actually what holds the femur in place, and when you remove the IT band, suddenly the femur is able to abduct. So the IT band is the key to everything, and they remove it from every one of my patients, and Frank got shocked. Five years before he took it away from all of our patients, wrote an article where he said it's the most important abductor of the hip. So I have a book that I'm showing here, biomechanics of Movement, which is at biomechstanfordedu, and it's missing the it band in the book. It's simply not there. So biomechanics just left it out. They just didn't include it because they didn't know how it fit.

Speaker 3 20:56

And then my smoking gun kinesiology. This textbook that I'm showing is don newman's kinesiology of the musculoskeletal system, and in fact it was one of the films that was used. One of the prosthetics programs is in hartford and I have an email from 2018 from the guy that wrote the book and he goes tom, we don't even know what the function of the IT band is. I'm like, wait, so the guy that wrote the book admits to me on Halloween 2018 that he didn't even know what it does and they take it away from every one of my patients and they take away skeletal support and they leave the bone marrow open. And they leave the bone marrow open. And I'm like, wait, guys, we need to fix this. It turns out that in page 49, 49, 78, 49, 68, 49, 78 of the Rutherford's but that's the atlas for the vascular surgeons Turns out only 10% of dysphagia, transfemoral amputees or geriatric amputees, only 10% of them use their light.

Speaker 3 22:15

Okay, I didn't want to believe it now. So when I did, it turns out and I talked to autobock and they were like, yeah, well, 70, only 30 percent of amputees get legs. Two-thirds of those leave them in their closet most of the time and we get 10. Imagine we could get that up to 50% or 40%. You just quadrupled how many legs you're fitting. You just quadrupled the number of seams. That's revenue. Now, if you just gave them a base of support skeletal support then you wouldn't be chasing volume after the fitting. You'd cut down what 75% of delivery follow-ups. So not only do you have more revenue up front, but you've got better productivity and you have the opportunity to now start getting that much more creative in socket designs a man socket with an open frame.

Speaker 3 23:29

Now I I want to have this conversation and I um, but it starts with there's a problem with the surgery and if you have a problem with the surgery, you can't fix those problems with the socket right, and what they you know, and the problem they came up with was osseointegration. They said get rid of the socket, because the socket was the source of all problems. And all I said was we need to have a conversation, and I have tried since 2016 to start the conversation properly. I've been rejected from bringing the topic up at conferences, at the National Academy Conference, four times I submitted. I went to the president of the academy. I was like people, we got to have this conversation and you're right, they go oh Tom.

Speaker 3 24:30

Now what I don't have is anybody that engaged me, because it is such a huge call to action. If it turns out that it is. If it turns out that it is. If it turns out that the surgery is the of a ton of our problems, then all of the research now becomes suspect and my and people would be like, oh my gosh, freak out. Like what do you mean, freak out? You just justified the need to get more funding dollars for O&P. Just had a chance to start over again. That's talking about tons of money flowing and, but they won't.

Speaker 1 25:10

So I want to go back to the IT band. You take it off Now, with it inserting distally on the tibia. That's what keeps everything in. So what you're proposing then is to keep the it band intact with something distally, right? So I guess that's the, that's the, that's the part. So I got the teeter-totter part right, but, like if the teeter-totter doesn't have a connection to prevent the abduction, how how do we harness the IT band when you take that joint away and the anchor point away? That was distal, I'm with you.

Speaker 3 25:47

So what happened was, when they cut the IT band, it flew laterally and it's like, well, yeah, you need to harness that power. They didn't say that, they just freaked out and said what's going on, make it go away. And they took half. They took the IT band and put it on a medial thigh to hold it. If you, if you want to, the IT band can function like the rope holding the uh, is it the uh? And I'll say on a sailboat. So if you have a boom or if you have a mainstay, you tie it down at the end of the, of the, of the, of the stick, right? If you're only trying to hold the sail at the mast, it's almost impossible, and that's where your glutes attach is way up at the top. You have nothing attaching at the end. So my answer was not to go through the skin but was to say, hey, why don't we just use the bone cap that they had in the 60s to address bone spikes apply? 60 years of joint and hip replacement implants? Let's just. We've been doing this for decades, 65 years. So let's just cut the, you know, let's just cut in amputee, let's cut them in on the action, and it's a simple radiator cap and I have a show here is it has weight bearing and it has an anchor physical anchor to attach the it band to the lateral femur. That's it. It's a radiator cap for the leg. You're going to cap it off. So you're going to do two things. By doing that, you're going to prevent fat embolism syndrome and you're going to restore 80% of the blood supply to the femur.

