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The Use and Perceived “Abuse” of Sinus Tarsi Implants
Michael E. Graham, DPM, FACFAS, FAENS, FAAFAS, FACFAP
There was recently a post on social media by a “foot specialist” criticizing another foot surgeon
for his positive use of a particular sinus tarsi stent claiming “over-use and abuse” of this implant
and procedure. It has been a continued amazement to me how such a powerful, minimally
invasive procedure has been shunned by so many in the very small “foot specialist” community.
There is an obvious bias by some “small minded” physicians against this truly life changing
procedure. The question I have to pose is why is the insertion of an FDA cleared medical device
into a patient’s foot, who has documented symptoms, positive clinical and radiographic
findings, so controversial?
Of course there are the many theories including the “old dog, new trick story” yet, this is not
the case. I’ve had the good fortune of lecturing and training foot surgeons all over the world on
the indications and contra-indications, surgical technique, potential complications and how to
prevent or handle them regarding the use of sinus tarsi implants. Believe it or not, most of the
“old guys” get it. Another possible theory is for a negative bias from a non-surgical foot
specialist who is not able to insert a sinus tarsi stent. How could that foot specialist sleep at
night after dispensing custom-made arch supports that provides the patient little to no
stabilization of their subtalar joint instability? There is no reduction or elimination of the
underlying etiology and it provides a “false sense of correction” to the patient. This should be
considered medical negligence.
Isn’t it the standard of care to take a proper history, to discover what kind of symptoms the
patient is experiencing? Symptoms like atraumatic, chronic pain to their knees, hips and back?
Or a history of growing pains or shin splints? Or a multitude of foot and ankle conditions that
are specifically linked to a hypermobile subtalar joint? How can a physician look at weight-
bearing radiographs and see an obliterated sinus tarsi with anteriorly deviated cyma, along with
a medial transverse plane rotation, and increased talar declination angle and tell their patient
that a foot orthotic will “fix it!” Where is the radiographic evidence that an arch support will
realign and stabilize the talus? Have you documented the “correction” achieved with this
device? Anything can be put in their shoe and it will feel different, and since it came from a
trusted medical professional, the patient will believe it is working. Optometrists could never get
away with it.
How many pairs of arch supports are sold to patients every day, week, month, or year? Most
likely, the majority of those patients are also potential candidates for a sinus tarsi implant. Yet,
these patients aren’t told that the sinus tarsi stent option exists. Going back to the standard of
care, isn’t it the responsibility of the physician to provide their patient with all or at least what
available options for care there are, even if there are associated complications and regardless
of insurance coverage? Every treatment offered has benefits as well as potential risks; the
patient is supposed to be the one to make their own medical decisions.
There is a long history on the use of sinus tarsi implants. And yes, there have been devices that
require removals. This happens with every single medical device. How many orthopedic screws
are removed daily? I had a close relative die as a result of a complication from the insertion of
an arterial stent. Does that make all arterial stents bad and that they should not be used or
even suggested to other patients who could have benefited from the device? Of course not, this
is why I don’t understand why there is such a push back for the use of sinus tarsi implants. I
have had my sinus tarsi stents in my feet for over 5 years. My wife and daughter also have
stents in both of their feet, for even longer. When the right patient is selected, the surgical
technique is followed and any secondary conditions are identified and addressed, conservative
or surgically, there will be more successes than failures.
There are some designs that have higher success rates over other designs. So, you have to make
sure you chose the design that makes the most sense to you as the surgeon. You should, of
course, do your homework on any available published studies. You may be surprised that there
is more literature available than most are aware of. It’s also very funny or strange that many
“non-believers” ask for literature regarding this fact or that fact, and this study or that study. To
be blunt, there will never be enough studies to change their minds. On the flip side, where are
the studies to show that a child with a misaligned hindfoot simply out-grows it? This is a major
myth. It is true that babies have “fat” feet and as they grow, the adipose tissue located in the
inner arch will disappear, however radiologically, a partially displaced talus has never been
shown to automatically realign and stabilize itself on the calcaneus.
