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Podcast Transcript: Sacroplasty I: Principles & New Data in the Treatment of Sacral Insufficiency Fractures

with Dr. Douglas Beall

In this episode of the BackTable MSK Podcast, Dr. Jacob Fleming and Dr. Douglas Beall discuss the challenges and advancements in treating sacral insufficiency fractures (SIF), the importance of real-world data in evaluating treatment efficacy, and the need to increase awareness of sacral fractures and sacroplasty. You can read the full transcript below and listen to this episode here on BackTable.com.

(1) The History of Recognizing Sacral Insufficiency Fractures

(2) The Ongoing Challenge of Sacral Insufficiency Fracture Diagnosis

(3) Imaging and Clinical Insights into Sacral Fracture Diagnosis

(4) Long Term Outcomes of Sacral Insufficiency Fracture Treatment

(5) Sacroplasty Registry Data: Validating Sacroplasty in Clinical Practice

(6) CT vs. Fluoro in Sacroplasty

(7) Recognizing Pain Patterns in Sacral Insufficiency Fractures

(8) Closing the Treatment Gap: Addressing Sacroplasty Adoption

This podcast is supported by:

Stryker Interventional Spine

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Sacroplasty I: Principles & New Data in the Treatment of Sacral Insufficiency Fractures with Dr. Douglas Beall on the BackTable MSK Podcast)

Ep 51 Sacroplasty I: Principles & New Data in the Treatment of Sacral Insufficiency Fractures with Dr. Douglas Beall

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[Dr. Jacob Fleming]
Hello, everyone, this is your host, Jacob Fleming, reporting from a beautiful day in Oklahoma City, and I'm here with the man himself, my soon-to-be former boss. Dr. Beall, how are you today?

[Dr. Douglas Beall]
Good afternoon, Dr. Fleming. It is a really nice day here, too nice to be inside, but this is an important topic, so I figured we'd take a few minutes to discuss. Soon-to-be-former, meaning in about a month you'll be off and on your own and it'll be an exciting time in your practice. I still remember my time on my own and it was absolutely one of the best times that you'll have. Here's a little secret. All the times following will continue to be the best times that you will have if you do whatever it takes to make that career your own.

(1) The History of Recognizing Sacral Insufficiency Fractures

[Dr. Jacob Fleming]
One of the other things I'm very passionate about having trained with you is finding those orphaned conditions where patients are often left without treatment, and hence the topic of our discussion today, which is sacral fractures and particularly sacroplasty. We'll just jump right in with the haymaker. Where are we with treatment of sacral fractures? We as in the larger medical community, how are we doing taking care of these patients?

[Dr. Douglas Beall]
I would say we're nowhere close to where we need to be. Not even close. Let's compare the experience we have now in your status in life in terms of where you are versus what it was when I came out. Shortly after the earth cooled, I finished my residency, and that was in the late '90s. I'm going to talk a little bit about some of the history of sacral insufficiency fractures or SIFs and a little bit about sacroplasty. When I came out, it was in 1988 is when I got out of residency. Sacral insufficiency fractures were described when I was in college.

It seems hard to believe, but Lourie did the first description of sacral insufficiency fractures in 1982. This was something that was just completely not recognized at all. We know that the CT scanner came out in the '70s. In the '80s, we had MRI, but people weren't experienced enough or hadn't had enough exposure to some of these fractures that are difficult to see to even describe them. It seems I can't quite fathom the fact that it was so late in terms of the ability to diagnose sacral insufficiency fractures. If you look at it, you understand why.
You look at sagittal views, and people really focus on sagittal views of the MRI lumbar spine. You've got to watch the corners because down at the bottom, any time you have disruption, increased signal in STIR, decreased signal in T1 to the bottom of the corners, that is not normal. It's difficult to see primarily because a lot of times the axial scans don't go far enough south or inferior.
The SI joint has an increased signal. It can have fluid in it. It can have cartilage, articular hyaline cartilage in there. It can mimic. It can have signal heterogeneity. You just gloss over the fact that the sacral insufficiency fractures, which may be subtle in terms of their signal, you can gloss over that. Oh, that's the SI joint. My mind doesn't recognize it, so my eyes don't see it. You miss these things fast and slow.
The incidence of these fractures, the best data I could get for incidence of fractures, having just finished the teaching curriculum for the Stryker course on how to do this, was between about 4.4% and 12.4%. That's quite a bit. It's a fairly common fracture in people that are 75 years old or older. As much as we think we're really good at recognizing these fractures, I can tell you that we still aren't great at recognizing these fractures. What happens after you do recognize the fractures?

