Myths and Misconceptions of HyProCure

The Myths & Misconceptions of HyProCure®

AlignMyFeet.com I © GraMedica®2
Introduction
Sinus tarsi implants have been used for decades
to address the underlying reason for many aches
and pains that occur in the feet, legs, hips and
back. These devices have been found to be effective
in getting patients back on their feet. However,
some of these devices have proven to be more
successful than others and because of this, there
are misconceptions behind their use.
Before any surgeon or patient decides to move
forward with any procedure, they should find out
which stories are fact and which are pure fiction.
This ebook will help to remedy any concerns you
might have when offering this treatment to a patient,
or considering this treatment for yourself or a loved
one.

AlignMyFeet.com I © GraMedica® 3

The
& Misconceptions
of HyProCure

Myths & Misconceptions
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+ Sinus tarsi devices are all the same.........................................................................................................
+ Don’t worry about your child’s misaligned feet. They’ll outgrow it............................................................
+ You don’t need a stent, we’ll just get you a pair of arch supports............................................................
+ There is limited scientific proof that sinus tarsi stents work......................................................................
+ Those implants will destroy the joints and bones.....................................................................................
+ They should only be used in combination with other procedures..................................................................
+ They must be replaced upon osseous maturity, so it’s better to wait until adulthood................................
+ What if it has to removed?.......................................................................................................................
+ You have to cut an “important structure” to place the stent.....................................................................

+ HyProCure is only used to fix flat feet.....................................................................................................
+ Sinus tarsi stents are being over-used....................................................................................................
+ Insurance companies call it experimental, so it must not work................................................................
+ It’s better to perform a traditional reconstructive surgery.........................................................................
+ These should never be used in diabetic patients.....................................................................................
+ If HyProCure would have been offered earlier, this could have been prevented.......................................
+ Conclusion.............................................................................................................................................
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Sinus tarsi devices are all the same.
Truth
There are actually several different types of sinus tarsi implants on the market.
Myths & Misconceptions #1
1. Intra-osseous Devices—Drilled into the hindfoot bones (rarely performed in the USA)
2. Extra-osseous Devices—Inserted into the soft-tissues of the sinus tarsi space.
Type I “arthroereisis”
• Placed into the outer half of the sinus tarsi.
• Function by blocking the motion of the ankle bone.
• High removal rate (30%-100%)
Type II “non-arthroereisis”
• Placed much deeper in the sinus tarsi
• Function by allowing natural range of motion
• Significantly lower removal rate (<6% vs >40%)

Type I arthroereisis device on
the undersurface of the talus.
Type II non-joint blocking device
on the undersurface of the talus.
Type I devices stabilize
the talus here.
Type II devices
stabilize the talus
here.
Bottom line
Type I “arthroereisis” devices have a higher likelihood of displacement and/or removal than Type II non-joint blocking
devices. Make sure your surgeon is using HyProCure, the implant with the highest rate of success.

Don’t worry about your child’s
misaligned feet. They’ll outgrow it.
Truth
A pediatric patient will not outgrow misaligned
feet and they will not auto-correct over time.
When the feet are over-pronated, or misaligned,
it alters the function within the foot and negatively
affects the knees, hips, and back. The most
common cause of misaligned feet is a partial
dislocation of the ankle bone (talus).
A common misconception is that children outgrow
misaligned feet. However, there is no medical
evidence to prove this is true. In fact, a number
of studies have proven that the longer a child’s
misaligned feet are ignored, the higher the
likelihood they will suffer from chronic pain and
irreversible damage throughout the musculoskeletal
structure as they age. ref
Case in point
Walk into any chiropractor’s office to see the number
of patients with chronic back pain who have
misaligned feet. If you still aren’t convinced, go
to any orthopedic surgeon’s office to see the
correlation between patients who have chronic
knee or hip pain who also have misaligned feet.
These are the same patients that would, and still
could, benefit from a sinus tarsi implant.
Bottom line
Misaligned feet need to be treated sooner rather
than later.

