1 | Page The Medical Necessity of Extra-osseous Talotarsal Stabilization (EOTTS). EOTTS more than meets the criteria to be considered a medical necessity. As a matter of fact, EOTTS plays the primary role in the treatment of many orthopedic pathologies. Failure to perform the EOTTS procedure will delay or prohibit full resolution of many orthopedic symptoms. The following information explains the requirements by most insurance companies to consider a treatment a necessity and the evidence shows that EOTTS exceeds the criteria. The first consideration is to obtain an understanding of what criteria is required to determine medical necessity. According to section 1862(a)(1)(A) of the Social Security Act, Medicare will not cover services that “are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.” Since this subject is regarding treatment, not diagnosis, the proposed treatment would have to be reasonable and necessary in the treatment of an illness or injury or to improve the function of a malformed part of the body. If the proposed treatment meets these criteria, then Medicare should approve that treatment. The American Medical Association’s Model Managed Care Contract, suggests this definition of medically necessary services: “Health care services or procedures that a prudent physician would provide to a patient for the purpose of preventing, diagnosing or treating an illness, injury, disease or its symptoms in a manner that is (a) in accordance with generally accepted standards of medical practice; (b) clinically appropriate in terms of type, frequency, extent, site and duration; and (c) not primarily for the economic benefit of the health plans and purchasers or for the convenience of the patient, treating physician or other health care provider. ” Again, these are very clear specific guidelines. Cigna HealthCare definition of medical necessity policy for physicians is published on-line and it states: "Medically Necessary" or "Medical Necessity" shall mean health care services that a Physician, exercising prudent clinical judgment, would provide to a patient for the purpose of evaluating, diagnosing or treating an illness, injury, disease or its symptoms, and that are: in accordance with the generally accepted standards of medical practice; clinically appropriate, in terms of type, frequency, extent, site and duration, and considered effective for the patient's illness, injury or disease; and not primarily for the convenience of the patient or Physician, or other Physician, and not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient's illness, injury or disease.
Transcript
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The Medical Necessity of Extra-osseous Talotarsal Stabilization (EOTTS).
EOTTS more than meets the criteria to be considered a medical necessity. As a matter of fact,
EOTTS plays the primary role in the treatment of many orthopedic pathologies. Failure to
perform the EOTTS procedure will delay or prohibit full resolution of many orthopedic
symptoms. The following information explains the requirements by most insurance companies
to consider a treatment a necessity and the evidence shows that EOTTS exceeds the criteria.
The first consideration is to obtain an understanding of what criteria is required to determine
medical necessity. According to section 1862(a)(1)(A) of the Social Security Act, Medicare will
not cover services that “are not reasonable and necessary for the diagnosis or treatment of
illness or injury or to improve the functioning of a malformed body member.” Since this subject
is regarding treatment, not diagnosis, the proposed treatment would have to be reasonable
and necessary in the treatment of an illness or injury or to improve the function of a malformed
part of the body. If the proposed treatment meets these criteria, then Medicare should approve
that treatment.
The American Medical Association’s Model Managed Care Contract, suggests this definition of
medically necessary services: “Health care services or procedures that a prudent physician
would provide to a patient for the purpose of preventing, diagnosing or treating an illness,
injury, disease or its symptoms in a manner that is (a) in accordance with generally accepted
standards of medical practice; (b) clinically appropriate in terms of type, frequency, extent, site
and duration; and (c) not primarily for the economic benefit of the health plans and purchasers
or for the convenience of the patient, treating physician or other health care provider.” Again,
these are very clear specific guidelines.
Cigna HealthCare definition of medical necessity policy for physicians is published on-line and it
states:
"Medically Necessary" or "Medical Necessity" shall mean health care services that a Physician, exercising prudent clinical judgment, would provide to a patient for the purpose of evaluating, diagnosing or treating an illness, injury, disease or its symptoms, and that are: in accordance with the generally accepted standards of medical practice; clinically appropriate, in terms of type, frequency, extent, site and duration, and considered effective for the patient's illness, injury or disease; and not primarily for the convenience of the patient or Physician, or other Physician, and not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient's illness, injury or disease.
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For these purposes, "generally accepted standards of medical practice" means: standards that are based on credible scientific evidence published in peer-reviewed, medical literature generally recognized by the relevant medical community; Physician Specialty Society recommendations; the views of Physicians practicing in the relevant clinical area; and any other relevant factors.
There are many other example policies that follow the same demands to consider the
treatment. Historically there have been many “hoky-poky” treatments that simply did not make
sense and should therefore not be a covered by an insurance policy. On the other hand, there
are treatments that do make sense and should be covered. Many factors support the evidence
and rationale that EOTTS more than qualifies as a medical necessity.
1. The service, procedure or supply must be provided for the diagnosis, treatment, cure, or relief of a health condition, illness, injury or disease; and, not for experimental, investigational or cosmetic purposes. EOTTS is a surgical procedure where a FDA cleared titanium stent is placed into the sinus tarsi, a naturally occurring space, formed by the talus (ankle bone) and calcaneus (heel bone). The primary purpose of the sinus tarsi stent is to maintain the alignment and stability of the articular surfaces, of a dislocated talotarsal joint (TTJ), while still allowing a normal range of pronation and supination motions. The TTJ is the articular osseous interaction between the talus and the calcaneus and navicular. This complex joint mechanism forms the “foundation” joint of the body. The alignment and stability of the TTJ is crucial for the biomechanical function of the lower extremity during standing, walking, and running.
The sinus tarsi is the naturally occurring space
located between the talus and calcaneus.
Partial dislocation of the talus leads to
obliteration of the sinus tarsi.
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EOTTS treats, cures, and relieves health conditions, illnesses, injury and diseases within the foot and ankle. The primary indication for the insertion of a sinus tarsi stent is to repair the partial dislocation of the talotarsal joint. There have been numerous peer-reviewed papers that have been published in multiple, well-respected journals domestically and internationally, that have documented the ability of the sinus tarsi stent to realign and stabilize the TTJ while still allowing normal ranges of motion (see appendix). Sinus tarsi stents are cleared by the Food and Drug Administration (FDA) after a very exhaustive process called 510(k). The FDA makes a determination that the device is safe for use when it grants 510(k) approvals. The FDA will not grant 510(k) approvals for a device that is considered “experimental or investigational.” Sinus tarsi implants have had FDA clearance for many decades. In fact, the use of sinus tarsi implants has a long history of clinical use by leading foot and ankle surgeons globally. The partial dislocation of the TTJ leads to a pathologic gait cycle, excessive unlocking of major joints of the foot, increased strain on very important soft tissue structures (spring ligament, plantar fascia, posterior tibial nerve, posterior tibial tendon), increased pressures within the tarsal tunnel and porta pedis, formation of flexor stabilization hammertoes, and a negative impact on 1st metatarsophalangeal joint function. The realignment and stabilization of the TTJ via EOTTS is essential to remove a major etiologic factor to the development of those many secondary pathologies. EOTTS is not recommend or used for cosmetic appearance issues, rather it is for a specific internal orthopedic pathology. This condition can only be addressed with internal physical measures. There is no evidence that external measures are capable of realigning and stabilizing the talus on the calcaneus. The partial dislocation will not get better but worse over time. It is blamed as a leading contributory force to the development of many pathologies within the foot and ankle, as well as, the knees, hips, and back. 2. It must be necessary for and appropriate to the diagnosis, treatment, cure, or relief of a health condition, illness, injury, disease or its symptoms. From the early beginnings of orthopedics, it has described the importance of a stable and aligned TTJ. There have been numerous methods that have been prescribed for patients since the beginning of orthopedics. Along the way, researchers have continued to develop innovative techniques to achieve realignment and stabilization of the talotarsal joint without arthrodesis. This long evolutionary process has finally lead to the success of EOTTS.