(2) The Ongoing Challenge of Sacral Insufficiency Fracture Diagnosis

[Dr. Douglas Beall]
The first sacroplasty description was made in 2000 and that was done by a guy named Marcy. This was done with sacral mets, metastatic disease to the sacrum. 2000, it seems just unfathomable but it really was true. Because I wasn't doing a lot of sacroplasty. I had done sacroplasty before the year 2000 but not a lot. As soon as we started seeing more and more of these, I started doing more and more of these and it was still uncharted territory. This was something that I started doing, just like 95% of the things I do today, I never was taught to do in residency or fellowship. That's not abnormal. That's the normal course of things. You have to keep on learning.

The best thing that you can do is to teach somebody how to learn new things. You could adapt your visual, spatial skills and perfect those and really understand the anatomy and the do's and don'ts and the general rules. You can quickly and effectively learn new techniques. These new techniques have really been acquired in the last 24 years since that original description. These are things treating sacral fractures as much as we've improved. We have improved.
We have improved treating sacral fractures. Still, if you look at the number of times these things are missed, statistically, it's going to be about 25%. For radiologists, the real number is 23.5%. 76% of other physicians, non-diagnostic-related physicians, will miss these things. We're still missing fast and slow. If this isn't a compelling enough story, a compelling enough case that we need to do better, how many people are treating underlying osteoporosis after fixing vertebral compression fractures? How many times have we seen this?
You've been with me for a year. I'd be interested in your-- We've seen hundreds of fractures, vertebral, and we've seen, oh, I don't know, probably 40 sacral fractures or something like this. How many times were these people already being treated for their underlying osteoporosis by someone else by the time they came to us? What do you think? What is a good guess number? I know we don't keep track of the answer to this.
[Dr. Jacob Fleming]
Somewhere in the range of 0% and -5%.
[Dr. Douglas Beall]
It sure seems like that. The demoralizing component puts it into the negative, I think. It sure seems like that. There's hardly anybody being treated for it. We've got a long way to go. This is one of these things that I can't really fathom how long we have to go. We have hip fractures in the early 2000s. Only about 22% of the patients were treated for that. It went down to 11% by the year 2011. This was after an anabolic bone agent, teriparatide, called Porteo, made by Lilly, was introduced. November 2001 when it was approved. Then April 2017, we had another anabolic bone agent, Tymlos, abaloparatide. Then April 2019, we had romosozumab, Evenity.

We now have three anabolic bone agents. These people get sacral fractures. We had somebody in here that that had SI pain just this last week or the week before, somewhere in that range. She couldn't get out of a chair. That doesn't really worry me very much but she's really tender. Her pain didn't seem to be with sitting. It seemed to be with movement and transition, and so didn't really see anything that had to do with sacral fractures. The transitional pain, standing to sitting to lying, getting up and moving around, comfortable as long as she wasn't moving.

Sure enough, we sent her for a CT scan and she had subtle but present and accounted for sacral insufficiency fractures that had been missed over the course of time. I think this is a combination of vigilance, knowing that they're there, especially after pelvic radiation. People after pelvic radiation, high rate of fractures, and 80% of those fractures in the pelvis will occur in the sacrum. This is something that should occur at the elderly patient. I bring the original patient up because she was somewhere in the range of 65, 66, maybe even a year older than that.

She wasn't 85 and I told her that this is something we typically see in 80, 85-year-old, then Caucasian females in Northern European, et cetera, people that otherwise have a biogenetic predisposition for sacral fractures. It's abnormal, whatever the reason, she had multiple factors which were beyond the scope. Nevertheless, it's something that raises the level of importance for treatment, raises the level of importance for vigilance. Just that little clinical scenario is something that really, hopefully, will stick with us both to know the difference between SI pain and sacral insufficiency fracture pain, even though they're about a few millimeters to a centimeter distance from one another.

(3) Imaging and Clinical Insights into Sacral Fracture Diagnosis

[Dr. Jacob Fleming]
It's very difficult, I think, clinical diagnosis when it's not on your plate what you're thinking about. For some reason, it's just commonly not. Even for us, it's not the first place where we go with diagnostic criteria that we're thinking of. We actually put that patient on the table, on our fluoro table, and had a look just because the suspicion was so high. As we know, most sacral fractures are not really apparent on radiographs, but it demonstrated the difference between reading a study blind and looking at your own patient who you know what you're looking for. We did see some subtle cortical disruption that sealed our suspicion. We sent the patient for CT.

