This document compares the HyProCure device to the Calcaneo-stop device for treating foot disorders. HyProCure is an extra-osseous device that stabilizes the talus bone at the subtalar joint axis without blocking motion, while Calcaneo-stop is an intra-osseous screw that blocks talus motion. HyProCure has advantages of allowing normal motion, lower removal rates, and no reports of bone fractures. In contrast, Calcaneo-stop blocks motion, has removal rates up to 100%, and complications of bone fractures. Studies show HyProCure decreases strain on soft tissues compared to no effect shown for Calcaneo-stop.

1. HyProCure®
v. Calcaneo-stop

2. One of these devices is far superior
than the other…you be the judge.

3. What is Calcaneo-stop?
• This is an Arthroereisis – joint blocking
procedure.
• Can also be called: Intra-osseous Talotarsal
stabilization – a screw is partially drilled into
talus or calcaneus.
• The head of a screw blocks or restricts talar
motion.
• Functions against the normal TTJ range of
motion.
• Does not stabilize the talus at the axis of the
subtalar joint.

4. What is HyProCure?
• Non-arthroereisis/Non-joint blocking
procedure.
• An Extra-osseous talotarsal stabilization
(EOTTS) device.
• It is NOT inserted into bone.
• Restores talotarsal joint motion at the
axis point of the subtalar joint.
• Does not block nor limit TTJ ROM.
• Functions with TTJ motion, not against.

5. A Closer Side-by-Side Comparison
HyProCure
Extra-osseous
HyProCure is not inserted into bone,
rather is it positioned within the canalis
and sinus portions of the sinus tarsi.
There is no reported damage to the bone.
Calcaneo-stop
Intra-osseous
Calcaneo-stop is partially drilled into
either the talus or calcaneus.
The integrity to the bone is weakened and
could lead to a possible fracture of the talus or
calcaneus. This is a reported complication.

6. Held in place by talocalcaneal interosseous ligament (TCIL)
adherence along with the osseous chamber forming the sinus
tarsi.
Advantage/Disadvantage: There is no interruption to the
integrity of bone. The TCIL is not functioning to stabilize the
talus on the calcaneus. It is transected, the stent is placed,
and the TCIL will heal back together to incorporate the stent
within the fibers of the ligament. A potential problem occurs
when the TCIL has atrophied due to chronic talar
hypermobility. In that situation, the anchoring mechanism is
compromised.
Anchoring Method
Partially drilled into the bone.
Advantage/Disadvantage: There is perceived
to be a less likelihood of device displacement,
yet this is still a reported complication. A major
disadvantage is that the integrity to the bone is
compromised and that lead to a fracture of the
bone. This is also a reported complication. A
bone defect occurs upon removal of the device.
HyProCure Calcaneo-stop

7. How is talar stabilization accomplished?
• The smooth tapered section of
HyProCure stabilizes the talus at the
axis point of the subtalar joint.
• The lateral process of the talus
smashes into the head of the screw
in the outer part of the sinus.
HyProCure Calcaneo-stop

8. Location on the calcaneus where the talus is
stabilized.
CalcaneoStop
device acts here:
HyProCure
internally stabilizes
the talus at the axis
point here.
Anterior
Posterior
MedialLateral

9. Non-Arthroereisis vs. Arthroereisis Stabilization
• Non-Arthroereisis
• This means HyProCure maintains
the alignment and stabilization of
the talus while allowing a normal
talotarsal joint range of motion.
• HyProCure restores TTJ ROM.
• Arthroereisis
• This means that there is an abrupt
blocking of talotarsal joint range of
motion.
• Calcaneo-stop blocks TTJ ROM.
HyProCure Calcaneo-stop

10. Who is a candidate – Age Restrictions?
HyProCure
• Minimum age: 3 years
• Maximum age: none
Calcaneo-stop
• Minimum age: 6 years
• Maximum age: 14 years

11. Stand-alone or Combination of Procedures?
HyProCure
• Pediatric (3 and older) can be
performed as a stand-alone, when
indicated.
• Adults – can be performed as a
stand-alone or combined with other
procedures, when indicated.
Calcaneo-stop
• Pediatric (8 – 14) can be a stand-
alone, when indicated.
• Adults – rarely recommended and
only when combined with other
surgical procedures.