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There are clear, concise, and validated findings that allow for the diagnosis of an osseous deformity where the preferred treatment is EOTTS. Specifically, that diagnosis is a talotarsal joint mal-alignment, displacement, medically referred to as a dislocation. This means that the articular facets of the talus are no longer in constant congruent alignment on the calcaneus, and/or navicular bones. This TTJ dislocation can be a recurrent or fixed deformity. The diagnosis of TTJ dislocation is made via clinical non-weightbearing and weightbearing examination and is confirmed by radiographic observations (see table below). Table – Clinical and radiographic findings to diagnose a patient with a partially dislocated talus.
3. It must be within generally accepted standards of medical care in the community. Foot and ankle surgeons have advocated for, recommended and used EOTTS in their patients for many decades. EOTTS is performed regularly and is an accepted standard of orthopedic treatment of partial TTJ dislocation. It is taught in podiatric medical schools, regularly presented in orthopedic and podiatric medical conferences, and has many published studies in peer-reviewed journals globally. Positive EOTTS research articles have been published in many specific publications within the foot and ankle care arena. There has not been negative advocacy against EOTTS. The use of EOTTS is well established within the medical care community. 4. It must not be solely for the convenience of the insured, the insured’s family or the provider.
The importance of a stable and aligned TTJ is essential for normal biomechanical function of
standing, walking, and running. EOTTS is a minimally invasive, soft tissue procedure that
internally fixes the problem without the associated limitations of external measures or
complications seen in patients who have required more aggressive hindfoot reconstructive
surgery. The primary factor is that EOTTS has a shorter procedure time, shorter recovery time
than traditional surgery, and yet it still allows a normal range of motion. The EOTTS option is a
The pre-op lateral radiograph exhibiting a partially
dislocated TTJ. The images on the right show various
methods to realign and stabilize the talus. EOTTS is the
only conservative option that achieves the desired result
without cutting, shifting, or fusing bones or joints.
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5. Compare the cost-effectiveness of alternative services or supplies when determining which
of the services or supplies will be covered.
Another important aspect regarding EOTTS is the financial component. EOTTS, as already
discussed, is a superior option to achieving the desired goal: TTJ realignment and stability while
still allowing a natural range of motion. It also is a very cost-effective alternative to traditional
reconstructive surgery. The EOTTS procedure is generally performed with a “twilight” sedation,
rather than an expensive and time consuming, and increased risk with a general or spinal
anesthesia. The actual procedure time to realign and stabilize the TTJ with a sinus tarsi stent,
typically takes 20 minutes, compared to traditional osseous reconstructive surgery that can
take at minimum, an hour or longer.
The post-op course is much easier with EOTTS as well. There is a much lower complication rate
when compared to typical reconstruction. EOTTS is considered a conservative surgical
procedure because it is reversible. Typical reconstructive surgery requires cutting and shifting
of bones, inserting bone grafts, screws, staples, plates, and/or pins. Most patients who undergo
traditional reconstruction will have to be taken back to the operating room for removal of
painful internal hardware. This is very costly to the insurance carrier.
The cost of the sinus tarsi stents is more expensive than a regular orthopedic screw but what
must be taken into consideration is the extremely high other costs associated with that
orthopedic screw. Most, if not all patients will require a reoperation to remove that screw. This
will incur thousands of dollars of cost. The need for removal of the sinus tarsi implant has a less
overall cost verses a screw that has a high likelihood that it will have to be removed.
6. Treatment is consistent with the symptoms or diagnosis of the illness, injury, or symptoms
under review by the provider of care.
The partial dislocation of the talus on the calcaneus has proven to be a very destructive
pathology that negatively affects the function and structure of the foot, ankle, knee, hip, pelvis,
and spine. A partially dislocating talus leads to excessive tissue strain to the plantar fascia,
posterior tibial tendon, and posterior tibial nerve. This increases the pressures within the tarsal
tunnel and leads to tarsal tunnel syndrome, plantar neuropathy. It also alters the weightbearing
forces acting on the plantar foot. The negative effects to the 1st metatarsophalangeal joint have
been well documented as the primary contributing force to the development of hallux valgus-
metatarsus primus varus, hallux limitus, and hallux rigidus.
There has long been a connection between abnormal hindfoot alignment and knee pathology.
The same is true with hip, pelvis and back alignment. The joints of the foot, ankle, and knee,
become excessively weakened during the stance or contact phase of the gait cycle. When the
talus partially dislocates on the heel bone, this increases the forces acting on the inner arch,
forces a strain to the inner knee, pulls the hip away from the pelvis, makes the pelvis tilt, and
that places a strain on the vertebrae of the lower and upper spine.
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It would seem very prudent that someone with chronic pain to the feet, knees, hips or back
that is connected to the partial dislocation of the talus, should have their talus realigned and
stabilized on the calcaneus. This has been proven to decrease the strain to those tissues and to
also improve the alignment of other osseous structures.
7. Treatment is necessary and consistent with generally accepted professional medical
standards (i.e., not experimental or investigational).
This is an important point that must be taken into consideration. What are the available
treatment options? And is there an advantage or superiority of EOTTS over other forms of
treatment?
There is no evidence to suggest of an “auto-repair” of this physical orthopedic malalignment. In
fact, the evidence suggests a progression of the deformity. It will only get worse, not better. To
simply “observe” this deformity is allowing the continued secondary tissue pathologies to
develop. This option is considered below the standard of medical care. This is an unreasonable
form of treatment of partial talotarsal joint dislocation.
The use of arch supports, foot orthosis, is an unregulated form of treatment. There is no
evidence that suggests a shoe insert will realign and stabilize the talus. In fact, there has been
studies that have showed progression of osseous deformation with the use of custom foot
orthosis. This form of treatment should also be considered below the standard of care for the
treatment of a partially dislocated talus. It is not proven and makes no sense. This is an
unreasonable form of treatment of partial talotarsal joint dislocation.
