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Risks and Potential Complications of
EOTTS Treatment
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 EOTTS Procedure Complications
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.
Risks of EOTTS Treatment
Surgical Procedure
• EOTTS is typically performed with an
incision about 1 inch long
• No major blood vessels, nerves, or
tendons in the surgical area
• No tourniquet is necessary
• No bone involvement
• Soft tissue procedure
• Relatively atraumatic
Risks of EOTTS Treatment
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- strong and durable
– Doesn’t set off metal detectors
– Patients can still have MRI or CT imaging
Risks of EOTTS Treatment
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.
Risks of EOTTS Treatment
• 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
Risks of EOTTS Treatment
• 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.
Risks of EOTTS Treatment
Risks of EOTTS Treatment
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.
– Trial sizing can sometimes result in similar
correction between two different sizes (1 mm
difference) so it is generally recommended to
use the smaller size (it is better to under-
correct than to over-correct).
Risks of EOTTS Treatment
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.
Risks of EOTTS Treatment
Post Procedure Risks
• 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.
– The amount and duration of pain varies from foot to
foot.
Risks of EOTTS Treatment
Post Procedure Risks
• 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 (how long varies from foot to
foot).
– 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
– Outer ankle feels like it is sprained.
– Front of the outer ankle bone
– 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
Risks of EOTTS Treatment
Post Procedure Risks
• “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 more
severe and longer-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 and 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.
Risks of EOTTS Treatment
Post Procedure Risks
• 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 given 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
may be warranted.
Risks of EOTTS Treatment
Post Procedure Risks
• Synovitis
– This is an inflammatory reaction with drainage
– Most likely due to 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)
Risks of EOTTS Treatment
Post Procedure Risks
• Generalized foot, ankle, or leg soreness
– Since the bones are now stabilized there are
potentially new forces acting on tissues that
just aren’t used to them.
– Specific tissues are the muscles, tendons and
ligaments to the lower leg, ankle and foot.
– 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.
Risks of EOTTS Treatment
Post Procedure Risks
• Misc. Device Risks
– Clicking feeling when walking (temporary)
– This is uncommon and could occur early in
the recovery period
– Only a matter of time before this clicking
resolves.
Risks of EOTTS Treatment
Post Procedure Risks
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.
• There has not been a single case of fracture to
the ankle or heel bone since the first use of
HyProCure in 2004 and over 20,000 device
placements .
EOTTS – HyProCure
Possibility of
• There has not been a single case where a
HyProCure device has been proven to case
arthritis to the subtalar joint.
• HyProCure should prevent arthritis not lead
to arthritis because it stabilizes the joint and
prevents the excessive wear and tear that
leads to arthritis.
EOTTS –
Possibility of Leading to Subtalar Joint
Arthritis.

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Risks and Potential Complications of EOTTS Treatment

  • 1. Risks and Potential Complications of EOTTS Treatment
  • 2. 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 EOTTS Procedure Complications
  • 3. 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.
  • 4. Risks of EOTTS Treatment Surgical Procedure • EOTTS is typically performed with an incision about 1 inch long • No major blood vessels, nerves, or tendons in the surgical area • No tourniquet is necessary • No bone involvement • Soft tissue procedure • Relatively atraumatic
  • 5. Risks of EOTTS Treatment 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- strong and durable – Doesn’t set off metal detectors – Patients can still have MRI or CT imaging
  • 6. Risks of EOTTS Treatment 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.
  • 7. Risks of EOTTS Treatment • 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.
  • 8. • 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 Risks of EOTTS Treatment
  • 9. • 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. Risks of EOTTS Treatment
  • 10. Risks of EOTTS Treatment 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. – Trial sizing can sometimes result in similar correction between two different sizes (1 mm difference) so it is generally recommended to use the smaller size (it is better to under- correct than to over-correct).
  • 11. Risks of EOTTS Treatment 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.
  • 12. Risks of EOTTS Treatment Post Procedure Risks • 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. – The amount and duration of pain varies from foot to foot.
  • 13. Risks of EOTTS Treatment Post Procedure Risks • 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 (how long varies from foot to foot). – Just like post-op pain, some individuals will walk normal right away, whereas other could take weeks to months to walk “normal” again.
  • 14. • “Sprained Ankle” Syndrome – Outer ankle feels like it is sprained. – Front of the outer ankle bone – 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 Risks of EOTTS Treatment Post Procedure Risks
  • 15. • “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 more severe and longer-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 and 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. Risks of EOTTS Treatment Post Procedure Risks
  • 16. • 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 given 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 may be warranted. Risks of EOTTS Treatment Post Procedure Risks
  • 17. • Synovitis – This is an inflammatory reaction with drainage – Most likely due to 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) Risks of EOTTS Treatment Post Procedure Risks
  • 18. • Generalized foot, ankle, or leg soreness – Since the bones are now stabilized there are potentially new forces acting on tissues that just aren’t used to them. – Specific tissues are the muscles, tendons and ligaments to the lower leg, ankle and foot. – 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. Risks of EOTTS Treatment Post Procedure Risks
  • 19. • Misc. Device Risks – Clicking feeling when walking (temporary) – This is uncommon and could occur early in the recovery period – Only a matter of time before this clicking resolves. Risks of EOTTS Treatment Post Procedure Risks
  • 20. 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.
  • 21. 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.
  • 22. 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.
  • 23. • There has not been a single case of fracture to the ankle or heel bone since the first use of HyProCure in 2004 and over 20,000 device placements . EOTTS – HyProCure Possibility of
  • 24. • There has not been a single case where a HyProCure device has been proven to case arthritis to the subtalar joint. • HyProCure should prevent arthritis not lead to arthritis because it stabilizes the joint and prevents the excessive wear and tear that leads to arthritis. EOTTS – Possibility of Leading to Subtalar Joint Arthritis.