Benefit – Risk Analysis of Extra-Osseous TaloTarsal StabilizationYour doctor has examined you clinically and              ...
Benefit – Risk Analysis of Extra-Osseous TaloTarsal Stabilizationsecondary sites without addressing the underlying        ...
Benefit – Risk Analysis of Extra-Osseous TaloTarsal Stabilizationmedications needed, especially those taken for          s...
Benefit – Risk Analysis of Extra-Osseous TaloTarsal StabilizationThe EOTTS procedure with HyProCure® takes less          a...
Benefit – Risk Analysis of Extra-Osseous TaloTarsal Stabilizationslip out of place along with the ankle bone. This is a   ...
Benefit – Risk Analysis of Extra-Osseous TaloTarsal Stabilizationexperienced varies from foot to foot and individual    an...
Benefit – Risk Analysis of Extra-Osseous TaloTarsal Stabilizationhand, chronic displacement of the ankle bone on          ...
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Extra-Osseous TaloTarsal Stabilization - Benefit to Risk Analysis


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Here is a document describing the benefits and risks of EOTTS.

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Extra-Osseous TaloTarsal Stabilization - Benefit to Risk Analysis

  1. 1. Benefit – Risk Analysis of Extra-Osseous TaloTarsal StabilizationYour doctor has examined you clinically and It is important to note that the displacement of theradiographically and diagnosed you as having ankle bone (talus) is not natural and willtalotarsal displacement (partial dislocation of the progressively get worse over time. It will also leadankle bone on the heel bone). The purpose of this to pain and damage to other areas of the foot anddocument is to inform you on your condition and to the rest of the provide an overview of the benefits and risks of The tissues within the foot and ankle are not thethe suggested surgical treatment, an extra-osseous only ones that will be affected by this deformity.talotarsal stabilization (EOTTS) procedure. This There will be a chain-reaction through the entiredocument will cover the natural progression of body. When the ankle bone slips off the heel bone,talotarsal displacement, the benefits of internal it drops down and turns inward. This partialcorrection and the potential risks associated with dislocation closes the natural space between theEOTTS. Though intended to be as thorough as ankle and heel bones (the sinus tarsi). The anklepossible, it is impossible to predict every scenario bone “drops out” from underneath the leg bonesthat may occur with your treatment. This guide (tibia/fibula), forcing them to also drop down andcovers all possible complications that have been turn inward. This places a twisting strain on thereported with at least a 1 in 1000 chance of knee and can lead to excessive wear-and-tear. Theoccurrence. thigh bone (femur) also drops and turns inward, Natural Progression of Partial TaloTarsal leading to a tilt of the pelvis. Pelvic tilt leads to Dislocation abnormal twisting and turning on the spine, placing tremendous force on the small cushions betweenWeight is placed on the hindfoot bones when the bones of the spine, which can lead tostanding, walking or running. Normally, there “herniated discs.” The back muscles tighten to tryshould be very little motion between the ankle and stabilize this misalignment and can becomebone (talus) and the hindfoot bones during painful. Twisting in the lower back leads to twistingweightbearing activities. The associated joints in the upper back in order to compensate. Thisshould remain in constant congruent contact at all leads to upper back problems and a twisting of thetimes. Partial displacement/dislocation occurs neck and skull. Some patients will even experiencewhen the ankle bone slips off the heel bone symptoms in their lower jaw (TMJ). All of this(calcaneus) as weight is placed on the foot. This occurs as a result of a misaligned hindfoot.partial dislocation leads to an abnormal shift offorces; forces that should pass through the back of Think about all the possible secondary effects thatthe heel instead pass through the inner part of the can occur as a result of the partial displacement offoot. This causes excessive strain on the bones and the ankle bone on the heel bone. The majority oftissues (ligaments, tendons, muscles, nerves and patients with this condition may be aware of theblood vessels) of the foot. It is only a matter of misalignment of their feet. If they do nottime until the excessive strain will take its toll and experience pain between the ankle and heel bone,one or more of the tissues will become they may believe the condition is not causing anysymptomatic. Every step leads to further ill-effects. However, pain is manifesting at thepathological forces acting on the tissue(s) which secondary site(s). Unfortunately, treatment is oftenwill continue to get worse and worse. focused on trying to eliminate the pain in the