This patient’s feet will not auto-correct.
This is the same patient after HyProCure.Progression of an untreated pediatric foot

You don’t need a stent, we’ll just get you a pair
of arch supports.
Truth
Arch supports are not corrective, they are
supportive. They can provide a false-sense
of treatment.
While there are great benefits that can be achieved
with arch supports, there is no evidence that an
arch support (even one that is custom made for
your foot) will realign and stabilize the ankle bone. ref
There is an easy way to verify this claim—simply
have your foot doctor take x-rays of while you are
standing on your foot and take a second set of
x-rays with the arch support under your foot.
There should be a realignment of the ankle bone.
The evidence shows that something placed on the
bottom of your foot simply doesn’t work. Furthermore,
there are certain cases where specific radiographic
measurements have worsened. ref
It is possible that an arch support can provide you
relief with your symptom and we are happy about
that, however there are hundreds of thousands of
patients who are wearing their arch support with the
hope their symptoms will go away and they aren’t.
These are the patients that could stand to benefit
from a sinus tarsi stent.

These x-rays show that something placed below the bone cannot realign or stabilize the ankle bone.

There is limited scientific proof that sinus
tarsi stents work.
Truth
There is a long list of peer-reviewed, scientific
studies and medical journals that have been
conducted by medical professionals from all
over the world.
HyProCure has been used in both children and
adults for several decades, but critics have continued
to downplay and ignore the scientific results.
Did you know?
Many foot surgeons have implanted HyProCure
into their own feet and have trusted it to be used
by their parents, children, friends and relatives.
Furthermore, the FDA and similar governmental
agencies around the world have cleared HyProCure
to be used in more than 60 countries around the world.

There is a large database of studies to support
the use of HyProCure. They include:
+ Retrospective studies
+ Radiographic studies
+ Soft tissue studies
+ Tolerability/removal rate studies
+ Prospective study
+ Out-come studies
Click Here to view published studies.

Those implants will destroy the joints and
bones.
Truth
HyProCure is placed into a naturally occurring
space, not into a joint or bone.
There are multiple papers that show clinical and
radiographic normalization of the misaligned
hindfoot. There is no evidence that a correctly sized
and properly positioned stent will lead to joint
destruction. Actually, the reverse is true.
The use of a sinus tarsi stent will help to restore
joint function and it serves to decrease the change
of arthritis to the joint.
Bottom line
There is no evidence to show that a sinus tarsi
stent has led to joint or bone destruction. Furthermore,
bone and joint destruction is far more likely, and in
most cases inevitable, to occur without the use of
a stent, then with one.
Click Here to view published studies.

This is what happens without early intervention
Here you can see how the prolonged collapse of the sinus tarsi has affected the musculoskeletal
structure of the foot.

They should only be used in
combination with other procedures.
Truth
It depends on how misaligned the foot is, and if
there are other parts of the foot that also need
to be surgically repaired.
Traditionally, the use of a sinus tarsi implant was com-
bined with other surgical procedures, but HyProCure
has shown to be very effective as a stand-alone
procedure, when indicated. In fact, HyProCure can be
used as a stand-alone, or in combination with other
surgical procedures to maximize results.
Keep in mind that each foot must be fully evaluated
and all co-existing conditions should be addressed
conservatively or surgically, when indicated.
There are published studies proving that HyProCure
can be used in pediatric and adult patients as a
stand-alone, when indicated.
Click Here to view studies
Before & after x-rays of a stand-alone procedure

This x-ray shows the abnormal alignment
of the ankle bone.
This is the same foot after the insertion of
HyProCure.

They must be replaced upon osseous maturity,
so it’s better to wait until adulthood.
Truth
The chamber that forms the sinus tarsi
becomes ossified by age 3, so it stays
roughly the same size while the talus and
calcaneus continue to grow peripherally.
Some foot specialists think that when a sinus tarsi
implant is placed into a pediatric patient’s foot,
they will outgrow it, and it will need to be replaced
later on in life. Therefore, the patient should wait
until their bones have stopped growing to have their
ankle bone stabilized and aligned.
However, it has been found that the most common
HyProCure sizes used in adult and pediatric patients
are sizes 6 and 7. Therefore, if a child has a 6 or
7 placed in their foot, they already have the most
common adult size.
While there are no guarantees that a HyProCure
stent placed into a child’s foot will never need a
revision later in life, the likelihood of this is minimal.
In the case of preventing damage to the hindfoot,
it is better to risk a potential revision, than to wait
till the body stops growing to correct a misalignment.
Pediatric Patient Adult Patient