Speaker 3 28:02

They didn't discover transcortical vessels until 2019. So they knew arteries in the 1600s. That's how your body gets blood, but they didn't discover how your bones get blood until 2019. But when you open it up and leave it open, like they do for amputees, you don't have any pressure. By capping it off, you restore pressure for him. By capping it off, you have weight bearing. So now, if you have weight bearing, you actually have better consistency. As far as fit, you have better stability. If you have weight failure, you're seeing the femur in alignment and then, by anchoring the IT band, you actually increase hip power by 44%. Now that would transform our ability to help amputees, to help them consistently, and I just I have not even been allowed to bring this up in the JPO. I asked them in 2017 and in 2022, and they're like no, we won't accept the manuscript from you, we don't have any business challenging amputation surgery. I'm like, okay, oh, tom, right, so here's, here's the.

Speaker 1 29:32

Okay, so what you're saying is like uh, the, what was the surgeon's name? That was the amputee? Like what was?

Speaker 3 29:38

the surgeon's name that was the amputee Perry.

Speaker 1 29:40

Rogers, perry Rogers, so what you're saying is essentially like that knee disarticulation patient, that's what the implant is doing. It still has all the. Essentially the insertions are the yeah, where the IT band inserts you can do your muscle attachments on the implant itself. Band inserts, you can do your muscle attachments on the implant itself. What do you say to people like with the implant stuff and how you put the tissue around distally and then bear weight through that? How does that actually work?

Speaker 3 30:12

well you're able to do. Everybody says, well, you have to do a myodesis. And yet, um, if you go, there's research in there and the muscle is 80 water and when the doctors are being honest they go you can't sew anything to something that's 80 water. So they the myo. The myodesis was speculation in the first place, let's just be clear about that. And I found in there's. You can look in the research where it says myodesis, or which is muscle to muscle, and they had orthopedic surgeons saying there's no way that a myodesis would be effective. You can't sew into the muscle and have the muscle and have the anchor hold where you're holding that body. So you're able to do that to provide good coverage. You're able to anchor the it band to have more power, but it's simply a radiator cap on the end of the leg that lets you put weight.

Speaker 3 31:22

I think the fascinating thing, perry Rogers, as a knee dysartic amputee and an orthopedic surgeon, goes why are you guys badmouthing the knee dysartic surgery? And he said it turns out it was us. The prosthetists were complaining about cosmesis and clearance, so for our benefit, they said, okay, we have to give them clearance, so let's shorten it. And it was the prosth they did, and that's in his research he goes listen, it's because of clearance that you have to shorten it, but there's a huge benefit by being able to stand frank. Gotshot came along and by that point in time, you know, perry rogers passed away and wasn't there to correct him, and so we didn't have a chance to give us the best of both worlds, where you could get clearance but still have weight there.

Speaker 2 32:49

Yeah, I have to choose, Because we do limb lengthening surgeries, we do replacements, and even if you don't want to use an implant in my head while you're doing the amputation, why couldn't you? You could still do a gritty stokes, you could still use the kneecap if you want to keep it biologically, the patients but cut out a chunk and you get the weight bearing and you get the length by removing some portion of the femur. So you get the benefits of the knee dysartic, the weight bearing and still a decently long lever arm which we all want. It's just so interesting because I've never heard anybody talk about this before and I'm like, yeah, and then you remove the equation of oh, the knee is is so damaged or the problem is so great that it's okay If you weren't. A need is our tick candidate in the beginning. Now here, don't worry about that. If you don't have the femur to use, use an implant. It's interesting.

Speaker 3 33:50

So I have an answer for you and it's. But there's a couple of. There's two things. One we are we. We are not allowed to weigh in as prosthetists. Your job as a prosthetist is to be the scapegoat. If the role of the scapegoat, so that you know, is and there's something fascinating called mimetic desire theory and um, and I learned about the role of the scapegoat is to allow everybody else on the interdisciplinary team to get along really well, so it allows the physical therapist and the nurse and the doctor and the patient and the patient support family, everybody's. We serve to allow everybody else to get along.

Speaker 3 34:35

Because this is kind of awkward when you realize we don't have all the answers. So the answers that you have is that their claim is that the knee has to have a ton of, it has to be big and wide for weight bearing. Okay, so you have to leave the full length of the femur for weight bearing, to which I respond 's like, well, that doesn't make sense. At the, at the calcaneus, it's very small. So when I land on the heel it turns out maybe it should just begin. So that's why a lot of the other implants have had big, wide, bulbous things. The other, but even more so. Here's your big ad. This changed everything for me. Okay, katie, how much does the surgeon get paid to do amputation surgery?

