ASTM F1223-2008 整个膝部复位固定情况测定的标准试验方法

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【英文标准名称】:StandardTestMethodforDeterminationofTotalKneeReplacementConstraint
【原文标准名称】:整个膝部复位固定情况测定的标准试验方法
【标准号】:ASTMF1223-2008
【标准状态】:现行
【国别】:美国
【发布日期】:2008
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:F04.22
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:arthroplasty;constraint;joint;laxity;prosthesis;totalkneereplacement;AP(anterior-posterior)drawtest;Condylardesign;Constraint;Dataanalysis--medicalapplications;Distractiontest;Jointprostheses;Kneereplacementprosthesis;ML(med
【摘要】:Thistestmethod,whenappliedtoavailableproductsandproposedprototypes,ismeanttoprovideadatabaseofproductfunctionalitycapabilities(inlightofthesuggestedtestregimens)thatishopedtoaidthephysicianinmakingamoreinformedtotalkneereplacement(TKR)selection.ApropermatchingofTKRfunctionalrestorativecapabilitiesandtherecipient''s(patient''s)needsismorelikelyprovidedforbyarationaltestingprotocoloftheimplantinanefforttorevealcertaindevicecharacteristicspertinenttotheselectionprocess.TheTKRproductdesignsarevariedandofferawiderangeofconstraint(stability).TheconstraintoftheTKRintheinvitroconditiondependsonseveralgeometricalandkinematicinteractionsamongtheimplant''scomponentswhichcanbeidentifiedandquantified.ThedegreeofTKR''skinematicinteractionsshouldcorrespondtotherecipient''sneedsasdeterminedbythephysicianduringclinicalexamination.Formobilebearingkneesystems,theconstraintoftheentireimplantconstructshallbecharacterized.Constraintofmobilebearingsisdictatedbydesignfeaturesatboththeinferiorandsuperiorarticulatinginterfaces.Themethodology,utility,andlimitationsofconstraint/laxitytestingarediscussed.Theauthorsrecognizethatevaluatingisolatedimplants(thatis,withoutsofttissues)doesnotdirectlypredictinvivobehavior,butwillallowcomparisonsamongdesigns.Constrainttestingisalsousefulforcharacterizingimplantperformanceatextremerangesofmotionwhichmaybeencounteredin-vivoatvaryingfrequencies,dependingonthepatientx2019;sanatomy,pre-operativecapability,andpost-operativeactivitiesandlifestyle.1.1Thistestmethodcoverstheestablishmentofadatabaseoftotalkneereplacement(TKR)motioncharacteristicswiththeintentofdevelopingguidelinesfortheassignmentofconstraintcriteriatoTKRdesigns.(SeetheRationaleinAppendixX1.)1.2ThistestmethodcoversthemeansbywhichaTKRconstraintmaybequantifiedaccordingtomotiondelineatedbytheinherentarticulardesignasdeterminedunderspecificloadingconditionsinaninvitroenvironment.1.3Testsdeemedapplicabletotheconstraintdeterminationareantero-posteriordraw,medio-lateralshear,rotarylaxity,valgus-varusrotation,anddistraction,asapplicable.Alsocoveredistheidentificationofgeometricalparametersofthecontactingsurfaceswhichwouldinfluencethismotionandthemeansofreportingthetestresults.(SeePracticesE4.)1.4Thistestmethodisnotaweartest.1.5ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:9P.;A4
【正文语种】:英语