Risks and Potential Complications of EOTTS Treatment
Risks and Potential Complications ofEOTTS Treatment
Risks of EOTTS Option• This is a surgical procedure and istherefore subject to certain risks andpotential complications.– Anesthesia Risks– Surgical Procedure Risks– Device Risks– Post EOTTS Procedure Complications
Risks of EOTTS TreatmentAnesthesia Risks• EOTTS procedure is usually performedunder “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 beunder this form of anesthesia for aprolonged period of time.
Risks of EOTTS TreatmentSurgical Procedure• EOTTS is typically performed with anincision about 1 inch long• No major blood vessels, nerves, ortendons in the surgical area• No tourniquet is necessary• No bone involvement• Soft tissue procedure• Relatively atraumatic
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- strong and durable– Doesn’t set off metal detectors– Patients can still have MRI or CT imaging
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.
Risks of EOTTS Treatment• Device displacement– HyProCure is not anchored into bone. Thetissues and the osseous chamber hold it inplace– It is possible that the soft tissues have beeneroded due to the chronicity of the RTTDdisease process or there is osseousmalformation of the middle/anterior faceteither one could lead to devicedisplacement.
• Device displacement– It could take up to 4 to 6 weeks or longer forthe soft tissues to adhere to the device tohold it in place (this is not scientificallyproven).– Could result from a patient who is tooactive, too soon or wearing improper shoesor from a traumatic episode such as asevere ankle sprainRisks of EOTTS Treatment
• Inability to achieve stabilization– Even though the device is adequately placedthere could be an unforeseen osseousdeformity such as erosion of the dorsal lip onthe posterior aspect of the middle/anteriorfacet. This lip acts as a counterforce to aid inthe stabilization achieved by the device.– Middle/Anterior facet erosions means that thefacets are flat so the device is just pushedanteriomedially and there is minimal to nocorrection achieved.Risks of EOTTS Treatment
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.– Trial sizing can sometimes result in similarcorrection between two different sizes (1 mmdifference) so it is generally recommended touse the smaller size (it is better to under-correct than to over-correct).
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 lowerleg.
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 and onlyneed anti-inflammatory meds whereas other patientscould experience significant pain requiring painmedication.– For patients who have pain, it could be shorted term foronly a few minutes to hours whereas others couldexperience pain long term, from weeks to months.– It is impossible to guess who will experience more painthan others.– The amount and duration of pain varies from foot tofoot.
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 (how long varies from foot tofoot).– Just like post-op pain, some individuals will walknormal right away, whereas other could take weeksto months to walk “normal” again.
• “Sprained Ankle” Syndrome– Outer ankle feels like it is sprained.– Front of the outer ankle bone– Pain is present when first getting out of bedin the AM or after prolonged period ofNWB.– After a few minutes (5 to 15) pain subsides– Due to adaptations of the anteriortalofibular ligamentRisks of EOTTS TreatmentPost Procedure Risks
• “Sprained Ankle” Syndrome– This is considered a somewhat common side effect (1 in10 to 1 in 100 individuals)– Could range from very mild and short-term to moresevere and longer-term ultimately requiring the needfor device removal.– The chance of permanent device removal is uncommon(1 in 100 to 1 in 1000)– Usually with proper shoe-gear, reduction in activitylevel, oral anti-inflammatories and 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
• 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 placed intothe sinus tarsi when the patient is non-weightbearing,upon weight-bearing the device may “seek it’s ownlevel” 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 given the patient pain- let it be.– On the other hand, if there is loss of correction orunexpected pain from the displaced device a revisionmay be warranted.Risks of EOTTS TreatmentPost Procedure Risks
• Synovitis– This is an inflammatory reaction with drainage– Most likely due to 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
• Generalized foot, ankle, or leg soreness– Since the bones are now stabilized there arepotentially new forces acting on tissues thatjust aren’t used to them.– Specific tissues are the muscles, tendons andligaments to the lower leg, ankle and foot.– 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
• Misc. Device Risks– Clicking feeling when walking (temporary)– This is uncommon and could occur early inthe recovery period– Only a matter of time before this clickingresolves.Risks of EOTTS TreatmentPost Procedure Risks
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.
EOTTS Benefit – Risk AnalysisBenefits• Internal permanent(but reversible) option• Scientifically proven todecrease strain to themost importantstructures within thefoot.• Far reaching benefitsup the musculoskeletalchain.• Overall health andwell-being arepositively affected.Risks• Every solution has thepotential of creating newproblems.• Potential risks are, for themost part, short-term & selfresolving.• The EOTTS device can beremoved and anycomplicationSHOULD/WOULD beexpected to resolve.
EOTTS Benefit – Risk Analysis• The benefits of EOTTS must be consideredgreater than the potential risks.• This is a case by cases, foot by footdecision.• EOTTS is an elective procedure andtherefore ultimately it is up to the patientor the patient’s guardian to make the finalcall to give consent to undergo thisprocedure.
• There has not been a single case of fracture tothe ankle or heel bone since the first use ofHyProCure in 2004 and over 20,000 deviceplacements .EOTTS – HyProCurePossibility of
• There has not been a single case where aHyProCure device has been proven to casearthritis to the subtalar joint.• HyProCure should prevent arthritis not leadto arthritis because it stabilizes the joint andprevents the excessive wear and tear thatleads to arthritis.EOTTS –Possibility of Leading to Subtalar JointArthritis.