Many surgeons advocate the weakening of the Achilles tendon by performing either a
tendoAchilles lengthening or cutting the fibers of the gastrocnemius muscle as they inert into
the Achilles tendon. The claim is that the tight posterior muscle-tendon is responsible for the
excessive tissue strain/forces. Yet, there are no positive studies to show decrease tissue strain
post-lengthening to the major soft tissue structure within the foot and ankle. Furthermore,
there is not a single case report showing realignment and stabilization of the talus on the
calcaneus. This form of treatment as a primary procedure in the realignment and stabilization
of the TTJ is below the standard of care. This is an unreasonable form of treatment of partial
talotarsal joint dislocation.
There have been many other forms of surgical treatments advocated to realign the foot
structure. Extra-articular osseous reconstructive procedures include the cutting and shifting of
the back of the heel bone to realign the heel (medial displacement calcaneal osteotomy). There
have been numerous studies that fail to show realignment and stabilization of the talus. Most
patients are taken back to the operating room to have painful screws removed, adding more
stress to the patient, more cost to the insurance carriers, and still a “unfixed” partial talotarsal
joint dislocation. This is an unreasonable form of treatment of partial talotarsal joint
dislocation.
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Another “popular” surgical procedure involves the cutting and insertion of a bone graft into the
front of the heel bone (lateral column lengthening). This procedure is thought to fix a forefoot
valgus, to reduce the “too many toes” sign associated. Again, this is an irreversible procedure
that is associated with complications, and is proven to lead to arthritic changes at the
calcaneocuboid joint within 6 months post-surgery. Still, there is no evidence of realignment
and stabilization of the talus on the calcaneus. This is an unreasonable form of treatment of
partial talotarsal joint dislocation.
Many surgeons have advocated the cutting and fusion of the posterior talocalcaneal (subtalar)
facet to stabilize the talocalcaneal bones. This accomplished the “mission” of realigning and
stabilizing the talus, however, at a significant biomechanical cost. First cutting out of the joint
facets removes at minimum 1 cm of bone or more. Instantly this will create a limb length
discrepancy and will lead to pelvic tilt and increased strain to the back. This is a very involved,
irreversible procedure performed while the patient is under a general anesthesia. There are
many other associated complications such as the need to remove painful hardware/screws,
ankle joint arthritis, talonavicular arthritis. Again, an unreasonable form of treatment.
Finally, in severe cases, typically end-stage hindfoot collapse, the talus is fused to both the
calcaneus and navicular bones. This is a complicated surgery that requires a long recovery,
general anesthesia, and is associated with many post-operative complications.
This brings us back to EOTTS and why it is considered that best form of treatment for the partial
dislocation of the talus. The sinus tarsi stents are proven to realign and stabilize the talus to fix
the partial dislocation. There is radiographic and clinical evidence of stabilization of the TTJ
while still allowing the normal range of motion. EOTTS does not have the associated
complications as other more aggressive, irreversible surgical procedures. EOTTS makes sense
and is a very reasonable and effective form of treatment.
8. Treatment is furnished at the most appropriate level that can be provided safely and
effectively to the patient, and is neither more or less than what the patient is requiring at
that specific point in time.
There are symptoms and there is an underlying cause or etiology for that symptom. Recurrence
of symptoms will occur if the underlying etiology is not adequately addressed. When one
considers the most “common” foot and ankle symptoms (plantar fasciitis, posterior tibial
tendon disorder, 1st metatarsophalangeal joint pain) the leading complication of treatment is
recurrence. That’s because the underlying etiology, tissue strain due to the partial dislocation of
the talus, is still present. EOTTS is proven to have positive effects to decrease tissue strain and
to improve the biomechanics of the foot. So, it is appropriate for a surgeon to recommend
EOTTS as a co-treatment for many other foot and ankle pathologies.
Many insurance carriers claim that they will not allow coverage for EOTTS because it is
performed for the correction of an over-pronating or flat foot surgery, yet they pay for several
other surgical procedures that are specifically created to fix flat or over-pronating feet. For
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instance, the “Kidner” procedure is performed on the navicular and includes a “tightening” and
repositioning of the posterior tibial tendon to strengthen the inner arch. The “Cotton”
procedure is an opening wedge osteotomy into the medial cuneiform as a primary or adjunct
procedure in the correction of flat foot. The “Evan’s” procedure is a lateral column lengthening
procedure that involves the cutting and the insertion of a bone graft into the anterior portion of
the calcaneus. A medical displacement calcaneal osteotomy is performed to fix a heel valgus
associated with flat feet. Furthermore, there are several joint fusion(s), arthrodesis, procedures
whose goal is to realign an arthritic joint due to the years of over-pronation, flat foot. A subtalar
or triple arthrodesis is primarily recommended for the treatment of end-stage flat feet.
There is a double standard against EOTTS. On one hand, the insurance companies report that
there is not a medical necessity for EOTTS yet the supporting literature has proven over the
past many decades that a more conservative approach is needed. Patients are made to suffer
for years of medical and orthopedic symptoms until their only option is complex surgery. That
is, an option which is more expensive than EOTTS, and has a significantly greater chance for
more revision surgery and complications. The time has come for insurance companies to accept
and to pay for this life-changing procedure.
The evidence is clear that there is more than an established rationale and medical necessity for
EOTTS. This minimally invasive procedure should not be considered experimental. There are
more than 70 peer-reviewed articles from leading foot and ankle surgeons. The recurrent,
partial dislocation of the talus is best fixed with EOTTS. Other forms of treatment should be
considered below the standard of care because they are not proven to fix the deformity,
misalignment and instability of the talotarsal joint. Other forms of non-conservative, radical
surgical procedures are associated with a long-recovery, many post-op complications, high rate
of return to removal painful hardware, and arthritic changes to adjacent joints.
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2017 Published Studies on EOTTS (July 2017)
Faldini C. Mazzotti A, Panciera A, Perna F, Stefanini N. Giannini S. Bioabsorbable implants for subtalar arthroereisis in pediatric flatoot. Musculoskelet Surg. (Epub ahead of print)
Xu J, Ma X, Wang D, Lu W Zhu W, Ouyang K, Liu H, Li H, Jiang L. Comparison of extraosseous talotarsal stabilization implants in Stage II Adult-Acquired Flatfoot Model: A Finite Element Analysis. J Foot Ankle Surg. (Epub ahead of print)
Wen J, Liu H, Xiao S, Li X, Fang K, Zeng M, Tang Z, Cao S, Li F. Comparison of mid-term efficacy of spastic flatfoot in ambulant children with cerebral palsy by 2 different methods. Medicine (Baltimore). 96(22):e7044, 2017.
Cao L, Miao XD, Wu YP, Zhang XF, Zhang Q. Therapeutic Outcomes of Kalix II in Treating Juvenile Flexible Flatfoot. Orthop Surg. 9(1):20-7, 2017.
Gianni S, Cadossi M, Mazzotti A, Persiani V, Tedesco G, Romagnoli M, Faldini C. J Foot Ankle Surg. 56(4):779-82, 2017.
Martinelli N, Bianchi A, Martinkevich P, Sartorelli E, Romeo G, Bonifacini C, Malerba F. Return to sport activities after subtalar arthroereisis for correction of pediatric flexible flatfoot. J Pediatr Ortohp B. (Epub ahead of print), 2017.