What if it has to be removed?
Truth
A HyProCure procedure is reversible, unlike
traditional reconstructive surgery.
30% of orthopedic surgical procedures involve the
removal of internal hardware. The obvious goal is
to use a device that is meant to remain in place for
the rest of the recipient’s life.
In terms of success rates, HyProCure has the
highest success rate of sinus tarsi implants. ref
There is still a small percentage of patients who
had to have the device removed, even when
fully indicated, but as with all surgical procedures,
there isn’t a 100% guarantee.
Bottom Line
The benefits of placing a HyProCure into the sinus
tarsi of patients who are candidates has shown
more benefits than risks. When indicated, it is
worth the attempt to prevent further damage to
the hindfoot, as shown in the photo below.

You have to cut an “important
structure” to place the stent.
Truth
The HyProCure stent is inserted into a natural
occurring space called the sinus tarsi. It replaces
a dysfunctional ITCL.
Within the sinus tarsi is a ligament that helps connect
the ankle bone to the heel bone and maintain
ankle bone alignment. That structure is called the
interosseous talocalcaneal ligament (ITCL). It is
one of many ligaments that serve to control ankle
bone motion.
Candidates for HyProCure have an ITCL that does
not function properly, so HyProCure simply replaces
it. Furthermore, the ITCL is not removed. A simple
cut is made through the mid-portion of the tissue.
When the stent is inserted, the cut fibers heal back
together around the stent. This actually helps anchor
the HyProCure stent within the sinus tarsi space.
Unfortunately, there are patients whose ITCL is
completely worn away due to the years of the ankle
bone grinding on the heel bone. These patients may
have a higher rate of stent displacement because
their anchoring mechanism has been compromised.
Bottom line
HyProCure replaces the function of the ITCL. ref

When the skin is cut, it heals.
When a bone is cut, it heals.
When a ligament is cut, it also heals.

HyProCure is only used to fix flat feet.
Truth
The actual indication for HyProCure is to maintain the alignment
of the ankle bone while allowing normal range of motion to occur.
Many doctors think that HyProCure is only used to “fix flat” feet, but
there are many different symptoms that can occur when the ankle
bone slides from its normal position onto the heel bone. The flexible
misalignment of the hindfoot leads to over-pronation, which is named
as the leading cause of foot deformities. Additionally, over-pronation
is named as the leading cause of a long list of issues to the legs,
knees, hips, and back.
Bottom line
HyProCure fixes only one problem: partial talotarsal joint dislocation.
However, fixing partial talotarsal dislocation helps to reduce, or
eliminate many other seemingly unrelated symptoms that are caused
by a flexible, misaligned hindfoot, including flat feet.
Images show a partial dislocation
of the ankle bone on the heel bone,
with a visible arch.

Sinus tarsi stents are being over-used.
Truth
The insertion of HyProCure is one of the most
under-utilized orthopedic procedures.
There are certain non-HyProCure advocates who
claim that the surgeons who are advocates place
too many stents. There were approximately 5.3
million orthopedic procedures performed in 2010
in the USA, while there are only a few thousand
HyProCure placements a year.
Bottom Line
The number of patients who have foot, knee, hip,
and back surgery that will have a recurrence of the
pain they were trying to rid themselves of because
their foundation, or talotarsal, joint wasn't realigned.
Analysis of Procedures
Performed in 2011
741,700 spine surgeries
> 310,000 hip joint replacements
> 700,000 knee replacements
> 1,000,000 arthroscopic surgeries
> 1,000,000 foot surgeries

Insurance companies call it
experimental, so it must not work.
Truth
HyProCure is by no means experimental. It was FDA cleared in
2004, CE marked in 2006, and has been declared safe for use in
nearly 60 countries.
Some insurance companies have made claims that HyProCure is
experimental, while others will pay for HyProCure. There are others that
want your only option to be no-care or traditional reconstructive surgery.
Bottom line
Don’t let the insurance carriers dictate your medical decisions, the insertion
of HyProCure can be a very affordable procedure.