12. Published Removal Rates?
6% or less
HyProCure is designed to stay in place
for the life of the patient.
Up to 100%
Calcaneo-stop screw is recommended
to be removed within a few years.
HyProCure Calcaneo-stop

13. What happens after device removal? Is there
any supporting radiographic data?
HyProCure
• No scientific published paper that
follows a patient after HyProCure
has been removed.
• The same statements can be made
concerning HyProCure.
Calcaneo-stop
• No scientific published paper that
follows a patient after the
CalcaneoStop screw has been
removed.
• There is non-scientifically proven
statements made in published
literature that suggest that
correction is maintain, yet there is
no proof to substantiate this claim.

14. Reported Complications specific to the
device:
• Revision/Repositioning/Resizing
• Permanent removal
• Screw breakage
• Resorption of cortical surfaces
• Metatarsal stress fracture
• Bone fracture
• Bone destruction
• Revision/Repositioning/Resizing
• Permanent removal
HyProCure Calcaneo-stop

15. Beliefs of the advocates of Calcaneo-stop?
• The device is a rather inexpensive orthopedic
screw.
• The smooth head should limit damage to bone.
• Because it is anchored into bone, there should
be less likelihood for displacement.
• It is extra-articular.
• No sinus tarsi dissection is required.
• Can be reversed.
• Superior option over calcaneal osteotomy.

16. The price of Calcaneo-stop is less than HyProCure.
• While it may appear that the
actual Calcaneo-stop screw is less
expensive, further considerations
must be explored.
• The removal rate of Calcaneo-
stop is reported to be as high as
100% of the time.
• How much does it cost to bring a
patient back to the operating
room for a second surgery? These
devices cannot be removed in a
private practice setting.
• The hospital and surgeon may see
this high removal rate as an
advantage because they get paid
to put the device into the
patient’s foot and also get paid to
take it out.
• There is a financial incentive to
use a device that is only slightly
less expensive, that has a
significantly higher removal rate.

17. The smooth head Calcaneo-stop should limit
bone trauma.
• Imagine that 5,000 to 10,000
times a day the ankle bone is
smashing into the head of this
screw.
• Eventually, this will take a toll on
the bone and could lead to
serious issues.
• That is why most surgeons want
to remove the device after a few
years. There are no long term
studies to show that no bone
damage occurs.
• To the contrary, there are reports
of complications including
fracture of the talus and
calcaneus.

18. Because Calcaneo-stop is anchored into bone,
there is less likelihood of displacement.
• Displacement still occurs, this is a
reported complication.
• There is no scientific data comparing
displacement rates of HyProCure to
Calcaneo-stop, however, there are
more potential risks and complications
associated with Calcaneo-stop.

19. Calcaneo-stop is Extra-Articular
• Both HyProCure and Calcaneo-stop
are placed outside of the articular
facets of the talocalcaneal joints.

20. HyProCure and Calcaneo-stop are a superior
option to calcaneal osteotomy.
• Surgeon advocates of both
HyProCure and Calcaneo-stop
will agree that the insertion of
these devices is a conservative
minimally invasive, reversible
option over a calcaneal
osteotomy. A procedure that is
aggressive, requires a longer
recovery, and is not reversible.

21. Neuroproprioceptive theory as a benefit for
the calcaneo-stop procedure.
• There are opinions that the TCIL has
“specialized” neurosensors that help to
control foot motions.
• There is no evidence to this –it still remains
an hypothesis.
• In fact, the TCIL is compromised in patients
with a hypermobile talus.
• There are no clinical supportive studies to
confirm this only a neurohistologic cadaver
analysis.
• Patients have the contents of their sinus
tarsi routinely removed without reported
complication. The sinus tarsi is explored via
arthroscopic surgery on a routine basis
without reported complication.
• The fact that there is no dissection of the
sinus tarsi is pointless because HyProCure
replaces the function of the TCIL. The TCIL
is not removed, it is transected and will
heal.

22. HyProCure Advocates:
• Routinely used in pediatric and
adult patients of all activity levels.
• Simple, minimally invasive,
conservative procedure to
stabilize the talus on the tarsal
mechanism without interrupting
the integrity of the talus or
calcaneus.
• It is reversible, without bone-
defect-formation.
• Has a significantly less removal
rate than Calcaneo-stop and other
arthroereisis devices.
• Extensive scientific basis.
• Less associated complications
than Calcaneo-stop.
• No case reports of fracture to the
talus or calcaneus with
HyProCure.