Yasui Y, Tongogai I, Rosenbaum AJ, Moore DM, Takao M, Kawano H, Kennedy JG. Use of the arthroereisis screw with tendoscopic delivered platelet-rich plasma for early stage adult acquired flatfoot deformity. Int Orthop. 41(2):315-21, 2017.
2016
Xu Y, Li SC, Xu SY. Calcaneal Z Lengthening Osteotomy Combined with Subtalar Arthroereisis for Severe Adolescent Flexible Flatfoot Reconstruction. Foot Ankle Int. 37(11):1225-31, 2016.
Saxena A, Via AG, Maffulli N, Chiu H. Subtalar Arthroereisis Implant Removal in Adults: A Prospective Study of 100 Patients. J Foot Ankle Surg. 55(3):500-3, 2016.
Faldini C, Nanni M, traina F, Fabbri D, Borghi R, Giannini S. Surgical treatment of hallux valgus associated with flexible flatfoot during growing age. Int Orthop. 40(4):737-43, 2016.
Nevalainen MT, Roedl JB, Zoga AC, Morrison WE. Imaging findings of arthroereisis in planovalgus feet. Radio Case Rep. 11(4):398-404, 2016.
Vulcano E, Maccario C, Myerson MS. How to approach the pediatric flatfoot. World J Orthop. 18(1):1-7, 2016.
Martinelli N, Romeo G, Bonifacini C, Vigano M, Bianchi A, Malerba F, Validation of the Italian version of the Oxford Ankle Foot Questionnaire for children. Aual Life Res. 25(1):117-23, 2016.
Carr JB, Yang S, Lather LA. Pediatric Pes Planus: A state-of-the-Art Review. Pediatrics. 137(3):1-10, 2016.
Chong DY, Macwilliams BA, Hennessey TA, Teske N, Stevens PM. Prospective comparison of subtalar arthroereisis with lateral column lengthening for painful flatfeet. J Pediatr Orthop B. 24(4)345-53, 2015.
Steber S, Kolodziej L. Analysis of Radiographic Outcomes Comparing Foot Orthosis to Extra-Osseous Talotarsal Stabilization in the Treatment of Recurrent TaloTarsal Joint Dislocation. J Min Inv Orthop. 1;1-11, 2015.
Flynn J, Wade A, Bustillo J, Juliano P. Bridle procedure combined with a subtalar implant: a case series and review of the literature. Foot Ankle Spec. 8(1):29-35, 2015.
Shah NS, Needleman RL, Bokhari O, Buzas D. 2013 Subtalar Arthroereisis Survey: The Current Practice Patterns of Members of the AOFAS. Foot Ankle Spec. 8(3):180-5, 2015.
Zhu Y, Xu XY. Treatment of Stage II Adult Acquired Flatfoot Deformity with Subtalar Arthroereisis. Foot Ankle Spec. 8(3):194-202, 2015.
2014
Tarissi N, Valiee A, Dujardin F, Duparc F, Roussignol X. Reducible valgus flat-foot: assessment of posterior subtalar joint surface displacement by posterior arthroscopy during sinus tarsi expansion screwing. Orthop Traumatol Surg Res. 100(8 suppl):S395-9, 2014.
Lui TH. Spontaneous subtalar fusion: an irreversible complication of subtalar arthroereisis. J Foot Ankle Surg. 53(5):652-6, 2014.
Kumar V, Clough TM. Talar neck fracture-a rare by important complication following subtalar arthroereisis. Foot (Edinb). 24(4):169-71, 2014.
De Pellegrin M, Moharamzadeh D, Strobl WM, Bidermann R, Tschauner C, Wirth T. Subtalar extra-articular screw arthroereisis (SESA) for the treatment of flexible flatfoot in children. J Child Orthop. 8(6):479-87, 2014.
2013
Jay RM, Din N. Correcting pediatric flatfoot with subtalar arthroereisis and gastrocnemius recession: a retrospective study. Foot Ankle Spec. 6(2):101-7, 2013.
Baker JR, Klein EE, Weil L JR, Weil LS Sr, Knight JM. Retrospective analysis of the survivability of absorbable versus nonabsorbable subtalar joint arthroereisis implants. Foot Ankle Spec. 6(1):36-44, 2013.
Fitzgerald RH, Vedpathak A. Plantar Pressure Distribution in a Hyperpronated Foot Before and After Intervention with an Extra-Osseous Talotarsal Stabilization Device – A Retrospective Study. J Foot Ankle Surg. 52(4):432-43, 2013.
Bali N, Theivendran K, Prem H. Computed Tomography Review of Tarsal Canal Anatomy with Reference To the Fitting of Sinus Tarsi Implants in the Tarsal Canal. J Foot Ankle Surg. 52(6): 714-716, 2013.
Bresnahan PJ, Chariton JT, Vedpathak A. Extra-Osseous TaloTarsal Stabilization using HyProCure®: Preliminary Clinical Outcomes of a Prospective Case Series. J Foot Ankle Surg. 52(2): 195-202 2013.
Graham, ME. Congenital Talotarsal Joint Displacement and Pes Planovalgus. Clin Podiatr Med Surg. 30:567-81, 2013.
Abbara-Czardybon M, Wingenfeld C, Arbab D, Frank D. Options and limits of subtalar arthroereisis in childhood. Orthopade. 42(1):12-9, 2013.
2012
Garras DN, Hansen PL, Miller AG, Raikin SM. Outcome of modified Kidner procedure with subtalar arthroereisis for painful accessory navicular associated with planovalgus deformity. Foot Ankle Int. 33(11):934-9, 2012.
Fernandez de Retana P, Alvarez F, Bacca G. Is there a role for subtalar arthroereisis in the management of adult acquired flatfoot. Foot Ankle Clin. 17(2):271-81, 2012.
Yen-Douangmala D, Vartivarian M, Choung JD. Subtalar arthroereisis and its role in pediatric and adult population. Clin Podiatr Med Surg. 29(3):383-90, 2012.
Graham ME, Jawrani, NT, Chikka A. Extra-Osseous TaloTarsal Stabilization using HyProCure® in Adults: A 5-Year Retrospective Follow-Up. J Foot Ankle Surg, 51(1): 23-29, 2012.
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Graham ME, Jawrani NT, Chikka A, Rogers RJ. Surgical Treatment of Hyperpronation Using an Extra-Osseous TaloTarsal Stabilization Device: Radiographic Outcomes in Adult Patients. J Foot Ankle Surg. 51 (5): 548-55, 2012.
Graham ME, Jawrani, NT. Extra-Osseous Stabilization Devices: A New Classification System. J Foot Ankle Surg. 51(5):613-9, 2012.
Graham ME. Talotarsal Joint Displacement – Diagnosis and Stabilization Options. Foot and Ankle Quarterly, Volume 23, Issue 4, Pages 165-179, winter 2012.
Hazany S, Ly N, Hazany D, Bader S, Ostuka N. Outcomes of subtalar arthroereisis for the planovalgus foot. 21(3):147-50, 2012.
