Designation:F3037−15StandardGuideforClinicalTrialDesignforHipReplacementSystems(HRSs)1ThisstandardisissuedunderthefixeddesignationF3037;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisguideisintendedasaresourceforindividualsandorganizationsinvolvedindesigningclinicaltrialsofhipreplacementsystems(HRSs)includingmetal/polymer,metal/metal,metal/composite,metal/ceramic/polymer,metal/polymer/metal,andceramic/ceramicbearingsurfaces;semi-constrainedandconstraineddesigns;andcemented,nonporousuncemented,andporous-coateduncementedfixation.1.2Inthisguide,methodstomeasuretheefficacy,effectiveness,andsafetyofHRSdevicesthroughstandardizingoutcomesmeasuresareprovidedfordesigning,reviewing,andacceptinghumanclinicaltrialprotocols.1.3Thisguideisintendedtoprovideconsistencyinstudydesign,review,regulatoryapproval,andcoverageapprovalforhipreplacementsystemstothehealthcaremarket.1.4Forthepurposeofthisguide,anHRSisanydevicethatisintendedtoreplacethehipjoint,inpartorintotal,asatreatmentforjointdisease,trauma,ordysfunction,wherelong-termfunctionalrestorationandpainreliefwithoutmajoradverseeventsarethedesiredoutcomes.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2F561PracticeforRetrievalandAnalysisofMedicalDevices,andAssociatedTissuesandFluidsF2809TerminologyRelatingtoMedicalandSurgicalMate-rialsandDevicesF2978GuidetoOptimizeScanSequencesforClinicalDi-agnosticEvaluationofMetal-on-MetalHipArthroplastyDevicesusingMagneticResonanceImagingF2979GuideforCharacterizationofWearfromtheArticu-latingSurfacesinRetrievedMetal-on-MetalandotherHard-on-Har...