Speaker 2 35:31

Jack diddly squat.

Speaker 3 35:33

You know what? The number is? Not much. Yeah, it's under a thousand. When I first did this, it was about $740. Suddenly, everything became clear to me. They don't want to talk to us, they don't want to listen, and I go oh now, how much do people make on a regular hip implant?

Speaker 3 35:51

from $12,000 to $15,000? And then for the first four years, you get an extra 65% bonus on an innovative medical device. Suddenly, everybody's thrilled and I was like, oh, so, that's, you're right. I kept going on. I was presenting in 2019 at the Florida conference about the surgery and I realized, tom, don't be just a whiner, what's the answer? And I was like, well, the answer is just, obviously, just to get a gap right, here's an implant and that's your solution.

Speaker 3 36:32

I never intended to make any money off of it. I filed the intellectual property, filed the patent just so it would contain. The office company found it financially worthwhile to develop a solution so I could get back to my clinical. I offered to assign and I have the emails to prove it. I went to the academy and I was like, guys, I can't do anything by myself out here. California is not great for business. So look, I'll give you guys, I'll assign my patent rights to the academy. It turns out it's a $500 million market. So even if you get a 3% royalty, that's $15 million a year. That could go towards research and grants and scholarships. Who knows, and when.

Speaker 3 37:27

I offered it to my. Please will you guys get this available for our patients, can you advocate? And I got, naturally, oh, tom, and they go. That's not what we do. I'm like what? What's not what you don't win? I'm like, why wouldn't you want to have money Anyway? So I've been trying to get this, and a lot of times, as a prosthetist. It's very difficult. I don't know of prosthesis. It's very difficult.

Speaker 1 37:59

You know. So, with the implant, what is the process to go? I mean, you've got to get some surgeons on board, essentially, and then there's probably some clearance sort of things and that sort of thing to happen. But there is some precedence, right, because the osseo integration side of things you don't automatically go get osseo integration right. There are some people that don't have a complete setup, uh, that have actually done well in sockets. Am I? Am I right on that?

Speaker 3 38:41

so, um, I actually had one of my patients get osteointegration and so I reached out and I was like you know that, grandma, can you give him his it band back? I was trying to email him and um, he, on the day of surgery he's like what am I supposed to do about this cutler guy? Am I what you're supposed to talk to me, buddy, you know? And so I was like you, don't dump it on your patient on the on his most vulnerable day, right. And um, so I started looking at his stuff.

Speaker 3 39:08

It turns out there was a teen article about optio integration on five-year follow-up, and in figure five they were. They were saying, um, um, here's the article. And they said well, the overwhelming majority have little or no trouble and it's only available for six percent of 6.6 of amputees. We don't have anything available for the 93.4 percent of amputees are just asking. And um, uh, and I looked at five, what do you mean? Overwhelming majority have no problem at all. And it turns out that even after they removed 8% of the implants that in figure five in the bottom, they still had like 18% of the patients had considerable trouble. And then I had to go look that up and that was an extreme reduction in quality of life. So at five years you've got 25% of the patients either had the implant pulled out or have an extreme reduction in quality of life and they have a 55% surgical revision rate at five years. So when they have the keep walking implant is a six inch long. It allows them to keep walking, but they have a weight bearing surface while they're waiting for the second stage. And they found that 87.5% of those patients are like no, I don't want to go for the through the skin, I'm happy they, it's they. They had weight bearing and they're like I don't have any problems. They were walking 25% faster, they had 82% less pain, they reported more stability and in the Canadian journal Prosthetic Orthotic Journal, they actually found that the most cost-effective implant was an internal implant Better than not giving them anything and more cost-effective than percutaneous implants.

Speaker 3 41:16

But we aren't allowed to have that conversation Like, hey, what about something for all the dysvascular amputee? And I spoke to one of the surgeons at university of Utah. I happened to catch her on vacation. She was in Palm desert on vacation and I said, yeah, I've got this implant, can I bring it? Can I show you guys, this implant? And she finally was like wait, but that doesn't get rid of the socket. Doesn't that tell you something? The goal was never make their life better. The goal was always get rid of the socket. And I'm like, no, I want to help. These are my friends. If they want to go percutaneous, then fine, let's do that. But if what they really need is the ability to have good clearance, have weight bearing, if we can give them back their primary muscle for flat ground walking, then why aren't we doing any of this? So, and if the company to cure that's doing to keep walking implant is in valencia, spain, and I think you have a buddy that lives, yeah, that's where you're yeah, we'll have to.