I think that commonly, this is just not thought of by the first-line diagnostic physicians who are involved in this. A lot of these patients have at least gone to the ER once, if not more, and these can often get glossed over. As you said, a lot of times, it's very subtle. A lot of times, I feel that we just see the trabecular disruption on the CT. MR, of course, you may see increased STIR signal, that's the thing we look for, but you can have fractures without much STIR signal as well, right?
[Dr. Douglas Beall]
These fractures are notoriously difficult. There's no way that we would have seen them had we had a high level of suspicious to see them. Looking at that and finding the little cortical disruption, that it's one of those things very hard to see, but once it, you can't unsee it. It's there, it's there, it's there, and sure enough, it was there on CT scan.

You see what you look for, you look for what you know, and that saying is based on Nobel Prize-winning data from Elie Wiesel in the '70s, but that really is, the visual cortex and the neocortex are related, and once it, once it, you have to be able to recognize and know what you're looking for to actually be able to see it literally. You have to be able to see it figuratively as well.

These are things and things like this will commonly get missed in physical examination tests for this, physical examination tests for SI pain, the sacral thrust, sacral compression, Gaenslen's, Patrick FABER's test, and the distraction test. These are in addition to things like Fortin's finger test. These things are positive in patients with sacral fractures because the lines of force go vertically up and down through the sacral ala.

They typically affect S1 and S2 predominantly, a little bit of S3 commonly, and then the force across the body of S2 is the side-to-side force and these things will transmit down, as you know, based on the biomechanical data, down through the superior and inferior pubic ramus. That's why you have sacral fractures associated with pubic rami fractures and the first thing we have to do is look at pubic rami and scour the rami to make sure they're not fractured as well because that provides additional instability in the pelvis and just cementation may not be enough.

The trauma literature says that any gap in a sacral fracture of about 10 millimeters, 1 centimeter or more, and you really probably should be using hardware as well. In my experience, these are not the same. You can't apply trauma rules and requirements to osteoporotic fractures. We try to because we don't really have enough data there for sacral insufficiency fractures, so we do apply that. Now, anything more than about a centimeter or more in terms of a hypotrophic, oligotrophic nonunion, a gap after a sacral fracture, we will go ahead and add screws, as you know, as you have done, and we've seen a good amount of success to this.

We count a low threshold to adding screws anyway because that's what we do for other sacral pelvic pain scenarios such as SI joint dysfunction and it's fairly easy to do. We have a low threshold to do that. Do we do it too much? I hope not and I surely don't think we do, but that's applying an L1 burst. If grandma falls down from a standing height, she has a fracture that's medial, laterally, and anteroposteriorly bigger than a level above, a level below. What is it? It's a burst, but we don't hesitate at all to treat it with standalone cement, just vertebroplasty, kyphoplasty, and now Spinejack, of course, but we've treated this for years.

[Dr. Douglas Beall]
It's very different from a high-velocity injury where you drive your car to a bank on I-35 and disrupt your PLL and have a traumatic burst. These are very different things and I think the same thing applies to the sacrum. It's very different than a motorcycle injury with a sheer force, using the scale to figure out exactly the mechanism. These are different issues. These are more traumatic issue.

I think we have a long way to go. I think we really need to have the ability to do sacroplasty. One of the things I see commonly in our registry and enrolling people for sacral fracture fixation is there are not very many people doing this. In our state, I think there are two people doing sacroplasty. I think my former fellow and us, three all together, soon to be two, but it's just not the number of people that do this. There are not nearly as many people that do sacroplasty as that do vertebral augmentation. That's a real travesty. One of the things that we have seen is that this is one of the best things that not only the people can do but that is dark.

The mortality rate for sacral insufficiency fractures and the common things that we use in terms of pain and debilitation. I'm going to go back a half step and here's what happens when we don't recognize and treat them, the one, three, or five-year mortality rates for sacral insufficiency fractures and this is, I'm going to quote some data. This is from Chandra, who did the best systematic review on that analysis on sacral insufficiency fractures and the classic paper, here's what happens if you don't treat these people that have sacral fractures. The one, three, and five-year mortality rate ranges from about 11.5% to 23.5% to almost 27% in one year, three years, and five years.

If you don't treat somebody with a fracture, by the time you hit a week, the bone loss goes up to 50 times normal bone loss and it's age-related, 50 times, which is crazy. At about the two-week time point, you're cracking along at about, you lose 10% to 15% of strength every week that you're down, and by the time you hit two weeks, about 10 days to 2 weeks, you're at about equivalent to a 10-year loss, age-related loss in conditioning, bone and muscle. By the time that you're five to six weeks out, you're half as strong as you once were. That's just incredible to me. You put a young guy down, 20-year-old male, and the bone loss is very swift, too. If you measure the calcium goes up, bone loss goes up, and this is something that happens in younger patients too.

