ASTM_F_3037_-_15.pdf

Designation:F303715Standard Guide forClinical Trial Design for Hip Replacement Systems(HRSs)1This standard is issued under the fixed designation F3037;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide is intended as a resource for individuals andorganizations involved in designing clinical trials of hipreplacement systems(HRSs)including metal/polymer,metal/metal,metal/composite,metal/ceramic/polymer,metal/polymer/metal,and ceramic/ceramic bearing surfaces;semi-constrained and constrained designs;and cemented,nonporousuncemented,and porous-coated uncemented fixation.1.2 In this guide,methods to measure the efficacy,effectiveness,and safety of HRS devices through standardizingoutcomes measures are provided for designing,reviewing,andaccepting human clinical trial protocols.1.3 This guide is intended to provide consistency in studydesign,review,regulatory approval,and coverage approval forhip replacement systems to the health care market.1.4 For the purpose of this guide,an HRS is any device thatis intended to replace the hip joint,in part or in total,as atreatment for joint disease,trauma,or dysfunction,wherelong-term functional restoration and pain relief without majoradverse events are the desired outcomes.1.5 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2F561 Practice for Retrieval and Analysis of MedicalDevices,and Associated Tissues and FluidsF2809 Terminology Relating to Medical and Surgical Mate-rials and DevicesF2978 Guide to Optimize Scan Sequences for Clinical Di-agnostic Evaluation of Metal-on-Metal Hip ArthroplastyDevices using Magnetic Resonance ImagingF2979 Guide for Characterization of Wear from the Articu-lating Surfaces in Retrieved Metal-on-Metal and otherHard-on-Hard Hip Prostheses2.2 ISO Standards3ISO 12891-1 Retrieval and analysis of surgical implants Part1:Retrieval and handlingISO 12891-2 Retrieval and analysis of surgical implants Part 2:Analysis of retrieved surgical implantsISO 14155 Clinical investigation of medical devices forhuman subjects Good clinical practiceISO 14971 Medical devices Application of risk manage-ment to medical devices3.Terminology3.1 Unless provided in 3.2.1 3.2.5,definitions shall be inconformance with Terminology F2809.3.2 Definitions:3.2.1 coverage,ninsurance decision to reimburse for adevice and/or procedure.3.2.2 effectiveness,nextent to which medical interven-tions achieve health improvements in real practice settings.3.2.3 effcacy,nextent to which medical interventionsachieve health improvements under ideal circumstances.3.2.4 level of evidencestrength of clinical evidence forevidence-based medicine(1)4.3.2.5 safetythe condition of being protected from orunlikely to cause risk or injury.See Appendix X1 for atabulated list of adverse events reported for hip replacementsystems(2).3.3 Acronyms:AJRRAmerican Joint Replacement RegistryASAAmerican Society of AnesthesiologistsDVTDeep Vein ThrombosisEQ-5DEuropean Quality of Life 5 DomainsFDAFood and Drug AdministrationHHSHarris Hip Score1This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.39 on Human Clinical Trials.Current edition approved June 1,2015.Published August 2015.DOI:10.1520/F3037-15.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.4The boldface numbers in parentheses refer to a list of references at the end ofthis standard.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 HOOSHip dysfunction and Osteoarthritis OutcomeScoreHRQLHealth-related quality of lifeHRSHip Replacement SystemICDInternational Classification of DiseasesLEASLower Extremity Activity ScaleMCIDMinimal clinically important differenceMRIMagnetic Resonance ImagingOHSOxford Hip ScorePROPatient-reported outcomePROMISPatient-Reported Outcomes MeasurementInformation SystemQALYQuality adjusted life yearRSARadiostereometric analysisSAESerious adverse eventSF-36Short Form(36 questions)SF-12Short Form(12 questions)SF-6DShort Form(6 dimensions)THATotal hip arthroplastyTUGTimed up and goUCLAUniversity of California at Los AngelesUTIUrinary tract infection