Sacroiliac Joint Fusion System - Xtant Medical Joint Fusion System ... , but recognized procedure...
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Silex ® Sacroiliac Joint Fusion System Sacroiliac compression and stability for rapid and solid joint fusion Restoring Lives. Embracing Growth.
Transcript of Sacroiliac Joint Fusion System - Xtant Medical Joint Fusion System ... , but recognized procedure...
Silex®
Sacroiliac Joint Fusion System
Sacroiliac compression and stabilityfor rapid and solid joint fusion
Restoring Lives. Embracing Growth.
Often Hidden DiagnosisTheSacroiliac(SI)Jointisasignificantpaingeneratorinnearly25% oflowerbackpainpatients.1SIjointpainanddysfunctionmaybecausedbymanyfactors,andisoftenmisdiagnosedasdiscogenicpain.2
WhileconservativetreatmentofSIjointdysfunctionisessential, itoftentargetspainalleviationwithoutaddressingtherootcause.
FusionoftheSIjointmaybetherightsolutionforpatientswho continuetobesymptomaticdespiteconservativetreatment.SIjoint fusionhasbeenshowntoresultinrapidandsustainedreliefofpainwhichissignificantlyimprovedoverconservativetreatment.3
Patient CandidateAssymptomsareoftensimilartothoseforlumbardisorders, asimplediagnosticalgorithmmaybeappliedtodetermineif thepainissacroiliacinorigin.
Duringphysicalexamination,thereareseveralorthopedic provocativetestswhichmayreproducesymptomsassociated withsacroiliacjointdysfunction.
Radiologycanhelpruleoutotherpotentialsourcesofpain, butisunabletodiscernSIjointdysfunction.
Analgesicinjectionsintothejointcanisolatethesourceofthe paindirectly,andmaytemporarilyimprovesymptoms.However, sinceanalgesicsfailtoaddressthecauseofthepain,symptomsmayrecurandfusionmaybethebesttreatmentoption.
Common Causes• Degenerativearthritis• Pregnancy• Trauma• Previouslumbarfusion• Leglengthdiscrepancy• Ankylosingspondylitisorother inflammatorydisease
Common Symptoms• Lowbackpain(belowL5)• Pelvis/buttock,hip/groinpain• Lowerextremitypain(numbness,tingling, weakness)• Worsenswithincreasedphysicalactivity orprolongedinactivity• Insomnia
SI Fusion Patient Selection• Chronicacutepain• Failedconservativetreatment• Faileddiagnosticexamsincluding provocativetestingandSIjointinjection• Motivatedandcapableofpost-surgical rehabilitation
Low Back Pain1
25%SACROILIAC
Coding LandscapeSacroiliacfusionisarelativelynew,butrecognizedprocedurewithCPTcodesforbothanopenandan MISprocedure,dependingprimarilyonwhetherdirectvisualizationisachieved.TheSilexsystemworks equallywellinanopen,mini-openoranMISprocedure.
Reimbursement Support
Inordertoassistmedicalfacilitiesinquickandreliablecoverageaccessforappropriatetreatments, XtantMedicalhaspartneredwithathirdpartyreimbursementconsultingfirm,MusculoskeletalClinical RegulatoryAdvisers(MCRA),toprovideexpertiseandservices.
IncompliancewithHIPAAregulations,aBusinessAssociateAgreement(BAA)isfirstestablishedbetween MCRAandthemedicalfacility,protectingbothparties.
ReimbursementServices:• Provideexpertinformationregardingthereportingpathwaysandpayorguidelines• Expeditesinsurancecoverageandappealstodrivepatientaccessfortheappropriatetreatment• Facilitatecoveragethroughpre-authorizationassistance• Managepre-authorizationdenialappeals
Reimbursement Hotline800-914-7211
Physician Coding Pathways*
*ASilexReimbursementResourceGuideisavailablewithdetailedcodingpathwayoptions
† CurrentProceduralTerminology(CPT®)copyright2016AmericanMedicalAssociation.Allrightsreserved.CPTisaregisteredtrademarkoftheAmericanMedicalAssociation.
†† 2016MedicarePhysicianFeeScheduleRVUmultipliedby2016conversionfactor,effectiveJanuary2016www.cms.gov
CPT Code † Code Descriptor RVU 2016 Medicare Payment ††
Open or Mini-Open Procedure
27280 Arthrodesis, sacroiliac joint (including obtaining graft) 39.50 $1,415.2027299 Unlisted procedure, pelvis or hip joint - Varies
MIS Procedure
27279
Arthrodesis, sacroiliac joint, percutaneous or minimally invasive (indirect visualization), with image guidance, includes obtaining bone graft when performed, and placement of transfixing device
20.15 $721.93
Reliable Fusion
Controlled CompressionTheSilex®implantshaveacompressionthreadpattern providing0.9mmofjointcompressionwitheveryturnoftheAnchorImplantoncethelockingthreadsareengaged.
Forpatientsdiagnosedwithsacroiliacjointdysfunction,theSilexsystemprovides controlledcompressionandstabilityencouragingrapidandsolidfusion.
