EOTTS: Benefit vs. Risk Analysis

E.O.T.T.S.
BENEFIT – RISK ANALYSIS

Therapeutic Decision
Natural Progression of
Recurrent TaloTarsal
Dislocation
Risks of
Treatment
Benefit-Risk
Analysis
Benefits of
Treatment

Natural Progression of RTTD
• Foot and ankle complications- (repetitive strain injury)
• Musculoskeletal chain effects
• Overall Health
• Economic factors

Foot and Ankle Complications
• Increased forces acting on the medial
column of the foot.
• Increased strain to
– spring ligament
– Posterior tibial tendon
– Medial band of the plantar fascia
– Tibialis posterior nerve
• Increased pressures within the tarsal
tunnel.

Proximal Musculoskeletal Effects
• Talus dislocates off
calcaneus
• Tibia/fibula internally rotates
• Twisting of the knee
• Head of the femur is pulled
from the hip (leg length
discrepancy)
• The pelvis tilts
• Stain/torsion on the back
• Shoulders tilt
• Neck strain

General Health
• Because of the inefficient talotarsal mechanism
– Tendons and muscles have to work harder
– Activity leads to increased generalized soreness
– Suffer due to activity, decrease activity level
– Decreased activity level leads to decreased
metabolism
– Decreased metabolism leads to increased weight

Increased weight leads to

Economic Factors
Continued pain leads to
“self-remedies/treatment” costs
OTC medications
buying special shoes
Medical costs
PCP, foot specialist, chiropractor,
orthopedist, physical therapist.
Insurance costs, co-pays, medicine, arch
supports, braces, other
Time away from work
when patients are away from work they aren’t
making money, they are losing money.

Emotional Factors
• Patients end up in a downward spiral
– Signs and symptoms get worse
– Psychological factors- “why can’t I get better”
– Affects the relationship with their loved ones
– They are in a losing battlei

Benefits
• Physiologic Measurements
• Clinical Events (disability, disease,
dissatisfaction, discomfort, destitution)
• Symptoms (difficulty walking, pain)
• Functional Measurements (quality of life)

Benefits
• Clinical benefits
• Absolute benefits- reduction in disability,
morbidity, and mortality
• Economic benefits
• Patient centered benefits (quality of life)

Benefits of EOTTS Treatment
• Internal option – does not rely on patient
compliance (arch support, brace, shoes)
• Extra-osseous – does not involve bone
surgery
• Minimally invasive soft tissue procedure
• Can be performed as a stand-alone
procedure or in conjunction with other
procedures.
• EOTTS devices are reversible, they can be
removed with minimal effort.

• Stabilization of the talotarsal mechanism
• Elimination of excessive talotarsal motion
• Articular facets remain in constant congruent
contact
• Reduction in excessive forces acting on the
osseous and soft tissues
• TTM is now an efficient machine

• Decreased stain to the knee
• Head of the femur is no longer pulled from the
hip – leg length discrepancy
• Pelvis is aligned
• Decreased stain to lower and upper spine
• Shoulders balanced
• Decrease strain to neck and TMJ

• Patients have a more efficient gait cycle
• Easier to walk/run
• Become more active
• Increase metabolism
• Decrease weight
• Lower blood pressure
• Lower blood sugar

Risks of EOTTS Option
• This is a surgical procedure and is therefore
subject to certain risks and potential
complications.
– Anesthesia Risks
– Surgical Procedure Risks
– Device Risks
– Post-Procedure Risks

Risks of EOTTS Treatment
Anesthesia Risks
• EOTTS procedure is usually performed under
“Twilight” or light sedation.
– Medication is given through the IV
– Patient is breathing on their own
– Fast acting
– Since the EOTTS procedure is relative quick (< 30)
the patient is not required to be under this form
of anesthesia for a prolonged period of time.

Surgical Procedure
• EOTTS is minimally invasive
• Incision is < 2 cm
• No major blood vessels, nerves, or
tendons in the surgical area
• No tourniquet is necessary
• No bone involvement
• Soft tissue procedure
• Relatively atraumatic

Device Risks
• EOTTS (HyProCure®) is entirely made
from medical grade titanium
• Titanium is considered the safest
material placed into the body
– Non-reactive
– Has a long life cycle
– Doesn’t set off metal detectors
– Patients can still have MRI or CT imaging

Device Risks
• EOTTS devices are placed into the sinus
tarsi.
• They are anchored into the sinus tarsi by
adherence of the soft tissues within the
sinus tarsi.
• In addition, the osseous chamber forming
the sinus tarsi needs to be complete. In
other words a full oval shape is needed.
The upper ½ is formed by the talus, the
lower ½ by the calcaneus.

• Device displacement
– HyProCure is not anchored into bone. The tissues
and the osseous chamber hold it in place
– It is possible that the soft tissues have been
eroded due to the chronicity of the RTTD disease
process or there is osseous malformation of the
middle/anterior facet either one could lead to
device displacement.

