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Michael E. Graham, DPM, FACFAS
                       Macomb, Michigan
Long Version
• What is EOTTS?
• Rationale/Indications for an EOTTS
  procedure
• Evidence Base
  – Cadaveric Research
  – Clinical Research
• Conclusions
Extra-Osseous TaloTarsal Stabilization
                  (EOTTS)
• The use of an internal
  fixation device to prevent
  excessive motion of the
  talus on the calcaneus and
  navicular.
• Differentiated from
  – inter-osseous
  – intra-osseous.
• Purely a soft tissues
  procedure to improve the
  function of hindfoot
  mechanism.
When would/should you recommend
    EOTTS to your patients?
Why has this patient presented to you?
       What is their chief complaint?
Do not limit your attention/treatment focus to
             symptom relief only.
         Must identify and eliminate
            any etiologic factor(s).
Terminology Break
• Normal – accepted measurement/value
• Abnormal – measurement/value
  outside of normal

• Recurrent- something that happens
  again and again.
• Dislocation- displaced from its normal
  position or alignment.
Normal TaloTarsal Motion
• Supination
• Pronation

• Normal strain is placed on the
  supporting structures.
• Articular facets of TTM remain in
  constant congruent contact.
• Efficient machine
This is a Normal TaloTarsal
             Mechanism




• “Normal” amount of motion of the talus on the
  tarsal mechanism.
• Articular facets remain in constant congruent
  contact.
• Sinus tarsi remains “open”.
Radiographic Evaluation
        NORMAL - Weightbearing AP View



• Talar Second Metatarsal Angle

• Normal < 16 degrees

• The bisection of the talus should
  be lateral to the medial shaft of
  the 1st metatarsal.
Radiographic Evaluation
      NORMAL Weightbearing Lateral View

• Talar Declination Angle
  < 26 degrees

• Cyma line

• Sinus tarsi “open”
This is an Abnormal TaloTarsal
               Mechanism




• Excessive amount of motion of the talus on the tarsal
  mechanism.
• Articular facets do not remain in constant congruent
  contact.
• Obliteration of the sinus tarsi.
TaloTarsal Dislocation
• Results in a pathologic talotarsal axis of
  motion.
• Leads to an excessive abnormal amount
  of pronation (over-pronation or
  hyperpronation).
• The resulting excessive forces will travel
  abnormally throughout the foot structure.
Radiographic Evaluation
       ABNORMAL-Weightbearing AP View

• Talar 2nd Met. Angle
  >16 degrees


• Transverse plane
  dislocation deformity
Radiographic Evaluation
ABNORMAL – Weightbearing Lateral View




•   Talar Declination > 26 degrees
•   Anterior deviated Cyma line
•   Obliterated sinus tarsi
•   Sagittal plane dislocation deformity
Comparison of NP-TTM vs RSP
  Evidence for Recurrent Talotarsal Dislocation
Comparison of NP-TTM vs RSP
  Evidence for Recurrent Talotarsal Dislocation
Clinical Evidence of Recurrent
     TaloTarsal Dislocation
Recurrent TaloTarsal Joint Dislocation

  • Is the primary etiologic factor to many
    secondary foot and ankle disorders.
  • Every step taken, leads to pathologic
    forces acting on supporting structures.
  • Eventually, the weakest link becomes
    symptomatic.
  • It is therefore of extreme importance to
    stabilize the talus on the calcaneus and
    navicular.
Recurrent TaloTarsal Joint Dislocation
                        (718.37)

• Chronic dynamic
  pathologic deformity of the
  hindfoot.
• Repeated displacement of
  one or more articular
  facets of the talus on the
  calcaneus and/or
  navicular.
• Differentiated from static
  talotarsal joint dislocation
  which is a rigid deformity.
Classification of EOTTS Devices

• Type I EOTTS:
     arthroereisis



• Type II EOTTS:
     non-arthroereisis



          Extra-osseous Talotarsal Stabilization Devices: A New
            Classification System. Vol. 51, No 5, p. 613-622.
Type I:
    Subtalar Joint Arthroereisis

The goal is to stop the
anterior progression of
lateral process by some
method within the outer
half of the sinus tarsi.


                  Arthroereisis
                implants act sole
                 within the lateral
                 half of the tarsal
                       sinus.
Subtalar Joint Arthroereisis
• This technique is focused on limiting or blocking
  the lateral process of the talus.




