eotts: benefit vs. risk analysis

E.O.T.T.S.BENEFIT – RISK ANALYSIS

Therapeutic Decision

Natural Progression of Recurrent TaloTarsal

Dislocation

Risks of

Treatment

Benefit-Risk Analysis

Benefits of Treatment

Natural Progression of RTTD

• Foot and ankle complications- (repetitive strain injury)

• Musculoskeletal chain effects

• Overall Health

• Economic factors


Foot and Ankle Complications

• Increased forces acting on the medial column of the foot.

• Increased strain to – spring ligament

– Posterior tibial tendon

– Medial band of the plantar fascia

– Tibialis posterior nerve

• Increased pressures within the tarsal tunnel.


Proximal Musculoskeletal Effects

• Talus dislocates off calcaneus

• Tibia/fibula internally rotates• Twisting of the knee• Head of the femur is pulled

from the hip (leg length discrepancy)

• The pelvis tilts• Stain/torsion on the back• Shoulders tilt• Neck strain

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 decreased metabolism

– Decreased metabolism leads to increased weight


Increased weight leads to

Natural Progression of RTTDEconomic Factors

Continued pain leads to “self-remedies/treatment” costs

OTC medicationsbuying special shoes

Medical costsPCP, foot specialist, chiropractor, orthopedist, physical therapist.Insurance costs, co-pays, medicine, arch supports, braces, other

Time away from workwhen patients are away from work they aren’t making money, they are losing money.

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

Benefits of EOTTS Treatment

Benefits

• Physiologic Measurements

• Clinical Events (disability, disease, dissatisfaction, discomfort, destitution)

• Symptoms (difficulty walking, pain)

• Functional Measurements (quality of life)

Benefits

• Clinical benefits

• Absolute benefits- reduction in disability, morbidity, and mortality

• Economic benefits

• Patient centered benefits (quality of life)


• Internal option – does not rely on patient compliance (arch support, brace, shoes)

• Extra-osseous – does not involve bone surgery

• Minimally invasive soft tissue procedure• Can be performed as a stand-alone

procedure or in conjunction with other procedures.

• EOTTS devices are reversible, they can be removed with minimal effort.


• Stabilization of the talotarsal mechanism

• Elimination of excessive talotarsal motion

• Articular facets remain in constant congruent contact

• Reduction in excessive forces acting on the osseous and soft tissues

• TTM is now an efficient machine


• Decreased stain to the knee

• Head of the femur is no longer pulled from the hip – leg length discrepancy

• Pelvis is aligned

• Decreased stain to lower and upper spine

• Shoulders balanced

• Decrease strain to neck and TMJ


• Patients have a more efficient gait cycle

• Easier to walk/run

• Become more active

• Increase metabolism

• Decrease weight

• Lower blood pressure

• Lower blood sugar

Risks of EOTTS Treatment

Risks of EOTTS Option

• This is a surgical procedure and is therefore subject to certain risks and potential complications.

– Anesthesia Risks

– Surgical Procedure Risks

– Device Risks

– Post-Procedure Risks


Anesthesia 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 form of anesthesia for a prolonged period of time.


Surgical Procedure

• EOTTS is minimally invasive

• Incision is < 2 cm

• No major blood vessels, nerves, or tendons in the surgical area

• No tourniquet is necessary

• No bone involvement

• Soft tissue procedure

• Relatively atraumatic


Device Risks

• EOTTS (HyProCure®) is entirely made from medical grade titanium

• Titanium is considered the safest material 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

Risks of EOTTS TreatmentDevice Risks

• EOTTS devices are placed into the sinus tarsi.

• They are anchored into the sinus tarsi by adherence of the soft tissues within the sinus tarsi.

• In addition, the osseous chamber forming the sinus tarsi needs to be complete. In other words a full oval shape is needed. The upper ½ is formed by the talus, the lower ½ by the calcaneus.


• Device displacement

– HyProCure is not anchored into bone. The tissues and the osseous chamber hold it in place

– It is possible that the soft tissues have been eroded due to the chronicity of the RTTD disease process or there is osseous malformation of the middle/anterior facet either one could lead to device displacement.

• Device displacement

– It could take up to 4 to 6 weeks or longer for the soft tissues to adhere to the device to hold it in place (this is not scientifically proven).