23. Published Reports on the Calcaneo-stop
Procedure
• Most literature has less than 2 years of follow up
• There are no long-term studies to support the fact
that correction of the angular deformities is
maintained after the screw is removed.
• Many of the claims are unsubstantiated, rather they
are opinion based.
• It is not expected that the screw will remain in place
for the life of the patient. Rather it is recommended to
be removed in 100% of cases.

24. Average follow up 2.9 years 24% of screws already
removed. Contra-indicated 13 years or older.

25. 100% removal rate of the calcaneo-stop screw.

26. Mean follow-up was less than 10 months.

27. Clinical Evidence-basis of
HyProCure:

28. Extra-osseous Talotarsal Stabilization Devices: A New Classification System
J Foot & Ankle Surgery – (52), 613-619, 2012.
• Stabilization of the talotarsal joint is a primary
consideration to the treatment of many lower
extremity pathologies.
• There are 2 main types of extra-osseous (not
inserted into bones):
• Type I – Arthroereisis devices
• Cylindrical or conically shaped
• Inserted lateral to medial so that the medial tip is aligned with the horizontal
bisection of the talus.
• Laterally anchored by the soft tissues within the sinus portion of the sinus
tarsi.
• Functions via impingement of the lateral process of the talus to block talar
motion.
• Works against normal talotarsal joint motion
• Reported removal rate 38% to 100%
• Type II – Non-Arthroereisis device
• Combination of conical and cylindral shapes
• Inserted along the normal orientation of the sinus and canalis tarsi.
• Medial tip is inserted beyond the horizontal bisection of the talus.
• Stabilizes the talus and restores the normal axis point of the subtalar joint.
• Medially anchored.
• Allows normal helicoidal motion of the talotarsal joint.
• Reported removal rate 4 to 6%
• Conclusion.
• Sinus tarsi implants are not all the
same.
• Type II (HyProCure) is a superior
design and function when compared
to Type I arthroereisis devices.
• Surgeons and patients must
understand the differences between
the 2 types.
• Type II (HyProCure) has a superior
success rate over Type I
arthroereisis devices.

29. Stabilization of Joint Forces of the Subtalar Complex via
the HyProCure Sinus Tarsi Stent
Journal of American Podiatric Medical Association, Volume 101 No. 5, Pages 390-399, 2011
• Proves that HyProCure stabilizes the talus on the tarsal
mechanism.
• The stabilization of the talus on the tarsal mechanism reduces
excessive abnormal forces acting on the medial column of the foot.
• Therefore, there would be a decrease in strain on the supporting
tissues on the medial column of the foot and decreased strain on
these tissue allowing for tissue healing.

30. Effect of Extra-Osseous TaloTarsal Stabilization on Posterior Tibial Tendon Strain
Journal of Foot and Ankle Surgery, Vol 50, N0. 6, Pages 676-681, 2011
• EOTTS with HyProCure decreased the
elongation and strain of the posterior tibial
tendon by 51%.
• PTTD is a very expensive disease and no other
form of treatment has shown a decreased strain
on the tendon without arthrodesis and extensive
hindfoot reconstructive surgery.

31. Evaluating Plantar Fascia Strain in Hyperpronating Cadaveric Feet Following
an Extra-Osseous TaloTarsal Stabilization Procedure
Journal of Foot and Ankle Surgery 50, Issue 6, Pages 682-686, 2011
• The #1 etiology of plantar fasciopathy is secondary to excessive tension/strain =
mechanical overloading.
• EOTTS-HyProCure decreased that strain by 33%.
• No other form of treatment has been shown to decrease the strain on the plantar
fascia.
• Conservative care has never been shown to decrease strain on the PF.
• Surgical release of the PF leads to further weakness in the foot and eventually
contributes to PTTD.

32. The Effect of HyProCureSinus Tarsi Stent on
Tarsal Tunnel and Porta Pedis Pressures.
Journal of Foot and Ankle Surgery Volume 50, Issue1 Pages 44-49, 2011
• TTD leads to excessive forces acting on the
tarsal tunnel and porta pedis. Eventually, this
can lead to tarsal tunnel syndrome (the foot’s
version of carpal tunnel). This, over time, leads
to tibialis posterior neuropathy and loss of
feeling to the bottom of the foot and toes.
• EOTTS was proven to decrease the pressures
within both the tarsal tunnel and porta pedis
back to normal range.

