ASTM F1814-2015 Standard Guide for Evaluating Modular Hip and Knee Joint Components《评估髋部和膝关节部件模数的标准指南》.pdf

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1、Designation: F1814 15Standard Guide forEvaluating Modular Hip and Knee Joint Components1This standard is issued under the fixed designation F1814; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number

2、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 covers a procedure to assist the developer ofa modular joint replacement implant in the choice of appropri-ate tests and evaluation

3、s to determine device safety.1.2 This guide does not attempt to define all test methodsassociated with modular device evaluation.1.3 This guide does not cover intentional intraoperativedisassembly but is meant only to suggest testing necessary todetermine inadvertent disassembly loads.1.4 This stand

4、ard 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 AS

5、TM Standards:2F648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF897 Test Method for Measuring Fretting Corrosion ofOsteosynthesis Plates and ScrewsF1800 Practice for Cyclic Fatigue Testing of Metal TibialTray Components of Total Knee J

6、oint ReplacementsF1875 Practice for Fretting Corrosion Testing of ModularImplant Interfaces: Hip Femoral Head-Bore and ConeTaper Interface2.2 ISO Standard:3ISO 7206-4:2010 Implants for surgery Partial and total hipjoint prostheses Part 4: Determination of enduranceproperties and performance of stemm

7、ed femoral compo-nentsISO 7206-6:2013 Implants for surgery Partial and total hipjoint prostheses Part 6: Endurance properties testing andperformance requirements of neck region of stemmedfemoral componentsISO 7206-10 Implants for surgery Partial and total hip-joint prostheses Part 10: Determination

8、of resistance tostatic load of modular femoral heads3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 modular femoral hip implantany device that isconstructed of two or more mating parts intended for implan-tation into the femur for the purpose of replacing the femoralhip joint.

9、3.1.1.1 bolts/screwsa fastener used to secure modularpieces of a femoral or tibial component.3.1.1.2 bullets/distal sleevesmodular accessories for in-creasing the length or distal diameter of the femoral compo-nent.3.1.1.3 collarmedial platform located immediately distalto the femoral neck.3.1.1.4 f

10、emoral heada modular bearing, spherical inshape, that mates with the femoral component.3.1.1.5 neck extensionan intermediate modular couplebetween the femoral component and the femoral head. Attach-ments (for example, threads and tapers) can vary.3.1.1.6 proximal sleeves/padsmodular accessories forv

11、arying the geometry of the femoral component in the meta-physeal area.3.1.2 modular knee implantany device that is constructedof two or more mating parts intended for implantation into thefemur or tibia for the purpose of replacing the knee joint.3.1.2.1 metal-backed patellaa modular patellar replac

12、e-ment consisting of an articular piece which is secured to ametal backing by means of a locking mechanism.3.1.2.2 metal tibial traya metal component secured to theproximal tibia which provides mechanical support to andcouples directly with the modular tibial inserts.3.1.2.3 stem extension or sleeve

13、modular extension toeither a knee-femoral or knee-tibial component which extendsinto the medullary canal. A stem extension may be attached to1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.22

14、 on Arthroplasty.Current edition approved Oct. 15, 2015. Published December 2015. Originallyapproved in 1997. Last previous edition approved in 2009 as F1814 97a(2009).DOI: 10.1520/F1814-15.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at servi

15、ceastm.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.Copyright ASTM International, 100 Barr Harbo

16、r Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1the femoral or tibial component by a variety of meansincluding a taper, screw, etc.3.1.2.4 tibial inserta modular bearing member of a tibialcomponent, usually made in accordance with SpecificationF648, that is secured to a knee ti

17、bial tray by means of a lockingmechanism.3.1.2.5 wedgea modular addition to a total knee replace-ment that serves the function of filling voids left by deficient orabsent bone stock.4. Significance and Use4.1 The tests suggested within this guide cover manydifferent, but not all possible, areas of r

18、esearch and concernwith regard to modular hip stems and modular knee compo-nents.4.2 Due to the unlimited possible modular designs, thisguide should be utilized as a guide for what should beconsidered with regard to device safety testing. There may becircumstances where alternative test methods may

19、be useful. Itis still the responsibility of the investigator to address all safetyconcerns that are inherent to individual modular designs.4.3 The tests suggested herein should be utilized in such away that the results reflect the effects of modularity, if any.4.4 Tests that are checked in Table 1 o

20、r Table 2 or indicatedin this guide as a possible test to consider may not beapplicable to every implant design.5. Testing5.1 AssemblyStatic assembly parameters should be evalu-ated to determine the minimum required loads (axial ortorsional) that ensure adequate assembly strengths. This testingcan b

21、e performed in conjunction with 5.2, Disassembly,toascertain how various assembly loads affect disassembly.5.1.1 Axial Engagement ForceThe force required to con-nect the components (for example, to engage a tapered con-nection). Consider the following:5.1.1.1 The procedure for applying the engagemen

22、t force(clinical relevance), and5.1.1.2 The environment in which the components areconnected (contamination).5.1.2 TorsionalThe torque required to connect the com-ponents (for example, bolt or screw). This may only beapplicable for threaded connections. Consider the following:5.1.2.1 The procedure f

23、or applying the torsional force (clini-cal relevance).5.2 DisassemblyStatic disassembly parameters should beevaluated to assess minimum design requirements for prevent-ing unintentional in vivo disassembly.5.2.1 AxialThe axial force required to disassemble matingcomponents (for example, the force re

