Myths and Misconceptions of HyProCure

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<ol><li> 1. The Myths &amp; Misconceptions of HyProCure </li><li> 2. AlignMyFeet.com I GraMedica2 Introduction Sinus tarsi implants have been used for decades to address the underlying reason for many aches and pains that occur in the feet, legs, hips and back. These devices have been found to be effective in getting patients back on their feet. However, some of these devices have proven to be more successful than others and because of this, there are misconceptions behind their use. Before any surgeon or patient decides to move forward with any procedure, they should find out which stories are fact and which are pure fiction. This ebook will help to remedy any concerns you might have when offering this treatment to a patient, or considering this treatment for yourself or a loved one. </li><li> 3. AlignMyFeet.com I GraMedica 3 The &amp; Misconceptions of HyProCure </li><li> 4. AlignMyFeet.com I GraMedica4 Myths &amp; Misconceptions 6 8 10 12 14 16 18 19 20 + Sinus tarsi devices are all the same......................................................................................................... + Dont worry about your childs misaligned feet. Theyll outgrow it............................................................ + You dont need a stent, well just get you a pair of arch supports............................................................ + There is limited scientific proof that sinus tarsi stents work...................................................................... + Those implants will destroy the joints and bones..................................................................................... + They should only be used in combination with other procedures.................................................................. + They must be replaced upon osseous maturity, so its better to wait until adulthood................................ + What if it has to removed?....................................................................................................................... + You have to cut an important structure to place the stent..................................................................... </li><li> 5. AlignMyFeet.com I GraMedica 5 + HyProCure is only used to fix flat feet..................................................................................................... + Sinus tarsi stents are being over-used.................................................................................................... + Insurance companies call it experimental, so it must not work................................................................ + Its better to perform a traditional reconstructive surgery......................................................................... + These should never be used in diabetic patients..................................................................................... + If HyProCure would have been offered earlier, this could have been prevented....................................... + Conclusion............................................................................................................................................. 22 23 24 25 26 28 29 </li><li> 6. AlignMyFeet.com I GraMedica6 Sinus tarsi devices are all the same. Truth There are actually several different types of sinus tarsi implants on the market. Myths &amp; Misconceptions #1 1. Intra-osseous DevicesDrilled into the hindfoot bones (rarely performed in the USA) 2. Extra-osseous DevicesInserted into the soft-tissues of the sinus tarsi space. Type I arthroereisis Placed into the outer half of the sinus tarsi. Function by blocking the motion of the ankle bone. High removal rate (30%-100%) Type II non-arthroereisis Placed much deeper in the sinus tarsi Function by allowing natural range of motion Significantly lower removal rate (40%) </li><li> 7. AlignMyFeet.com I GraMedica 7 Type I arthroereisis device on the undersurface of the talus. Type II non-joint blocking device on the undersurface of the talus. Type I devices stabilize the talus here. Type II devices stabilize the talus here. Bottom line Type I arthroereisis devices have a higher likelihood of displacement and/or removal than Type II non-joint blocking devices. Make sure your surgeon is using HyProCure, the implant with the highest rate of success. </li><li> 8. AlignMyFeet.com I GraMedica8 Dont worry about your childs misaligned feet. Theyll outgrow it. Truth A pediatric patient will not outgrow misaligned feet and they will not auto-correct over time. When the feet are over-pronated, or misaligned, it alters the function within the foot and negatively affects the knees, hips, and back. The most common cause of misaligned feet is a partial dislocation of the ankle bone (talus). A common misconception is that children outgrow misaligned feet. However, there is no medical evidence to prove this is true. In fact, a number of studies have proven that the longer a childs misaligned feet are ignored, the