       Plantar view of talus
Function – Type I

• This device
  acts/acted as an
  anterior extension of
  the lateral process of
  the talus.
Limits Talar Pronation
• As the talus moves
  from a supinated to
  pronated position the
  anterior extension of
  the talus hit against
  the posterior aspect
  of the anterior facet of
  the calcaneus to
  block/limit further
  pronation.
Type I Subtalar Arthroereisis
      Device Evolution
• The initial device had a
  cylindrical design.
• It should be noted that
  the outer sinus tarsi
  shaped is conical not
  cylindrical.
• Newer devices were
  designed with that in
  mind as well as other
  features with ways to
  make device removal
  easier.
Type I Subtalar Arthroereisis
• Unfortunately, the new designs did little to
  decrease the overall removal rate.
• Reported rates from 38% to 100% removal
Type II: Non-arthroereisis
 Extra-Osseous TaloTarsal
Stabilization with HyProCure.
Type I – arthroereisis implants
                                 limits/blocks talar motion here.




 Type II- HyProCure stabilizes
the talotarsal mechanism here.



             HyProCure
   is not an arthroereisis device.
TYPE I
The leading edge of                                        TYPE II
arthroereisis devices                                    HyProCure
 come into contact                                  internally stabilizes
 with the calcaneus                                    the talus at the
        here.                                       cruciate pivot point
                                                            here.




                        Top view of the calcaneus




Type II does not block or limit motion.
Normal amount of pronation and
 supination is still available with
         Type II device.
      (There is a limitation of motion with Type I)
HyProCure stabilizes the talus at
the cruciate pivot point to restore
the talotarsal axis of motion back
            to normal.
• Cadaveric Based
• Retrospective Clinical Findings
• Prospective Clinical Analysis
Scientific Evidence Base for EOTTS Type II

-   Decreased strain to the posterior tibial tendon – 51%
-   Decreased strain to the plantar fascia – 33%
-   Decreased strain to tibial posterior nerve
-   Decreased pressures within tarsal tunnel/porta pedis
-   Improved post-procedure functional scores
-   Normalization of abnormal radiographic
    correction/angles
-   Low device removal rate <6%
-   Proven to stabilize the talotarsal joint displacement
-   Proven to decrease forces acting on the medial
    column
-   Internal restoration of navicular height
-   Improved/normalization of plantar forces
Cadaveric Based Research
• Measurement of talocalcaneal joint forces
• Strain measurement on:
  – Posterior tibial tendon
  – Tibialis posterior nerve
  – Plantar fascia
• Pressure Measurements within the tarsal
  tunnel and porta pedis
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, Sept/Oct 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.
Cadaveric Based Research
    TaloCalcaneal Joint Rebalancing
• Premise of this study
  was to show the
  excessive force placed
  anteriomedially onto the
  middle and anterior
  talocalcaneal facets.
• Transducers were
  placed into the
  posterior, middle and
  anterior TC facets in
  cadaveric specimens
  with TTD.
Cadaveric Based Research
 TaloCalcaneal Joint Rebalancing

• The foot was loaded giving maximum
  pronatory force dislocating the
  talotarsal mechanism.
• EOTTS HyProCure device was inserted
  and the same maximum pronatory
  force was again applied.
EOTTS Cadaver Study
Cadaveric Based Research
  TaloCalcaneal Joint Rebalancing

• Findings showed
  – With TTD, the posterior talar facet forces
    shifted anteriomedially onto the middle and
    anterior facets
  – Upon EOTTS
    • The forces were stabilized on the posterior TC
      facet
    • The excessive force acting on the
      middle/anterior facets decreased
Talocalcaneal Articulations after
           EOTTS
Cadaveric Based Research
 TaloCalcaneal Joint Rebalancing

• This proves that excessively abnormal
  forces are placed anteromedially
  instead of posteriolaterally
• Excessive force there will be placed
  onto the medial column of the foot
Cadaveric Based Research
   TaloCalcaneal Joint Rebalancing

• Upon EOTTS those forces were
  rebalanced
• Reduction of force anteriomedially and
  increased force posteriolaterally
• Therefore decreasing the forces acting
  on the medial column
Cadaveric Based Research
         Strain Measurements

• Theorized that recurrent talotarsal
  dislocation leads to increase strain
  acting on the posterior tibial tendon,
  tibialis posterior nerve and the plantar
  fascia
• EOTTS would decrease the strain
  placed on these structures
Cadaveric Based Research
         Strain Measurements