For those of you who continue to believe the myth that children with a misaligned talus will
realign with age, walk into the office of any chiropractor and look at the feet of any patient with
chronic back pain, the majority have “over-pronated feet.” Go to a knee or hip surgeon’s office
and look at the feet of the patients who are having arthroscopic or joint replacement surgery.
The majority have misaligned, over-pronating feet. Finally, look at your own office and see how
many of your patients have chronic foot conditions that are related to a flexible, unstable,
misaligned subtalar joint. Did any of those patients outgrow their hypermobile talus deformity?
The global medical community is in a crisis trying to deal with the exploding costs of healthcare.
The underlying reason has to do with the lack of treating the underlying etiology. The majority
of medical specialists are mainly focused on the amelioration of symptoms and they ignore or
under treat the underlying etiology or cause of that symptom. Most of the chronic foot
deformities seen in the foot specialist’s office can be linked back to a hypermobile, displaced
talus. There is an abnormal transfer of forces anteriomedially, rather than posteriolaterally.
This increased anterior force wreaks havoc to the spring ligament, medial band of the plantar
fascia, increases the strain on the posterior tibial tendon, crushes the posterior tibial nerve
within the tarsal tunnel and porta pedis, produces an elongation of the posterior tibial nerve
within the tarsal tunnel and porta pedis, forces the first metatarsal anterior and/or medially,
produces flexor stabilization hammer toes, and is the cause of over-pronation of the foot. I
hope that no one is surprised about that information. You treat the secondary conditions yet,
leave the hypermobile, misaligned talus unchecked.
What is the leading complication to back, hip, knee, and foot conditions? Anyone, anyone? Yes,
you are right, it’s recurrence. Hammertoes can come back, bunion deformities reoccur, hallux
limitus reoccurs-unless the 1st metatarsophalangeal joint was fused. Knee implants wear out,
hip implants wear out, ankle implants wear out. Why? Perfectly designed devices, cleared by
the FDA were inserted by very skilled surgeons. The answer is that no one looked at the
misaligned talus. Think how much money would be saved if patient’s hindfoot was realigned
early in life and the over-pronation was internally corrected.
What are the worst complications that have occurred as the result of a sinus tarsi implant? No
one has died, no one has lost a leg, and there have been no long-term complications that have
occurred. There are more long-term complications that occur because nothing is done verses
from the insertion of a sinus tarsi implant. What are the complications of traditional
reconstructive surgery? There is a very long list of potential risks and complications. It is
common and also expected that patients will require additional surgical procedures either to
remove painful internal hardware or to revise failures.
It is my estimation that more people need sinus tarsi implants annually than the number of
arterial stents being placed. In the US there are roughly 310,000,000 people. I believe that at
least 20%; if not more than 30% have misaligned, over-pronating feet. That’s 62,000,000 people
x 2 feet that are possible candidates for an extra-osseous talotarsal stabilization procedure.
There are less than 8,000 people in the US a year having sinus tarsi implants placed into their
feet. To say that this procedure is being overused makes the accuser look absolutely
uninformed and inappropriately biased.
According to the American Academy of Implant dentistry, there are more than 500,000 dental
implants placed a year. While having a nice smile is pleasant, I believe having an aligned,
stabile, yet flexible subtalar joint is more important than a nice smile. Is that missing tooth
named as the leading underlying etiology to chronic musculoskeletal diseases? Yet, the dental
implant business is estimated to reach $6.4 billion within the US alone. For some reason, that is
acceptable, but Extra-Osseous TaloTarsal Stabilization (EOTTS) is not.
The time is now to recognize the need to properly diagnose our patients’ maladies and offer the
best care in pursuit of the best potential outcomes for the benefit of our patients and the global
health care systemwithout unwarranted bias. To this goal, it is the duty of the physician to be
fully educated and cognizant regarding diagnostic parameters and all treatment alternatives,
and to avail the alternatives to the patients with full disclosure about the care without insertion
of personal prejudice. To learn more about the importance of aligned feet and the EOTTS
option I urge you to visit www.AlignMyFeet.com.