higher the likelihood they will suffer from chronic pain and irreversible damage throughout the musculoskeletal structure as they age. ref Case in point Walk into any chiropractors office to see the number of patients with chronic back pain who have misaligned feet. If you still arent convinced, go to any orthopedic surgeons office to see the correlation between patients who have chronic knee or hip pain who also have misaligned feet. These are the same patients that would, and still could, benefit from a sinus tarsi implant. Bottom line Misaligned feet need to be treated sooner rather than later. Myths &amp; Misconceptions #2 </li><li> 9. AlignMyFeet.com I GraMedica 9 This patients feet will not auto-correct. This is the same patient after HyProCure.Progression of an untreated pediatric foot </li><li> 10. AlignMyFeet.com I GraMedica10 You dont need a stent, well just get you a pair of arch supports. Truth Arch supports are not corrective, they are supportive. They can provide a false-sense of treatment. While there are great benefits that can be achieved with arch supports, there is no evidence that an arch support (even one that is custom made for your foot) will realign and stabilize the ankle bone. ref There is an easy way to verify this claimsimply have your foot doctor take x-rays of while you are standing on your foot and take a second set of x-rays with the arch support under your foot. There should be a realignment of the ankle bone. The evidence shows that something placed on the bottom of your foot simply doesnt work. Furthermore, there are certain cases where specific radiographic measurements have worsened. ref It is possible that an arch support can provide you relief with your symptom and we are happy about that, however there are hundreds of thousands of patients who are wearing their arch support with the hope their symptoms will go away and they arent. These are the patients that could stand to benefit from a sinus tarsi stent. Myths &amp; Misconceptions #3 </li><li> 11. AlignMyFeet.com I GraMedica 11 These x-rays show that something placed below the bone cannot realign or stabilize the ankle bone. </li><li> 12. AlignMyFeet.com I GraMedica12 There is limited scientific proof that sinus tarsi stents work. Truth There is a long list of peer-reviewed, scientific studies and medical journals that have been conducted by medical professionals from all over the world. HyProCure has been used in both children and adults for several decades, but critics have continued to downplay and ignore the scientific results. Did you know? Many foot surgeons have implanted HyProCure into their own feet and have trusted it to be used by their parents, children, friends and relatives. Furthermore, the FDA and similar governmental agencies around the world have cleared HyProCure to be used in more than 60 countries around the world. Myths &amp; Misconceptions #4 </li><li> 13. AlignMyFeet.com I GraMedica 13 There is a large database of studies to support the use of HyProCure. They include: + Retrospective studies + Radiographic studies + Soft tissue studies + Tolerability/removal rate studies + Prospective study + Out-come studies Click Here to view published studies. </li><li> 14. AlignMyFeet.com I GraMedica14 Those implants will destroy the joints and bones. Truth HyProCure is placed into a naturally occurring space, not into a joint or bone. There are multiple papers that show clinical and radiographic normalization of the misaligned hindfoot. There is no evidence that a correctly sized and properly positioned stent will lead to joint destruction. Actually, the reverse is true. The use of a sinus tarsi stent will help to restore joint function and it serves to decrease the change of arthritis to the joint. Bottom line There is no evidence to show that a sinus tarsi stent has led to joint or bone destruction. Furthermore, bone and joint destruction is far more likely, and in most cases inevitable, to occur without the use of a stent, then with one. Click Here to view published studies. Myths &amp; Misconceptions #5 </li><li> 15. AlignMyFeet.com I GraMedica 15 This is what happens without early intervention Here you can see how the prolonged collapse of the sinus tarsi has affected the musculoskeletal structure of the foot. </li><li> 16. AlignMyFeet.com I GraMedica16 They should only be used in combination with other procedures. Truth It depends on how misaligned the foot is, and if there are other parts of the foot that also need to be surgically repaired. Traditionally, the use of a sinus tarsi implant was com- bined with other surgical procedures, but HyProCure has shown to be very effective as a stand-alone procedure, when indicated. In fact, HyProCure can be used as a stand-alone, or in combination with other surgical procedures to maximize results. Keep in mind that each foot must be fully evaluated and all co-existing conditions should be addressed conservatively or surgically, when indicated. There are published studies proving that HyProCure can be used in pediatric and adult patients