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E.O.T.T.S.BENEFIT – RISK ANALYSIS
Therapeutic DecisionNatural Progression ofRecurrent TaloTarsalDislocationRisks ofTreatmentBenefit-RiskAnalysisBenefits ofT...
Natural Progression of RTTD• Foot and ankle complications- (repetitive strain injury)• Musculoskeletal chain effects• Over...
Natural Progression of RTTDFoot and Ankle Complications• Increased forces acting on the medialcolumn of the foot.• Increas...
Natural Progression of RTTDProximal Musculoskeletal Effects• Talus dislocates offcalcaneus• Tibia/fibula internally rotate...
Natural Progression of RTTDGeneral Health• Because of the inefficient talotarsal mechanism– Tendons and muscles have to wo...
Natural Progression of RTTDIncreased weight leads to
Natural Progression of RTTDEconomic FactorsContinued pain leads to“self-remedies/treatment” costsOTC medicationsbuying spe...
Natural Progression of RTTDEmotional Factors• Patients end up in a downward spiral– Signs and symptoms get worse– Psycholo...
Benefits of EOTTS Treatment
Benefits• Physiologic Measurements• Clinical Events (disability, disease,dissatisfaction, discomfort, destitution)• Sympto...
Benefits• Clinical benefits• Absolute benefits- reduction in disability,morbidity, and mortality• Economic benefits• Patie...
Benefits of EOTTS Treatment• Internal option – does not rely on patientcompliance (arch support, brace, shoes)• Extra-osse...
Benefits of EOTTS Treatment• Stabilization of the talotarsal mechanism• Elimination of excessive talotarsal motion• Articu...
Benefits of EOTTS Treatment• Decreased stain to the knee• Head of the femur is no longer pulled from thehip – leg length d...
Benefits of EOTTS Treatment• Patients have a more efficient gait cycle• Easier to walk/run• Become more active• Increase m...
Risks of EOTTS Treatment
Risks of EOTTS Option• This is a surgical procedure and is thereforesubject to certain risks and potentialcomplications.– ...
Risks of EOTTS TreatmentAnesthesia Risks• EOTTS procedure is usually performed under“Twilight” or light sedation.– Medicat...
Risks of EOTTS TreatmentSurgical Procedure• EOTTS is minimally invasive• Incision is < 2 cm• No major blood vessels, nerve...
Risks of EOTTS TreatmentDevice Risks• EOTTS (HyProCure®) is entirely madefrom medical grade titanium• Titanium is consider...
Risks of EOTTS TreatmentDevice Risks• EOTTS devices are placed into the sinustarsi.• They are anchored into the sinus tars...
Risks of EOTTS Treatment• Device displacement– HyProCure is not anchored into bone. The tissuesand the osseous chamber hol...
• Device displacement– It could take up to 4 to 6 weeks or longer for thesoft tissues to adhere to the device to hold it i...
• Inability to achieve stabilization– Even though the device is adequately placed therecould be an unforeseen osseous defo...
Risks of EOTTS TreatmentDevice Risks• Under/Over-correction– Trial sizing is performed while the individual islaying on th...
Risks of EOTTS TreatmentPost Procedure Risks• Incision– Delayed healing– Suture reaction– Scar tissue formation• Swelling–...
Risks of EOTTS TreatmentPost Procedure Risks• Pain– This is a surgical procedure and pain will be expectedafter the proced...
Risks of EOTTS TreatmentPost Procedure Risks• Period of abnormal walking– Due to• corrected foot position• Natural post-pr...
• “Sprained Ankle” Syndrome– Feeling like the patient suffers from a sprainedankle.– Area surrounding the front of the fib...
• “Sprained Ankle” Syndrome– This is considered a somewhat common side effect (1in 10 to 1 in 100 individuals)– Could rang...
• EOTTS Migration-Displacement– It is possible that the device could shift from its initialplacement during the surgical p...
• Synovitis– This is an inflammatory reaction with drainage– Could result from a/the pre-existing chronicinternal inflamma...