It's just more debilitating in older patients because there's no reserve there. You get the idea that if you thump them too hard, they lose their grip on the edge of the sink and go down. This is not something that they can or should or have to withstand. By the time these people are discharged, the data is half of them can't be discharged at the level they once were when they came in and 40% of them will have chronic pain. 40% will have chronic pain. Just can't imagine that. There are people that would advocate for non-treatment because it's too risky to do treatment, too risky, too risky, and too risky. What about–

[Dr. Jacob Fleming]
Too risky is the lack treatment.

(4) Long Term Outcomes of Sacral Insufficiency Fracture Treatment

[Dr. Douglas Beall]
What about we compare the treatment versus a non-treatment? In the US registry, there is one case of extravasation with neural injury, one, there's one case. If you combine the vertebral augmentation and the sacroplasty registry, there's one patient total out of 732 patients in the vertebral augmentation, 102 in the sacral augmentation, and error of analysis. One, the mortality rate of five years, 27%, 26.9% mortality, people that are dead. We conducted a long-term follow-up, Mike Fry did the original paper. It was 52 patients and said that the pain goes from an 8.1 to 3.6 immediately after the fracture repair and down to 0.9 a year out.

We got the idea a few years back to wonder what happens to this long-term cohort. We were about, that was post-2007. We did it. This was right around 2018. We wanted to publish a 10-year follow-up. We looked back 10 years, late 2017, we looked back and the pain score went from an 8.1 to 0.9, as I mentioned, and 10 years out, the same cohort had a 0.5 pain score. Those maintained out through 10 years. The cohort that did not receive treatment, we put in the paper that these patients weren't contacted is the way that we put that in. We debated on what to say about this.

The reason they weren't contacted is because they weren't living. There was nobody still alive at 10 years after the sacral insufficiency fracture. We elected, I thought that was a little bit too powerful of a statement that would take away from the main message that sacroplasty works and is durable. I didn't really want to put the surrogate mortality data in there because it's not a mortality. It's not a mortality article. It's not a claims-based mortality article that we've seen in other papers and assertions, and our group publishing this with the entire Medicare claims database.

That's the way to do it. Propensity score matching the mortality data and being really sure how much good we're doing for people. We elected not to mention that, but it's due to a combination, not only the fact that sacroplasty, sacral insufficiency fracture is associated with really high rate of mortality relative to other conditions, but people are old. When you say I have a patient that needs a sacroplasty, in my mind's eye, I see an 85-year-old Caucasian female. That's who I see because that's who typically gets sacral insufficiency fractures are about 10 years older than the people that typically will get a vertebral compressive fracture.

How many people that are that range will be alive in 10 years? Of course, there are natural causes. People die of deconditioning. They die of pneumonia by and large. Then one of the other things is pulmonary emboli for DVTs from laying around in bed. One of these other interesting things that I did, I learned putting out the sacroplasty curriculum, the how to, and we did this how to do a sacroplasty because there's nothing out there. That's probably one of the questions I get asked the most. "We're going to do the sacroplasty. I know it's beneficial. I want to start this up. How do I do it?"

I sent him a book chapter, the book chapter I did with Michael a long time ago. I sent him a talk on sacroplasty. I sent him some examples and I've done some work setting up how-to's in a vestigial form, not really something that was extensive. I thought that was really important. One of the things that I've learned on the paper, people said they had included bed sores. I thought, "huh, I wondered, why don't I include a bed sore in there? These things like coronary dysfunction, heart dysfunction, the ejection fraction goes down. The pulmonary efficiency goes way down. The force vital capacity goes way down.

You get pneumonia, you get DVTs and PEs and then, the urinary tract infections and then pressure sores. I looked this up and pressure sore has good Medicare data. I was surprised about that. If you develop pressure sore, it's defined in the cost that it takes to treat that pressure sore ranges at the low end $20,000 and at the upper end $150,000. It's really a little bit over both of those values, but that's the approximate value, $20,000 to $150,000. There's good Medicare data on this. It turns out granddad lays in the bed and gets a fracture, especially, sacral decubitus fracture over his fractured sacrum.