33. Effect of Extra-Osseous TaloTarsal Stabilization on Posterior Tibial Nerve Strain in
Hyperpronating Feet: A Cadaveric Evaluation
Journal of Foot and Ankle Surgery Volume 50, Issue 6 , Pages 672-675, 2011
• Strain and elongation of the tibialis posterior
nerve leads to decreased blood flow within the
nerve and decreased to complete loss of nerve
function. Eventually, tibialis posterior
neuropathy (TPN) forms leading to numbness to
the bottom of the foot.
• TTD is the primary etiology for this strain in
non-traumatic cases.
• By stabilizing the talotarsal mechanism, EOTTS
with HyProCure was shown to decrease the
nerve strain and elongation by 43%, bringing it
back to the normal range.
• This would benefit patients with TPN.

34. Radiographic Evaluation of Navicular Position in the Sagittal Plane – Correction
Following an Extra-Osseous TaloTarsal Stabilization Procedure
Journal of Foot and Ankle Surgery Volume 50, Issue 5 Pages 551-557, 2011
• Internal stabilization of TTD with
HyProCure stabilized the medial column of
the foot by preventing navicular drop.
• This retrospective radiographic analysis
proves the importance of stabilizing the
talus and therefore decreasing the forces
on the medial column of the foot.

35. Extra-osseous TaloTarsal Stabilization using HyProCure® in Adults:
A 5 year Retrospective follow up.
J Foot & Ankle Surgery (51) 2012, 23-29.
• 1st review of EOTTS as a stand-alone
procedure in adults.
• 83 adults 18 yrs or older at time of surgery
• 117 feet/cases
• Mean age 58 yrs (22-85)
• Average follow up 51 months
• Results:
• 6% removal rate (compared to up to 100% with
Type I arthroereisis devices)
• Patient satisfaction score showed excellent
long-term results
• Conclusion
• HyProCure has been proven to have the
highest success rate over any other EOTTS
device .
• HyProCure has the lowest removal rate over
any EOTTS device (6% compared to 38% to
100% of arthroereisis devices).
• Even though there were removals and/or
revisions there were no long-term
complications.
• Not a single patient/foot developed chronic
pain post-HyProCure removal.
• Patients who required a revision went on to a
successful outcome.
• HyProCure is a safe and effective option for
adult patients with recurrently talotarsal
dislocation, when indicated.

36. Extra-osseous Talotarsal Stabilization using HyProCure®:
Preliminary Clinical Outcomes of a Prospective Case Series.
J Foot & Ankle Surgery (52) 2013, 195-202.
• Prospective, multicenter study
• Pediatric and Adult patients
• Mean age 41 yrs (8 to 72)
• 35 patients (46 feet)
• Minimum of 1 year post-procedure
• Results
• Foot pain decreased by 37%
• Improved functional activities 14%
• Improved foot appearance 29%
• Removal rate of 4%
• No unresolved complications
• Improvement of secondary conditions
• Greatest magnitude of recovery occurred at 4 weeks
post-procedure period
Conclusion
• HyProCure is safe and
effective in both pediatric
and adult patients.
• There was a 96% success
rate
• HyProCure removal rate
was 4%
• Shows that HyProCure has
the highest success rate
over any other EOTTS stent.
• Not a single patient
developed a unresolved
complication.

37. Extra-Osseous Talotarsal Stabilization with HyProCure-
Radiographic Outcomes in Adult Patients
Journal of Foot and Ankle Surgery– Vol 51, No 5, 2012.
• EOTTS with HyProCure in adult patients as a stand-alone
procedure.
• 95 feet in 70 patients.
• Normalization of the talar second metatarsal angle on the
AP view.
• Normalization of the talar declination angle on the sagittal
view.
• No effect on the calcaneal inclination angle.
• Shows both transverse and sagittal plane
correction/stabilization of the talotarsal mechanism and
therefore also frontal plane correction.

38. Radiographic Analysis Journal of Foot and Ankle Surgery– Vol 51, No 5, 2012.
Talar Declination Angle
(Sagittal plane)
• Average pre-op: 25.1 degrees
• Average post-op: 19.4 degrees
• Mean decrease: 5.7 degrees (23%)
Talar 2nd Metatarsal Angle
(Transverse plane)
• Average pre-op : 24.8 degrees
• Average post-op : 5.8 degrees
• Mean decrease = 19 degrees (77%)

39. Plantar Pressure Distribution in a Hyperpronated Foot before and after Intervention with an
Extra-osseous Talotarsal Stabilization Device – A Retrospective Study.
J Foot Ankle Surgery – 52, 432-443, 2013 .
• Weightbearing plantar force measurements
before and after EOTTS-HyProCure®.
• Increased forces could lead to callus
formation or tissue destruction in a sensory
compromised patient, i.e. neuropathy.
• Results
• Significant reduction of peak pressures by 42%
over the entire plantar foot.
• Significant increase in contact area by 20%
between the foot and weightbearing surface.
Conclusion
• EOTTS-HyProCure has been proven
to normalize pathologic plantar
foot forces
• Patients with plantar skin
pathology should be evaluated for
hindfoot misalignment and
HyProCure should be considered a
part of the treatment solution.