• Generalized foot, ankle, or leg soreness– Since the TTM is stabilized there arepotentially new forces acting on tissues ...
Benefit – Risk Analysis• Overwhelming majority of patients havebenefited from the EOTTS treatment option.• Adverse events ...
EOTTS Benefit – Risk AnalysisBenefits• Internal permanent (butreversible) option• Scientifically proven todecrease strain ...
EOTTS Benefit – Risk Analysis• The benefits of EOTTS must be consideredgreater than the potential risks.• This is a case b...
EOTTS:  Benefit vs. Risk Analysis
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EOTTS: Benefit vs. Risk Analysis

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Find out the risks and benefits associated with extra-osseous talotarsal stabilization.

Learn more at www.GraMedica.com.

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Transcript of "EOTTS: Benefit vs. Risk Analysis"

  1. 1. E.O.T.T.S.BENEFIT – RISK ANALYSIS
  2. 2. Therapeutic DecisionNatural Progression ofRecurrent TaloTarsalDislocationRisks ofTreatmentBenefit-RiskAnalysisBenefits ofTreatment
  3. 3. Natural Progression of RTTD• Foot and ankle complications- (repetitive strain injury)• Musculoskeletal chain effects• Overall Health• Economic factors
  4. 4. Natural Progression of RTTDFoot and Ankle Complications• Increased forces acting on the medialcolumn of the foot.• Increased strain to– spring ligament– Posterior tibial tendon– Medial band of the plantar fascia– Tibialis posterior nerve• Increased pressures within the tarsaltunnel.
  5. 5. Natural Progression of RTTDProximal Musculoskeletal Effects• Talus dislocates offcalcaneus• Tibia/fibula internally rotates• Twisting of the knee• Head of the femur is pulledfrom the hip (leg lengthdiscrepancy)• The pelvis tilts• Stain/torsion on the back• Shoulders tilt• Neck strain
  6. 6. Natural Progression of RTTDGeneral Health• Because of the inefficient talotarsal mechanism– Tendons and muscles have to work harder– Activity leads to increased generalized soreness– Suffer due to activity, decrease activity level– Decreased activity level leads to decreasedmetabolism– Decreased metabolism leads to increased weight
  7. 7. Natural Progression of RTTDIncreased weight leads to
  8. 8. Natural Progression of RTTDEconomic FactorsContinued pain leads to“self-remedies/treatment” costsOTC medicationsbuying special shoesMedical costsPCP, foot specialist, chiropractor,orthopedist, physical therapist.Insurance costs, co-pays, medicine, archsupports, braces, otherTime away from workwhen patients are away from work they aren’tmaking money, they are losing money.
  9. 9. Natural Progression of RTTDEmotional Factors• Patients end up in a downward spiral– Signs and symptoms get worse– Psychological factors- “why can’t I get better”– Affects the relationship with their loved ones– They are in a losing battlei
  10. 10. Benefits of EOTTS Treatment
  11. 11. Benefits• Physiologic Measurements• Clinical Events (disability, disease,dissatisfaction, discomfort, destitution)• Symptoms (difficulty walking, pain)• Functional Measurements (quality of life)
  12. 12. Benefits• Clinical benefits• Absolute benefits- reduction in disability,morbidity, and mortality• Economic benefits• Patient centered benefits (quality of life)
  13. 13. Benefits of EOTTS Treatment• Internal option – does not rely on patientcompliance (arch support, brace, shoes)• Extra-osseous – does not involve bonesurgery• Minimally invasive soft tissue procedure• Can be performed as a stand-aloneprocedure or in conjunction with otherprocedures.• EOTTS devices are reversible, they can beremoved with minimal effort.