• Cadaveric specimens exhibiting
  recurrent TTD were placed on an MTS
• Strain gauges were placed on the
  – Posterior tibial tendon proximal to the
    navicular tuberosity
  – Tibials posterior nerve proximal to the
    porta pedis
  – Plantar fascia medial band
Cadaveric Based Research
            Strain Measurements

•   TTM was maximally pronated
•   3 readings per test area each limb
•   Blinded study (examiner could not see the metrics)
•   Pressure sensor was placed under the
    4th & 5th metatarsal heads to ensure
    same force was applied for every
    measurement
Cadaveric Based Research
        Strain Measurements

• First data set was maximum talotarsal
  dislocation
• Second data set was collected using
  the exact same method after the
  insertion of the EOTTS device
The Effect of HyProCure Sinus Tarsi Stent on
 Tarsal Tunnel and Porta Pedis Pressures.
         Journal of Foot and Ankle Surgery,
     Volume 50, Issue 1 Pages 44-49, January 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.
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, November 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
                       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.
Nerve Strain/Tension
           What do we know?

• Pronation increases the strain/tension
  on the posterior tibial nerve


  – Francis et al: Benign Joint Hypermobility with Neuropathy:
    Documentation and Mechanism of Tarsal Tunnel Syndrome. J
    Rheumatol 14:577-581, 1987
  – Daniels et al: The Effects of Foot Position and Load on Tibial
    Nerve Tension. Foot Ankle Int. 19:73-78, 1998
Nerve Strain/Tension
         What do we know?

• 8% venular flow obstructs
• 15% complete arterial occlusion occurs


  – Kwan el al: Strain, stress, and stretch of peripheral nerve.
    Acta Orthop Scand, 83:267-272, 1992
  – Lundborg, G, Rydevik, B: Effects of stretching the tibial
    nerve of the rabbit. JBJS 55B:390-401, 1973
Nerve Strain/Tension
           What do we know?

• 6 % Strain decreases the amplitude of the
  action potential which recovers after
  removal of the strain.
• 12% strain produced a complete block
  and showed minimal recovery


  – Wall et al: Experimental stretch neuropathy. JBJS 74B:126-
    129, 1992
9 Cadaver Specimens
                                                                         %
                                                                     Reduction
                                                                         in
                 Elongation                       Strain             Elongation
            Without                     Without
            EOTTS     With EOTTS        EOTTS         With EOTTS
                    in mm                         in %


Mean ± 1
 S.D.      5.91 ± 0.91   3.38 ± 1.20   26.81 ± 4.6    15.38 ± 5.65      43%
 Range     3.02 - 7.19   1.25 - 5.23   12.5 - 33.87   5.24 - 23.57
Cadaveric Based Research
   Strain Measurements - Results

• Tibialis Posterior Nerve

  – EOTTS decreased TPN strain by 43%




  *JFAS Nov/Dec 2011
Cadaveric Based Research
Pressure Measurements within the Tarsal Tunnel


• Long been know that over-pronation is a
  major contributing factor in the
  development of neuropathy of the tibialis
  posterior nerve.
• Previously published papers have used
  pressure gauges to measure this.
• HOWEVER- no one has shown a method
  to reduce these forces outside of surgical
  decompression.
Cadaveric Based Research
Pressure Measurements within the Tarsal Tunnel


• Already have learned recurrent talotarsal
  dislocation leads to an excessive amount
  of pronation
therefore
• If we can stabilize the talus on the tarsal
  mechanism this should decrease the
  pressures/forces acting on the
  neurovascular structures within the tarsal
  tunnel.
Tarsal Tunnel Pressures-
                   What do we know?
• Neutral STJ            2 (0-7) mmHg
• Maximally pronated 32 (12-60) mmHg
• Pronation = significantly increases pressure within the
  tarsal tunnel with every step taken

Kumar et al: Evaluation of Various Fibro-Osseous Tunnel Pressures in Normal Human
   Subjects. Indian J Physiol Pharmaol, 32:139-145, 1988
Trepman et al.:Effect of Foot & Ankle Position on Tarsal Tunnel Compartment Pressure.
   Foot Ankle Int. 20:721-726, 1999
Barker et al: Pressures Changes in the Medial & Lateral Plantar and Tarsal Tunnels
   Related to Ankle Position: A Cadaver Study. Foot Ankle Int 28:250-254, 2007
Rosson et al: Tibial Nerve Decompression in Patients with Tarsal Tunnel Syndrome:
   Pressures in the Tarsal, Medial Plantar, and Lateral Plantar Tunnels. Plast Reconstr
   Surg 124:1202-1210, 2009
Increased Tarsal Tunnel Pressures
            What do we know?