  2. 2. Benefit – Risk Analysis of Extra-Osseous TaloTarsal Stabilizationsecondary sites without addressing the underlying The minimally invasive insertion of thedeformity. Until the underlying etiology (ankle HyProCure® extra-osseous talotarsal stabilizationbone displacement/misalignment) is fixed, the pain device into the sinus tarsi is a quick but extremelywill keep recurring. Imagine all of the money spent powerful procedure. HyProCure® acts as a stent toon medication and physical therapy, the time away prevent the collapse of this naturally occurringfrom work and the inability to do various activities space while still allowing the normal amount ofbecause of the pain that ensues following those motion to occur. The benefits of this option are faractivities. This deformity and the resulting diseases reaching, especially when compared to otherwill even take a toll emotionally as painful options such as padding, arch supports/orthotics orsymptoms won’t go away and nothing helps to major rearfoot reconstructive surgery.solve the problem(s). It may even affect personal Realignment of the ankle bone on the hindfootrelationships. bones decreases strain on the supporting tissues.Overall health could also be affected by a This has been scientifically proven and published inmisaligned hindfoot. Painful secondary conditions peer-reviewed foot and ankle surgical journals.will slow you down. Decreased activity leads to Decreased strain should prevent the progression ofdecreased metabolism which leads to increased secondary deformities and could allow the body toweight or obesity. It has been proven time and “heal” itself by repairing the damaged tissues. Intime again that obesity leads to diabetes, heart some cases, it is possible there is already so muchdisease, acid reflux (GERD), high blood pressure, damage that other surgical procedures will besleep apnea and even several forms of cancer. necessary. However, in most cases symptoms such as soreness and pain should significantly reducePartial talotarsal dislocation will not “self-correct.” and possibly completely resolve. Walking isThere is a defect with the joint surfaces along with improved and should be easier once swelling andover-stretching and weakness of the ligaments pain from the procedure have diminished. Thereand/or tendons. It is important to realize that this should be improved function not only of thedeformity is occurring internally above the heel structures within the foot but also of the knee(s),bone (above the bottom of the foot). This hip(s) and back.deformity can be present without pain, but aspreviously stated, it is only a matter of time until a Since it is easier to walk and exercise, thesymptom develops somewhere in the body. A great metabolism of the body is increased. Increasedillustration is an unbalanced car tire. Initially, the metabolism helps to reduce weight and thereforetire functions okay, but the more the car is driven, has a positive effect on the associated medicalthe faster the tire wears out. This can lead to conditions related to obesity and a higher bodydamage to the wheel well, the shocks and struts, mass index (BMI). Many patients have lost weight,the alignment of the car… you get the picture. The lowered their blood pressure and lowered theirmore active someone is with a misaligned hindfoot blood sugar levels naturally after the EOTTSthe faster a painful symptom will develop procedure.somewhere in the body as a direct result. There are also economic benefits. It could be The Benefits of the EOTTS Procedure possible to decrease the amount of prescription
  3. 3. Benefit – Risk Analysis of Extra-Osseous TaloTarsal Stabilizationmedications needed, especially those taken for surgery but a soft tissue procedure as there are nopain management, but also those taken for modifications made to the bone. The HyProCure®conditions associated with extra weight. The device is simply pushed into place. There areimprovement in health may also lead to a threads on the end of the device that serve as adecreased need for medical appointments to foot way for soft tissues to adhere to this portion of thespecialists, chiropractors, physical therapists, stent to anchor it firmly in place. However, if theorthopedists and primary care physicians. This device does need to be removed it can be easily,means more time to work and less time taken off simply by releasing the tissue on-growth anddue to medical conditions. pulling it out. EOTTS with HyProCure® can be performed by itself or in conjunction with otherOne of the most important benefits is the surgical procedures, depending on the severity ofimprovement in quality of life. It’s a shame when the overall foot and ankle misalignment and othersomeone is unable to do the things they love due co-existing their painful symptoms. Even simple things thatmost of us take for granted, such as shopping, EOTTS with HyProCure® has been performed onwalking the dog or playing with our children or pediatric and adult patients since 2004. This is notgrandchildren are affected. It is possible that once considered a purely pediatric nor an adult-onlythe EOTTS procedure is performed, things that procedure. There are still debates on whether thewere thought of as impossible before or just not device has to be replaced once a pediatric recipientworth the suffering that would follow are now becomes an adult. The common opinion is that thispossible without the associated pain. This internal