  14. 14. Benefits of EOTTS Treatment• Stabilization of the talotarsal mechanism• Elimination of excessive talotarsal motion• Articular facets remain in constant congruentcontact• Reduction in excessive forces acting on theosseous and soft tissues• TTM is now an efficient machine
  15. 15. Benefits of EOTTS Treatment• Decreased stain to the knee• Head of the femur is no longer pulled from thehip – leg length discrepancy• Pelvis is aligned• Decreased stain to lower and upper spine• Shoulders balanced• Decrease strain to neck and TMJ
  16. 16. Benefits of EOTTS Treatment• Patients have a more efficient gait cycle• Easier to walk/run• Become more active• Increase metabolism• Decrease weight• Lower blood pressure• Lower blood sugar
  17. 17. Risks of EOTTS Treatment
  18. 18. Risks of EOTTS Option• This is a surgical procedure and is thereforesubject to certain risks and potentialcomplications.– Anesthesia Risks– Surgical Procedure Risks– Device Risks– Post-Procedure Risks
  19. 19. Risks of EOTTS TreatmentAnesthesia Risks• EOTTS procedure is usually performed under“Twilight” or light sedation.– Medication is given through the IV– Patient is breathing on their own– Fast acting– Since the EOTTS procedure is relative quick (< 30)the patient is not required to be under this formof anesthesia for a prolonged period of time.
  20. 20. Risks of EOTTS TreatmentSurgical Procedure• EOTTS is minimally invasive• Incision is < 2 cm• No major blood vessels, nerves, ortendons in the surgical area• No tourniquet is necessary• No bone involvement• Soft tissue procedure• Relatively atraumatic
  21. 21. Risks of EOTTS TreatmentDevice Risks• EOTTS (HyProCure®) is entirely madefrom medical grade titanium• Titanium is considered the safestmaterial placed into the body– Non-reactive– Has a long life cycle– Doesn’t set off metal detectors– Patients can still have MRI or CT imaging
  22. 22. Risks of EOTTS TreatmentDevice Risks• EOTTS devices are placed into the sinustarsi.• They are anchored into the sinus tarsi byadherence of the soft tissues within thesinus tarsi.• In addition, the osseous chamber formingthe sinus tarsi needs to be complete. Inother words a full oval shape is needed.The upper ½ is formed by the talus, thelower ½ by the calcaneus.
  23. 23. Risks of EOTTS Treatment• Device displacement– HyProCure is not anchored into bone. The tissuesand the osseous chamber hold it in place– It is possible that the soft tissues have beeneroded due to the chronicity of the RTTD diseaseprocess or there is osseous malformation of themiddle/anterior facet either one could lead todevice displacement.
  24. 24. • Device displacement– It could take up to 4 to 6 weeks or longer for thesoft tissues to adhere to the device to hold it inplace (this is not scientifically proven).– Could result from a patient who is too active, toosoon or wearing improper shoes or from atraumatic episode such as a severe ankle sprainRisks of EOTTS Treatment
  25. 25. • Inability to achieve stabilization– Even though the device is adequately placed therecould be an unforeseen osseous deformity such aserosion of the dorsal lip on the posterior aspect of themiddle/anterior facet. This lip acts as a counterforceto aid in the stabilization achieved by the device.– Middle/Anterior facet erosions means that the facetsare flat so the device is just pushed anteriomediallyand there is minimal to no correction achieved.Risks of EOTTS Treatment
  26. 26. Risks of EOTTS TreatmentDevice Risks• Under/Over-correction– Trial sizing is performed while the individual islaying on the operating-room table, it is notpossible to insert the trial sizer and have thepatient stand.• Misc. Device Risks– Clicking feeling when walking (temporary)
  27. 27. Risks of EOTTS TreatmentPost Procedure Risks• Incision– Delayed healing– Suture reaction– Scar tissue formation• Swelling– Both to the local procedure area as well asgeneralized to the foot, ankle, and lower leg.
  28. 28. Risks of EOTTS TreatmentPost Procedure Risks• Pain– This is a surgical procedure and pain will be expectedafter the procedure.– Some patients experience very little discomfort andonly need anti-inflammatory meds whereas otherpatients could experience significant pain requiringpain medication.– For patients who have pain, it could be shorted termfor only a few minutes to hours whereas others couldexperience pain long term, from weeks to months.– It is impossible to guess who will experience morepain than others.– Pain level can vary from foot to foot.
