Osseointegration goals and options

Thomas Cutler

Description

Title:

Osseointegration goals and options

Creator:

Thomas Cutler

Date:

10/26/2017

Text:

Hello List,

Like most in our field, I maintain interest in osseointegration. Recently, I attended the AOPA conference and was interested to hear about the latest progress with regard to what we abbreviate as OI. Not content to simply partake of that which was proffered to me by those presenting, I decided to become a man of action! This led me to my local coffee bistro where my first action was to order a cappuccino. None of that vanilla flavoring or unicorn sprinkles, folks! I'm a man on a mission and the topic I'm about to tame was osseointegration! Besides, Mike at Tazz Coffee will sometimes sketch in the milk foam and the cappuccino artwork lasts the longest...but I digress.

Ever had someone in an excited frenzy about something? No, not multi-level marketing. I mean like suspension or socket technique or a clinical concern. There are two logical options: lemming or skeptic. If the reimbursement is awesome, then it's easy to become a lemming. Lemmings gotta keep the lights on too, right? Skeptics fall into two categories: resistant and receptive. The resistant ones may be lazy since they believe that they're doing fine just the way things are. They may have an interest in the status quo. They may even have some stake in opposing or preventing the change, whatever it might be. When I am in this camp, lazy and doing fine are the ones that usually apply to me.

However, I love what I do so I'm usually a receptive skeptic. I love this field more than I hated my first job at Carl's Jr. with my nemesis, the fry machine. I view it as a sacred trust to care for these folks. And I'm not content with where our technology is now. We only get paid for the devices, and not for our clinical expertise. The only designated HCPCS code truly unrelated to a product is ischial containment/narrow m-l. When I once counted all our different L-codes, they numbered 674. No matter what it currently numbers this month, one product-exempt code is a pretty pathetic representation. It also means that pure clinical exploits in our field are not well-rewarded extrinsically. Thus, the door lays open to remedy the situation. I believe that due to our complacency, this led us to where we are today and the orthopedic field is stepping in to address what they see as a need. Reap the whirlwind... am I right?

The goals of osseointegration:
According to AOPA's magazine issue on OI this summer, the two stated goals of osseointegration are as follows---
1. Increased ambulation
2. Improved comfort

This is terrific! I'm on board. The better they walk, the healthier they are and the more they wear out prostheses and I get to continue buying feet over the long term. The better the comfort, the less time they spend with me during the 90 days I'm ethically obligated to provide unlimited follow ups and adjustments. Long-term, sustained, responsible growth sounds like a dream.

But:
AOPA didn't say that the goal was percutaneous and it currently seems like if it isn't percutaneous OI, then it isn't real OI. What is that? Well, percutaneous means through the skin and our model for this in the human body is our teeth. But nowhere else is it present in our body. This is why it totally makes sense to have percutaneous dental implants. Heck, the concept of osseointegration came from the dental field. Now, here's where I hang back and start asking a few questions.

  1. How similar is a mandible and a femur? Is a tooth a long bone? (I ask this rhetorically to give perspective)
  2. Did you try non-percutaneous osseointegration and find that the shortcomings from this outweighed the additional risks and time?
  3. If you did not, let's please do so in light of the hippocratic oath?

Driving to Vegas for AOPA gave me time in the car to think. You see, in addition to having been in clinical practice for a bit, I've started engaging with other disciplines that required me to actually read. I came across an implant in Spain called the Keep Walking implant. It provides a weight bearing surface and allows for patient choice. Do you want to go percutaneous or leave it solely internal? Are infection problems too much and do you want to change back from percutaneous? Wow...I like how the solution doesn't discount the input of the patient! Besides, now it's up to me to make a better socket to dissuade them from percutaneous. Raise the bar for O&P ladies and gentlemen! Besides, since 85% of amputations every year in the US are dysvascular in nature, there's a major noncompliance component associated with amputation. When only 10% of amputees actually qualify for percutaneous without escalating the liability, doesn't it also make better business sense to provide an option that safely increases sales by 1000%? Unlike those in the university setting, I'm very familiar with various patient mindsets as well as my standing in the pecking order in the medical community. How many lawsuits does it take to ruin your day? Remember that when considering the non-eligible patient who's mind is resolute that they need OI. Are you telling me it's not possible for them to convince a surgeon and for the prosthetist warnings to be ignored? All of our opinions are seen as biased towards profiting from a socket. If a local surgeon sees a self-promotion opportunity, it's possible that their justifications could cloud their judgement in this case, unnecessarily causing problems writ large for eligible OI folks. And yes, I've already seen blind faith in this demonstrated by patients. Don't forget that research proves that diabetics have twice the rate of cognitive decline towards dementia and Alzheimer's. I'm happy to address your counterarguments about emotions and logic as soon as you've had to take the car keys away from your elderly father.