• A pressure of 20 – 30 mmHg has been
  shown to impair intraneural blood flow


  – Gelberman et al: Tissue Pressure Threshold for Peripheral Nerve
    Viability. Clin Orthop Relat Res 285-291, 1983
  – Rydevik et al: Effects of graded comprssion of intraneural blood
    flow. An in vivo study on rabbit tibial nerve. J Hand Surg AM 6:3-
    12, 1981
Overall Results




  32   21          29   18



34% reduction- Tarsal tunnel
38% reduction- Porta pedis
Effect of Extra-Osseous TaloTarsal Stabilization on
           Posterior Tibial Tendon Strain
Journal of Foot and Ankle Surgery, Volume 50, Issue 6 , Pages 676-
                      681, November 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.
Cadaveric Based Research
     Strain Measurements - Results
• Posterior Tibial Tendon

  – EOTTS decreased PTT strain by 51%




  *JFAS Nov/Dec 2011
Evaluating Plantar Fascia Strain in Hyperpronating
Cadaveric Feet Following an Extra-Osseous TaloTarsal
               Stabilization Procedure
              Journal of Foot and Ankle Surgery,
         Vol 50, No 6, Pages 682-686, November 2011
                  • The #1 etiology of plantar
                    fasciitis/fasciopathy is secondary to
                    excessive tension/strain.
                  • EOTTS 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.
Cadaveric Based Research
  Strain Measurements - Results

• Plantar Fascia Medial Band
Cadaveric Based Research
  Strain Measurements - Results

• Plantar Fascia Medial Band

  – EOTTS decreased PF strain by 33%




  *JFAS Nov/Dec 2011
Cadaveric Based Research
Pressure Measurements within the Tarsal Tunnel


• Therefore patients who exhibit
  symptomatology/pathology from their
   –   Posterior tibial tendon
   –   Tibialis posterior nerve
   –   Plantar fascia
   –   Tarsal tunnel syndrome
• And have co-existing RTTD
• They could benefit from the use of
  EOTTS.
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, September 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.
Retrospective Radiographic Analysis

• Restoration of Navicular Height
  following EOTTS – HyProCure.




* JFAS, Vol 50, Issue 5, Pages 551-557
Retrospective Radiographic Analysis


• Premise
  – Stabilization of talotarsal mechanism
    decreases anteriomedial forces
  – Decreased force acting on the joints
    anterior to the sinus tarsi
  – So it would be assumed that if a navicular
    drop was evidenced via a loss of arch
    height, internal stabilization of the TTM
    would reduce the loss of arch height.
Retrospective Radiographic Analysis


• IRB Approved Study
• 86 feet were evaluated in patients who
  had EOTTS with HyProCure   ®



• Pre-procedure navicular height
  measurements were measured and
  compared to post-EOTTS radiographs.
Retrospective Radiographic Analysis


• EOTTS procedure maintained the
  normal alignment of the navicular.
Retrospective Radiographic Analysis


• This proves that there is a stabilization of
  the medial column on the lateral column.
• Decreased strain to the supporting soft
  tissues.
• Shows that it is the osseous malformation
  that leads to soft tissue pathology and not
  vice versa otherwise stabilization of the
  TTM would not result in decreased strain
  to these supporting tissues.
Extra-Osseous Talotarsal Stabilization with
              HyProCure-
 Radiographic Outcomes in Adult Patients
      Journal of Foot and Ankle Surgery –
        Vol. 51, No. 5, p. 548-556, 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.
EOTTS-HyProCure Analysis   ®




• Removal rate as a stand-alone
  procedure?

• 7 of the 117 patients considered for this
  study had permanent removal- 6%
• None of these patients had any long-
  term complications following removal.
EOTTS HyProCure Removal      ®




• Due to
  – Pain to the superficial area of the ATFL
    • 4 cases
  – Psychogenic reaction
    • 2 cases
  – Post-op infection
    • 1 case
Short-term Self-resolving
    Complications Experienced

•   Incision dehiscence
•   Prolonged skin healing
•   Synovitis
•   Period of abnormal gait
•   Prolonged pain and swelling
Future/On-going Prospective Studies

 • Prospective Functional Outcomes of
   EOTTS- Multi-centered study.
 • Gait analysis following EOTTS
 • Effect of EOTTS on Compression
   Tibialis Posterior Neuropathy
• EOTTS - it just makes sense and is
  becoming the gold standard.