  29. 29. Risks of EOTTS TreatmentPost Procedure Risks• Period of abnormal walking– Due to• corrected foot position• Natural post-procedure guarding tendency• bandaging• shoe-gear• post-op pain– there is expected to be a temporary period ofwalking abnormally.– Just like post-op pain, some individuals willwalk normal right away, whereas other couldtake weeks to months to walk “normal” again.
  30. 30. • “Sprained Ankle” Syndrome– Feeling like the patient suffers from a sprainedankle.– Area surrounding the front of the fibularmalleolus– Pain is present when first getting out of bed inthe AM or after prolonged period of NWB.– After a few minutes (5 to 15) pain subsides– Due to adaptations of the anterior talofibularligamentRisks of EOTTS TreatmentPost Procedure Risks
  31. 31. • “Sprained Ankle” Syndrome– This is considered a somewhat common side effect (1in 10 to 1 in 100 individuals)– Could range from very mild and short-term to verysevere and long-term ultimately requiring the need fordevice removal.– The chance of permanent device removal isuncommon (1 in 100 to 1 in 1000)– Usually with proper shoe-gear, reduction in activitylevel, oral anti-inflammatories, a series of steroidinjections leads to resolution of this condition.– It is possible that a revision to a smaller size devicecould be a good solution.Risks of EOTTS TreatmentPost Procedure Risks
  32. 32. • EOTTS Migration-Displacement– It is possible that the device could shift from its initialplacement during the surgical procedure– Goes back to the fact that EOTTS devices are placedinto the sinus tarsi when the patient is non-weightbearing, upon weight-bearing the device may“seek it’s own level” since it is not anchored into bone.– There is an allowable variation in device placement thatis acceptable.– Bottom line is: if the device is maintaining correctionand not give the patient pain- let it be.– On the other hand, if there is loss of correction orunexpected pain from the displaced device a revision iswarranted.Risks of EOTTS TreatmentPost Procedure Risks
  33. 33. • Synovitis– This is an inflammatory reaction with drainage– Could result from a/the pre-existing chronicinternal inflammatory process within the sinustarsi.– Could mimic a foreign-body reaction (unlikelydue to the use of titanium)– Self-resolving condition– Chance of this occurring is uncommon (1:100to 1:1000)Risks of EOTTS TreatmentPost Procedure Risks
  34. 34. • Generalized foot, ankle, or leg soreness– Since the TTM is stabilized there arepotentially new forces acting on tissues thatjust aren’t used to them.– Extensor tendons, middle/lateral band of theplantar fascia (middle of the arch).– Muscles that haven’t been working as theyshould now have to work harder.– Temporary effect and is uncommon– If present it is self resolving within a matter ofdays to weeks.Risks of EOTTS TreatmentPost Procedure Risks
  35. 35. Benefit – Risk Analysis• Overwhelming majority of patients havebenefited from the EOTTS treatment option.• Adverse events and side effects are generallyuncommon; however they do occur and thisimpact is disproportionate relative to thenumber of patients receiving a benefit. This isdue to the emotional component associatedwith the risks. Nonetheless, risks do causeharm, and they do occur randomly and mayappear unexpectedly.
  36. 36. EOTTS Benefit – Risk AnalysisBenefits• Internal permanent (butreversible) option• Scientifically proven todecrease strain to the mostimportant structures withinthe foot.• Far reaching benefits up themusculoskeletal chain.• Overall health and well-beingare positively affected.Risks• Every solution has thepotential of creating newproblems.• Potential risks are, for themost part, short-term & selfresolving.• The EOTTS device can beremoved and any complicationSHOULD/WOULD be expectedto resolve.
  37. 37. EOTTS Benefit – Risk Analysis• The benefits of EOTTS must be consideredgreater than the potential risks.• This is a case by cases, foot by foot decision.• EOTTS is an elective procedure and thereforeultimately it is up to the patient or thepatient’s guardian to make the final call togive consent to undergo this procedure.
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