That's going to impede our ability to treat because one of the only absolute contraindications is an active infection in the region of the treatment site. That's a tough one. You'd have to do an MRI to make sure he doesn't have osteomyelitis. If it's a superficial fracture involving the skin, the underlying soft tissue, then you go lateral. We'd probably do the lateral base transileal approach to the sacrum and go across S1, and then across or across S2, or do both of those if needed.

These are things that provide a tremendous amount of debilitation. Not to mention the fact that what I said previously, that 40% of these have chronic pain. I don't think I've seen a case of sacral insufficiency fractures with chronic pain in 10 years. I don't recall a single one of these. We typically fix them. They get better. They stay better because we use anabolic bar aids to bring the bone density back up. It meant maybe they're out, but they're there without my knowledge.

(5) Sacroplasty Registry Data: Validating Sacroplasty in Clinical Practice

[Dr. Jacob Fleming]
Absolutely. You gave us a whirlwind tour of the current data. Do have to give a shout out to the most recent article in JVIR, which of course you're head author on the sacroplasty registry interim analysis of 102 patients. This was one of the winners, one of the best papers of the year at SIR.

[Dr. Douglas Beall]
How about that?

[Dr. Jacob Fleming]
How about that from just a really excellent and overwhelmingly humble group of researchers? We will, of course, link to that as well as the other literature that you mentioned. I'm really glad to focus on that because this is something that even as a resident few years ago, there seemed to be a dearth of good literature out there. Of course, the Fry study as you mentioned, and now with the interim analysis, I think we're really starting to show the power of this technique to keep away from what you described, this downward spiral that happens in these deconditioned patients. Of course, that's predominantly the patients that we see it in.

As you mentioned, pelvic radiation, sometimes we're seeing even young patients, in their 40s, even men who've undergone pelvic radiation and they are more prone to do this. It's something we have to keep in our differential diagnosis because it can pop up if we're not expecting it. You talked about a little bit about the technique and I definitely want to get to that. One of the things I wanted to mention first is that I think every time this gets brought up at a meeting, inevitably there will be a question of is CT or fluoro better.

I think that's a really interesting question because a lot of our colleagues have easy access to CT, paradoxically easier than the more primitive C arm, which is really all you need. Could you just say a little bit about your thoughts to people who are looking to add this on to their practice?

[Dr. Douglas Beall]
Sure. I'm going to tie that to the registry data and then we're going to go back and there's a couple more things I want to put together in terms of, I want to put the fit and polish on the literature data. the registry in general, I just want to have a comment about this and I'll get to the a CT guided versus fluoro guided and what's better. The secret is coming. It's coming here in a few moments. What's better?

For those of you guys out there listening to the back table, I want to tell you that yes, it is a, an award winning paper. Yes, it was published by JVIR and yes, this has been recognized by a number of different outlets. It's been popularized. It's been, it's been put out on press releases. It is one of the most, salient pieces of literature that has gotten rejected three times before it was accepted. Finally, the re-re-re-revision was accepted to JVIR. He recognized, I think that this had incredible value.

The point is don't lose focus. Don't assume that your paper is bad when it's not. Some of the best things I've ever written have gotten rejected the most times and vice versa. I've gotten comments back from the registry that they criticize the fact that we didn't have a control arm. I'm like, "This is a registry. It doesn't have a control arm. This is a perspective, multi-site collection of data, similar to post-market FDA phase IV.

This is as treated on label type collect the data in the real world and see how people do." I've had comments that are that vacant by what should be expert reviewers that are not expert. Otherwise, I even put the word registry in the title of the paper to specify what this was, just so people wouldn't make a mistake. There were comments. There were reviews, of course, that were excellent and very accurate.

There were also reviews for the papers, the times that we submitted to a couple of the other journals that were not excellent, that were pedestrian, that were simplistic, that really you get the idea of reading the reviewer's comments. They didn't even know what they were reading, didn't have enough expertise to be really judging this in a critical way. Having said that, we were finally glad that this found a home in JVIR. I think it's one of the most salient pieces of literature. I'm going to make just a quick comment about the literature.

The problem with sacroplasty is this doesn't have industry sponsorship, and if you take industry away from the sponsorship for the research data, you have, of course, no research data. Who's going to pay for this? The academic centers? Okay. Where's the research? I mentioned the original paper done by Mike Fry. You have pain score 8.1 down to 0.9 of the year. Keith Kortman, he had 200-plus patients and the average pain score 9.2 to 1.9 of the year. I mentioned Chandra's meta-analysis and then our registry data. All these are very similar. Our pain pre and post, 7.8 after 6.9.