• The scientific evidence is here.

• Its time we challenge the status-quo
  treatments
Because at the end of the day
 We are just trying our best
  to keep everyone walking.
EOTTS – HyProCure            ®




• Used in patients from 3 to 95 years old
• Every sports activity
• There has not been a single case showing
  a significant complication, i.e. fracture,
  osteomyelitis, amputation, or death.
For more information please visit:



  www.HyProCure.com
Thank you.

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Extra-Osseous TaloTarsal Stabilization - HyProCure: The Scientific Evidence is HERE!

  • 1. Michael E. Graham, DPM, FACFAS Macomb, Michigan Long Version
  • 2. • What is EOTTS? • Rationale/Indications for an EOTTS procedure • Evidence Base – Cadaveric Research – Clinical Research • Conclusions
  • 3. Extra-Osseous TaloTarsal Stabilization (EOTTS) • The use of an internal fixation device to prevent excessive motion of the talus on the calcaneus and navicular. • Differentiated from – inter-osseous – intra-osseous. • Purely a soft tissues procedure to improve the function of hindfoot mechanism.
  • 4. When would/should you recommend EOTTS to your patients?
  • 5. Why has this patient presented to you? What is their chief complaint? Do not limit your attention/treatment focus to symptom relief only. Must identify and eliminate any etiologic factor(s).
  • 6. Terminology Break • Normal – accepted measurement/value • Abnormal – measurement/value outside of normal • Recurrent- something that happens again and again. • Dislocation- displaced from its normal position or alignment.
  • 7. Normal TaloTarsal Motion • Supination • Pronation • Normal strain is placed on the supporting structures. • Articular facets of TTM remain in constant congruent contact. • Efficient machine
  • 8. This is a Normal TaloTarsal Mechanism • “Normal” amount of motion of the talus on the tarsal mechanism. • Articular facets remain in constant congruent contact. • Sinus tarsi remains “open”.
  • 9. Radiographic Evaluation NORMAL - Weightbearing AP View • Talar Second Metatarsal Angle • Normal < 16 degrees • The bisection of the talus should be lateral to the medial shaft of the 1st metatarsal.
  • 10. Radiographic Evaluation NORMAL Weightbearing Lateral View • Talar Declination Angle < 26 degrees • Cyma line • Sinus tarsi “open”
  • 11. This is an Abnormal TaloTarsal Mechanism • Excessive amount of motion of the talus on the tarsal mechanism. • Articular facets do not remain in constant congruent contact. • Obliteration of the sinus tarsi.
  • 12. TaloTarsal Dislocation • Results in a pathologic talotarsal axis of motion. • Leads to an excessive abnormal amount of pronation (over-pronation or hyperpronation). • The resulting excessive forces will travel abnormally throughout the foot structure.
  • 13. Radiographic Evaluation ABNORMAL-Weightbearing AP View • Talar 2nd Met. Angle >16 degrees • Transverse plane dislocation deformity
  • 14. Radiographic Evaluation ABNORMAL – Weightbearing Lateral View • Talar Declination > 26 degrees • Anterior deviated Cyma line • Obliterated sinus tarsi • Sagittal plane dislocation deformity
  • 15. Comparison of NP-TTM vs RSP Evidence for Recurrent Talotarsal Dislocation
  • 16. Comparison of NP-TTM vs RSP Evidence for Recurrent Talotarsal Dislocation
  • 17. Clinical Evidence of Recurrent TaloTarsal Dislocation
  • 18. Recurrent TaloTarsal Joint Dislocation • Is the primary etiologic factor to many secondary foot and ankle disorders. • Every step taken, leads to pathologic forces acting on supporting structures. • Eventually, the weakest link becomes symptomatic. • It is therefore of extreme importance to stabilize the talus on the calcaneus and navicular.
  • 19. Recurrent TaloTarsal Joint Dislocation (718.37) • Chronic dynamic pathologic deformity of the hindfoot. • Repeated displacement of one or more articular facets of the talus on the calcaneus and/or navicular. • Differentiated from static talotarsal joint dislocation which is a rigid deformity.
  • 20. Classification of EOTTS Devices • Type I EOTTS: arthroereisis • Type II EOTTS: non-arthroereisis Extra-osseous Talotarsal Stabilization Devices: A New Classification System. Vol. 51, No 5, p. 613-622.
  • 21. Type I: Subtalar Joint Arthroereisis The goal is to stop the anterior progression of lateral process by some method within the outer half of the sinus tarsi. Arthroereisis implants act sole within the lateral half of the tarsal sinus.