Speaker 1 42:34

uh, uh, see about hearing from him. That would be interesting. We'll send him down there. That's right, because I think they're in the same town. That would be wild, they're in the same town. That is hilarious. Last thing I'm going to tell you.

Speaker 3 42:54

Here's what I'm going to tell you. And when people are going, oh, tom, the IT man, the tensor fasciae latae is the muscle. Here's what I'm gonna tell you. And when people are going, oh tom, the it band. Um, the tensor fasciae latae is the muscle and the it band is the super long ligament. And if you were to go to, uh, michael pole, p-o-h-l 2015, did a nerve block where he did an experimental nerve block to weaken the glute muscles In 2015, I don't know where it is, I got it, I got a copy. And when he did a nerve block that weakened the glutes, he said there were no changes in their gait and he emailed me goes. Yeah, nobody wanted me to print, but they were walking on the flat ground of the gate lab. If they'd put the patients walking down a hill when you're walking downhill, your knees and your hips stay bent they would have gotten exactly what they expected to see hiking downhill, just not on flat ground. There's two different systems and they have they. That's not reflected in biomechanics or in game.

Speaker 1 44:07

Let's, let's hop into just a little bit of the the history of like socket design that has tried to correct some of that stuff which has been a little bit interesting. Right, you've got the issue of containment, you've got the hi-fi stuff, you've got what Long did with the super adduction of the socket on healthy patients. I do understand that as well and you know, and I'd love to hear you know, even through your journey of the 15 years.

Speaker 1 44:39

socket-wise, how do we work with what we have given right now? Obviously, we want weight-bearing, we want the IT band and that sort of thing. Yes, or is it a little bit of a lost cause?

Speaker 3 44:51

I'm very gregarious and familiar with my patients. I do everything to bring myself down to their level so you get much better data when they you know they'll be blunt with you but whereas they won't say something. So I would get down in front of them and I'd put them in a chair and I'd say, okay, have your leg kind of out to the side, your thigh, and they would abduct their femur. And I say, push against my leg. And they would push against it and I go, great, now bring it in. And you know AD duct, you know towards the middle. And they would do that. I go now, push against my leg. They go, wow, it goes stronger, right.

Speaker 3 45:35

So it turns out that we have been told it puts the muscles on stretch, right, you want to AD duct your socket to put the muscles on stretch? Sure, maybe that's part of it. But what I figured out is only for the hip. Is there a linear slope on that line? It turns out that you actually increase your leverage once you start looking at the femur. Lever Abduction is important, important, but it's important. Because it's important, because it it increases the leverage of the muscle on your femur, but we've never looked at it because we don't look at the vertical, we never look at the horizontal. So abduction is in the middle of the ball Right. Okay, so if you're looking at the ball of the femur and then if you look at where the muscle attaches, is way over to the side, is way over to the side, and so as they step onto their so adduction, bottom line adduction is important because it provides more power.

Speaker 3 47:09

Socket design. We need to hold the femur there and if you're not allowed to touch the bottom of the socket, how are you supposed to hold the femur? Of course it's going to slosh laterally through the tissue right and because their model doesn't have any horizontal forces in their hip, it's covered up by the IT band, so they have no horizontal forces in their hip model. Literally, I was was like where's the horizontal when you go to the? You know it's because they only measured at the ground. When you get up to the hip, it's 60 of your body weight thrusting laterally. They don't have it in their models.

Speaker 3 47:54

So hi-fi started putting these vertical struts on either side of the quads, either side of the hamstrings, and started exploiting all that real estate below the brim. And what I found is if you're going to go sub-issue. If you're going sub-issue it's not necessarily just for the bony lock, but you have to have that weight bearing. When you're going sub-ischiel you lose that critical support. So with socket design you got to grab the femur better and I do that with hi-fi. Uh, I can do sub-ischel or I can do ischial containment. I don't. I always wondered about vacuum and it's not my area of expertise.

Speaker 3 48:52

But. But when you have that proximal lateral gapping and the wobbliness, you don't have that with vacuum, but that means that you're using the vacuum to hold to the skin so that you don't get that coupling action. That make sense, and so, anyway. So when it comes to socket design, yeah, I'm a big believer in it, and I was. I love the high five. But then I was like, why are my patients still struggling with the Hi-Fi? Why are my patients saying, Tom, give me my ischial containment back? And I listened to my patients. They are supposed to have all of their hip power but they never did so. I think once we fix the surgery then we can get into a socket discussion. But everybody argues about socket and I'm over there raising my hand, going great, you've all been screwed over by the surgery and now you're bickering of your sockets. Makes it, makes life suck the least. I'm like let's, let's go back to the beginning.