as a stand-alone, when indicated. Click Here to view studies Myths &amp; Misconceptions #6 Before &amp; after x-rays of a stand-alone procedure </li><li> 17. AlignMyFeet.com I GraMedica 17 This x-ray shows the abnormal alignment of the ankle bone. This is the same foot after the insertion of HyProCure. </li><li> 18. AlignMyFeet.com I GraMedica18 They must be replaced upon osseous maturity, so its better to wait until adulthood. Truth The chamber that forms the sinus tarsi becomes ossified by age 3, so it stays roughly the same size while the talus and calcaneus continue to grow peripherally. Some foot specialists think that when a sinus tarsi implant is placed into a pediatric patients foot, they will outgrow it, and it will need to be replaced later on in life. Therefore, the patient should wait until their bones have stopped growing to have their ankle bone stabilized and aligned. However, it has been found that the most common HyProCure sizes used in adult and pediatric patients are sizes 6 and 7. Therefore, if a child has a 6 or 7 placed in their foot, they already have the most common adult size. While there are no guarantees that a HyProCure stent placed into a childs foot will never need a revision later in life, the likelihood of this is minimal. In the case of preventing damage to the hindfoot, it is better to risk a potential revision, than to wait till the body stops growing to correct a misalignment. Myths &amp; Misconceptions #7 Pediatric Patient Adult Patient </li><li> 19. AlignMyFeet.com I GraMedica 19 What if it has to be removed? Truth A HyProCure procedure is reversible, unlike traditional reconstructive surgery. 30% of orthopedic surgical procedures involve the removal of internal hardware. The obvious goal is to use a device that is meant to remain in place for the rest of the recipients life. In terms of success rates, HyProCure has the highest success rate of sinus tarsi implants. ref There is still a small percentage of patients who had to have the device removed, even when fully indicated, but as with all surgical procedures, there isnt a 100% guarantee. Bottom Line The benefits of placing a HyProCure into the sinus tarsi of patients who are candidates has shown more benefits than risks. When indicated, it is worth the attempt to prevent further damage to the hindfoot, as shown in the photo below. Myths &amp; Misconceptions #8 </li><li> 20. AlignMyFeet.com I GraMedica20 You have to cut an important structure to place the stent. Truth The HyProCure stent is inserted into a natural occurring space called the sinus tarsi. It replaces a dysfunctional ITCL. Within the sinus tarsi is a ligament that helps connect the ankle bone to the heel bone and maintain ankle bone alignment. That structure is called the interosseous talocalcaneal ligament (ITCL). It is one of many ligaments that serve to control ankle bone motion. Candidates for HyProCure have an ITCL that does not function properly, so HyProCure simply replaces it. Furthermore, the ITCL is not removed. A simple cut is made through the mid-portion of the tissue. When the stent is inserted, the cut fibers heal back together around the stent. This actually helps anchor the HyProCure stent within the sinus tarsi space. Unfortunately, there are patients whose ITCL is completely worn away due to the years of the ankle bone grinding on the heel bone. These patients may have a higher rate of stent displacement because their anchoring mechanism has been compromised. Bottom line HyProCure replaces the function of the ITCL. ref Myths &amp; Misconceptions #9 </li><li> 21. AlignMyFeet.com I GraMedica 21 When the skin is cut, it heals. When a bone is cut, it heals. When a ligament is cut, it also heals. </li><li> 22. AlignMyFeet.com I GraMedica22 HyProCure is only used to fix flat feet. Truth The actual indication for HyProCure is to maintain the alignment of the ankle bone while allowing normal range of motion to occur. Many doctors think that HyProCure is only used to fix flat feet, but there are many different symptoms that can occur when the ankle bone slides from its normal position onto the heel bone. The flexible misalignment of the hindfoot leads to over-pronation, which is named as the leading cause of foot deformities. Additionally, over-pronation is named as the leading cause of a long list of issues to the legs, knees, hips, and back. Bottom line HyProCure fixes only one problem: partial talotarsal joint dislocation. However, fixing partial talotarsal dislocation helps to reduce, or eliminate many other seemingly unrelated symptoms that are caused by a flexible, misaligned hindfoot, including flat feet. Myths &amp; Misconceptions #10 Images show a partial dislocation of the ankle bone on the heel bone, with a visible arch. </li><li> 23. AlignMyFeet.com I GraMedica 23 Sinus tarsi stents are being over-used. Truth The insertion of HyProCure is one of the most under-utilized orthopedic procedures. There are certain non-HyProCure advocates who claim that the surgeons who are advocates place too many sten...</li></ol>