It’s better to perform a traditional
reconstructive surgery.
Truth
In many cases, jumping to reconstructive
surgery may be too aggressive and could still
lead to further complications.
It depends on the flexibility of the hindfoot, as well
as other coexisting issues. While there are severe
conditions where reconstructive surgery is the only
option, this can only be determined after a physical
examination by a qualified foot specialist.
Bottom line:
All treatment options should be assessed. The correct
option will ultimately depend on the flexibility and
severity of the foot misalignment.
Reversible
Early weightbearing
Low risk of
permanent removal
Minimally invasive
procedure
No scientific evidence linking
HyProCure to arthritis
Irreversible
Extended period of
non-weightbearing
Patient will require more
surgery to remove painful
screws/pins
Typically involves multiple
incisions
Proven to cause arthritis
in adjacent joints
HyProCure Procedure Reconstructive Surgery
Quick Comparison

These should never be
used in diabetic patients.
Truth
Diabetes itself is not a contra-indication. The
fact that a potential EOTTS with HyProCure
candidate has diabetes, has no bearing on
patient selection.
HyProCure has been used in patients with diabetes
for more than 10 years. There isn’t a single case
that proves there was an issue linked to diabetes.
To the contrary, there have been many positive
outcomes with the use of HyProCure in diabetic
patients. Post surgery, they are able to increase
their activity level and even show improvement in
blood sugar levels.
Additionally, there are positive attributes of a
realigned hindfoot on decreasing the pressures
and strain acting on the posterior tibial nerve
and it’s branches. The plantar foot pressures have
also been improved.
Studies have shown that peak pressures on the
bottom of a misaligned foot can lead to ulcers in
some people with diabetes. HyProCure has been
clinically proven to redistribute pressure to the bottom
of the foot.
Their have also been reports of surgeons using
HyProCure in conjunction with a tendoAchilles
lengthening in patients who are at high risk of
developing a Charcot foot.*
* HyProCure should not be used in a patient with an active—acute Charcot neuroarthopathy.

The red and orange areas in this image show areas with
the most pressure under the foot. The image on the left is of
a misaligned foot. Notice the red area on the ball of the foot
where the foot pressures are unevenly distributed. This is an
area where a foot ulcer is likely to occur.
Compare with the right image after the insertion of HyProCure.
The foot pressures are more evenly distributed decreasing
the likelihood that an ulcer will form.
Bottom line:
There are no additional risk factors linked to use in diabetic
patients. In fact, HyProCure has been shown to have positive
effects when used in patients with diabetes, when indicated.

If HyProCure would have been offered
earlier, this could have been prevented.
The Bottom Line
This is the result of years of neglecting to address a
collapsed sinus tarsi. This patient could have been
a candidate for HyProCure*, but will most likely need
to resort to reconstructive surgery to fix the extensive
amount of damage that has been allowed to occur.
Here you can see a less severe case of Hyperpronation.
Because its been treated with HyProCure, the rolling
inwards of the ankle has been corrected and any
further damage to the sinus tarsi will be prevented.
This is the result of “conservative” care. Treated with HyProCure
Before After
*along with any additional treatment measures, to decrease the forces acting on the midfoot.

Conclusion
The benefits of HyProCure have proven to be
superior to conservative measures, as well as
aggressive surgical correction.
Here are the HyProCure facts:
• HyProCure stent was FDA cleared, in 2004,
for use in children and adults, when indicated.
• There is extensive published, peer-reviewed,
scientific evidence that shows HyProCure realigns
the hindfoot and decreases the strain/forces acting
on the structures within the foot.
• Ankle bone displacement leads to the majority of
foot and ankle disorders.
• A displaced ankle bone will throw the body out
of alignment, resulting in negative effects to the
knees, hips, and back.

www.HyProCure.com
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Learn More About Hindfoot Misalignment at
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A body at rest seeks more rest.
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Myths and Misconceptions of HyProCure

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