• Device displacement
– It could take up to 4 to 6 weeks or longer for the
soft tissues to adhere to the device to hold it in
place (this is not scientifically proven).
– Could result from a patient who is too active, too
soon or wearing improper shoes or from a
traumatic episode such as a severe ankle sprain

• Inability to achieve stabilization
– Even though the device is adequately placed there
could be an unforeseen osseous deformity such as
erosion of the dorsal lip on the posterior aspect of the
middle/anterior facet. This lip acts as a counterforce
to aid in the stabilization achieved by the device.
– Middle/Anterior facet erosions means that the facets
are flat so the device is just pushed anteriomedially
and there is minimal to no correction achieved.

Device Risks
• Under/Over-correction
– Trial sizing is performed while the individual is
laying on the operating-room table, it is not
possible to insert the trial sizer and have the
patient stand.
• Misc. Device Risks
– Clicking feeling when walking (temporary)

Post Procedure Risks
• Incision
– Delayed healing
– Suture reaction
– Scar tissue formation
• Swelling
– Both to the local procedure area as well as
generalized to the foot, ankle, and lower leg.

• Pain
– This is a surgical procedure and pain will be expected
after the procedure.
– Some patients experience very little discomfort and
only need anti-inflammatory meds whereas other
patients could experience significant pain requiring
pain medication.
– For patients who have pain, it could be shorted term
for only a few minutes to hours whereas others could
experience pain long term, from weeks to months.
– It is impossible to guess who will experience more
pain than others.
– Pain level can vary from foot to foot.

• Period of abnormal walking
– Due to
• corrected foot position
• Natural post-procedure guarding tendency
• bandaging
• shoe-gear
• post-op pain
– there is expected to be a temporary period of
walking abnormally.
– Just like post-op pain, some individuals will
walk normal right away, whereas other could
take weeks to months to walk “normal” again.

• “Sprained Ankle” Syndrome
– Feeling like the patient suffers from a sprained
ankle.
– Area surrounding the front of the fibular
malleolus
– Pain is present when first getting out of bed in
the AM or after prolonged period of NWB.
– After a few minutes (5 to 15) pain subsides
– Due to adaptations of the anterior talofibular
ligament

• “Sprained Ankle” Syndrome
– This is considered a somewhat common side effect (1
in 10 to 1 in 100 individuals)
– Could range from very mild and short-term to very
severe and long-term ultimately requiring the need for
device removal.
– The chance of permanent device removal is
uncommon (1 in 100 to 1 in 1000)
– Usually with proper shoe-gear, reduction in activity
level, oral anti-inflammatories, a series of steroid
injections leads to resolution of this condition.
– It is possible that a revision to a smaller size device
could be a good solution.

• EOTTS Migration-Displacement
– It is possible that the device could shift from its initial
placement during the surgical procedure
– Goes back to the fact that EOTTS devices are placed
into the sinus tarsi when the patient is non-
weightbearing, upon weight-bearing the device may
“seek it’s own level” since it is not anchored into bone.
– There is an allowable variation in device placement that
is acceptable.
– Bottom line is: if the device is maintaining correction
and not give the patient pain- let it be.
– On the other hand, if there is loss of correction or
unexpected pain from the displaced device a revision is
warranted.

• Synovitis
– This is an inflammatory reaction with drainage
– Could result from a/the pre-existing chronic
internal inflammatory process within the sinus
tarsi.
– Could mimic a foreign-body reaction (unlikely
due to the use of titanium)
– Self-resolving condition
– Chance of this occurring is uncommon (1:100
to 1:1000)

• Generalized foot, ankle, or leg soreness
– Since the TTM is stabilized there are
potentially new forces acting on tissues that
just aren’t used to them.
– Extensor tendons, middle/lateral band of the
plantar fascia (middle of the arch).
– Muscles that haven’t been working as they
should now have to work harder.
– Temporary effect and is uncommon
– If present it is self resolving within a matter of
days to weeks.

Benefit – Risk Analysis
• Overwhelming majority of patients have
benefited from the EOTTS treatment option.
• Adverse events and side effects are generally
uncommon; however they do occur and this
impact is disproportionate relative to the
number of patients receiving a benefit. This is
due to the emotional component associated
with the risks. Nonetheless, risks do cause
harm, and they do occur randomly and may
appear unexpectedly.

EOTTS Benefit – Risk Analysis
Benefits
• Internal permanent (but
reversible) option
• Scientifically proven to
decrease strain to the most
important structures within
the foot.
• Far reaching benefits up the
musculoskeletal chain.
• Overall health and well-being
are positively affected.
Risks
• Every solution has the
potential of creating new
problems.
• Potential risks are, for the
most part, short-term & self
resolving.
• The EOTTS device can be
removed and any complication
SHOULD/WOULD be expected
to resolve.

EOTTS Benefit – Risk Analysis
• The benefits of EOTTS must be considered
greater than the potential risks.
• This is a case by cases, foot by foot decision.
• EOTTS is an elective procedure and therefore
ultimately it is up to the patient or the
patient’s guardian to make the final call to
give consent to undergo this procedure.

EOTTS: Benefit vs. Risk Analysis

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