will be uncommon as the most common adult sizeoption does not rely on external devices such as is also the most common size used on children.pads, arch supports, shoe modifications or braces. Some may argue to wait until the child is an adultThe only way those external devices work is if they to perform this procedure to be sure. In theare being worn. Even then, there is no scientific meantime, years of strain will add up. To make aevidence that they truly work. External options child walk or run on “broken” feet for 10 to 15cannot prevent the collapse of the sinus tarsi. years just doesn’t make sense.Secondary issues, such as a collapsing arch, may Risks Associated with the EOTTS Procedureappear better when the orthotic is in use, but it isstill possible that other structures are being This is a surgical procedure and is therefore subjectstrained. Also, it is impossible to use these all the to certain risks and potential complications. Theretime. Every step without the use of these devices are four main risk categories including anesthesia,results in maximum strain on the tissues. surgical procedure, device and post-procedure. TheHyProCure® is internally placed and is always risks associated with this procedure are not severeworking to decrease strain. It functions no matter when compared to the potential risks andthe weightbearing surface, such as walking/running complications associated with more aggressiveon the beach, performing gymnastics barefoot and reconstructive procedures. Nonetheless, it ison and on. important to have a thorough understanding of what could potentially go wrong.EOTTS is usually performed through a small incisionof less than ½ inch. It is not considered a bone
  4. 4. Benefit – Risk Analysis of Extra-Osseous TaloTarsal StabilizationThe EOTTS procedure with HyProCure® takes less area where stabilization should occur is at the half-than thirty minutes on average and can be way point of this structure or the entrance to theperformed with only a local anesthetic. The canalis tarsi. This is where the tapered portion ofnumbing medicine is injected into the area below HyProCure® maintains the natural opening of thethe outer ankle bone, which is the least painful sinus tarsi to allow normal triplane motion tospot on the foot or ankle to have an injection. occur.Many patients prefer “twilight” sedation. With It should be noted that the sinus tarsi has antwilight sedation, additional medications are given oblique orientation. The outer-half is angled morethrough an IV to put the individual into a sleep-like toward the front of the foot and the inner-half isstage. This is not general anesthesia where a angled toward the back of the foot. The ankle bonebreathing tube would have to be inserted. (talus) is the most complicated bone of our bodyMedicine given through an IV is rather fast-acting and it has more variations than any other bone.and safe. Although reaction to these medications is Because of the many variables in the anatomy ofextremely uncommon, it is possible. In rare cases, a this area, it is possible that there could be ageneral anesthesia is required. limitation in the placement of the HyProCure®The actual EOTTS surgical incision is placed below stent within the sinus tarsi. The canalis tarsi couldthe outer ankle bone, usually one index finger be extremely narrow, preventing the appropriatebelow the inferior (lower) edge. There are no major placement of the device in this deeper portion. Orblood vessels, nerves or tendons in this area. An there could be angulation irregularity which wouldankle tourniquet is usually not necessary since lead to the device being placed too deep or toothere should be very little bleeding. This is a soft superficial. Remember that surgery is an “art” andtissue procedure and there is no bone involvement. is not an exact science like mathematics.Basically, this is a relatively atraumatic procedure. HyProCure® displacement is one of the mostThe HyProCure® extra-osseous talotarsal fixation common risks as it is not anchored into bone butdevice is composed entirely of medical grade rather held in place by tissue adherence and thetitanium. Titanium has been found to be the safest overall bony chamber forming the space. It ismaterial to be implanted into the body. It is non- possible that the supporting tissues within thereactive, lasts a very long time, doesn’t set off sinus tarsi have eroded due to the chronicmetal detectors and patients can still have various progression of the disease process. This meansradiologic studies such as a CT scan or an MRI. The there are no tissues within the space to adhere tochance of having an allergic reaction to titanium is the device to anchor it. Another possibility is thatextremely rare. an important portion of the heel bone has been worn down due to years of the ankle bone grindingThere are two main areas to the sinus tarsi. The on it. In this case, it is possible that theouter, conically shaped area is the “sinus” portion HyProCure® device could be placed correctly intoof the sinus tarsi and the deeper, cylindrically the sinus tarsi, but upon weightbearing, the ankleshaped area is the canalis tarsi. The undersurface bone would push against the device. If the heelof the ankle bone and upper surface of the heel bone has been flattened there would be nothing tobone form the halves of the sinus tarsi. The exact support the front side of HyProCure® , so it would