Speaker 1 49:58

So let's let's look into the crystal ball a little bit, into maybe some what-if stuff. I know you and I have kind of just talked about some of that. And let's talk about a dream scenario. So let's say, we get the implants on some people, what do you see as far as and I mean you're not, this is yours will kill me if I don't ask about additive manufacturing, specifically what you're doing. I mean, I know you said, hey, Brent, I think what you're doing is pretty cool, but in your practice, you know, are you doing any? Is it something that you're interested in? What are you seeing? And then, where do you see where this crossroads of implant and additive manufacturing help both ways?

Challenges in Implant Technology Development

Speaker 3 50:46

So let's look at the future. It turns out that a bone cap is actually the lowest, the lowest, the safest classification level with the FDA, and there is a pathway that allows you to start clinical trials, to do probably 10 of them right away without even having to do an IRB or get FDA approval ahead of time. There's a custom device exemption pathway and it lets you do it right away. I think that there's a tremendous opportunity for additive manufacturing and there's been a big push for 3D printing of hip implants and doing the bespoke anatomically correct in the field of orthopedics, and you can imagine remember I've been telling the problems in biomechanics that have harmed us. Those same problems from biomechanics have actually prevented the 3D printed implants from recognizing their actual value. It's when we go to it that the ruler you're using is broken. So when we take it to the biomechanics people, there's a problem, but it has nothing to do with 3D printing.

Speaker 3 52:15

I would love to see the implant in patients. I would love to see the implant in patients and my boys are graduating. I'm in California where nobody wants to do business, and so really what I've done is I've been actually scaling back my clinic so that I can actually go elsewhere. I'm poised to find a place to watch this take off, and that's why it's very difficult. It's been very difficult for me to help patients knowing that they've already been harmed by a suboptimal surgeon.

Speaker 2 52:59

You know, I have many strong women in my life who are in the medical field and one of the things that I'm thinking about doing next year, if possible, is attending a conference of women in healthcare and, like the being ignored you are describing, I I'd be interested to know who you have talked to, and there may be a benefit in talking to those who have been ignored themselves um, actually that's I don't know.

Speaker 3 53:35

I know that's kind of vague oh gosh.

Speaker 3 53:40

Okay. So the hidden profile principle in psychology is where we get the echo from. And when somebody comes in with a unique perspective, they found that everybody else wanted to talk about what everybody knew Nobody wanted. They only gave lip service to that unique perspective and then they went right back to the other and ignored it. They found that when everybody has all the information, we're smarter in groups. They found when one person has the information and everybody else doesn't listen to them, we're dumber in groups, because that one person, a lot of those people, doubt themselves and that's why the prosthetists have started to doubt.

Speaker 3 54:30

Well, maybe it is okay that I balance the inner hip to the outer hip. It's me so it's almost like they're being gaslit. And so I have spoken to anybody and every daniel melton I met by, I chatted with her back in I think it was last march, she, she, she got it more than anybody else in the but um, the orthopedic surgeon, the physical therapist, the engineers, none of them, but she was the physiatrist. I said, oh, this is interesting, I go. Oh yeah. But I challenged orthopedic surgery at UCLA. I got a letter of support from the director of their antics lab, the director of their. But when I went to be with Dr Kwong, head of orthopedic surgery at UCLA, he panicked and got real uncomfortable because I was talking about stuff he wasn't aware of and he got this sterling silver bowl behind him on the shelf and he goes look, tom, I know biomechanics. I don't think it's just leaving an appreciation of teaching biomechanics from Harvard, but I've talked to tons of people and nobody wants to listen. Everybody wants to go get rid of this. I love this nifty idea of coming through the skin and I'm like, yeah, but the patients don't. Of coming through the skin. And I'm like, yeah, but the patients don't. And so I've talked with I don't even know how many emails I've tried to go to. You know what I've done Ready for this, katie I, when people in Owen.

Speaker 3 56:20

The problem we have is I've vast divided about this, but my own local hospital just couldn't get their act together. Honest, to be honest, they they don't want to listen to us. We're seen as vendors. They thought it was a sales rep. I'm like I'm a clinician, you know. Uh. So I have the vascular surgeons, orthopedic surgeons, in us and say why should we, why should we even consider this if the prosthetic community won't acknowledge that there's a problem. You see what I mean. So if, if o and p won't, won't look at it, if they don't have the courage, hey, there's a problem with surgery then how can you really expect vascular surgeons and orthopedic surgeons to go? Oh yeah, we should take a look at this. They're, they're counting on us now.