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The Use and Perceived Abuse of Sinus Tarsi Stents

  • 1. The Use and Perceived “Abuse” of Sinus Tarsi Implants Michael E. Graham, DPM, FACFAS, FAENS, FAAFAS, FACFAP There was recently a post on social media by a “foot specialist” criticizing another foot surgeon for his positive use of a particular sinus tarsi stent claiming “over-use and abuse” of this implant and procedure. It has been a continued amazement to me how such a powerful, minimally invasive procedure has been shunned by so many in the very small “foot specialist” community. There is an obvious bias by some “small minded” physicians against this truly life changing procedure. The question I have to pose is why is the insertion of an FDA cleared medical device into a patient’s foot, who has documented symptoms, positive clinical and radiographic findings, so controversial? Of course there are the many theories including the “old dog, new trick story” yet, this is not the case. I’ve had the good fortune of lecturing and training foot surgeons all over the world on the indications and contra-indications, surgical technique, potential complications and how to prevent or handle them regarding the use of sinus tarsi implants. Believe it or not, most of the “old guys” get it. Another possible theory is for a negative bias from a non-surgical foot specialist who is not able to insert a sinus tarsi stent. How could that foot specialist sleep at night after dispensing custom-made arch supports that provides the patient little to no stabilization of their subtalar joint instability? There is no reduction or elimination of the underlying etiology and it provides a “false sense of correction” to the patient. This should be considered medical negligence. Isn’t it the standard of care to take a proper history, to discover what kind of symptoms the patient is experiencing? Symptoms like atraumatic, chronic pain to their knees, hips and back? Or a history of growing pains or shin splints? Or a multitude of foot and ankle conditions that are specifically linked to a hypermobile subtalar joint? How can a physician look at weight- bearing radiographs and see an obliterated sinus tarsi with anteriorly deviated cyma, along with a medial transverse plane rotation, and increased talar declination angle and tell their patient that a foot orthotic will “fix it!” Where is the radiographic evidence that an arch support will realign and stabilize the talus? Have you documented the “correction” achieved with this device? Anything can be put in their shoe and it will feel different, and since it came from a trusted medical professional, the patient will believe it is working. Optometrists could never get away with it. How many pairs of arch supports are sold to patients every day, week, month, or year? Most likely, the majority of those patients are also potential candidates for a sinus tarsi implant. Yet, these patients aren’t told that the sinus tarsi stent option exists. Going back to the standard of care, isn’t it the responsibility of the physician to provide their patient with all or at least what available options for care there are, even if there are associated complications and regardless
  • 2. of insurance coverage? Every treatment offered has benefits as well as potential risks; the patient is supposed to be the one to make their own medical decisions. There is a long history on the use of sinus tarsi implants. And yes, there have been devices that require removals. This happens with every single medical device. How many orthopedic screws are removed daily? I had a close relative die as a result of a complication from the insertion of an arterial stent. Does that make all arterial stents bad and that they should not be used or even suggested to other patients who could have benefited from the device? Of course not, this is why I don’t understand why there is such a push back for the use of sinus tarsi implants. I have had my sinus tarsi stents in my feet for over 5 years. My wife and daughter also have stents in both of their feet, for even longer. When the right patient is selected, the surgical technique is followed and any secondary conditions are identified and addressed, conservative or surgically, there will be more successes than failures. There are some designs that have higher success rates over other designs. So, you have to make sure you chose the design that makes the most sense to you as the surgeon. You should, of course, do your homework on any available published studies. You may be surprised that there is more literature available than most are aware of. It’s also very funny or strange that many “non-believers” ask for literature regarding this fact or that fact, and this study or that study. To be blunt, there will never be enough studies to change their minds. On the flip side, where are the studies to show that a child with a misaligned hindfoot simply out-grows it? This is a major myth. It is true that babies have “fat” feet and as they