  5. 5. Benefit – Risk Analysis of Extra-Osseous TaloTarsal Stabilizationslip out of place along with the ankle bone. This is a patient stand. Therefore, the surgeon will do theirrare but possible scenario. best to select the most appropriate size to achieve the optimum correction. Sometimes, trial sizing willGenerally speaking, it takes about four (4) to six (6) show little to no difference in correction betweenweeks for the soft tissues within the sinus tarsi to two sizes. If this should occur the general advice isadhere to HyProCure® , locking it within the sinus to go with the smaller size as it is better to have atarsi. The chance of HyProCure® displacement slight under-correction than over-correction.after the four to six week period is less than 1%.Device displacement can range from partial to full. Occasionally, patients may experience a clickingIt is quite normal for the device to shift up to a few sensation in the initial post-procedure time frame.millimeters from the position it was in intra- This is not necessarily an indication that somethingoperatively. This is due to the fact that is wrong and it should just be a matter of time forHyProCure® is inserted while the patient is lying that feeling to resolve on its own. On the otheron an operating room table, off their feet (non- hand, if the clicking persists it could indicate thatweightbearing). When the patient first stands, it is the device has displaced. A complete displacementpossible for HyProCure® to seek its final position, of the device will be followed by loss of correction.where it naturally needs to be to do what it was Another potential procedure problem is failure todesigned to do. As long as the desired correction is achieve the desired correction. Even if the device isachieved and the device is in an acceptable adequately placed there could be unforeseen bonyposition there is no reason for repositioning. As adaptations/variations or severe ligament damage.much as a surgeon wants to be as accurate and It is not always possible to predict this scenarioprecise with the device placement as possible, it prior to surgery. There may also be an inability tocould be the case that the HyProCure® device place the device in the desired position due tofunctions better in another location. anatomic limitations or restrictions.The most common causes of device displacement There are other risk factors common to all surgicalare very manageable. These include being too procedures such as delayed incision site healing,active too soon, wearing improper or worn out suture reaction, nerve entrapment, scar tissueshoes or a traumatic episode such as a severe ankle formation and post-procedure infection. Swelling issprain. The displacement could also occur from an a normal post-procedure reaction. Depending onimproper decompression of the sinus tarsi, the patient, swelling can range from nearly non-improper device sizing (too small or too large) or existent to excessive. It is advised to maintain a lowincorrect placement. sodium diet and to avoid consumption of excessiveAn important aspect of the procedure is liquids. Salt is a magnet for water retention anddetermining the perfect size device for the patient. combined with decreased/minimized walking leadsThere are six (6) different sizes of the HyProCure® to swelling in the ankle and lower leg. Swelling isdevice. One of the limitations of this procedure only a temporary post-op phenomenon and shouldalready mentioned is that it is performed while the resolve over time.patient is off their foot. It simply is not possible to Some degree of pain should be expected since thisinsert the trial sizer into the foot and have the is a surgical procedure. The amount of pain
  6. 6. Benefit – Risk Analysis of Extra-Osseous TaloTarsal Stabilizationexperienced varies from foot to foot and individual and pains; if these do develop they usually resolveto individual. Everyone has different thresholds for within a short period of time. Occasionally, certainpain. Usually, the pain is simply controlled with tissues, such as one specific ligament on the frontanti-inflammatory medication and possibly pain side of the outer ankle bone, may take longer thanmedication. It is very rare for someone to normal to adapt to the corrected hindfootexperience severe pain, but again, this is something alignment. In most cases this will subside on itsthat cannot be predetermined. Increased swelling own by wearing more supportive shoes, takingusually results in increased pain. anti-inflammatory medications, physical therapy, wearing an ankle brace or from a steroidOne of the greatest challenges of foot surgery is injection(s). Some degree of soreness and pain inthat the foot is one of the most used parts of your this area is a somewhat common side-effect (1 inbody. It is relative easy to rest a shoulder, elbow, 10 to 1 in 100 individuals). However, it iswrist or hand, but trying to rest your foot is quite uncommon (1 in 100 to 1 in 