  • 22. Subtalar Joint Arthroereisis • This technique is focused on limiting or blocking the lateral process of the talus. Plantar view of talus
  • 23. Function – Type I • This device acts/acted as an anterior extension of the lateral process of the talus.
  • 24. Limits Talar Pronation • As the talus moves from a supinated to pronated position the anterior extension of the talus hit against the posterior aspect of the anterior facet of the calcaneus to block/limit further pronation.
  • 25. Type I Subtalar Arthroereisis Device Evolution • The initial device had a cylindrical design. • It should be noted that the outer sinus tarsi shaped is conical not cylindrical. • Newer devices were designed with that in mind as well as other features with ways to make device removal easier.
  • 26. Type I Subtalar Arthroereisis • Unfortunately, the new designs did little to decrease the overall removal rate. • Reported rates from 38% to 100% removal
  • 27. Type II: Non-arthroereisis Extra-Osseous TaloTarsal Stabilization with HyProCure.
  • 28. Type I – arthroereisis implants limits/blocks talar motion here. Type II- HyProCure stabilizes the talotarsal mechanism here. HyProCure is not an arthroereisis device.
  • 29. TYPE I The leading edge of TYPE II arthroereisis devices HyProCure come into contact internally stabilizes with the calcaneus the talus at the here. cruciate pivot point here. Top view of the calcaneus Type II does not block or limit motion.
  • 30. Normal amount of pronation and supination is still available with Type II device. (There is a limitation of motion with Type I)
  • 31. HyProCure stabilizes the talus at the cruciate pivot point to restore the talotarsal axis of motion back to normal.
  • 32. • Cadaveric Based • Retrospective Clinical Findings • Prospective Clinical Analysis
  • 33. Scientific Evidence Base for EOTTS Type II - Decreased strain to the posterior tibial tendon – 51% - Decreased strain to the plantar fascia – 33% - Decreased strain to tibial posterior nerve - Decreased pressures within tarsal tunnel/porta pedis - Improved post-procedure functional scores - Normalization of abnormal radiographic correction/angles - Low device removal rate <6% - Proven to stabilize the talotarsal joint displacement - Proven to decrease forces acting on the medial column - Internal restoration of navicular height - Improved/normalization of plantar forces
  • 34. Cadaveric Based Research • Measurement of talocalcaneal joint forces • Strain measurement on: – Posterior tibial tendon – Tibialis posterior nerve – Plantar fascia • Pressure Measurements within the tarsal tunnel and porta pedis
  • 35. 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, Sept/Oct 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.
  • 36. Cadaveric Based Research TaloCalcaneal Joint Rebalancing • Premise of this study was to show the excessive force placed anteriomedially onto the middle and anterior talocalcaneal facets. • Transducers were placed into the posterior, middle and anterior TC facets in cadaveric specimens with TTD.
  • 37. Cadaveric Based Research TaloCalcaneal Joint Rebalancing • The foot was loaded giving maximum pronatory force dislocating the talotarsal mechanism. • EOTTS HyProCure device was inserted and the same maximum pronatory force was again applied.
  • 39. Cadaveric Based Research TaloCalcaneal Joint Rebalancing • Findings showed – With TTD, the posterior talar facet forces shifted anteriomedially onto the middle and anterior facets – Upon EOTTS • The forces were stabilized on the posterior TC facet • The excessive force acting on the middle/anterior facets decreased
  • 41. Cadaveric Based Research TaloCalcaneal Joint Rebalancing • This proves that excessively abnormal forces are placed anteromedially instead of posteriolaterally • Excessive force there will be placed onto the medial column of the foot
  • 42. Cadaveric Based Research TaloCalcaneal Joint Rebalancing • Upon EOTTS those forces were rebalanced • Reduction of force anteriomedially and increased force posteriolaterally • Therefore decreasing the forces acting on the medial column
  • 43. Cadaveric Based Research Strain Measurements • Theorized that recurrent talotarsal dislocation leads to increase strain acting on the posterior tibial tendon, tibialis posterior nerve and the plantar fascia • EOTTS would decrease the strain placed on these structures
