ASTM F2665-2009 Standard Specification for Total Ankle Replacement Prosthesis《全踝关节置换假体的标准规范》.pdf

1、Designation: F 2665 09Standard Specification forTotal Ankle Replacement Prosthesis1This standard is issued under the fixed designation F 2665; 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 p

2、arentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers total ankle replacement (TAR)prostheses used to provide functioning articulation by employ-ing talar and tibial componen

3、ts that allow for a minimum of15 of dorsiflexion and 15 to 25 (1)2of plantar flexion, asdetermined by non-clinical testing.1.2 Included within the scope of this specification are anklecomponents for primary and revision surgery with modular andnon-modular designs, bearing components with fixed or mo

4、bilebearing designs, and components for cemented and/or cement-less use.1.3 This specification is intended to provide basic descrip-tions of material and prosthesis geometry. In addition, thosecharacteristics determined to be important to in vivo perfor-mance of the prosthesis are defined.1.4 The va

5、lues stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.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 s

6、afety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:3F67 Specification for Unalloyed Titanium, for SurgicalImplant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700)F75 Specification for Cobalt-28 Chro

7、mium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)F86 Practice for Surface Preparation and Marking of Me-tallic Surgical ImplantsF90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions (UNS R30605)F 136 Specificati

8、on for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for SurgicalImplant Applications (UNS R56401)F 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F 451 Specification for Acrylic Bone CementF 562

9、 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications (UNS R30035)F 563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloyfor Surgical Implant Applications (UNS R30563)4F 565 Practice for Care and Handling

10、of Orthopedic Im-plants and InstrumentsF 648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF 732 Test Method for Wear Testing of Polymeric MaterialsUsed in Total Joint ProsthesesF 745 Specification for 18Chromium-12.5Nickel-2.5Molybdenum

11、 Stainless Steel for Cast and Solution-Annealed Surgical Implant ApplicationsF 746 Test Method for Pitting or Crevice Corrosion ofMetallic Surgical Implant MaterialsF 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and DevicesF 799 Specification for Cobalt-28Chromium-6Molyb

12、denumAlloy Forgings for Surgical Implants (UNS R31537,R31538, R31539)F 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF 983 Practice for Permanent Marking of Orthopaedic Im-plant ComponentsF 1044 Test Method fo

13、r Shear Testing of Calcium Phos-phate Coatings and Metallic CoatingsF 1108 Specification for Titanium-6Aluminum-4VanadiumAlloy Castings for Surgical Implants (UNS R56406)1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct

14、 responsibility ofSubcommittee F04.22 on Arthroplasty.Current edition approved Feb. 1, 2009. Published June 2009.2The boldface numbers in parentheses refer to a list of references at the end ofthis standard.3For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer

15、 Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.4Withdrawn. The last approved version of this historical standard is referencedon www.astm.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Bo

16、x C700, West Conshohocken, PA 19428-2959, United States.F 1147 Test Method for Tension Testing of Calcium Phos-phate and Metallic CoatingsF 1160 Test Method for Shear and Bending Fatigue Testingof Calcium Phosphate and Metallic Medical and Compos-ite Calcium Phosphate/Metallic CoatingsF 1223 Test Me

17、thod for Determination of Total Knee Re-placement ConstraintF 1377 Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants(UNS R30075)F 1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNSR56400)F 1537 Specificatio

18、n for Wrought Cobalt-28Chromium-6MolybdenumAlloys for Surgical Implants (UNS R31537,UNS R31538, and UNS R31539)F 1580 Specification for Titanium and Titanium-6Aluminum-4 Vanadium Alloy Powders for Coatings ofSurgical ImplantsF 1800 Test Method for Cyclic Fatigue Testing of MetalTibial Tray Component

19、s of Total Knee Joint ReplacementsF 1814 Guide for Evaluating Modular Hip and Knee JointComponents2.2 ISO Standards:5ISO 6474 Implants for SurgeryCeramic Materials Basedon AluminaISO 142432 Implants for SurgeryWear of Total Knee-Joint ProsthesesPart 2: Methods of Measurement2.3 FDA Document:621 CFR