1000) for the device todifficult. The good news is that if EOTTS was the be downsized or permanently removed.only procedure performed, you may be allowed towalk on the foot immediately. It is expected there Another important fact is that the HyProCure®will be a period of abnormal walking. There is a device is not placed into a joint. Even thoughnatural guarding mechanism that occurs after HyProCure® stabilizes the talotarsal joint complexsurgery that forces one to walk on the outside of it is not placed within the joint itself. A joint isthe foot. This may be discerning. However, once formed by the articular or joint surfaces of two orthe inflammation within the sinus tarsi subsides more bones. There is no articular surface withinyou will be able to walk more normally, on the the sinus tarsi and therefore the sinus tarsi is not aentire bottom surface of your foot. This sensation joint. However, it is possible that joint fluid will leakof “walking on the outside of the foot” could out of the large joint behind or in front of the sinusresolve within a matter of days or it could take tarsi. This fluid, called synovium, could beseveral months and even up to a full year. accumulating within the sinus tarsi. Once anGenerally, it is recommended that this procedure is incision is made this fluid can “leak” out of theperformed one foot at a time for a faster recovery surgical site until the skin incision has healed. Someand to lessen potential complications. However, if individuals have mistaken this fluid leakage as anboth feet exhibit the deformity and require allergic reaction from the titanium. The chance ofstabilization, the first foot will not fully recover synovitis occurring is uncommon (1 in 100 to 1 inuntil the second foot is also internally stabilized. 1000 cases). If it does occur this drainage willThink of balancing the tires on one side of your car resolve in a short period of time.and not the other. It has been implied that a device in the sinus tarsiOnce the hindfoot is stabilized there will be many could ultimately lead to arthritis within the spaceadaptations that may occur. Certain muscles will or to degenerative bony changes. However,not have to work as hard whereas others that have arthritis can only occur within a joint and we havenot been “pulling their weight” will have to work a already learned the sinus tarsi is not a joint. It islittle harder. The same is true of the ligaments and highly unlikely that a device placed in front of ortendons. Not everyone will experience new aches behind a joint can lead to arthritis. On the other
  7. 7. Benefit – Risk Analysis of Extra-Osseous TaloTarsal Stabilizationhand, chronic displacement of the ankle bone on foot function leads to increased walking and athe hindfoot bones leads to excessive and general improvement to overall health and well-abnormal joint motion that will most definitely lead chronic inflammation of the joint and eventually Every solution has the potential of creating newarthritis. problems. This is a surgical procedure and thereIt is highly unlikely that anyone would develop are potential risks. Overall, these risks are, for theincreased pain to their knee, hip, or back after this most part, short-term and self-resolving. Should aprocedure. It could be possible that during the more serious risk develop, the device can beearly recovery phase an increased strain could be removed with very low probability of permanentplaced on the rest of the body. This may be due to ill-effects.the altered walking pattern. As soon as walking The overwhelming majority of both pediatric andnormalizes, any increased strain to the rest of the adult patients have benefited from the EOTTS withbody should settle down and resolve. HyProCure® treatment option. Adverse events andFinally, it is important to emphasize that nothing side effects are generally uncommon; howeverworks on everyone. There is a reported six percent they do occur. This impact is disproportionate(6%) permanent removal of HyProCure® . This is relative to the number of patients receiving amainly due to failure of soft tissue adaptation, benefit. This is due to the emotional componentpsychogenic reaction (the device was functioning associated with the risks. The overall life-changingpain free but the patient was unable to accept the benefits of EOTTS with HyProCure® far outweighfact that the device was in their body), and post- the potential risks.operative infection (less than 1% chance).EOTTS, unlike rearfoot reconstructive foot surgery,has never been shown to cause a serious bone orsoft tissue infection, has no reported cases offracture of the ankle or heel bones, has not lead toamputation of the foot or leg nor to any otherserious complications. EOTTS Benefit versus Risk Analysis SummaryExtra-osseous talotarsal stabilization with ®HyProCure is a minimally invasive, internal,permanent, yet reversible option that has beenscientifically shown to realign the hindfoot and atthe same time significantly decrease strain toseveral important structures of the foot and ankle.The positive effects of hindfoot realignment arenot limited solely to the foot as there are additionalbenefits up the musculoskeletal chain. Improved