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StandAloneCagesvs.CagewithPedicleScrewsCages-DoTheyWork?JohnKostuik-OrthopedicsTodayMarch2002“Metalfusioncageswerepickedupprimarilybyneurosurgeonsbecauseit’stechnicallyeasytodo,buttheresultshavebeenterrible,byandlarge.”Non-Threaded(Impacted)

InterbodyConstructsBoneMetalCompositeTangent?PLIFBonePrecision-Graft?ALIFBoneTELAMON?InterbodyFusionDeviceContactFusionCageSynthesImpactedALIFTiDeviceSyncageDeviceBrantiganPosteriorI/FCage?AcromedTELAMON?CInterbodyFusionDeviceImpactedALIFCompositeDevicePYRAMESH?CageAnteriorI/FCage?AcromedHarmsCageDePuyPLIFSpacerSynthesFRASpacerSynthesVertigraftDePuyOgivaleTi

StrykerProspaceAesculapCageCHScient’xTISSynthesOstaPekPLIFColigneI/FRampAcromedOgivalePEEKStrykerTELAMON?PDevicePYRAMESH?PCageThreadedInterbodyConstructsBoneMetalCompositeCylindricalTaperedReducedProfileMD-IIThreadedCorticalDowelMD-IIIThreadedCorticalDowelMD-IVThreadedCorticalDowelINTERFIX?ThreadedFusionDeviceBAK?DeviceSulzerRayTFCDeviceUSSurgicalLordotec?InterbodyFusionDeviceINCLINE?InterbodyFusionDeviceINTERFIX?RPThreadedFusionDeviceBAKProximity?DeviceSulzerINCLINE?RPInterbodyFusionDeviceINTERFIX?CThreadedFusionDeviceOsteotechBIO-dDowelBioresorbableCageIVISAesculapLIFECProconceptBiomechanicsofPOLArConstructMeanROMperNmofForceT.Zdeblick,MDet.al.,NASSChicago,IL1999Zeidman-CageBiomechanicsALIFcagesprovidebetterstabilizationthanPLIFcagesinaxialrotationandlateralbendingALIFandPLIFcagesstabilizeinflexion,butnotinextension(thisismuchimprovedwiththeadditionoffacetscrews)BAK/LIndicationsforUseWithorwithoutherniationAtoneortwocontiguouslevelsWithorwithoutspondylolisthesis,GradeIorlessUsinganterior,posterior,andlaproscopicsurgicalapproachesContraindication:InfectionatoperativesiteFortreatmentofchronic,painful,degenerativediscdiseaseofthelumbarspineStudyInclusionCriteriaDegenerativediscdiseasewithorwithoutherniation<GradeIspondylolisthesisInvolvementofoneortwocontiguousspinalsegmentsfromL2toS-1Age:21-65Persistentbackpainunresponsivetoconservativetreatmentforminimumof6monthsLUMBARINTERBODYFUSIONWITHTHREADEDCAGES:

SIX-YEARFOLLOW-UPJohnE.ShermanMDStephenD.KuslichMDStevenL.GriffithPhDRoseGriffith

BikashBose,MD,etal,StandAlonevsInterbodywithPosteriorfixation72interbodyalone/65posteriorfixationLOS4.7(SA)vs6.2(PF)EqualimprovementinbackandlegpainFusionrate94%(SA)vs89%(PF)BoseStudyMultilevelcaseshadtrendforbetterresultwithpostertiorfixationRevisionratewas4.2%(SA)vs9.1%(PF)ComplicationratesamebothgroupsIntroductionPreviouslypublishedstudiesdemonstratesafety&effectivenessofthreadedcagesMatgeG,LeclerqTA.ActaNeurochir(Wien)142:425-434,2000.RayCD.Spine22:667-680,1997.VamvanifV,etal.JSpinalDisorders11(5):375-382,1998.IntroductionPreviouslyreportedstudiesdemonstratesafety&effectivenessofthreadedcagesCarlAL,etal.,NASS1999SchoffermanJ,etal.,NASS1999BrodkeDS,etal.,NASS2000Brodke,etal-BAKComparedtoSyncage157patientreportPreopOswestry=51PreopVAS=68PostopOswestry=35(p<0.001)PostopVAS=33(p<0.001)Reoperationforadditionalfixation3%Kitcheletal-NASS2001BMP-2intitaniumcagesandthreadedbonedowelsOswestryimproved50%inbothgroupsFusionsuccesswas>95%at24monthsDiscussionO’DowdJK,LamK,MulhollandRCD,HarrisM.BAKCage:Nottinghamresults.NASS1998GenerallypoorresultsCarlAL,KostuikJP,AbitbolJJ,HuckellC,MatsumotoM,SieberA.Interdiscalcagecomplications-Ageneralconsensus.

