Saturday, October 5, 2024

Solutions for O&P

Thomas Cutler

Dear Colleagues,
On August 3rd at the annual meeting of the Florida Association of Orthotists and Prosthetists (FAOP) I was privileged to go public for the first time about a series of discoveries that started in 2015.
And now that the discoveries are on the record at the conference, it is time to equip all prosthetists with these same insights about what has hindered our well-intentioned efforts. Hopefully this allows us to take a more prominent role in discussions about prosthetic care and improve care for amputees.
The surgical foundation for our profession developed the wrong surgical goals (transfemoral) whose origins stem from flawed biomechanical principles. The AAOS (American Academy of Orthopedic Surgeons) developed a safe and effective surgical technique (their role) to accomplish those incorrect surgical goals. This flaw is something for which the American Society of Biomechanics (ASB) will have to answer. I submitted an open letter to the leadership of the ASB at the beginning of this year asking them to partner in this process from the beginning. They politely, and very abruptly, refused without asking a single question.

Are patients being harmed? Without a doubt, my answer for that question is yes.
Two specifics and one general observation.
Specific 1: The IT band is 30% of hip power. Rather than preserving this necessary vehicle of hip abduction, it is intentionally removed in transfemoral amputation in an effort to obtain balance which was never present before. That’s partly why your TF patients are weak and fall. This has been determined mathematically and confirmed pragmatically for decades (Kummer, 1993 and Ryser 1988 respectively). While the purported claim is that surgery must aim to avoid hip abduction contractures, this very claim further exposes the surgical goal naiveté regarding hip anatomy and biomechanics. The truth is that the IT band’s constraint of the femur is obviously released when it is cut during amputation. The myopic “tunnel vision” of a surgeon decades ago may have noticed the femur’s new unconstrained abduction and thought “Quick! Make it vertical!”, disregarding the fact that femoral abduction is simply what supports body weight. Rather than being afraid of “hip abduction”, we should be afraid of not harnessing the hip’s femoral power that provides a reactive support for the pelvis.
Specific 2: Fat embolism syndrome (FES). Ever wonder about the result of leaving the medullary canal open? You’re spewing bone marrow, white blood cells, and fat into a dysvascular patient with a compromised circulatory structure. What could possibly go wrong? In other medical conditions like femur fractures, FES is known to cause respiratory failure, neurocognitive deficits, and even death. In amputees? Perhaps researchers assume that it somehow doesn’t apply. Cut the femur and leave the medullary canal open? How did this become acceptable?
General observation: Weight-bearing bone implants (because a joint implant is simply a bone implant) have been used for the hip since 1960 and for the knee since 1968. They are provided to 1.5 million people annually in joint replacement. How many of those successful procedures are percutaneous? Zero. Why have we then never had an implant for amputees that provides simple internal weight bearing support? Why is it that we must leapfrog over this prudent step and relentlessly pursue an implant that protrudes through the skin as though nobody’s ever heard of something called litigation? The more you mull it over, the more surreal it becomes to consider that a simple internal implant isn’t already our standard of care. And weight bearing will also control femoral adduction where a femur free-floating in soft tissue cannot be controlled. Note: while the historical claim is that knee disarticulation level keeps its position due to the adductor attachment, grounded theory research methods prove this to be false. The qualitative data shows that the weight bearing capacity and socket contours of KD were the true benefits. (but that’s a different conversation also supported by references)
Do you see a pattern? Gottschalk 1989 says TFL is the most important muscle for hip abduction in gait, but he removes it in the adductor myodesis for amputees 5 years later. FES is seen as a concern for typical trauma patients, but the question isn’t even broached for amputees. Implants have seen tremendous innovation for adult joint reconstruction, but not for amputees. It’s time for our profession to step in front of those who have failed for decades and say, “This is what we’re going to do for amputees.”

Dear colleagues, the FAOP presentation was initially focused only on connecting the dots on what is obviously the wrong biomechanical view resulting in a surgery which significantly limits the potential success of hundreds of thousands of transfemoral amputees. But instead of leaving conference attendees in despair, it was also an opportunity to articulate an effective solution. One that could improve our practices and make us more effective and efficient.

The obvious solution is to provide simplicity, safety, and strength to amputees. To all amputees, especially those with deconditioning and dysvascular issues. The simplicity of a “radiator cap” used by all surgeons for the femur instead of what appears to be a permanent femoral colonoscopy from current OI designs. The safety of an internal implant that seals up the medullary canal, preserving homeostasis and preventing fat embolism syndrome and other soft tissue conditions. And finally, the strength that comes from an implant with stable skeletal support as well as one that harnesses the critical power of the IT band.

