动态固定和Dynesys系统回顾(中文)

动态固定和Dynesys系统回顾

一个暂新的概念在治疗下腰痛和腿痛方面，Dynesys系统是一个新个的概念，它将传统的融合方法与动态理念结合在一起，使用柔韧材料固定脊柱，同时保持脊柱的解剖结构。Overview动态固定DYNESYS

系统Dynesys系统是一个新的概念，其目的在于稳定受累关节保留大部分脊柱解剖结构解除疼痛以获得更好的结果=DynamicStabilizationOverviewDynesys

SystemMaterials绳索Sulene®-PET间隔杆Sulene®-PCU钛合金螺钉及固定螺帽(Protasul®-100OverviewDynesys

系统历史由法国医生G.Dubois设计1994年生产出第一个内置物对3个医疗中心的83例病人进行了前瞻性研究1999年投放欧洲市场全球应用已超过13,000例目前正在美国进行临床研究Overview预期的特性和优点稳定受累关节保留大部分脊柱解剖结构解除疼痛以获得更好的效果采用熟悉的后路方法，简化训练过程能够采取微创手术Overview生物力学检测的目的:证明该系统能够存在下去证明该系统有效合理的生物力学检测方法:检测每一个组件保证设计正确检测完整组件验证系统的正常功能体外构建系统证实结构能够Biomechanics生物力学椎弓根螺钉椎弓根螺经受100-800N之间的周期载荷，以评估螺钉的疲劳折断强度最小螺钉(5.2x35mm)能够耐受5百万次载荷周期BiomechanicsPET绳索能够耐受5百万次100-800N周期载荷绳索静态抗张强度接近3000N20小时拉伸延长原长度的1.27%没有发生断裂BiomechanicsPCU间隔杆室温条件下抗压强度为243N/mm体温条件下抗压强度为136N/mm.- 注意:脊柱后柱的抗压强度为400N/mm.

出处:WhiteandPanjabi:ClinicalBiomechanicsoftheSpine,2ndEdition,pp39,47.Biomechanics螺钉/绳索构造在固定螺帽理论扭距(4Nm)条件下，螺钉/绳索结构静态拔出力为1060N在固定螺帽理论扭距(4Nm)条件下，

螺钉/绳索组配能够耐受5百万次周期的100-800N拉力负荷，绳索没有发生移位Biomechanics螺钉/绳索/间隔杆结构系统能够耐受1千万次周期剪切位移(

5mm)或轴向旋转(

3)而没有出现绳索折断

1千万次周期剪切位移(

5mm)或轴向旋转(

3)后绳索的磨损并不明显Biomechanics检测结果:螺钉/绳索/间隔杆结构Biomechanics椎体切除模型Dynesys设计结构采用椎体切除模型，检测单间单节段结构轴向后伸、压迫(

1.5mm)和轴向旋转(3).结果显示结构应力弛豫:接近25%主要发生在头1百万周期内理论上发生变化在1-10百万周期之间

在轴向压迫检测中，after10millioncycles,theDynesyssystemmaintains525Ntension(includingthe300Npreload)and200Ncompression.Sources:ASTM:F1717-96,Standardtestmethodsforstaticandfatigueforspinal implantconstructsinacorpectomymodel.WhiteandPanjabi:ClinicalBiomechanicsoftheSpine,2ndEdition,pp47,106-107.Biomechanics结论螺钉和绳索有足够的静态和动态力学强度螺钉和绳索有足够强度的拉伸特性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