Speaker 3 57:16

Not only did I try to present four times at the clinic and that resident going listen, can you please talk to clinical content. I said look, if I'm wrong, I don't want you to waste your time. If I'm wrong, I'll donate $5,000 to the hospital or to whatever you want. If I'm wrong and I did it to NAAOP, I did it to wrong and I did it to NAOP. I did it to COPA, I did it for Hanger.

Speaker 3 57:44

I said, hey, I'll donate $5,000 to the Hanger Foundation, but if I'm right and nobody, oh, if you're right, we'll give you an hour to speak at one of the guys they just wouldn't engage. They just say, oh, we'll give you an hour to speak at one of the guys they just wouldn't engage. They just say, oh, we can't talk about them. And that's cowardice, not courage. You have to be bold, you have to step up. I've taken incredible hits, taking this stand myself. You know, brent, you know everybody in leadership rolls their eyes. I have all these people in the rank and file that go Tom, this is amazing, we should do something. But until our shift and I kept thinking our leadership could leverage this to get license, I want O&P to benefit. O&p is my tribe. If we don't do something with this now, with your podcast, I don't know, maybe get some, but the PT, if they claim or if they want to lay claim, we miss out.

Speaker 2 58:46

Is this something you're imagining being done at time of amputation for dysvascular patients, or is this a go in after or what? Because the other question then becomes if I'm a vascular surgeon, we've kind of already that patient has been a hospital sepsis. We're seeing it coming. We have an opportunity to send a custom sized and shaped model to be fabricated in, you know, additive manufacturing, and then does that come back and it's the vascular surgeon who is doing the amputation and putting the implant in, or do we need to involve then an orthopedic? I don't know. No.

Innovative Implants in Healthcare

Speaker 3 59:47

So I have an answer for that Turns out, your vascular surgeons are most accustomed to little, tiny, delicate implants like a stint, little delicate wires, implants like a stent, little delicate wires or with a silicone artery or something. And they look at this and they go, ah, and I and I and I had to take a look. I talked to my local surgeons and I'm like it's a cork, and look at this, right, all it is is you're putting the cork in a wine bottle, and then I have a sign. So it's intuitive that there's nothing to it. You only need a vascular surgeon. They can have it ready. Um, you have a two centimeter diameter. Um, if something ever went wrong, guess what? You do an outpatient procedure, uh, procedure, pull out and they're back to square one. So they haven't been harmed at all.

Speaker 3 1:00:46

Right Now, what I found is that these patients are so compromised that nobody wants to go in after the fact. It's like if they have to have anything, just put it in. Now, here's the bonus is, if you do this and provide them with weight-bearing, they know the physical therapists now get to develop an entire protocol of weight-bearing that simulates hip replacement or knee replacement who knows what that is but you're getting the patient up right away. If they don't even want to use a leg, okay, they don't qualify for a leg. Now, when they want to brush their teeth, they're still only on one leg. Imagine if you gave them a weight-bearing surface on it with an implant that they could stand on the seat of their wheelchair and put the other foot on the ground. They're a much lower fall risk when it comes to just ADLs. So it's a very well.

Speaker 3 1:01:53

I learned I want to do this. I learned that the vascular surgeons freaked out a little and I kind of said you know, I was like Bob, it's a cork. I understand you've never not finished off a bottle of wine, but theoretically you can put a cork back in a wine bottle and they go. Oh, I guess it is pretty simple and it's only one inch versus all the other ones which are totally long, versus all the other ones which are totally long, and it creates more revenue so that they actually have the time that they can invest. You get better outcome. We get new stock at design.

Speaker 2 1:02:32

And maybe it doesn't get pawned off to the lowest man on the totem pole and yeah, just get it done. It is a way of a reconstruction, it's not an that's yes, katie, that's perfect.

Speaker 1 1:02:48

Yeah, that's a way to say it. I mean the reconstruction. You get paid for that kind of stuff and it's I mean it. It will be up there with, say, a hip implant or something like that and you you may even get people like that that specialize just in that, you know, and you could have regional specialties that come into, in and out of hospitals and all that. That. Yeah, I could definitely see it. That's cool. Do you know what the market is? What's that? Do you know what the market is? I think you said 500 million, I think it was Askinology, yeah, okay, so do you guys know?

Speaker 3 1:03:28

It's fascinating when people aren't forthcoming with data, right, that's when they have something to hide. That's the good stuff, the stuff you can't find. I think it was. Aristotle said that science isn't about finding the right answers, it's about asking the right questions. How many trans-femoral mutations are done every year? You don't hear that. It turns out, according to Askenazy and I think he's on the board of OSER I'm probably mispronouncing the name, but he did an article but it turns out that a million amputations every year 26%, 24% are transfemoral. So that's 240,000 to 260,000 amputations every year according to that data. But you don't find people talking about that. So if we have between 100,000 and 250,000 transfemoral amputations happening every year, then imagine what an amazing opportunity it is for one of the implant companies.