The reason why this real-world data is important is because this amount of pain reduction. In the EVOLVE trial, the largest as-treated unlabeled kyphoplasty trial, the amount of pain reduction was 6.3. The average amount of pain reduction in the US registry out of 1,000-plus people enrolled with full data sets collected on 732 is 6.7. The average, if you've been keeping track, mentally, the average pain reduction for 102 patients on an interim analysis of sacroplasty was 6.9. Explain this to me. If you have a bunch of people out there just treating fractures, and I don't really screen the number of sites that we enroll, I have an idea about who's doing what. I want to get these sites distributed all throughout the United States.

We'll take people from West Coast, East Coast, North, South, Middle. I want to distribute this around and it's a little bit of a crapshoot. You roll the dice on this thing, and you're getting a 6.3 to 6.9-point reduction in pain. What about the free trial? The similar trial comparing kyphoplasty versus 3.5 point reduction. Half basically. The Pompidou-Sassey on Mental Analysis with 50-- It came down to be 27 level one and level two articles out of over 1,000 papers examined. 4.55 reduction in pain. Some of the common reductions in pain for the randomized controlled trials are far less in the real-world data. This is the value of the real-world data.

It's not a specific patient treated a specific way by a specific group or person done with specific parameters to measure the outcome and compare it to another group. This is anybody that has one condition treated by a number of different people all around the country with essentially no inclusion and exclusion criteria other than the typical ones that are used in the region and just seeing what transpires, seeing how the person does.

This data, this paper, this emphasizes a real-world data. If we do something radical, like actually collect our data and look at it, we seem to be doing a lot better than what's published commonly in some of the randomized controlled trials. Some of the registry data that we publish is, and to mention the parent data comment on this, is this is ongoing. I want to run this out to 250 patients. Big nod to the SIR Foundation that sponsors this, sponsored by the SIR Society Foundation. We were so successful in the vertebral augmentation registry to enroll patients quickly and cheaply that we had room to do some other patients, and so we did a sacroplasty registry.

Hopefully, by the time this is all done, we will have 250 patients. This is important because, as you know, Medicare and some of the other payers are consistently mining the procedures that are done and often draw things into question. They have a lot of Medicare regions that sacral kyphoplasty has a T-code. It's really lumbosacral vertebroplasty is what's coded. This is done a little bit to protect the reimbursement.

By protecting the reimbursement, what I mean by that is protect the patients against the increased rate of mortality, dramatic increased rate of mortality, chronic pain, dysfunction, UTIs, pressure sores, and everything else that come along with untreated sacroplasty because if you don't reimburse for it, nobody pays for it, very few people get treated and you're relying on things like cash pay, which is, I think, totally unacceptable.
A lot of this is done just to see how we do and we know how we do. We do pretty darn well. Now, at least the interim analysis has put that in terms of data, real-world outcomes is put down into print. If you look at the data of the sacroplasty, I mentioned there was no industry sponsorship. The article that we published in the 10-year follow-up in the original paper, this was level three evidence. There's no level one evidence, none. We have to have something like real-world outcomes, patient-reported real-world outcomes to be able to put a firm flag, plant that flag, here's how we do, here's what's done.

Then one of the few papers done recently by Liu et al, 2019 paper, I love this paper because most people say you do vertebral augmentation or you do non-surgical management. Then if you do non-surgical management, suddenly, poof, people do what they do and you record them. You don't really record fastidiously all the AEs and SAEs. I think they just go into the pool that it's non-surgical management, conservative. Then you record, do record all the AEs and SAEs in the vertebral augmentation.

What Liu did is he recorded both augmentation and non-surgical management and found AEs and SAEs nine times more commonly in the patients treated with non-surgical management than the ones that were treated with vertebral augmentation. This was a kyphoplasty trial, but it certainly does have some overlap in this and I want to try to preserve this for the people who need it.

My mother is, of no surprise, is a thin, caucasian female, Northern European descent, and her age is 80. If she fell down and had a sacral fracture or vertebral fracture or developed sacral insufficiency fractures, for God's sake, I'd want somebody to be able to fix her if she wasn't in my area and wasn't able to get back and do so without any blockade or any type of hurdle.

(6) CT vs. Fluoro in Sacroplasty

[Dr. Douglas Beall]
Rolling back to CT versus fluoro. Here's how it broke down in the sacroplasty registry. It was interesting. 7% of the time balloons were used as compared with most vast majority in the vertebral augmentation registry. We had 35% of patients used CT versus about 3% in vertebral augmentation registry. 35%, and then there was about 7% that used a combination of cone beam CT plus fluoro. I was surprised that that wasn't a little higher. Then the rest was done under fluoroscopy. The advantages, of course, under fluoroscopy is it's quicker, it's pretty easy, it's very prevalent.