Martinelli N, Marinozzi A, Schulze M, Denaro V, Evers J, Bianchi A, Rosenbaum D. Effects of subtalar arthroereisis on the tibiotalar contact characteristics in a cadaver flatfoot model. J Biomech. 45(9):1745-8, 2012.
Corpus M, Shoffer D, Labovitz J, Hodor L, Yu K. Fracture of the talus as a complication of subtalar arthroereisis. J Foot Ankle Surg. 51(1):91-4, 2012.
Van Ooij B, Vos CJ, Saouti R. Arthroereisis of the subtalar joint: an uncommon complication and literature review. J Foot Ankle Surg. 51(1):114-7, 2012.
Brancheau SP, Walker KM, Northcutt DR. An analysis of outcomes after use of the Maxwell-Brancheau Arthroereisis Implant. J Foot Ankle Surg. 51(1):3-8, 2012.
2011
Metcalfe SA, Bowling FL, Reeves ND. Subtalar joint arthroereisis in the management of pediatric flexible flatfoot: a critical review of the literature. Foot Ankle Int. 32(12):1127-39, 2011.
Yu T, Yang Y, Yu G. Application progress of subtalar arthroereisis for correction of pediatric flatfoot in children. Zhonggou Xiu Fu Chong Jian Wai Ke Za Zhi. 25(2):1513-6, 2011.
Graham ME, Jawrani NT, Goel VK. Evaluating plantar fascia strain in hyperpronating cadaveric feet following an extra-osseous talotarsal stabilization procedure. J Foot Ankle Surg. 50(6):682-6, 2011.
Graham ME, Jawrani NT, Chikka A. Radiographic Evaluation of Navicular Position in the Sagittal Plane – Correction Following an Extra-Osseous TaloTarsal Stabilization Procedure. J Foot Ankle Surg, 50(5):551-7, 2011.
Graham ME, Jawrani, NT, Goel VK. Effect of Extra-Osseous TaloTarsal Stabilization on Posterior Tibial Tendon Strain in Hyperpronating Feet. J Foot Ankle Surg. 50(6): 676-81, 2011.
Graham ME. Jawrani NT, Goel VK. Effect of extra-osseous talotarsal stabilization on posterior tibial nerve strain in hyperpronating feet: a cadaveric evaluation. J Foot Ankle Surg. 50(6):672-5, 2011.
Graham ME, Jawrani, NT, Goel VK. The Effect of HyProCure® on Tarsal Tunnel Compartment Pressures in Hyperpronating Feet. J Foot Ankle Surg. 50(1):44-9, 2011.
Graham ME, Jawrani, NT, Goel VK. Evaluating Plantar Fascia Strain in Hyperpronating Cadaveric Feet Following an Extra-Osseous TaloTarsal Stabilization Procedure. J Foot Ankle Surg. 50(6): 682-86, 2011.
Highlander P, Sung W, Weil L Jr. Subtalar Arthroereisis. Clin Podiatr Med Surg. 28(4):745-54, 2011.
Graham ME, Parikh R, Goel V, Mhatre D, Matyas A. Stabilization of joint forces of the subtalar complex via HyProCure sinus tarsi stent. J Am Podiatr Med Asso. 101(5):390-9, 2011.
Grant WP, Garcia-Lavin S, Sabo R. Beaming the columns for Charcot diabetic foot reconstruction: a retrospective analysis. J Foot Ankle Surg. 50(2):182-9, 2011.
Cook EA, Cook JJ, Basile P. Identifying risk factors in subtalar arthroereisis explantation: a propensity-matched analysis. J Foot Ankle Surg. 50(4):395-401, 2011.
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2010
Fernandez de Retana P, Alvarez F, Viladot R. Subtalar arthroereisis in pediatric flatfoot reconstruction. Foot Anke Clin. 15(2):323-35, 2010.
Kwon JY, Myerson MS. Management of the flexible flat foot in the child: a focus on the use of osteotomies for correction. Foot Ankle Clin. 15(2):309-22, 2010.
Scharer BM, Black BE, Sockrider N. Treatment of painful pediatric flatfoot with Maxwell-Brancheau subtalar arthroereisis implant a retrospective radiographic review. Foot Ankle Spec. 3(2):67-72, 2010.
2009
Koning PM, Heesterbeek PJ, de Visser E. Subtalar arthroereisis for pediatric flexible pes planovalgus: fifteen years experience with the cone-shaped implant. J Am Podiatr Med Assoc. 99(5):447-53, 2009.
Arangio GA, Salathe EP. A biomechanical analysis of posterior tibial tendon dysfunction, medial displacement calcaneal osteotomy and flexor digitorum longus transfer in adult acquired flat foot. Clin Biomech (bristol, Avon). 24(4):385-90, 2009.
Molayem I, Persiani P, Marcovici LL, Rosi S, Calistri A, Villani C. Complications following correction of the planovalgus foot in cerebral palsy by arthroereisis. Acta Orthop Belg. 75(3):374-9, 2009.
2008
Adelman VR, Szczepanski JA, Adelman RP. Radiographic evaluation of endoscopic gastrocnemius recession, subtalar joint arthroereisis, and flexor tendon transfer for surgical correction of stage II posterior tibial tendon dysfunction: a pilot study. J Foot Ankle Surg. 47(5):400-8, 2008.
Cicchinelli LD, Pascual Huerta J, Carcia Carmona FJ, Fernandez Morato D. Analysis of gastrocnemius recession and medial column procedures as adjuncts in arthroereisis for the correction of pediatric pes planovalgus: a radiographic retrospective study. J Foot Ankle Surg. 47(5):385-91, 2008.
Scialpi L, Mori C, Mori F, Sperti M, Solarino G. Arthroereisis with Giannini’s endo-orthotic implant and Pisani’s talocalcaneal arthroereisis. A comparison of surgical methods. Chir Organi Mov. 92(1):61-5, 2008.
2007
Chang TJ, Lee J. Subtalar joint arthroereisis in adult-acquired flatfoot and posterior tibial tendon dysfunction. Clin Podiatr Med Surg. 24(4):687-97, 2007.
Jacobs AM. Soft tissue procedures for the stabilization of medial arch pathology in the management of flexible flatfoot deformity. Clin Podiatr Med Surg. 24(4):657-65, 2007.
Arangio GA, Chopra V, Voloshin A, Salathe EP. A biomechanical analysis of the effect of lateral column lengthening calcaneal osteotomy on the flat foot. Clin Biomech (Bristol, Avon). 22(4):472-7, 2007.
Schon LC. Subtalar arthroereisis: a new exploration of an old concept. Foot Ankle Clin. 12(2):329-39, 2007.
Saxena A, Nguyen A. Preliminary radiographic findings and sizing implications on patients undergoing bioabsorbable subtalar arthroereisis. J Foot Ankle Surg. 46(3):175-80, 2007.