Speaker 1 1:04:41

I just did. I just pulled out the calculator on that one and I was like okay, so let's just say you get half of that, that's a $750 million, and that's on the low end. Yeah, five grand a piece. So it's probably more than that.

Speaker 3 1:05:00

I'm saying you get it and that's on the low end. Yeah, $5,000 a piece. So it's probably more than that. You don't have to do it for $5,000. I'm saying if a hip implant is getting $12,000 to $15,000, so is a knee, then $10,000 for one of these.

Speaker 1 1:05:16

If you can get $10,000 from insurance then you can sell it $1.5 billion.

Speaker 3 1:05:18

Yeah, you can sell it for uh, 2500. Now it was. The company was signature orthopedics and my local circle of surgeons says, oh, tom, yeah, I'm on, I'm on. I think I'm on track to do between 40 and 50 amputations. You could see the jaw drop on the head of innovation. He goes that was when. He goes, oh, this market is diabetics, not soldiers.

Speaker 3 1:05:48

And I'm like, yeah, and that's why they're like, hey, we'd love to be part of this. But my local hospital freaked out because here in the middle of nowhere, they don't, they've never done innovation. I'm like, come on, guys, we have a chance, let's do this. And they wouldn't do it the same way that I have O&P saying, hey, guys, let's get licensure, let's harness this. Hey, we've been screwed over. What can we get out of this opportunity? And they go, oh, what can we get out of this opportunity? And and they go, oh, we're not used to doing anything like, all right, fine. So that's why I'm so excited.

Speaker 3 1:06:31

It, you know it's, it's been heartbreaking. Watching what has happened to O&P, I mean I love the it's my tribe, it's my people. And I mean I love the it's my tribe, it's my people. And and watching how we've taken all these hits.

Speaker 3 1:06:45

Or, or, you know, anytime you have anything, you know your, your podiatrists or your orthopedic surgeons, they're going hey, we're trying to make you know, have a business as well. They take all of our revenue sources. And how many times does a podiatrist go? Oh, I can do an arch support better than them, even though I don't have any equipment to do modifications at my office. And if they've taken that revenue stream, how do they then, you know, can? How do they then justify taking it away from you, unless they say, oh, I, cognitively, they have to then consider us less than which would justify them fitting all the arch supports themselves instead of sending it to a place that's better qualified. So I have, I don't have any opinions, mind you. Um, but yeah, I want to do. I don't know. That was a yeah, uh, there's a rant.

Speaker 3 1:07:50

Okay, where's that soapbox? Do I?

Speaker 1 1:07:52

I don't need any more, yeah well, tom, this has been, this has been great. I think that there needs to be a part two, because one thing that I wanted to get to that we did not get to was the heel lift thing, and I think that's important. But we're going to foreshadow another episode together and talk about that part. But I really appreciate you coming on and sharing this about the implant, some of the biomechanics of the transfemoral sockets, and I think that's a go ahead. You said the thing.

Speaker 3 1:08:31

it turns out that the first diabetic shoe study in 1994 by Woolridge had 47% higher amputation rates in the diabetic shoe group than in the control group. It turns out that the diabetics were provided that were flat, put more tension caused more ulcers, more amputations. So if we would love to get away from doing diabetic shoes, so we'll talk about it later. But yeah, there's more. I kept finding one thing after another. I just I want to be able to channel it through somewhere.

Speaker 1 1:09:12

And O&P wants to do. Well, there's a couple of things that's very interesting. I think there's a and where I'm encouraged. So, yes, we've taken our hits and such, but I would say this new generation of clinicians is very interesting. So not only are they, I think they are asking the right questions, they're asking why and is that truly the way it is? And they're bringing that into the clinical practice. So I think, as that education occurs, there will be more of those findings right, and then they can look for themselves whether or not they want to take in the data and continue on the way that they've always done or potentially, you know, carve another way, and so I'm really excited about that. And the other thing that I think is very interesting is that CMS has I don't know if generous is the right word, because we don't get paid truly for what we do, even though those numbers can be big. But they have given us some validation by not only continuing to raise rates, even though they're small percentages, but they're also saying hey, we see this going into robotics, exoskeleton, we see additive manufacturing coming in and we're going to pay for that, and so, out of all the things and the hits and stuff that keeps on coming.