We do our cases with a marginally competent C-arm held together by tape. Then you have the other option of--But it requires more expertise, more experience. You have to understand sacral pelvic anatomy and it's been my experience that this anatomy is probably not understood as well as it should be across the board. Then with CT, you get a better view of where it goes. You get a better view of extravasation patterns into the sacral foramina close to the lumbosacral trunk, then lumbosacral plexus into the spinal canal if that is applicable but it's slower and it's more expensive and it's more cumbersome.

Some of the original sacroplasty approaches that we do now can be developed under CT, and then did it work backwards? I call that working backwards, developing in a cross-section, figuring out what's a safe approach based on anatomy, figuring out what to look for in terms of extravasation patterns, and then taking that, extrapolating that back into what I perceive is quicker and easier, and as long as you have enough expertise to watch for the extravasation patterns, you're okay. An extravasation pattern that you have to watch out for is people think it's around the foramen, the foramina. No, it's anterior, around the lumbosacral trunk.

If you don't know what a pelvic inlet view is, please get on your computer and look up pelvic inlet view because that is what shows you the pelvic brim anteriorly and you want a sharp line and you want to see absence of extravasation anteriorly because the lumbosacral trunk and the lump that becomes the lumbosacral plexus goes along the anterior portion of the sacral ala. If you extravasate around that lumbosacral trunk, both you and the patient will hurt greatly. That's the only complication that we saw in the sacroplasty registry was one of these extravasations.

(7) Recognizing Pain Patterns in Sacral Insufficiency Fractures

[Dr. Douglas Beall]
When people present with SI pain inlet sacral fracture pain, they'll commonly present with, yes, pelvic girdle pain, yes, low back pain, yes, posterior hip pain, but it is really common to get an L5 radiculopathy, and variant of L5 radiculopathy means pain in the groin and then pain that radiates down the outside of the thigh, over the top of the knee, front of the leg, to the top and bottom of the foot. That is an L5 radiculopathy and of course, you can add certain variations, it can affect the S1 or the L4 but mainly it's an L5 and this is a pseudo radiculopathy, pseudo sciatica because it's just being irritated. It's being irritated by that lumbosacral trunk.

That's one of the things with it, a stretch, movement of the pelvis, bony anatomy with irritation that either comes from sacral pelvic dysfunction, SI joint dysfunction, or a fracture of the sacral ala, you can have a pseudo-radiculopathy. I've heard people say it can't be a sacral insufficiency fracture because a person has sciatic. Whoa, be careful, watch out for that because that does not mean that.

In fact, you hear some of our receptionists talking to the patient and they'll ask, "Do you have that wraparound pain and you have that pain down your leg?" They don't know that you're not supposed to have sciatica or sacral fractures, but just talking to enough people with thoracic pain, thoracic radiculopathy around the ribs, sacral fractures, or sciatica down the legs, they've suddenly become expert in this.

That's what happens when you talk to a lot of people and get a lot of feedback on that. That really, it plays out well and you understand you get a good understanding of the pain pattern or presentation and most importantly, you're not don't have a lot of influence by your colleagues telling you this can never happen, that can never happen, stay away from this, stay away from that, don't use this, don't use that. That's one of the worst things that can happen and I think for sacral insufficiency fractures, the best thing that could happen is a sacroplasty followed by treatment of the underlying disorder of osteoporosis.

(8) Closing the Treatment Gap: Addressing Sacroplasty Adoption

[Dr. Jacob Fleming]
Absolutely. We've seen with time that the people who have added this to their practice have unanimously said it's one of the best things they do and you've outlined that with the data that's been rigorously collected at this point and we do want to continue expanding the registry. This is something that I think it's a matter of a lack of awareness and we've seen this with, I think, the majority of patients we've done a sacroplasty on this year. They were initially, if not persistently, told there was nothing to do for this fracture. Just let it heal. That dichotomy of treatment versus non-treatment and the treatment nihilism, as you refer to.

[Dr. Douglas Beall]
The Friedrich Nietzsche of the treatment, there are lots of treatment nihilists.
[chuckling]

[Dr. Jacob Fleming]
This false dichotomy that it's oh just let it heal and we know that a lot of them will not heal versus more of a ortho trauma approach as you spoke to earlier, it brings up the adage, an old AO adage, that metal does not hold bone but bone holds metal and so even when you're doing something like what I would refer to as an augmented sacroplasty putting in hardware, wouldn't think of not doing that without cement because these patients are severely osteoporotic most of the time have just butter.