  • 44. Cadaveric Based Research Strain Measurements • Cadaveric specimens exhibiting recurrent TTD were placed on an MTS • Strain gauges were placed on the – Posterior tibial tendon proximal to the navicular tuberosity – Tibials posterior nerve proximal to the porta pedis – Plantar fascia medial band
  • 45. Cadaveric Based Research Strain Measurements • TTM was maximally pronated • 3 readings per test area each limb • Blinded study (examiner could not see the metrics) • Pressure sensor was placed under the 4th & 5th metatarsal heads to ensure same force was applied for every measurement
  • 46. Cadaveric Based Research Strain Measurements • First data set was maximum talotarsal dislocation • Second data set was collected using the exact same method after the insertion of the EOTTS device
  • 47. The Effect of HyProCure Sinus Tarsi Stent on Tarsal Tunnel and Porta Pedis Pressures. Journal of Foot and Ankle Surgery, Volume 50, Issue 1 Pages 44-49, January 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.
  • 48. 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, November 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 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.
  • 49. Nerve Strain/Tension What do we know? • Pronation increases the strain/tension on the posterior tibial nerve – Francis et al: Benign Joint Hypermobility with Neuropathy: Documentation and Mechanism of Tarsal Tunnel Syndrome. J Rheumatol 14:577-581, 1987 – Daniels et al: The Effects of Foot Position and Load on Tibial Nerve Tension. Foot Ankle Int. 19:73-78, 1998
  • 50. Nerve Strain/Tension What do we know? • 8% venular flow obstructs • 15% complete arterial occlusion occurs – Kwan el al: Strain, stress, and stretch of peripheral nerve. Acta Orthop Scand, 83:267-272, 1992 – Lundborg, G, Rydevik, B: Effects of stretching the tibial nerve of the rabbit. JBJS 55B:390-401, 1973
  • 51. Nerve Strain/Tension What do we know? • 6 % Strain decreases the amplitude of the action potential which recovers after removal of the strain. • 12% strain produced a complete block and showed minimal recovery – Wall et al: Experimental stretch neuropathy. JBJS 74B:126- 129, 1992
  • 52. 9 Cadaver Specimens % Reduction in Elongation Strain Elongation Without Without EOTTS With EOTTS EOTTS With EOTTS in mm in % Mean ± 1 S.D. 5.91 ± 0.91 3.38 ± 1.20 26.81 ± 4.6 15.38 ± 5.65 43% Range 3.02 - 7.19 1.25 - 5.23 12.5 - 33.87 5.24 - 23.57
  • 53. Cadaveric Based Research Strain Measurements - Results • Tibialis Posterior Nerve – EOTTS decreased TPN strain by 43% *JFAS Nov/Dec 2011
  • 54. Cadaveric Based Research Pressure Measurements within the Tarsal Tunnel • Long been know that over-pronation is a major contributing factor in the development of neuropathy of the tibialis posterior nerve. • Previously published papers have used pressure gauges to measure this. • HOWEVER- no one has shown a method to reduce these forces outside of surgical decompression.
  • 55. Cadaveric Based Research Pressure Measurements within the Tarsal Tunnel • Already have learned recurrent talotarsal dislocation leads to an excessive amount of pronation therefore • If we can stabilize the talus on the tarsal mechanism this should decrease the pressures/forces acting on the neurovascular structures within the tarsal tunnel.
  • 56. Tarsal Tunnel Pressures- What do we know? • Neutral STJ 2 (0-7) mmHg • Maximally pronated 32 (12-60) mmHg • Pronation = significantly increases pressure within the tarsal tunnel with every step taken Kumar et al: Evaluation of Various Fibro-Osseous Tunnel Pressures in Normal Human Subjects. Indian J Physiol Pharmaol, 32:139-145, 1988 Trepman et al.:Effect of Foot & Ankle Position on Tarsal Tunnel Compartment Pressure. Foot Ankle Int. 20:721-726, 1999 Barker et al: Pressures Changes in the Medial & Lateral Plantar and Tarsal Tunnels Related to Ankle Position: A Cadaver Study. Foot Ankle Int 28:250-254, 2007 Rosson et al: Tibial Nerve Decompression in Patients with Tarsal Tunnel Syndrome: Pressures in the Tarsal, Medial Plantar, and Lateral Plantar Tunnels. Plast Reconstr Surg 124:1202-1210, 2009
  • 57. Increased Tarsal Tunnel Pressures What do we know? • A pressure of 20 – 30 mmHg has been shown to impair intraneural blood flow – Gelberman et al: Tissue Pressure Threshold for Peripheral Nerve Viability. Clin Orthop Relat Res 285-291, 1983 – Rydevik et al: Effects of graded comprssion of intraneural blood flow. An in vivo study on rabbit tibial nerve. J Hand Surg AM 6:3- 12, 1981