20、888.6 Degree of Constraint21 CFR 888.3110 Ankle Joint Metal/Polymer Semi-Constrained Cemented Prostheses21 CFR 888.3120 Ankle Joint Metal/Polymer Non-Constrained Cemented Prostheses2.4 ANSI/ASME Standard:5ANSI/ASME B46.11995 Surface Texture (Surface Rough-ness, Waviness, and Lay)3. Terminology3.1 De

21、finitions of Terms Specific to This Standard:3.2 constraint, nthe relative inability of a TAR, inherentto its geometrical and material design, to be further displacedin a specific direction under a given set of loading conditions.3.3 dorsiflexion, nrotation of the tibial component to-wards the anter

22、ior talar surface.3.4 flexion, nrotation of the talar component relative tothe tibial component around the medial-lateral axis. Flexion isconsidered positive when it is dorsiflexion, and negative whenit is plantar flexion.3.5 interlock, nmechanical design feature used to increasecapture of one compo

23、nent within another and to restrictunwanted displacement between components, that is, compo-nent locking mechanism for modular components.3.6 plantar flexion, nrotation of the tibial componenttoward the posterior talar surface.3.7 talar component, nbearing member fixed to the talusfor articulation w

24、ith the tibial component. This could bemetallic or from some other suitably hard surface material.3.8 radiographic marker, na nonstructural wire or beaddesigned to be apparent on X-rays taken after implantation forthose components that would otherwise not be apparent onsuch X-rays.3.9 subluxation, n

25、instability or partial dislocation whichoccurs when the relative translational or rotational motionbetween the talar and tibial components reaches an extremewhere the two components would cease to articulate over thedesignated low friction bearing surfaces.3.10 tibial component, nfixed or mobile bea

26、ring memberattached to the tibia for articulation with the talar component,typically consisting of two major components, a metallic tibialtray and a UHMWPE (see Specification F 648) bearing sur-face.3.11 total ankle replacement (TAR), nprosthetic parts thatsubstitute for the natural opposing tibial

27、and talar articulatingsurfaces.3.12 IE rotation, nrotation of the tibial component rela-tive to the talar component around the tibial axis. IE rotation isconsidered positive when the tibial component rotates inter-nally (clockwise when viewed proximally on the left ankle). IErotation is considered n

28、egative when the tibial componentrotates externally.4. Classification4.1 The following classification by degree of constraint issuggested for all total joint prostheses including total anklereplacement systems based on the concepts adopted by the U.S.Food and Drug Administration (see 21 CFR 888.6).4

29、.1.1 ConstrainedA constrained joint prosthesis preventsdislocation of the prosthesis in more than one anatomic planeand consists of either a single, flexible, across the-jointcomponent or more than one component linked together oraffined.4.1.2 Semi-constrainedA semi-constrained joint prosthe-sis lim

30、its translation or rotation, or both to translation androtation, of the prosthesis in one or more planes via thegeometry of its articulating surfaces. Its components have noacross-the-joint linkages.4.1.3 Non-constrainedA non-constrained joint prosthesisminimally restricts prosthesis movement in one

31、 or more planes.Its components have no across-the-joint linkages.4.2 Currently, most ankle designs are considered eithersemi-constrained or non-constrained. Most mobile bearingankle components are considered non-constrained. The USgovernment 21 CFR 888.3110 identifies ankle joint metal/polymer semi-

32、constrained cemented prosthesis and21 CFR 888.3120 identifies ankle joint metal/polymer non-constrained cemented prosthesis.5. Material5.1 All devices conforming to this specification shall befabricated from materials with adequate mechanical strength,durability, corrosion resistance, and biocompati

33、bility.5Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.6Available from Food and Drug Administration (FDA), 5600 Fishers Ln.,Rockville, MD 20857, http:/www.fda.gov.F2665092NOTE 1The choice of materials is understood to be

34、a necessary butnot totally sufficient assurance of proper function of the device made fromthem.5.1.1 Mechanical StrengthVarious metallic componentsof total ankle replacement devices have been successfullyfabricated from materials, as examples, found in SpecificationsF75, F90, F 136, F 138, F 562, F