Now that we see pitfalls of percutaneous OI brewing, let me share the results of the Keep Walking implant study in light of AOPA's stated goals. A 2017 POI article by Guirao found that with the implant, the patients walked 25% faster. That sounds like goal #1 of increased ambulation to me. Before you go dismissing the results as not clinically significant, realize that the 2011 Resnick and Borgia article which set this standard at 112 feet is hogwash. (don't ponder what hogwash truly is...it takes your mind to a vile place.) They used TT, TF, K1-K4, 33 years to 85 years. If you don't understand the importance of those details, here's a hint: it objectifies amputees as much as it would if they said all black people fit in this health demographic. Did I just go there? Yes, because both are wrong. Amputees come in all shapes and sizes and we do well to retain sight of their individuality in this process. Soapbox done. What about goal 2, you say? I'm with you! So, I notice a comment 80% have pain at the beginning of the Results section, but nothing else. What the? Like every one of you probably did, I reached out to the company asking about this, figuring not much change or that there may have been problems so it got left out. When he got back to me right away showing that there was an 82% drop in socket discomfort, I asked why the author would leave that out. Sounds like we have our #2 goal met.

Why again do we insist on going percutaneous?

More power? No. I found out that the VA subjects are still suseptible to trendelenburg gait.

I remember an osseointegration panel comment on my drive home. It was delivered in a manner that was so charmingly confident. The balance of hip flexors and extensors causes the flexion contractures... It didn't quite register at first... Perhaps I only found it humorous because I spent hours driving west looking into the sun, but it hit me... nowhere is our body balanced in the mid-coronal plane (front to back). Is your ankle? Nope. Who cares if there's imbalance in hip flexors and extensors? And furthermore, isn't it rather ridiculous to expect, when over 97% of our ambulation is walking unidirectionally forward, the structures to be balanced for 50/50 forward to backward for walking? If our feet aren't balanced front to back, why expect the rest to be? Wolff's law determines that form follows function. Walking is a bipedal activity, so we should always seek muscle balance in the sagittally mirrored muscles in the contralateral limb. List members, we all know that it's sitting too much that causes the hip flexion contractures. If you need a reference, Clavet 2008 found that functionally limiting contractures develop in as little as 2 weeks. When I found out that some surgeons move the IT band from the lateral side to the medial or posterior femur to address this (part of the adductor myodesis procedure), I politely asked them to please leave it where they found it, since I find that my IT band works quite well where it was designed to be.

Wow, this got long...so, why would I take the time to write this? A few reasons, to be honest. I think that feebly-challenged percutaneous OI may unwittingly lead to possible unintended, unnecessary complications down the road. I want the best for my patients and for those of my colleagues. I'm truly concerned that our failure to provide robust discussion and challenges has failed to bring out the best advances in collaboration with innovators who also desire to advance our field in areas which have frankly been neglected by our own ranks. I was disappointed to find that insufficient attention was given to non-percutaneous amputee osseointegration at the AOPA conference. If I'm intentionally looking and attending the OI sessions and I hear nothing, that's insufficient. I was delighted to later find out that multiple efforts are underway without insisting on going through the skin. I freely offered them my insights (such as they are) because I believe it is a more prudent approach at the current time. If I can share my insights (ramblings, whatever...) in this forum, I hope to equip others in the field who are wondering about this and instead of emotionally based opposition to OI, perhaps it will lead to more intellectual collaboration that benefits our patients.

Now...Go Dodgers!

Tom


Thomas J. Cutler, CPO, FAAOP, CPHM
Limb.itless, LLC
113 N. Church Street
Suite 312
Visalia, CA 93291
559-334-3741 phone
559-553-8837 fax



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Citation

Thomas Cutler, “Osseointegration goals and options,” Digital Resource Foundation for Orthotics and Prosthetics, accessed November 2, 2024, https://library.drfop.org/items/show/208825.