動(dòng)態(tài)固定和Dynesys系統(tǒng)回顧(中文)

動(dòng)態(tài)固定和Dynesys系統(tǒng)回顧

一個(gè)暫新的概念在治療下腰痛和腿痛方面，Dynesys系統(tǒng)是一個(gè)新個(gè)的概念，它將傳統(tǒng)的融合方法與動(dòng)態(tài)理念結(jié)合在一起，使用柔韌材料固定脊柱，同時(shí)保持脊柱的解剖結(jié)構(gòu)。Overview動(dòng)態(tài)固定DYNESYS

系統(tǒng)Dynesys系統(tǒng)是一個(gè)新的概念，其目的在于穩(wěn)定受累關(guān)節(jié)保留大部分脊柱解剖結(jié)構(gòu)解除疼痛以獲得更好的結(jié)果=DynamicStabilizationOverviewDynesys

SystemMaterials繩索Sulene?-PET間隔桿Sulene?-PCU鈦合金螺釘及固定螺帽(Protasul?-100OverviewDynesys

系統(tǒng)歷史由法國醫(yī)生G.Dubois設(shè)計(jì)1994年生產(chǎn)出第一個(gè)內(nèi)置物對(duì)3個(gè)醫(yī)療中心的83例病人進(jìn)行了前瞻性研究1999年投放歐洲市場全球應(yīng)用已超過13,000例目前正在美國進(jìn)行臨床研究Overview預(yù)期的特性和優(yōu)點(diǎn)穩(wěn)定受累關(guān)節(jié)保留大部分脊柱解剖結(jié)構(gòu)解除疼痛以獲得更好的效果采用熟悉的后路方法，簡化訓(xùn)練過程能夠采取微創(chuàng)手術(shù)Overview生物力學(xué)檢測(cè)的目的:證明該系統(tǒng)能夠存在下去證明該系統(tǒng)有效合理的生物力學(xué)檢測(cè)方法:檢測(cè)每一個(gè)組件保證設(shè)計(jì)正確檢測(cè)完整組件驗(yàn)證系統(tǒng)的正常功能體外構(gòu)建系統(tǒng)證實(shí)結(jié)構(gòu)能夠Biomechanics生物力學(xué)椎弓根螺釘椎弓根螺經(jīng)受100-800N之間的周期載荷，以評(píng)估螺釘?shù)钠谡蹟鄰?qiáng)度最小螺釘(5.2x35mm)能夠耐受5百萬次載荷周期BiomechanicsPET繩索能夠耐受5百萬次100-800N周期載荷繩索靜態(tài)抗張強(qiáng)度接近3000N20小時(shí)拉伸延長原長度的1.27%沒有發(fā)生斷裂BiomechanicsPCU間隔桿室溫條件下抗壓強(qiáng)度為243N/mm體溫條件下抗壓強(qiáng)度為136N/mm.- 注意:脊柱后柱的抗壓強(qiáng)度為400N/mm.

出處:WhiteandPanjabi:ClinicalBiomechanicsoftheSpine,2ndEdition,pp39,47.Biomechanics螺釘/繩索構(gòu)造在固定螺帽理論扭距(4Nm)條件下，螺釘/繩索結(jié)構(gòu)靜態(tài)拔出力為1060N在固定螺帽理論扭距(4Nm)條件下，

螺釘/繩索組配能夠耐受5百萬次周期的100-800N拉力負(fù)荷，繩索沒有發(fā)生移位Biomechanics螺釘/繩索/間隔桿結(jié)構(gòu)系統(tǒng)能夠耐受1千萬次周期剪切位移(

5mm)或軸向旋轉(zhuǎn)(

3)而沒有出現(xiàn)繩索折斷

1千萬次周期剪切位移(

5mm)或軸向旋轉(zhuǎn)(

3)后繩索的磨損并不明顯Biomechanics檢測(cè)結(jié)果:螺釘/繩索/間隔桿結(jié)構(gòu)Biomechanics椎體切除模型Dynesys設(shè)計(jì)結(jié)構(gòu)采用椎體切除模型，檢測(cè)單間單節(jié)段結(jié)構(gòu)軸向后伸、壓迫(

1.5mm)和軸向旋轉(zhuǎn)(3).結(jié)果顯示結(jié)構(gòu)應(yīng)力弛豫:接近25%主要發(fā)生在頭1百萬周期內(nèi)理論上發(fā)生變化在1-10百萬周期之間

在軸向壓迫檢測(cè)中，after10millioncycles,theDynesyssystemmaintains525Ntension(includingthe300Npreload)and200Ncompression.Sources:ASTM:F1717-96,Standardtestmethodsforstaticandfatigueforspinal implantconstructsinacorpectomymodel.WhiteandPanjabi:ClinicalBiomechanicsoftheSpine,2ndEdition,pp47,106-107.Biomechanics結(jié)論螺釘和繩索有足夠的靜態(tài)和動(dòng)態(tài)力學(xué)強(qiáng)度螺釘和繩索有足夠強(qiáng)度的拉伸特性Screw/Cord/Spacerconstructsexhibitrobuststaticandcyclicinterconnectionstrengths.TheDynesyssystemexhibitedinitialandlong-termrigidityinassemblytestsandeffectivelyacteduponspinalinstabilityininvitrokinematictests.