Enhancing FusionEarlyboneappositionisencouragedbythe titaniumplasma-spraycoatingonthesurface oftheimplant.Thiscoatingfurtherenhances thestabilityofthelargethreadedimplant,and providesanosteoconductivesurfacefor bonyongrowth.4
Fusionacrossthejointspaceisencouraged bytheadditionofbonegraftmaterialwhich canbefilledintothelumenoftheimplant andexudedthroughthefenestrations.
Routine ProcedureWhetherperformedopen,mini-openorMIS,theSilex®proceduremirrorsthetechniqueforatraditionalcannulatedbonescrew.
Eachimplantistargetedusinga Steinmannpinunderfluoroscopy, withorwithoutdirectvisualization.
Theboneispreparedbyadvancing acannulateddrillandtapoverthe Steinmannpin.
Theimplantisdrivenintoplaceby threadingovertheSteinmannpin andisadvanceduntilthesecondset ofthreadshavefullyengagedand compressedthejointspace.
Thisprocedureisrepeateduntil allimplantsareimplanted.
Clinical Outcomes
A2016studyfollowed45patientswithdegenerativesacroiliitis followingjointfusionwiththeSilexsystem.5Painwasmeasuredpre-operativelyandat10weekspost-operatively(range6-12weeks)usingavisualanalogscale(VAS).Allpatientsreporteda reductioninpainwithanaveragereductionof69%,and84%ofthesepatientsreportedpostoperativepainscoresoflessthanhalfoftheirpre-operativepainlevel.Basedontheresultsofthisstudy,theuseofSilex®SacroiliacJointFusionSystemiseffectiveat significantlyreducingpaininpatientswithdegenerativesacroiliitis. 3Years of
Clinical Excellence
Graph 1. Mean VAS pain scores pre-operative and 10 weeks post-operative Silex sacroiliac joint fustion.
p < 0.001
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Case ReportPatient DemographicsAge:44Sex:M
Clinical History Thepatientpresentedwithanineyearhistoryofnon-radiatingleftsacroiliacpainwithrecentexacerbationover theprevioussixmonths.Aworkinjuryhadoccurredandwasfelttobecontributingtothepatient’sdiagnosis. ThepatienthadundergoneapriorL4toS1fusion,withcontinuedlowbackandsacroiliacsymptomology.
Physical Examination and Diagnosis OnofficeevaluationthepatienthadapositiveresponsetotheFortinFingertestandprovocativetestingwiththefollowingmaneuvers:FABERtest,compressiontest,andthighthrust.Thepatientexhaustedconservativetreatment.Coursesofphysicaltherapy,acupunctureandinterventionalpainmanagementwereattemptedwithoutimprovement.Adiagnosisofrefractorysacroiliacdysfunctionwasmade.
Treatment InNovember2014,thepatientunderwentaleftsacroiliacfusionandfixationusingthreeSilex®(XtantMedical) implantsthroughtheleftSIjoint.Allthreeimplantswere12.5mmindiameterandrangedinlengthfrom40-50mm.Thesacroiliacjointwasvisualizedandcuretted.Eachimplantwaspackedwithlocalautograft,BMA,and OsteoSponge®Strip(XtantMedical).Operativetimewasonehourandsevenminutes,with2.2minutes offluoroscopytimeand150mLofbloodloss.
Post Operation Protocol Thepatientwasdischargedonpostoperativedayone.Hispostoperativecoursewasunremarkable,consistingofsixweeksofpartialweightbearing,followedbysixweeksofnormalambulationandphysicaltherapyatthreemonths.Radiographicfollow-upwasperformedatonedaypostoperatively,sixweeks,threemonths,andaCTscanatsixmonths(shownbelow).Pre-operativeVASscorewasa7/10andthreemonthpost-operativeVASscorewasa3/10.
Fig. 1. A/P view of sacroiliac joint 6 weeks post-operative
Fig. 2. Axial view of sacroiliac joint 6 weeks post-operative
BMI:21.9Other:Smoker
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PL-16 0013 A 08/2016 © Xtant Medical. All Rights Reserved.Silex® is a product and trademark of X-spine Systems.
References1. SembranoJ,PollyD:HowOftenisLowBackPainNot ComingFromtheBack?SPINE.2008;34:27-32.2. SembranoJ,etal:Diagnosisandtreatmentofsacroiliacjoint pain.CURRENTORTHOPAEDICPRACTICE.2011.3. PollyD,etal:RandomizedControlledTrialofMinimally InvasiveSacroiliacJointFusionUsingTriangularTitanium ImplantsVsNonsurgicalManagementforSacroiliacJoint Dysfunction:12-MonthOutcomes.NEUROSURGERY.2015; 77:674-691.4. Novaes,etal.:InfluenceofImplantSurfaceson Osseointegration.BrazDentJ(2010)21(6):471-481.5. ScottB,GravenT:ClinicalOutcomesoftheSilexSacroiliac JointFusionSystem:AMulti-CenterRetrospectiveReview. XTANTMEDICALWHITEPAPER.2016;F-1060.4.
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