2006
Soomekh DJ, Baravaraian B. Pediatric and adult flatfoot reconstruction: subtalar arthroereisis versus realignment osteotomy surgical options. Clin Podiatr Med Surg. 23(4):695-708, 2006.
Needleman RL. A surgical approach for flexible flatfeet in adults including a subtalar arthroereisis with the MBA sinus tarsi implant. Foot Ankle Int. 27(1):9-18, 2006.
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Vora AM, tie TR, Parks BG, Schon LC. Correction of moderate and severe acquired flexible flatfoot with medializing calcaneal osteotomy and flexor digitorum longus transfer. J Bone Joint Surg AM. 88(8):1726-34, 2006.
2005
Needleman RL. Current topic review: subtalar arthroereisis for the correction of flexible flatfoot. Foot Ankle Int. 26(4):336-46, 2005.
Nelson SC, haycock DM, Little ER. Flexible flatfoot treatment with arthroereisis: radiographic improvement and child health survey analysis. J Foot Ankle Surg. 43(3):144-55, 2004.
Arngio GA, Reinert KL, Salathe EP. A biomechanical model of the effect of subtalar arthroereisis on the adult flexible flat foot. Clin Biomech (Bristol, Avon). 19(8):847-52, 2004.
2003
Viladot R, Pons M, Alaverz F, Omana J. Subtalar arthroereisis for posterior tibial tendon dysfunction: a preliminary report. Foot Ankle Int. 24(8):600-6, 2003.
Gianini S, Ceccarelli F, Vannini F, Baldi E. Operative treatment of flatfoot with talocalcaneal coalition. Clin Orthop Relat Res. 411: 178-87, 2003.
Zaret DJ, Myerson MS. Arthroereisis of the subtalar joint. Foot Ankle Clin. 8(3):605-17, 2003.
Maxwell JR, Carro A, Sun C. Use of the Maxwell-Brancheau arthroereisis implant for the correction of posterior tibial tendon dysfunction. Clin Podiatr Med Surg. 16(3):479-89, 1999.
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Medical Necessity and Evidence Basis for Extra-osseous Talotarsal Joint Stabilization
Background:
Extra-osseous talotarsal joint stabilization (EOTTS) is a minimally invasive surgical procedure
that involves the insertion of an internal fixation device, stent, into the sinus tarsi. The goal of
this stent is to realign and stabilize the “foundation joint” of the body, while still allowing a
normal joint range of motion. There are more than 100 peer-reviewed, published articles that
prove the medical necessity for and the effectiveness of EOTTS.
EOTTS implants are cleared for use in more than 70 countries. Obtaining the clearance from the
Food and Drug Administration (FDA) and CE mark for European countries is a major hurdle. This
means that the government has validated the evidence that the device contains sufficient valid
scientific evidence that provides reasonable assurance that the device is safe and effective for
its intended use or uses. These sinus tarsi stents are advocated for and inserted by leading
orthopedic and podiatric foot surgeons around the world. The end-users, foot surgeons,
recommend and use these sinus tarsi stents for a reason. It works and patients get better. The
only reason why more patients are not offered this solution is simply due to limited insurance
coverage.
EOTTS Advantages:
Of importance is the fact that EOTTS is a surgical procedure that does not involve cutting
and/or shifting of any bones. It does not have a negative impact on the very important joints of
the hindfoot. In fact, the EOTTS procedure should reverse or delay arthritic damage caused to
joints due to the partial dislocation of the TTJ.
There are many advantages of EOTTS over other forms of “treatment” of talotarsal joint
dislocation. EOTTS can be used as a “stand-alone procedure”, meaning there are situations
where the only form of treatment required is EOTTS. It can also be used in conjunction with
both external measures, or along with other surgical procedures to correct co-foot/ankle
deformities. EOTTS can be performed on both children and adults. Patients can walk, run,
perform any activity of their choice, once the tissues have recovered from the initial procedure.
The muscles, ligaments, and tendons will work more efficiently. Patients claim to “run faster”
and “jump higher” due to their realigned talotarsal joint.
One of the many other advantages of this procedure is that it is reversible. This is very
important when compared to other surgical procedures where tendons are sacrificed, bones
are cut and shifted, or joints are fused to eliminate motion. EOTTS is the only reversible surgical
procedure that can realign and stabilize the talotarsal joint.
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Primary Indication of EOTTS:
There is only one primary indication/diagnosis that a surgeon would recommend EOTTS to a
patient and that is talotarsal joint dislocation. There are clear, validated clinical and radiologic
measurements that are used to diagnose this complex orthopedic deformity. The majority of
cases where EOTTS is performed is for recurrent talotarsal joint dislocation (RTTJD), as opposed
to the minority of cases where there is a fixed deformity such as a tarsal coalition. RTTJD is a
pathologic anomaly where the talus repeatedly dislocates on the calcaneus and/or the
navicular bone. This deformity will never auto-repair. It won’t get better; it will only get worse
and has been proven to be the underlying etiology to many chronic lower extremity
EOTTS is the superior treatment of choice for many reasons. Unlike observation, foot orthotics,
and many other surgical procedures, EOTTS is proven to realign and stabilize the TTJ while still
allowing a normal range of motion. 77,78,79 ,80,81,82,83,84,85,86,87,88,89,90,91,92
Evidence Basis of EOTTS
The primary reason why many in the insurance industry have denied the reimbursement of the
EOTTS procedure is due to “limited published data” on the effectiveness of EOTTS.
What is the minimum evidence required to show that EOTTS is an effective treatment option?
1. Is there evidence that the EOTTS procedure maintains the stability and alignment of the
TTJ clinically and radiographically? YES!
2. Is there evidence that the EOTTS procedure normalizes the range of motion of the TTJ?
YES!
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3. Is there evidence that the EOTTS procedure normalizes the joint forces acting on the
tarsal mechanism? YES!
4. Is there evidence that the EOTTS procedure decreases strain acting on supporting soft
tissue structures? YES!
5. What are the reported “worst case” complications? Limited and no long lasting
“complications”, simply the stent was removed without negative long-term issues.
Armed with that information, the insurance carriers should decide that the EOTTS procedure
should be reimbursed.
There have been numerous scientific papers looking at the short and long-term effects of the
EOTTS procedure. (77-92) There are multiple papers that have proven both clinical and radiologic
normalization of TTJ alignment and stability. (77-92) Research shows that following the EOTTS
procedure, there are decreased forces acting on the front of the foot and increased forces
acting on the heel.93 Likewise, there are studies that have shown a significant decrease in tissue
strain and elongation.94,95,96,97,98 Furthermore, long-term studies have shown limited post-
EOTTS complications.81, 82, 85, 86, 89
There have only been a few reported cases of “worst case” complications.99,100,101,102,103 There
estimates that as many as 250,000 EOTTS procedures have been performed globally. Yet, only a
few “complications” have been reported? The worst of these involved a sinus tarsi implant that
shifted 180 degrees from where it was initially placed and it became partially embedded into
the ankle bone.99 The device was removed and there was no long-term negative effect. The
article made it appear as if the ankle bone was fractured. There are many surgeons who
partially insert screws into either the ankle bone or heel bone in a similar fashion to block
excessive ankle bone motion. 104 ,105,106,107,108,109,110,111,112,113 That is not a true “complication.”