[Dr. Douglas Beall]
Corollary to that AO is if the bone doesn't heal, the hardware will fail and that's a good cardinal rule. The bone quality is everything. Knowing how to help that bone heal is also everything. Some of the new 3D printed screws that we have the ability to-- That are approximately 60% porous, very similar to cancellous bone, and that really have the diameter of the pores are similar to the diameter of cancellous bone, 200, 300 microns. they have what's called a wettability and excitability.

These sound semi-obscene, but their descriptions of titanium alloy screws, the ability to take and conduct things that are liquid, including blood, with all the factors and growth factors in the blood, and the ability to change the 2 plus cation versus in the calcium onto the screw and these things are very effective in terms of providing good long-term relief. The people that will say, "Oh, it'll heal," okay, yes. I don't necessarily philosophically disagree with that, but if plan A is rest, analgesic, bracing, plan B cannot be rest, analgesic, bracing.

I would also call into question plan A. Why would you use rest, analgesic, bracing when you know it's nine times more risky? Why would you do that knowing that if this guy gets a pressure sore, that's going to be worth $150,000? How many sacroplasties does it take to match that, right? That's one of the cheapest things that we do. When people get them to-- They have sacral fractures, the average amount of time that is unrecognized is 29 days, unrecognized, average amount of time. Don't worry, it'll heal. What happens when it doesn't heal? Do all fractures heal? We see them every day. We will see them tomorrow, we will see them the next day, and the next day for fractures that haven't healed.

Fractures don't always heal, and if you have an oligotrophic or hypertrophic nonunion in your femur, you know it because you can't freakin' walk on it. If you have one in the sacrum, it's hard to walk, but you can walk on it and people say, "Oh, don't worry about it. It'll heal." That can't be both plan A and it can't be both plan B. This is something that oligotrophic or hypertrophic nonunions leading to the so-called Kümmell's disease, it doesn't really exist. It's really a hypertrophic nonunion developing a cleft in the vertebrae. You can also have a chronic collapse in the sacrum. We've seen lots of those. These are things that require additional stability to heal, 29 days on the average.

For a patient that has a fracture, that is, I'm going to roll back to the vertebral fracture because the data has been collected with this. If somebody goes in with an acute vertebral fracture, they're in the hospital on the average of eight days, and eight days of opioid control and bracing and typically, on the average, a 75-year-old patient doesn't seem like a good idea. In fact, it's not. We discussed what happens when you don't treat these people and these people just don't do well. They don't come out of the hospital and they don't get back to it. The statistic on hip fractures is 50% of the women that get a hip fracture, even though it's treated, will not regain their previous level of function, 50%.

It's very similar to that in sacral insufficiency fractures and 40% of those people have chronic pain. Let's not let these people suffer because of shame and unrecognition, lack of recognition. I hear often that it's a failure of treatment, either medical or augmentation. It's really not a failure of treatment. It's a failure of recognition, seeing it, and it's a failure of diagnosis, thinking about what this could be and coming to formulate, again, thinking with a good treatment plan based on literature data based on the things that we know for sure.

These are the things that, hopefully, we're going to start popularizing pretty soon with sacroplasty treatment courses.

I do commend my colleagues. This is one of the things that people are interested in the most. The single thing that they probably want to add to their treatment armamentarium, at least among interventional radiologists and people that practice interventional pain, this can be a very valuable thing that's added on and it should be added on. This is under-treated in terms of the number of people that do vertebral augmentation versus the number of people that do sacroplasty. We need to really expand the number of people doing sacroplasty and we'll see concerted effort to do that.

Podcast Contributors

Dr. Douglas Beall

Dr. Douglas Beall is the Chief of Radiology Services at Clinical Radiology of Oklahoma.

Dr. Jacob Fleming

Dr. Jacob Fleming is a diagnostic radiology resident and future MSK interventional radiologist in Dallas, Texas.

Cite This Podcast

BackTable, LLC (Producer). (2024, June 19). Ep. 51 – Sacroplasty I: Principles & New Data in the Treatment of Sacral Insufficiency Fractures [Audio podcast]. Retrieved from https://www.backtable.com

Disclaimer: The Materials available on BackTable.com are for informational and educational purposes only and are not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The opinions expressed by participants of the BackTable Podcast belong solely to the participants, and do not necessarily reflect the views of BackTable.