BiomechanicaltestsverifythattheDynesyssystemhasthecapacity

tosurvive

and

towork.BiomechanicsTheDynamicNeutralizationSystemfortheSpine;amulti-centerstudyofanovelnon-fusionsystem

G.Dubois,T.M.Stoll,O.SchwarzenbachEuropeanSpineJournal2002Objective:EvaluationofSafetyandEffectivenessoftheDynesys?SpinalSystemStudyperiod:May1994-December2000StudyDemographicsStudySize: n=83Gender: Male: 34(41.0%)

Female: 49(59.0%)AgeatOperation[years]:58.2(26.8–85.3)Follow-up[months]: 38.1±(11.2–79.1)StudyIndications

N % SpinalStenosis 50 60.2 DDD 20 24.1 DiscHerniation 7 8.4 RevisionSurgery 5 6.0 Other 1 1.2 Total 83 100.0 DegenerativeSpondy 39 47.0 Prev.Therap.Interventions 30 36.1LevelsTreated*

Formulti-levelconstructs,toplevelreported

Location* n % L1-L2 2 2.4 L2-L3 8 9.6 L3-L4 23 27.7 L4-L5 44 53.0 L5-S1 6 7.2

Construct Length n % 1-Level 55 66.3 2-Level 17 20.5 3-Level 8 9.6 4-Level 3 3.6MethodsOutcomeassessments:BackPainVAS(1-100)LegPainVAS(1-100)OswestryProloEconomic&FunctionScaleAnalysisofcomplicationsPatientsnotavailableforfollow-upevaluation:2dead(non-related)8explantedOswestryDisabilityIndexVASPainScalesProloFunctionalCategoryProloEconomicCategoryComplications(n=83)UnrelatedtoImplant Durallesion 2 Infection 1 Paresis 1 Hypesthesia(resolved) 1 Seroma 1 ScarNeuroma 1 Cardiovascular 1 Thromboembolism 1RelatedtoImplant ScrewLoosening 1 RadiographicIndications OfScrewLoosening 7 ScrewMisplacement 2 Hypesthesia(resolved) 1 PedicleFracture 1 (Intraop)Re-operation8patientsnot-followedaftersystemexplant3patientsunresolvedpain–2fused,1laminectomy5patientshadadjacentsegmentbreakdown1directdecompressionofadjacentlevelandfusion4extendedfusion2PatientsfollowedaftersystemextensionBothforadjacentlevelbreakdown2DiametersofScrew5.2mmand6.0mmThesewerethefirstcasescompletedwithTheDynesysSpinalSystemStudyConclusionsTheDynesysSpinalSystemaffordssubstantialpainreductionandfunctionalimprovement.ImplantationoftheDynesysSpinalSystemcanbedonewithlittlesurgicalmorbidity.Screwloosening,BreakageorImplantfailureisatorbelowlevelswithrigidfixationsystems.Properpatientselection,diagnosisandbroaderimplantselectionshouldreducerateofreoperations.TheDynesys?SpinalSystemUSClinicalIDE

InterimClinicalResultsUSClinicalIDEStudyProspective,randomized,multi-centerstudy460randomizedpatientsat30centersTheDynesys?SpinalSystem(Investigational)armandPLFwithTheSilhouette?FixationSystem(ControlArm)2Investigational:1ControlOnenon-randomizedpatientateachsitewillreceivetheDynesysSpinalSystem(20total)Totalcohortwillbe490patientsCaution-InvestigationalDevice.LimitedbyU.S.FederalLawtoInvestigationalUse.

Methods:AllpatientstreatedwithDynesysstabilizationORPLFwithSilhouetteaspartofanongoingclinicalIDEstudywereincluded.Patients:substantialradicularpathologyduetosegmentalinstabilityorstenosinglesionsat1or2contiguouslumbarsegmentsbetween20and80yearssubstantiallegpainand/orresultantfunctionaldisabilityforgreaterthan3monthsassessedforanumberofexclusionfactors,anyofwhichwouldhaverenderedthemineligibleInadditiontodemographicsandsurgicaldetails,patientswereassessedforbackpain,legpain,iliaccrestpain(100mmVAS),dailyfunctionalstatus(Oswestry),generalhealth(SF-12),satisfaction(100mmVAS),recommendation(100mmVAS)andmedicationuse.CurrentIDEClinicalDataSamplesizeateachfollow-uppointasshownResultsincludebothrandomandnon-randomsurgeriesDynesysSurgeries923Weeks923Months716Months4312months50=Notsatisfiedatall100=Completelysatisfied0=Iwouldneverrecommendthissurgerytoanyone100=IwouldhighlyrecommendthissurgerytoanyoneProneorKnee-Chestpositionsareacceptableprovidedthatcareistakentopreservethenaturallordosisinthelumbarspine.Theuseoffluoroscopyisstronglyrecommendedforplacementofthepediclescrews.SurgicalProcedureOverview01二月2025ChristophLang,MarketingSpineandSupportSystemInsertallpediclescrews.Usethelargestandlongestpediclescrewspossible.01二月2025ChristophLang,MarketingSpineandSupportSystemTheDynesyspediclescrewsshouldbeplacedlateraltothefacetsleavingthefacetjointsintact.Determineappropriatespacerlength.CutUniversalSpacertothemeasuredlengthInsertthecordthroughthecaudalpediclescrewuptothemiddleofthefunctionalzonePushthecordthroughtheappropriatelysizedspacerandplacethespaceragainstpediclescrewheadPushthecordthroughthesecondpediclescrewheadUsetheCordTensioningInstrumenttopullthespacercarefullyintopositionIntroducethesecondsetscrewwithoutengagingitwiththecord.PlacetheCordTensioningInstrumentonthepediclescrewheadandtensionthesystem.Fixthecordatthecaudalendwiththe