HyProCure is an extra-osseous talotarsal stabilization device used for flexible talotarsal dislocation. There are many perceived myths and misconceptions that are addressed in this presentation.
Learn more at www.GraMedica.com or www.HyProCure.com.
7. the birth of
extra-articular talotarsal stabilization
stemmed as an alternative over
arthrodesis procedures in
pediatric patients.
(Chambers, 1946)
7
8. The first generation arthroereisis devices were
made of high-grade medical plastics/silicone
and were theorized to be “too weak” for adults
so they were only used in pediatric patients.
(Subotnick 1974/Valenti 1976/Giannini 1985/Viladot 1992)
8
9. The second generation of
arthroereisis devices,
made of medical grade titanium,
lead to the acceptance
of use in adults.
9
10. The only problem
was that up to 40%
of the 2nd generation titanium
arthroereisis devices
had to be removed.
(Needleman 2005/Schon 2007)
10
11. There had to be a better solution.
That solution is
HyProCure®
11
12. HyProCure®
was created with a
better anatomic fit and biomechanical
function. This has dropped the removal
rate to 6%.
12
17. HyProCure® has been successfully
used, when indicated, in pediatric
patients as young as
three years of age.
17
18. What other options are there to truly stabilize
the talus on the tarsal mechanism?
18
19. The chamber forming the sinus tarsi is ossified
by three years of age and is therefore strong
enough to withstand the interaction with
HyProCure®.
19
30. HyProCure’s® shape and position within the
sinus tarsi is completely different from the
cylindrical and conical shapes of the
arthroereisis devices.
30
35. HyProCure®
stabilizes the talus
on the tarsal mechanism.
It “fixes” talotarsal displacement.
35
U.S.A. Food & Drug Administration – 510(k)
36. A “flat” foot (pes planovalgus)
is a generic term
and
has a wide range of perceived meanings.
(is it flexible, semi-flexible, or rigid?)
36
37. Components of a “flat” foot include:
l lower than normal calcaneal inclination angle
l navicular drop
l elevated 1st ray
l increased talar declination angle
l talar second metatarsal angle >16 (AP view)
37
38. HyProCure® can, in a foot with a reducible
talotarsal dislocation, normalize the:
talar second metatarsal angle
talar declination angle
navicular height
(Graham 2011)
38
39. HOWEVER
HyProCure® has no effect
on the calcaneal inclination angle.
39
Surgical Treatment of Hyperpronation Using An Extraosseous Talotarsal Stabilization Device:
Radiographic Outcomes in 70 Adult Patients, Journal of Foot & Ankle Surger, 51(5):548-555, 2012
40. HyProCure®
will not and cannot
correct a pathologic
calcaneal inclination angle
40
41. HyProCure® stabilizes the medial column on
the lateral column of the foot.
Think about the implications of a stable medial column.
41
42. Myth & Misconception
#6
HyProCure® is contra-indicated
in a high-arched pes cavus foot.
42
45. A “high” arch is the result of a higher than
normal calcaneal inclination angle.
45
46. BUT
it is possible to still have talotarsal dislocation
in a high arched foot resulting in excessive
medial column motion on the lateral column.
46
47. The talus can still dislocate off the tarsal
mechanism and cause many similar cumulative
traumatic disorders that are seen in a lower
than normal arched foot.
47
48. Since HyProCure® has no effect on the
calcaneal inclination angle,
it can still be used in “high” arched feet.
48
Surgical Treatment of Hyperpronation Using An Extraosseous Talotarsal Stabilization Device:
Radiographic Outcomes in 70 Adult Patients, Journal of Foot & Ankle Surger, 51(5):548-555, 2012
49. What other options do you have?
Observation?
Special shoes?
Arch supports?
Rearfoot reconstructive surgery?
49
50. Myth & Misconception
#7
Cutting the structures within t
he sinus tarsi is devastating
and will lead to
long-term complications.
50
57. During the EOTTS procedure with HyProCure®
the interosseous TC ligament is only cut and
NOT removed.
The cut ends will heal back together around the
threads of HyProCure® anchoring HyProCure®
into the medial canalis tarsi.
57
58. Even if HyProCure® had to be removed
at a later date, the ends of the ligament
would again heal.
Ligaments are like skin,
in that they repair themselves.
58
63. We suggest that once HyProCure® is advanced
as deep as possible into the sinus tarsi to give
it a few clock-wise spins. This only assists in
wrapping the ligamentous tissues around the
threads.
63
64. EOTTS with HyProCure® is a
soft tissue procedure only.
The threads do not engage into the osseous
chamber of the sinus tarsi.
HyProCure® will not tighten like a screw.
64
65. Myth & Misconception
#9
If placed into a child’s foot
HyProCure® will have to be
changed when the child
becomes an adult.
65
68. The osseous chamber creating the sinus tarsi is
formed by 3 years of age,
as we learned earlier.
At that point, the talus and calcaneus will grow
peripherally and the overall sinus tarsi diameter
stays the same size.
68
69. The most common adult sizes are 7 and 6
therefore
if a size 7 or 6 HyProCure® is placed
into a child’s foot
they already have one of the
most common adult sizes.
69
70. Obviously, this is not a guarantee and it is
possible that HyProCure® will have to be
revised.
70
71. Myth & Misconception
#10
You should wait until the child
becomes an adult to insert
HyProCure®
71
74. The sooner the talotarsal mechanism is
stabilized with HyProCure®the better.
Every step taken with talotarsal dislocation
leads to cumulative traumatic disorders.
74
75. Think about all the various foot disorders that
occur as a result of years of
excessive repeated forces:
first ray deformities
plantar fasciopathy
tarsal tunnel syndrome
posterior tibial neuropathy
posterior tibial tendon dysfunction
adult acquire flat foot
75
76. We don’t wait to balance the tires on our car
until we have 50,000 miles on them.
76
77. The benefit to risk analysis shows that it is
better to internally stabilize the talus on the
tarsal mechanism with HyProCure® than to:
do nothing/observe
try to wear a shoe insert
perform rearfoot reconstructive surgery
77
78. Myth & Misconception
#11
HyProCure® will end up
destroying
the sinus tarsi and lead
to arthritis long-term.
78
85. Arthritis is a disease
within a joint usually due to
chronic excessive motion which
leads to a chronic inflammatory
reactionthat eventually destroys
the cartilage within the joint.
85
88. HyProCure®
can be used in
both adults and children with
flexible reducible talotarsal dislocation.
88
89. HyProCure®
does not block or restrict motion.
It restores the normal amount of
talotarsal motion.
89
90. HyProCure®
is not an arthroereisis device.
It is an extra-osseous
talotarsal stabilization (EOTTS) device.
It does not block the
lateral process of the talus.
Instead, the talus glides over and is
stabilized by HyProCure®
.
90
91. HyProCure®
is indicated for
reducible talotarsal dislocation
regardless of the calcaneal inclination angle
(high or low arch).
91
94. HyProCure®
should be inserted as soon as reducible
talotarsal dislocation is diagnosed (three
years old and older) to help prevent the
devastating cumulative traumatic disorders
that WILL adversely affect not only the foot
and ankle but the rest of the body.
94
95. “Changing Lives, One Step at a Time”
For more information please visit:
www.HyProCure.com
On-line training
www.HyProCuredoctors.com