Another “complication” case-report occurred when the surgeon failed to remove a dislocated
stent and allowed the patient to continue to walk on their foot, knowing full well the stent was
not placed in the desired alignment.102 Later that patient developed arthritic changes. The issue
is that it occurred “spontaneously” after more than 2 years. It should have been a malpractice
case against the surgeon, rather than a knock against sinus tarsi implants. This was a
complication that could have been prevented if the surgeon would have intervened when the
initial displacement was visualized on the x-ray.
What has not been reported is that not a single patient ended up with a serious complication.
Typically, the worst thing that can occur is prolonged pain and the EOTTS implant must be
removed. There is not a single reported case where a patient required more extensive surgical
procedures because of undergoing an EOTTS procedure. Most times, patients would be told
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they need more aggressive surgery and the EOTTS procedure is performed as a more
conservative option.
Benefit-Risk Analysis of EOTTS:
A few of the benefits include a minimally invasive procedure that internally realigns and
stabilizes the TTJ while still allowing a normal range of motion. This procedure is reversible and
can be used in conjunction with both external measures and other surgical procedures. It is
commonly performed in both children and adults. Patients, once recovered, can participate in
sporting activities of their choosing.
Besides the very important benefits listed above, is the fact that not only is the TTJ realigned,
but also the normalization of forces acting within the foot structures. Instantly, there are
decreased forces acting on the bones, joints, tendons, ligaments, and neurovascular structures
of the foot. The ankle joint is realigned, and there are positive effects to the knee, hips, pelvis,
and spine.
Patients who have had the EOTTS procedure have been able to increase their activity levels,
increase their metabolism, decrease their weight, improve their blood sugar levels and blood
pressure. Simply put, they get their lives back. They don’t have to think about whether an
activity is worth the pain they would experience due to walking or standing. They just get back
to living.
What are the potential risks of EOTTS? First off, they are nowhere near the potential risks of
traditional corrective surgery. There are no chances of non-union or implant breakage
(orthopedic screws have been known to break from time-to-time). The worst possible issue is
simply that there is prolonged pain due to soft tissue adaptation. The EOTTS stent can be
removed or downsized. Occasionally the stent can displace. This is because it is only anchored
by the soft tissues in the sinus tarsi space and many times those tissues no longer exist due to
the duration of the RTTJD deformity. Other times, there could be a need to down or up-size the
stent. The size of the EOTTS implant is determined while the patient is lying on a procedure
table. The best way to determine size would be to insert the stent and have the patient walk.
However, this cannot be performed during the procedure, so the surgeon must use their best
judgment.
Bottom-line: The benefits of EOTTS far outweigh any potential risks.
Summary
EOTTS is a time-tested, evidence-based solution that makes sense. The fact that this procedure
has been approved for use by the health officials in 70 countries and it is performed by leading
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orthopedic and podiatric surgeons globally, is very telling. The EOTTS procedure makes sense,
fixes the underlying etiology of many chronic lower extremity deformities, and the benefits far
outweigh any potential risks. There is a crisis in the treatment of musculoskeletal disorders. The
governments around the world are trying to figure out how they can lower healthcare
expenditures to chronic diseases. The answer is prevention, yet it is all talk and no action. When
one considers the existing healthcare frame of mind, it is focused on symptom-relief rather
than fixing the underlying etiology. If you address the symptoms without fixing what is broken,
it is only a matter of time until the symptoms reoccur. The underlying problem is still present
and will continue to cause the same condition that made that symptom occur in the first place.
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75 Pell RF 4th, Myerson MS, Schon LC. Clinical outcome after primary triple arthrodesis. J Bone Joint Surg Am. 82(1):47-57, 2000. 76 Cooper PS, Nowak MD, Shaer J. Calcaneocuboid joint pressures with lateral column lengthening (Evans) procedures. Foot Ankle Int. 18(4):199-205, 1997. 77 Steber S, Kolodziej L. Analysis of Radiographic Outcomes Comparing Foot Orthosis to Extra-Osseous Talotarsal Stabilization in the Treatment of Recurrent TaloTarsal Joint Dislocation. J Min Inv Orthop. 1;1-11, 2015. 78 Graham ME, Jawrani NT, Chikka A, Rogers RJ. Surgical Treatment of Hyperpronation Using an Extra-Osseous TaloTarsal Stabilization Device: Radiographic Outcomes in Adult Patients. J Foot Ankle Surg. 51 (5): 548-55, 2012. 79 Graham ME, Jawrani NT, Chikka A. Radiographic Evaluation of Navicular Position in the Sagittal Plane – Correction Following an Extra-Osseous TaloTarsal Stabilization Procedure. J Foot Ankle Surg, 50(5):551-7, 2011. 80 Chong DY, Macwilliams BA, Hennessey TA, Teske N, Stevens PM. Prospective comparison of subtalar arthroereisis with lateral column lengthening for painful flatfeet. J Pediatr Orthop B. 24(4)345-53, 2015. 81 Jay RM, Din N. Correcting pediatric flatfoot with subtalar arthroereisis and gastrocnemius recession: a retrospective study. Foot Ankle Spec. 6(2):101-7, 2013. 82 Baker JR, Klein EE, Weil L JR, Weil LS Sr, Knight JM. Retrospective analysis of the survivability of absorbable versus nonabsorbable subtalar joint arthroereisis implants. Foot Ankle Spec. 6(1):36-44, 2013. 83 Fernandez de Retana P, Alvarez F, Bacca G. Is there a role for subtalar arthroereisis in the management of adult acquired flatfoot. Foot Ankle Clin. 17(2):271-81, 2012. 84 Hazany S, Ly N, Hazany D, Bader S, Ostuka N. Outcomes of subtalar arthroereisis for the planovalgus foot. J Surg Orthop Adv. 21(3):147-50, 2012. 85 Brancheau SP, Walker KM, Northcutt DR. An analysis of outcomes after use of the Maxwell-Brancheau Arthroereisis Implant. J Foot Ankle Surg. 51(1):3-8, 2012. 86 Metcalfe SA, Bowling FL, Reeves ND. Subtalar joint arthroereisis in the management of pediatric flexible flatfoot: a critical review of the literature. Foot Ankle Int. 32(12):1127-39, 2011. 