  • 58. Overall Results 32 21 29 18 34% reduction- Tarsal tunnel 38% reduction- Porta pedis
  • 59. Effect of Extra-Osseous TaloTarsal Stabilization on Posterior Tibial Tendon Strain Journal of Foot and Ankle Surgery, Volume 50, Issue 6 , Pages 676- 681, November 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.
  • 60. Cadaveric Based Research Strain Measurements - Results • Posterior Tibial Tendon – EOTTS decreased PTT strain by 51% *JFAS Nov/Dec 2011
  • 61. Evaluating Plantar Fascia Strain in Hyperpronating Cadaveric Feet Following an Extra-Osseous TaloTarsal Stabilization Procedure Journal of Foot and Ankle Surgery, Vol 50, No 6, Pages 682-686, November 2011 • The #1 etiology of plantar fasciitis/fasciopathy is secondary to excessive tension/strain. • EOTTS 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.
  • 62. Cadaveric Based Research Strain Measurements - Results • Plantar Fascia Medial Band
  • 63. Cadaveric Based Research Strain Measurements - Results • Plantar Fascia Medial Band – EOTTS decreased PF strain by 33% *JFAS Nov/Dec 2011
  • 64. Cadaveric Based Research Pressure Measurements within the Tarsal Tunnel • Therefore patients who exhibit symptomatology/pathology from their – Posterior tibial tendon – Tibialis posterior nerve – Plantar fascia – Tarsal tunnel syndrome • And have co-existing RTTD • They could benefit from the use of EOTTS.
  • 65. 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, September 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.
  • 66. Retrospective Radiographic Analysis • Restoration of Navicular Height following EOTTS – HyProCure. * JFAS, Vol 50, Issue 5, Pages 551-557
  • 67. Retrospective Radiographic Analysis • Premise – Stabilization of talotarsal mechanism decreases anteriomedial forces – Decreased force acting on the joints anterior to the sinus tarsi – So it would be assumed that if a navicular drop was evidenced via a loss of arch height, internal stabilization of the TTM would reduce the loss of arch height.
  • 68. Retrospective Radiographic Analysis • IRB Approved Study • 86 feet were evaluated in patients who had EOTTS with HyProCure ® • Pre-procedure navicular height measurements were measured and compared to post-EOTTS radiographs.
  • 69. Retrospective Radiographic Analysis • EOTTS procedure maintained the normal alignment of the navicular.
  • 70. Retrospective Radiographic Analysis • This proves that there is a stabilization of the medial column on the lateral column. • Decreased strain to the supporting soft tissues. • Shows that it is the osseous malformation that leads to soft tissue pathology and not vice versa otherwise stabilization of the TTM would not result in decreased strain to these supporting tissues.
  • 71. Extra-Osseous Talotarsal Stabilization with HyProCure- Radiographic Outcomes in Adult Patients Journal of Foot and Ankle Surgery – Vol. 51, No. 5, p. 548-556, 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.
  • 72. EOTTS-HyProCure Analysis ® • Removal rate as a stand-alone procedure? • 7 of the 117 patients considered for this study had permanent removal- 6% • None of these patients had any long- term complications following removal.
  • 73. EOTTS HyProCure Removal ® • Due to – Pain to the superficial area of the ATFL • 4 cases – Psychogenic reaction • 2 cases – Post-op infection • 1 case
  • 74. Short-term Self-resolving Complications Experienced • Incision dehiscence • Prolonged skin healing • Synovitis • Period of abnormal gait • Prolonged pain and swelling
  • 75. Future/On-going Prospective Studies • Prospective Functional Outcomes of EOTTS- Multi-centered study. • Gait analysis following EOTTS • Effect of EOTTS on Compression Tibialis Posterior Neuropathy
  • 76. • EOTTS - it just makes sense and is becoming the gold standard. • The scientific evidence is here. • Its time we challenge the status-quo treatments
  • 77. Because at the end of the day We are just trying our best to keep everyone walking.
  • 78. EOTTS – HyProCure ® • Used in patients from 3 to 95 years old • Every sports activity • There has not been a single case showing a significant complication, i.e. fracture, osteomyelitis, amputation, or death.
  • 79. For more information please visit: www.HyProCure.com