24、quired to disassociate atapered junction).5.2.2 ShearThe shear force required to disassemble mat-ing components (for example, the force required to shear awedge from a tray).5.2.3 BendingThe possibility of static disassociation un-der combined loading. Consider the following:5.2.3.1 Reporting a load

25、-versus-deflection curve.5.2.4 TorsionThe torque required to disconnect the com-ponents (for example, bolt or screw). This may only beapplicable for threaded connections.5.3 Cyclic Fatigue PropertiesThe nature of in vivo load-ing generates the need for cyclic fatigue evaluation. Testsshould be desig

26、ned to examine pre-cycle and post-cycleproperties to gain an understanding of how the designwithstands, and is affected by, cyclic loading.5.3.1 FractureThe possibility of fracture of either amodular construct or the connections under fatigue loading.Consider the following:5.3.1.1 Loading that repre

27、sents that applied to the compo-nent in vivo;5.3.1.2 An P-N curve to determine the load levels at whichthe construct can withstand cyclic loading without fracture; and5.3.1.3 Test Methods F1800, and ISO 7206-4,-6, and -10.5.3.2 DisassemblyThe possibility of disassembly of themodular components under

28、 fatigue loading. Consider thefollowing:5.3.2.1 Loading that represents that applied to the compo-nent in vivo, and5.3.2.2 Measuring the disassembly force after fatigue load-ing and comparing it to static values.5.3.3 SterilizationThe effects of sterilization on the fa-tigue integrity of the modular

29、 connection. Sterilization maycause material changes which could affect the performance ofthe modular connection. Sterilization should be performedaccording to the manufacturers specifications. Consider thefollowing:5.3.3.1 The effect of sterilization of plastic components.5.3.4 CorrosionThe environ

30、ment in which the modularconnection will be used may affect the ability of the connectionto resist disassociation or fracture. Consider the following:5.3.4.1 Corrosion of similar metal connections,5.3.4.2 Corrosion of dissimilar metal connections,5.3.4.3 The fluid environment,5.3.4.4 The temperature

31、,5.3.4.5 The frequency of cyclic loading,5.3.4.6 The dwell period, if any, used in the loading profile,and5.3.4.7 See Test Method F897.5.3.5 FrettingMicromotion between two components of amodular connection may produce adverse effects (that is, weardebris, increased risk for disassociation). Conside

32、r the follow-ing:5.3.5.1 Fretting of taper junctions5.3.5.2 Fretting of mating, non-articulating surfaces5.3.5.3 Environmental test, and5.3.5.4 See Practice F1875 and Test Method F897.6. Keywords6.1 arthroplasty; disassembly; hip arthroplasty; knee arthro-plasty; modular; orthopaedic medical devices

33、F1814 152TABLE1TotalHipImplantsNOTE1Thisguideisintendedtoaddressmodularconnectionsofafemoralhipsystem.Thetablebelowincludesthemajorityofmodulardevicesutilizedtoday.Thetableisnotallinclusive.Modularattachmentsnotaddressedinthisguideshouldbeevaluatedattheusersdiscretion.ASSEMBLYDISASSEMBLYCYCLICFATIGU

34、EPROPERTIESAxialTorsionalAxialShearBendingTorsionalFatigueDisassemblyPost-fatigueEffectsofSterilizationCorrosionFrettingProximalModularityFemoralHeadsXXXXXXXNeckExtensionsXXXXXXXCollarsXXXXXXXXBoltsXXXXXXXXMid-BodyModularitySleevesXXXXXXXXXXXPadsXXXXXXXXXXXDistalModularityBulletsXXXXXXXXXXSleevesXXX

35、XXXXXXXTotalImplantXXXF1814 153TABLE2TotalKneeImplantNOTE1Thisguideisintendedtoaddressmodularconnectionsofatotalkneesystem.Thetablebelowincludesthemajorityofmodulardevicesutilizedtoday.Thetableisnotallinclusive.Modularattachmentsnotaddressedinthisguideshouldbeevaluatedattheusersdiscretion.ASSEMBLYDI

36、SASSEMBLYCYCLICFATIGUEPROPERTIESAxialTorsionalAxialShearBendingTorsionalFailureDisassemblySterilizationCorrosionFrettingStemExtensionsXXXXXXXXXXWedgeXXXXXModulartibialinsert(cruciateretaining)XXXXXModulartibialinsert(posteriorstabilized)orsemi-constrainedXXXXXXXMetal-backedpatellaXXXXXXTotalImplantX

37、XXXXF1814 154APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 This guide is intended to be used to direct the reader tosome of the most common areas of concern for modular hipand knee prosthetic implants. For each area of concern, there isa checklist of possible junctions to evaluate with appropr

38、iatetopics to consider for each test. This guide is not intended to beall inclusive of the potential areas of concern or tests that canbe performed for modular implants but is meant to cover someof the more common topics of modular implants. It is felt thatthis document will be particularly useful t

39、o novice investiga-tors in directing their efforts in the investigation of the safetyand efficacy of a modular hip or knee implant, or both.X1.2 Assembly and disassembly may be useful to theinvestigator in determining the strength of a modular connec-tion. The strength of the modular connection may

40、be deter-mined as a ratio of disassembly force to assembly force. Thisnumber may also provide information as to the strength of themodular connection over time.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this stan

41、dard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be revie

42、wed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsibl

43、e technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Con

44、shohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 155