40. Pediatric Congenital TaloTarsal Joint Displacement and Pes Planovalgus Evaluation,
Conservative Management, and Surgical Management.
Clinics Podiatric Medicine and Surgery – (30) 2013, 567-581.
• Recurrent Talotarsal joint
displacement/dislocation/instability is a pathologic
deformity that does not improve with age.
• RTTJD does not get better, it gets worse.
• RTTJD leads to many secondary pathologies to the
lower extremity and can adversely affect health in
general.
• Results:
• RTTJD is diagnosed via physical examination
(non-weightbearing/weightbearing) and
confirmed by weightbearing radiographs.
• RTTJD is a condition that does not present an
immediate life-threatening disease, yet it slowly
leads to the destructive effects to the
musculoskeletal chain and to the body/health in
general.
Conclusion
• RTTJD is a deformity that must be diagnosed
and explained to pediatric/adult
patients/guardians.
• Observation is a poor-treatment choice simply
due to the fact that further destruction occurs to
the lower extremity.
• Arch supports are not capable of realigning
and/or stabilizing the talotarsal joint.
• Traditional reconstructive surgery is simply too
aggressive for most patients.
• EOTTS-HyProCure is proven safe and effective
device that is capable of realigning and
stabilizing the talotarsal joint without long-term
complications.

41. Analysis of Radiographic Outcomes Comparing Foot Orthosis to Extra-osseous Talotarsal
Stabilization in the Treatment of Recurrent Talotarsal Joint Dislocation.
J Minimally Invasive Orthopedics – January 2015
Multicenter Prospective Study
Compared weightbearing radiographs
barefoot – no intervention
barefoot - orthosis
barefoot - EOTTS-HyProCure®
Results:
Transverse plane improvement
orthosis = 3.2% average change
EOTTS = 58.9% average change
Sagittal plane improvement
orthosis = 2.2 % average change
EOTTS = 28.3% average change
Conclusions:
EOTTS-HyProCure® is a very effective
form of treatment to realign and
stabilize RTTJD.
Orthosis are ineffective in the
realignment and stabilization of RTTJD
EOTTS is a superior option over an arch
support/orthosis in realigning and
stabilizing the TTJ.

42. Analysis of Radiographic Outcomes Comparing Foot Orthosis to Extra-osseous Talotarsal
Stabilization in the Treatment of Recurrent Talotarsal Joint Dislocation.
J Minimally Invasive Orthopedics – January 2015

43. Comparison HyProCure Calcaneo-stop
Permanent solution – device is designed to remain in place. X
Temporary solution – device should be removed within 3 years X
Routinely used in pediatric and adult patients, when indicated X
Only used in pediatric patients (7 to 14 years) X
Associated with bone fractures X
Device has broken/fractured X
Stabilizes the talus at the axis point of the subtalar joint X
Arthroereisis – joint blocking/limiting procedure X
Non-arthroereisis – restores talotarsal joint range of motion X
Extensive published studies X
Cost-saving solution – less likelihood of return to the operating
room to remove the device.
X
Is a more conservative but highly effective option X
Biomechanically “friendly” X
Works against normal biomechanics of the subtalar joint X

44. Conclusion:
• HyProCure is by far the most
logical choice.
• It is proven to be a far superior
option over the calcaneo-stop
procedure.
• While it may seem that the screw
is more economical, the reality is
that even though the price of
HyProCure is slightly higher, the
cost savings with HyProCure
exceeds that of the calcaneo-stop
by thousands of dollars.
• HyProCure is shown to be backed
by extensive research.
• HyProCure is a more conservative
procedure that shows both
clinical and radiographic
improvement.
• HyProCure has wider indications
and can be routinely used in
pediatric and adults patients as a
stand-alone or in combination of
other surgical procedures, when
indicated.

45. HyProCure is the biomechanic solution you
and your patients have been waiting for!

46. For more information:
www.HyProCure.com