動態(tài)固定和Dynesys系統(tǒng)回顧(中文)

動態(tài)固定和Dynesys系統(tǒng)回顧

一個暫新的概念在治療下腰痛和腿痛方面，Dynesys系統(tǒng)是一個新個的概念，它將傳統(tǒng)的融合方法與動態(tài)理念結合在一起，使用柔韌材料固定脊柱，同時保持脊柱的解剖結構。Overview動態(tài)固定DYNESYS

系統(tǒng)Dynesys系統(tǒng)是一個新的概念，其目的在于穩(wěn)定受累關節(jié)保留大部分脊柱解剖結構解除疼痛以獲得更好的結果=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設計1994年生產(chǎn)出第一個內(nèi)置物對3個醫(yī)療中心的83例病人進行了前瞻性研究1999年投放歐洲市場全球應用已超過13,000例目前正在美國進行臨床研究Overview預期的特性和優(yōu)點穩(wěn)定受累關節(jié)保留大部分脊柱解剖結構解除疼痛以獲得更好的效果采用熟悉的后路方法，簡化訓練過程能夠采取微創(chuàng)手術Overview生物力學檢測的目的: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檢測方法:檢測每一個組件保證設計正確檢測完整組件驗證系統(tǒng)的正常功能體外構建系統(tǒng)證實結構能夠Biomechanics生物力學椎弓根螺釘椎弓根螺經(jīng)受100-800N之間的周期載荷，以評估螺釘?shù)钠谡蹟鄰姸茸钚÷葆?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)抗張強度接近3000N20小時拉伸延長原長度的1.27%沒有發(fā)生斷裂BiomechanicsPCU間隔桿室溫條件下抗壓強度為243N/mm體溫條件下抗壓強度為136N/mm.- 注意:脊柱后柱的抗壓強度為400N/mm.

出處:WhiteandPanjabi:ClinicalBiomechanicsoftheSpine,2ndEdition,pp39,47.Biomechanics螺釘/繩索構造在固定螺帽理論扭距(4Nm)條件下，螺釘/繩索結構靜態(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拉力負荷，繩索沒有發(fā)生移位Biomechanics螺釘/繩索/間隔桿結構系統(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檢測結果:螺釘/繩索/間隔桿結構Biomechanics椎體切除模型Dynesys設計結構采用椎體切除模型，檢測單間單節(jié)段結構軸向后伸、壓迫(

1.5mm)和軸向旋轉(zhuǎn)(3).結果顯示結構應力弛豫: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

在軸向壓迫檢測中，after10millioncycles,theDynesyssystemmaintains525Ntension(includingthe300Npreload)and200Ncompression.Sources:ASTM:F1717-96,Standardtestmethodsforstaticandfatigueforspinal implantconstructsinacorpectomymodel.WhiteandPanjabi:ClinicalBiomechanicsoftheSpine,2ndEdition,pp47,106-107.Biomechanics結論螺釘和繩索有足夠的靜態(tài)和動態(tài)力學強度螺釘和繩索有足夠強度的拉伸特性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