Why should you as a prosthetist care? Because harnessing more power increases the number of legitimate candidates for transfemoral prostheses. That means more opportunity. Getting away from endless follow up visits chasing volume is feasible since your patients will finally have skeletal support. You get a consistent fit instead of a variable fit. That means more productivity.

Why should the surgeon care? Let’s be honest. No surgeon wants to be known as the “salvage surgeon” when Medicare pays barely $700 for the procedure. Having a simple implant transforms it from a salvage to a reconstruction. And along with those improved outcomes comes improved compensation. Even Medicare understands this since they’ve included a 65% add-on code in 2020 for Breakthrough Medical Devices. With better surgical goals and sensible implants that compensate them for better outcomes, surgeons may begin to welcome us as collaborators.

Why should insurers care? Two thoughts quickly come to mind. The first is that with skeletal support, the number of socket replacements will drop drastically, compensating for the increased number of prosthetic candidates. But the most logical is that with the amputated side able to tolerate greater loads, that means less destruction to the sound side which leads to lower costs overall.

Who will oppose this? Those married to percutaneous osseointegration. Regardless of whether their investment is financial, vocational, personal, or simply their ego, this undermines the very premise for which they advocate percutaneous implants: the claim that the problem is “the socket”, thus requiring extreme measures for its elimination. The origin of the problem, regardless of the elements comprising it, includes the surgical recommendations. Let’s be blunt: it’s not just socket issues. Before you go blaming everything on the socket, you should have checked your surgery. If you had, we would be having a different conversation now.

Are you wondering “is there more?” The answer is yes. The errors from improperly converting physics to biomechanics have far reaching consequences. There’s the vastus lateralis which inflates/tensions the IT band much the way air inflates a tire. Just like you can’t study tire function without it being inflated, you can’t understand the IT band without knowing the muscle’s role is supporting it. …but they missed it. There’s also the boundaries… The IT band is 30% of hip power. But since it inserts below the knee, this means that a third of the hip model takes place on the OTHER side of the knee. The concept of “closed chain” was misappropriated to pertain to kinematics to “explain” this. Our very modeling of the joints is proved to be unsound. I have 8 binders, a couple of databases, 9 hours of footage with some guys doing a documentary on this (and another 2 hours with local ABC news), and gathered over 130 peer reviewed journal articles supporting what is the true nature of biomechanics. Biomechanics that also understands the reactions and not only the actions.

This is being posted now so that you as prosthetists have time to discuss this with your referring vascular surgeons, general surgeons, and orthopedic surgeons prior to AOPA. Until then, also take a moment at each visit to look in the eyes of transfemoral amputees as you treat them. Do something, like reciting the names of their children, to be sure you see them as people. Look deeper into their eyes… think about what they’ve been through… about what they are going through… People matter. And people have been hurt. This needs to change.

Full disclosure- in 2015, based on what shocked me about TF amputation, I started developing a hip replacement implant. This evolved into a patent for an IT band implant. Those have been my focus for years. This summer, ahead of going public at the conference, I hurriedly filed a patent on such a “radiator cap” implant.

What’s next? That’s a common question. The answer depends on who chooses to be involved. We can remain passive, allowing both our profession and our patients to limp along as they are now. We can permit the perc-OI groups to proceed unchecked, but with this post and with the FAOP conference presentation on public record, that’s now a bit sketchy. I could go to the FDA. I could go to the US surgeon general. I could go to AO about the surgery. But…

Perhaps it’s time for “I” to become “We”. As the African proverb says, “If you want to go fast, go alone. If you want to go far, go together.”

To summarize, is this post saying?…:

1. There are flawed foundational assumptions in kinesiology/biomechanics that compromise the scientific integrity of that entire field of study.
2. The field of kinesiology/biomechanics affects scores of professions, only one of which is orthopedic surgery.
3. Orthopedic surgery as a field plays a critical role that affects multiple professions and medical conditions, only one of which is prosthetics.
4. Therefore, it’s possible that these flawed biomechanical assumptions act similarly to a toxin, infecting other fields of science, and that those fields in turn pass on, to others, consequences of the shortcomings of biomechanics… just one of which may be surgical goals that currently hamper every transfemoral amputee alive today.
…yep. I think you’ve about got it right…
Folks, this isn’t a matter of who’s right. This is a matter of math. Wherever your math is wrong, you are wrong. And in so much of biomechanics, their math is wrong.
The question we now ask is, “What do we do about it?”
Respectfully,
Thomas J. Cutler, CPO, FAAOP
Limbitless LLC
Visalia, CA

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