NASS1999GenerallyfavorableresultsIntroductionPreviouslypublishedclinicalseriesofBAKcages:

KuslishSD,UlstromCL,Griffith,AhernJW,

DowdleJD.

“TheBAK(BagbyandKuslish)MethodofLumbarInterbodyFusion:History,

Techniques,andTwo-yearFollow-up”.

Spine23(11):1267-1279,1998.KuslishSD,DanielsonG,DowdleJD,ShermanJ,FredricksonB,YuanH,GriffithSL.

“Four-yearFollow-upResultsofLumbarSpineArthrodesisUsingtheBAK/LFusionCage”.Spine25(20):2656-2662,2000.Materials&MethodsLumbarfusion

cageimplant:BAK/LStudycohort

13investigators

7centersBothanterior&

posteriorcasesMaterials&MethodsOriginalIDE/PMA(2-yrfollow-up)1992-1995Currentstudy

(6-yrfollow-up)1996-2002#ofSurgeons4213InvestigativeSites197PtsEnrolledinStudy(Implanted)947598PtsEligibleatFollow-up299382PtsIncludedinFollow-up283(94.6%)239(62.6%)Materials&Methods:73%57%53%72%60%77%EligiblePtsStudyPtsMaterials&Methods:Outcomes

Fusion:neutrallateralradiographs&

Flexion/Extensionoverlays<3degrees=“fused”3to7degrees=independentover-read

Pain:6-pointscalesimilartoProlo

Function:32-pointfunctional

impairmentscale

Complications:Kaplan-MeieranalysisResults:FusionExamples6Yearspost-surgeryResults:PainRelief“normal”…mild/occasionalResults:PainRelief“normal”…mild/occasionalResults:PainRelief“normal”…mild/occasionalResults:FunctionalImprovement“normal”Results:FunctionalImprovement“normal”Results:FunctionalImprovement“normal”Results:Fusion1year2years4years6yearsALLANTERIORCASES86.395.6%99.3%100%One-Level90.599.9%100%100%Two-levels81.391.8%98.6%100%ALLPOSTERIORCASES84.295.3%98.8%96.0%One-Level85.499.0%100%100%Two-Levels80.683.9%95.2%84.6%ALLPATIENTS85.495.5%99.1%98.2%Results:AdditionalSurgeryRemoval/revisionatindexlevel:n=10(2.6%)Allwithin2yearsAll2-levelcases,exceptone Suppl.fixationatindexlevel:n=18(4.7%)UsuallyposteriorfixationAveF/U-30+18months44%1-levelcasesand56%2-levelcasesRe-operationforadjacentlevelpath:n=14(3.7%)8of14(57%)requiredfusionAvef/u-39+21monthsResults:Fusion1

year2years4years6yearsALLPATIENTS85.4%95.5%99.1%98.2%ALLPATIENTS(withadditionalsurgeries)80.8%87.8%85.2%83.5%Cumulativelyaccountingforadditionalsurgerycasesovertimereducesoverallapparentfusionrates,butstillremains>80%Results:ComplicationsMonths

42

7266605448363024181260

1.0

0.8

0.60.4

0.2

0.0

OddsRatioFreedomfromAdditionalSurgeryFreedomfromAdverseEventsConclusions:StudyDesignPositiveaspectsofstudyProspective,multi-centerstudyLargestudycohortwithlongfollow-upCriticalaspectsofstudyNon-randomizedFollow-upcompliancePerceivedpatientselectionbiasConclusions:OutcomesFusionwiththreadedinterbodycagesfordegenerativediscdiseaseinproperlyselectedpatientsshow…greatestclinicalimprovementwith

first3to6months,fusionratesandclinicalimprovements

thatremainpositiveuptosix-years,alowcomplicationandre-operationrateAnteriorapproachappearsslightlyadvantageoustoposteriorapproach,particularlyfor2-levelsCageFailuresBestapproachistoavoidoccurrenceProperpreoperativeindicationsDonotignorepsychosocialfactorsAttentiontosurgicaldetailAggressivediscectomyMaintainmidlineorientationProperannulartensionAvoidthe“talldiscspace”MJPreoperativeMRI33yofemale18monthssevereLBPPT,NSAID,ESIMJpostoperativeSurgerytime45minutesHospitalstay1dayRWTat4weeksVAS=0Oswestry=01yearradiographNewTechnologyThreadedradiolucentcages-allowsforbetterassessmentoffusionBioresorbablecages-notbiomechanicallystrongenoughtobestandaloneatthistimeBMPlikelyincreasesthefusionrateoverautograftDiscussionUntilresultsofadditionalscientificallyrigorousstudiesareavailable,thereremainscompellingevidencefromthesestudiessuggestingthreadedinterbodyfusioncagescontinuetobeeffectiveandsafesurgeryinproperlyselectedpatientstreatedwithtechnicalprecision.StandAloneCagesvs.CagewithPosteriorFixationPatientselectionisprimarypredictorofsuccessSe

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