Sacral Insufficiency Fracture Treatment Strategies & Outcomes

[Dr. Douglas Beall]
How about we compare treatment versus 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 a 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 grand dad 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.

[Dr. Jacob Fleming]
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.

[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.