grow, the adipose tissue located in the inner arch will disappear, however radiologically, a partially displaced talus has never been shown to automatically realign and stabilize itself on the calcaneus. For those of you who continue to believe the myth that children with a misaligned talus will realign with age, walk into the office of any chiropractor and look at the feet of any patient with chronic back pain, the majority have “over-pronated feet.” Go to a knee or hip surgeon’s office and look at the feet of the patients who are having arthroscopic or joint replacement surgery. The majority have misaligned, over-pronating feet. Finally, look at your own office and see how many of your patients have chronic foot conditions that are related to a flexible, unstable, misaligned subtalar joint. Did any of those patients outgrow their hypermobile talus deformity? The global medical community is in a crisis trying to deal with the exploding costs of healthcare. The underlying reason has to do with the lack of treating the underlying etiology. The majority of medical specialists are mainly focused on the amelioration of symptoms and they ignore or under treat the underlying etiology or cause of that symptom. Most of the chronic foot deformities seen in the foot specialist’s office can be linked back to a hypermobile, displaced talus. There is an abnormal transfer of forces anteriomedially, rather than posteriolaterally. This increased anterior force wreaks havoc to the spring ligament, medial band of the plantar fascia, increases the strain on the posterior tibial tendon, crushes the posterior tibial nerve within the tarsal tunnel and porta pedis, produces an elongation of the posterior tibial nerve within the tarsal tunnel and porta pedis, forces the first metatarsal anterior and/or medially,
  • 3. produces flexor stabilization hammer toes, and is the cause of over-pronation of the foot. I hope that no one is surprised about that information. You treat the secondary conditions yet, leave the hypermobile, misaligned talus unchecked. What is the leading complication to back, hip, knee, and foot conditions? Anyone, anyone? Yes, you are right, it’s recurrence. Hammertoes can come back, bunion deformities reoccur, hallux limitus reoccurs-unless the 1st metatarsophalangeal joint was fused. Knee implants wear out, hip implants wear out, ankle implants wear out. Why? Perfectly designed devices, cleared by the FDA were inserted by very skilled surgeons. The answer is that no one looked at the misaligned talus. Think how much money would be saved if patient’s hindfoot was realigned early in life and the over-pronation was internally corrected. What are the worst complications that have occurred as the result of a sinus tarsi implant? No one has died, no one has lost a leg, and there have been no long-term complications that have occurred. There are more long-term complications that occur because nothing is done verses from the insertion of a sinus tarsi implant. What are the complications of traditional reconstructive surgery? There is a very long list of potential risks and complications. It is common and also expected that patients will require additional surgical procedures either to remove painful internal hardware or to revise failures. It is my estimation that more people need sinus tarsi implants annually than the number of arterial stents being placed. In the US there are roughly 310,000,000 people. I believe that at least 20%; if not more than 30% have misaligned, over-pronating feet. That’s 62,000,000 people x 2 feet that are possible candidates for an extra-osseous talotarsal stabilization procedure. There are less than 8,000 people in the US a year having sinus tarsi implants placed into their feet. To say that this procedure is being overused makes the accuser look absolutely uninformed and inappropriately biased. According to the American Academy of Implant dentistry, there are more than 500,000 dental implants placed a year. While having a nice smile is pleasant, I believe having an aligned, stabile, yet flexible subtalar joint is more important than a nice smile. Is that missing tooth named as the leading underlying etiology to chronic musculoskeletal diseases? Yet, the dental implant business is estimated to reach $6.4 billion within the US alone. For some reason, that is acceptable, but Extra-Osseous TaloTarsal Stabilization (EOTTS) is not. The time is now to recognize the need to properly diagnose our patients’ maladies and offer the best care in pursuit of the best potential outcomes for the benefit of our patients and the global health care systemwithout unwarranted bias. To this goal, it is the duty of the physician to be fully educated and cognizant regarding diagnostic parameters and all treatment alternatives, and to avail the alternatives to the patients with full disclosure about the care without insertion of personal prejudice. To learn more about the importance of aligned feet and the EOTTS option I urge you to visit www.AlignMyFeet.com.