Speaker 1 1:11:01

I think that there is a tide that is changing where we're really going to be focusing on good patient outcomes. Which outcome measure is all the rage and how cool would it be to have something that increases outcome measures in the prosthetic side of things. And, man, if the vendors Oser, autobach, all the big guys wouldn't get behind some of this Like we, just I can't. This is another foreshadowing, or it might be after. I don't know which way I'm going to do it, but yours and I broke down the Embla, which is Oser's umbrella. So embla is the umbrella over oser and a couple other companies.

Speaker 1 1:11:47

Um annual report and they go through some of these numbers and the amount of people that we're not reaching so, not only in the us but worldwide, that need a prosthesis is is astronomical. Um, so, like that percentage that you said uh, it sounded low, but that's they can. They corroborated that in their report. Um, so that's what's interesting about all this. Like, if you can move the needle one little bit and get people up and walking and healthier and all that stuff, that's a win for patients. And so to me I've been around long enough, definitely been on the beat down side of things. It may be skewed, but of what I'm seeing with the young people even some of the young surgeons coming in too and being in, hearing some of them, and their open-mindedness to this, to the grand rounds and all that stuff, I would say I'm very excited for the next chapter. I want to be real about it still, but I am very excited about the next chapter because I think this is where we're going to see a lot of gains.

Speaker 3 1:13:08

I think that you and Katie, I think you'd probably agree that I'd be willing to take a cut on the fee schedule that was then replaced with office visits. If you got paid to do an assessment and they said, okay, you have 10 assessments, we're paying you this much, we're going to take that amount off of the top or whatever, I don't know Okay, then we get actually reimbursed for our for for getting those outcomes. Now, I'm I'm throwing that out who wants to make less money? But until we actually get compensation for the time spent, I think it's going to be very difficult to get people to actually commit to doing it. Right, we're motivated by money. I don't know what the answer is.

Speaker 1 1:14:10

I'm throwing that out. We agree on a lot of things, tom, but I think I 100% disagree with you on the paying for time. Look at what has happened when we have. When you look at the fee schedules of doctors and surgeons getting paid for their time, guess which way they're going? They are getting squeezed like nobody's business. Look at our fee schedules. Yes, it sucks, but if you have good patient outcomes and take good care of the patient and fit the patient, you can make those margins work, and so I am not of the mind.

Speaker 3 1:14:51

Let's get paid for our time.

Speaker 1 1:14:52

So we can agree to disagree on that. Mind, let's get paid for our time. So we can agree to disagree on that. I'm okay on that. But I would not want to be an orthopedic surgeon in this thing right now I am 100%. If my kid says I want to be an orthopedic surgeon, I said you better become a prosthetist before that, because their reimbursements are going down.

Speaker 3 1:15:16

Here's the best part, and you're right. And the best part is I love the fact that we're able to even have the conversation. Do you see? My point is that so often people aren't willing to just throw stuff out on the table and muddle our way through, because I don't disagree with you In a perfect world, but when I'm looking at how often we are excluded from our own profession and you have these other people that come in going, I can do bracing and and I can do the research and I can leave this, and they don't even.

Speaker 3 1:15:54

You know, you've got these, these companies. Now how about the fact that Donjoy the knee brace company that we all know, djo and whatever I was actually talking to surgical division and I went to the you know, the conference they don't have a single orthotist on staff. We're not part of the process, for everywhere else, my, my point is how do we actually have agency in where our field goes and how do we make sure that we have a voice in what kind of research happens? Because if they bring up dumb stuff or if they don't actually ask the right questions, then we never make progress. So the fact that we just hashed that out and disagreed is great.

Speaker 1 1:16:46

So I might be on the minority of that, but I do feel. I feel for the, I feel with the surgeons. I'm okay jumping into your camp.

Pushing Forward Through Challenging Conversations

Speaker 3 1:16:55

You know I do, I agree with you and I'm, but I'm right there with you. I'm not opposed to coming over to yours. I go yeah, I, I don't want to give up any money, but I'm just going geez, how do we move forward? Well, why won't we change? Why won't we be open to a conversation about something? That's all. And my problem is nobody wants to have conversations about sketchy stuff, but there's so much neat stuff we can do anyway well, thanks, tom, for that.

Speaker 1 1:17:28

Uh, that that combination was probably the longest foreshadowing of a second episode we've ever done so far. So thank you, but I this is. This has been great, and Katie, thank you for being on. Of course, this was super cool, and thank you for your questions and and such for for Tom around the the surgery stuff, because I think that's really important as well, and thank you to our listeners making it all happen. Thank you for listening and we will see you on the next time.