35、563, F 745, F 799, F 1108,F 1377, F 1472, F 1537, and F 1580. Polymeric bearing com-ponents have been fabricated from UHMWPE, as an example,as specified in Specification F 648. Porous coatings have beenfabricated from example materials specified in SpecificationsF67and F75. Not all of these material

36、s may possess sufficientmechanical strength for critical, highly stressed components orfor articulating surfaces. Conformance of a selected material toits standard and successful clinical usage of the material in aprevious implant design are not sufficient to ensure the strengthof an implant. Manufa

37、cturing processes and implant design canstrongly influence the devices performance characteristics.Therefore, regardless of the material selected, the ankle im-plant must meet the performance requirements of Section 6.5.1.2 Corrosion ResistanceMaterials with limited or nohistory of successful use fo

38、r orthopaedic implant applicationshall exhibit corrosion resistance equal to or better than one ofthe materials listed in 5.1.1 when tested in accordance withTest Method F 746.5.1.3 BiocompatibilityMaterials with limited or no his-tory of successful use for orthopaedic implant application shallexhib

39、it acceptable biological response equal to or better thanone of the materials listed in 5.1.1 when tested in accordancewith Practices F 748 and F 981 for a given application.6. Performance Requirements6.1 Component FunctionEach component for total anklearthroplasty is expected to function as intende

40、d when manu-factured in accordance with good manufacturing practices andto the requirements of this specification. The components shallbe capable of withstanding static and dynamic physiologicloads (1) without compromising their function for the intendeduse and environment. All components used for e

41、xperimentalmeasures of performance shall be equivalent to the finishedproduct in form and material. Components shall be sterilized ifthe sterilization process will affect their performance.NOTE 2Computer models may be used to evaluate many of thefunctional characteristics if appropriate material pro

42、perties and functionalconstraints are included and the computer models have been validatedwith experimental tests.6.1.1 Individual tibial (that is, tibial tray and bearing surfacecomponents) and talar components should be fatigue testedusing relevant or analogous test methods under appropriateloadin

43、g conditions (that is, should consider worst-case sce-narios) to address loss of supporting foundation leading topotential deformation and/or component fracture.6.1.1.1 Tibial tray components may be evaluated in amanner similar to Test Method F 1800, with a loading momentvalue chosen to compare with

44、 a clinically successful implant,or justified in other suitable ways for the design being tested)(3). In choosing the loading moment, both the moment arm andthe load used shall be specified with explanation as to how andwhy they were chosen. Each of five specimens shall be testedfor 10 million cycle

45、s with no failure. All tibial componentsdesignated by this specification shall pass this minimumrequirement.6.1.1.2 Tibial bearing surface components shall be fatiguetested considering worst-case scenarios to demonstrate that thecomponent is able to withstand anticipated physiologicalloading conditi

46、ons and is not susceptible to the failure modesthat have been reported in the literature (4-6). The worst casescenarios should take into consideration loads, componentsizes, thickness of plastic bearing insert, bony support, lockingmechanism, edge loading, misalignments and how these canaffect the i

47、ndividual design.6.1.2 Contact area and contact pressure distributions may bedetermined at various flexion angles using one of severalpublished methods (7-12) to provide a representation ofstresses applied to the bearing surfaces and to the components.Flexion angles of 0, 610, and 615 are recommende

48、d. If theprosthesis is designed to function at higher angles of eitherdorsiflexion or plantar flexion, then it is recommended thatthese measurements be continued at 5 increments to the fullrange of motion. If these tests are performed, it is important tomaintain consistent test parameters and to eva

49、luate other TARprostheses under the same conditions.6.1.3 Range of motion in dorsiflexion and plantar flexionshall be greater than or equal to 15 (each) required for walking(13-15). These measurements apply to components mounted inneutral alignment in bone or in an anatomically representativesubstitute. It is critical to define the location of the neutralalignment position, for example, center of contact areas orpatches, in terms of dimensions from outside edges of thecomponents. The initial positioning or location of the neutralalignment point will aff