87 Fernandez de Retana P, Alvarez F, Viladot R. Subtalar arthroereisis in pediatric flatfoot reconstruction. Foot Ankle Clin. 15(2):323-35, 2010. 88 Scharer BM, Black BE, Sockrider N. Treatment of painful pediatric flatfoot with Maxwell-Brancheau subtalar arthroereisis implant a retrospective radiographic review. Foot Ankle Spec. 3(2):67-72, 2010. 89 Koning PM, Heesterbeek PJ, de Visser E. Subtalar arthroereisis for pediatric flexible pes planovalgus: fifteen years’ experience with the cone-shaped implant. J Am Podiatr Med Assoc. 99(5):447-53, 2009. 90 Adelman VR, Szczepanski JA, Adelman RP. Radiographic evaluation of endoscopic gastrocnemius recession, subtalar joint arthroereisis, and flexor tendon transfer for surgical correction of stage II posterior tibial tendon dysfunction: a pilot study. J Foot Ankle Surg. 47(5):400-8, 2008. 91 Cicchinelli LD, Pascual Huerta J, Carcia Carmona FJ, Fernandez Morato D. Analysis of gastrocnemius recession and medial column procedures as adjuncts in arthroereisis for the correction of pediatric pes planovalgus: a radiographic retrospective study. J Foot Ankle Surg. 47(5):385-91, 2008. 92 Soomekh DJ, Baravaraian B. Pediatric and adult flatfoot reconstruction: subtalar arthroereisis versus realignment osteotomy surgical options. Clin Podiatr Med Surg. 23(4):695-708, 2006. 93 Graham ME, Parikh R, Goel V, Mhatre D, Matyas A. Stabilization of joint forces of the subtalar complex via HyProCure sinus tarsi stent. J Am Podiatr Med Asso. 101(5):390-9, 2011. 94 Graham ME, Jawrani, NT, Goel VK. Effect of Extra-Osseous TaloTarsal Stabilization on Posterior Tibial Tendon Strain in Hyperpronating Feet. J Foot Ankle Surg. 50(6): 676-81, 2011. 95 Graham ME, Jawrani NT, Goel VK. Evaluating plantar fascia strain in hyperpronating cadaveric feet following an extra-osseous talotarsal stabilization procedure. J Foot Ankle Surg. 50(6):682-6, 2011. 96 Graham ME, Jawrani, NT, Goel VK. Evaluating Plantar Fascia Strain in Hyperpronating Cadaveric Feet Following an Extra-Osseous TaloTarsal Stabilization Procedure. J Foot Ankle Surg. 50(6): 682-86, 2011. 97 Graham ME. Jawrani NT, Goel VK. Effect of extra-osseous talotarsal stabilization on posterior tibial nerve strain in hyperpronating feet: a cadaveric evaluation. J Foot Ankle Surg. 50(6):672-5, 2011. 98 Graham ME, Jawrani, NT, Goel VK. The Effect of HyProCure® on Tarsal Tunnel Compartment Pressures in Hyperpronating Feet. J Foot Ankle Surg. 50(1):44-9, 2011. 99 Corpus M, Shoffer D, Labovitz J, Hodor L, Yu K. Fracture of the talus as a complication of subtalar arthroereisis. J Foot Ankle Surg. 51(1):91-4, 2012.
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100 Van Ooij B, Vos CJ, Saouti R. Arthroereisis of the subtalar joint: an uncommon complication and literature review. J Foot Ankle Surg. 51(1):114-7, 2012. 101 Cook EA, Cook JJ, Basile P. Identifying risk factors in subtalar arthroereisis explantation: a propensity-matched analysis. J Foot Ankle Surg. 50(4):395-401, 2011. 102 Lui TH. Spontaneous subtalar fusion: an irreversible complication of subtalar arthroereisis. J Foot Ankle Surg. 53(5):652-6, 2014. 103 Kumar V, Clough TM. Talar neck fracture -a rare by important complication following subtalar arthroereisis. Foot (Edinb). 24(4):169-71, 2014. 104 Samaila E, Bonetti I, Bruno C, Argentini E, Magnan B. Navicular tenosuspension with anterior tibialis tendon (Young procedure) associated to calcaneo-stop for the treatment of paediatric flexible flatfoot clinical and ultrasound study. Acta Biomed. 87(1S):69-74, 2016. 105 Calvo Calvo S, Marti Niruelos R, Rasero Ponferrada M, Gonzaled de Orbe G, Vina Fernandez R. More than 10 years of follow of the stop screw technique. Rev Esp Cir Ortop Traumatol. 60(1):75-80, 2016. 106 Abbara-Czardybon M, Frank D, Arbab D. The talus stop screw arthroereisis for flexible juvenile pes planovalgus. Oper Orthop Traumtol. 26(6):625-31, 2014. 107 Pavone V, Costarella L, Testa G, Conte G, Riccioli M, Sessa G. Calcaneo-stop procedure in the treatment of the juvenile symptomatic flatfoot. J Foot Ankle Surg. 52(4):444-7, 2013. 108 Richter M, Zech S. Arthrorisis with calcaneostop screw in children corrects Talo-1st Metatarsal-Index-TMT-Index. Foot Ankle Surg. 19(2):91-5, 2013. 109 Usuelli FG, Montrasio UA. The calcaneo-stop procedure. Foot Ankle Clin. 17(2):183-94, 2012. 110 Kellermann P, Roth S, Gion K, Boda K, Toth K. Calcaneo-stop procedure for paediatric flexible flatfoot. Arch Orthop Trauma Surg. 131(10):1363-7, 2011. 111 Jerosch J, Schunck J, Abdel-Aziz H. The stop screw technique - a simple and reliable method in treating flexible flatfoot in children. Foot Ankle Surg. 15(4):174-8, 2009. 112 Roth S, Sestan B, Tudor A, Ostojic Z, Sasso A, Durbesic A. Minimally invasive calcaneo-stop method for idiopathic, flexible pes planovalgus in children. Foot Ankle Int. 28(9):991-5, 2007. 113 De Pellegrin M. Subtalar screw-arthroereisis for correction of flat foot in children. Orthopade. 34(9):941-53, 2005.
RE: Medical Necessity of Extra-osseous Talotarsal Stabilizaton (EOTTS)
Dear Dr.
The importance of an aligned and stable talotarsal joint (TTJ) is crucial for a properly functon
foot. We know that misalignment and instability of the TTJ contributes to many other foot and
ankle pathologies. Treatment measures such as observaton and arch supports cannot fx the
TTJ partal dislocaton and most surgical measures are simply too aggressive for most patents.
Therefore, EOTTS is the preferred soluton to realign and stabilize the TTJ while stll allowing the
normal range of moton.
Unfortunately, most insurance carriers want to deny coverage of this tme-test, evidenced
based procedure. It is for that reason that we’ve developed 3 enclosed documents. The frst is a
generic cover leter that is patent specifc. The second is “The Medical Necessity of EOTTS”
illustrates what’s required by insurance companies to consider a treatment a necessity. The 3rd
document contains more than 100 peer-reviewed published artcles to provide the evidence-
basis for EOTTS.
Our request for you and your ofce team is to food the insurance agencies with copies of these
documents. Maybe they will eventually get the point that you are recommending this
treatment and that you feel it is the best for your patents. It will only with a collaboratve efort
with your help that we will win the insurance batle that will beneft your patents. We all have
the same goal – to help patents get beter.
Thank you in advance for your support. If you have any questons for input please feel free to
contact us.
Most sincerely,
Michael E. Graham, DPM, FACFAS, FAENS, FAAFAS, FACFAP