– Could result from a patient who is too active, too soon or wearing improper shoes or from a traumatic episode such as a severe ankle sprain


• Inability to achieve stabilization

– Even though the device is adequately placed there could be an unforeseen osseous deformity such as erosion of the dorsal lip on the posterior aspect of the middle/anterior facet. This lip acts as a counterforce to aid in the stabilization achieved by the device.

– Middle/Anterior facet erosions means that the facets are flat so the device is just pushed anteriomedially and there is minimal to no correction achieved.



Device Risks

• Under/Over-correction

– Trial sizing is performed while the individual is laying on the operating-room table, it is not possible to insert the trial sizer and have the patient stand.

• Misc. Device Risks

– Clicking feeling when walking (temporary)


Post Procedure Risks

• Incision

– Delayed healing

– Suture reaction

– Scar tissue formation

• Swelling

– Both to the local procedure area as well as generalized to the foot, ankle, and lower leg.


Post Procedure Risks• Pain

– This is a surgical procedure and pain will be expected after the procedure.

– Some patients experience very little discomfort and only need anti-inflammatory meds whereas other patients could experience significant pain requiring pain medication.

– For patients who have pain, it could be shorted term for only a few minutes to hours whereas others could experience pain long term, from weeks to months.

– It is impossible to guess who will experience more pain than others.

– Pain level can vary from foot to foot.



• 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 of walking abnormally.

– Just like post-op pain, some individuals will walk normal right away, whereas other could take weeks to months to walk “normal” again.

• “Sprained Ankle” Syndrome

– Feeling like the patient suffers from a sprained ankle.

– Area surrounding the front of the fibular malleolus

– Pain is present when first getting out of bed in the AM or after prolonged period of NWB.

– After a few minutes (5 to 15) pain subsides

– Due to adaptations of the anterior talofibularligament



• “Sprained Ankle” Syndrome– This is considered a somewhat common side effect (1

in 10 to 1 in 100 individuals)– Could range from very mild and short-term to very

severe and long-term ultimately requiring the need for device removal.

– The chance of permanent device removal is uncommon (1 in 100 to 1 in 1000)

– Usually with proper shoe-gear, reduction in activity level, oral anti-inflammatories, a series of steroid injections leads to resolution of this condition.

– It is possible that a revision to a smaller size device could be a good solution.



• EOTTS Migration-Displacement– It is possible that the device could shift from its initial

placement during the surgical procedure– Goes back to the fact that EOTTS devices are placed

into 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 that is acceptable.

– Bottom line is: if the device is maintaining correction and not give the patient pain- let it be.

– On the other hand, if there is loss of correction or unexpected pain from the displaced device a revision is warranted.



• Synovitis

– This is an inflammatory reaction with drainage

– Could result from a/the pre-existing chronic internal inflammatory process within the sinus tarsi.

– Could mimic a foreign-body reaction (unlikely due to the use of titanium)

– Self-resolving condition

– Chance of this occurring is uncommon (1:100 to 1:1000)



• Generalized foot, ankle, or leg soreness– Since the TTM is stabilized there are

potentially new forces acting on tissues that just aren’t used to them.

– Extensor tendons, middle/lateral band of the plantar fascia (middle of the arch).

– Muscles that haven’t been working as they should now have to work harder.

– Temporary effect and is uncommon

– If present it is self resolving within a matter of days to weeks.



Benefit – Risk Analysis

• Overwhelming majority of patients have benefited from the EOTTS treatment option.

• Adverse events and side effects are generally uncommon; however they do occur and this impact is disproportionate relative to the number of patients receiving a benefit. This is due to the emotional component associated with the risks. Nonetheless, risks do cause harm, and they do occur randomly and may appear unexpectedly.

EOTTS Benefit – Risk AnalysisBenefits

• Internal permanent (but reversible) option

• Scientifically proven to decrease strain to the most important structures within the foot.

• Far reaching benefits up the musculoskeletal chain.

• Overall health and well-being are positively affected.

Risks

• Every solution has the potential of creating new problems.

• Potential risks are, for the most part, short-term & self resolving.

• The EOTTS device can be removed and any complication SHOULD/WOULD be expected to resolve.

EOTTS Benefit – Risk Analysis

• The benefits of EOTTS must be considered greater than the potential risks.

• This is a case by cases, foot by foot decision.

• EOTTS is an elective procedure and therefore ultimately it is up to the patient or the patient’s guardian to make the final call to give consent to undergo this procedure.

eotts: benefit vs. risk analysis

Health & Medicine

increased strain

eotts devices

decreased stain

harder activity

increased generalized

foot specialist

excessive forces

workwhen patients