ASTM F1378-2017 Standard Specification for Shoulder Prostheses《肩关节假体的标准规格》.pdf

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1、Designation: F1378 17Standard Specification forShoulder Prostheses1This standard is issued under the fixed designation F1378; 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 indica

2、tes the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers shoulder prostheses for total orhemiarthroplasty used to provide functioning articulation byemploying glenoid and humeral components.1.2

3、Devices for custom applications are not covered by thisspecification. Modular prostheses are included in this specifi-cation.1.3 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.4 This international standard was developed in ac

4、cor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 A

5、STM Standards:2F75 Specification for Cobalt-28 Chromium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)F86 Practice for Surface Preparation and Marking of Metal-lic Surgical ImplantsF90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical

6、Implant Applica-tions (UNS R30605)F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial)Alloy for SurgicalImplant Applications (UNS R56401)F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)

7、F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications (UNS R30035)F563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloyfor Surgical Implant Applications (UNS R30563) (With-drawn 2005)3F603 Specificati

8、on for High-Purity Dense Aluminum Oxidefor Medical ApplicationF648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF745 Specification for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant A

9、pplications (Withdrawn2012)3F746 Test Method for Pitting or Crevice Corrosion ofMetallic Surgical Implant MaterialsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF799 Specification for Cobalt-28Chromium-6MolybdenumAlloy Forgings for Surgical Implants (UNS R31537,

10、R31538, R31539)F981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Insertion into BoneF983 Practice for Permanent Marking of Orthopaedic Im-plant ComponentsF1044 Test Method for Shear Testing of Calcium PhosphateCoatin

11、gs and Metallic CoatingsF1108 Specification for Titanium-6Aluminum-4VanadiumAlloy Castings for Surgical Implants (UNS R56406)F1147 Test Method for Tension Testing of Calcium Phos-phate and Metallic CoatingsF1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UN

12、SR31537, UNS R31538, and UNS R31539)F1829 Test Method for Static Evaluation of Anatomic Gle-noid Locking Mechanism in ShearF2028 Test Methods for Dynamic Evaluation of GlenoidLoosening or Disassociation1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materia

13、ls and Devices and is the direct responsibility ofSubcommittee F04.22 on Arthroplasty.Current edition approved Dec. 1, 2017. Published January 2018. Originallyapproved in 1992. Last previous edition approved in 2012 as F1378 12. DOI:10.1520/F1378-17.2For referenced ASTM standards, visit the ASTM web

14、site, 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.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM Internationa

15、l, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides

16、and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.12.2 ANSI Standard:4ASME B46.119953. Terminology3.1 Anatomic Total Shoulder Replacement (TSR) Definitions3.1.1 anatomic total shoulder arthroplasty system,nshoulder implant system that has a concav

17、e glenoid com-ponent and a convex humeral component design.3.1.2 anatomic glenoid component, nthe concave pros-thetic portion that replaces, in part or in total, the glenoid fossaof the scapula and articulates with the natural humeral head ora prosthetic replacement.3.1.3 glenoid backing, nthe metal

18、lic or composite mate-rial prosthetic portion of a multi-piece anatomic glenoidcomponent that attaches to the scapula.3.1.4 glenoid liner, nthe polymeric prosthetic portion of amultiple-piece anatomic glenoid component that articulateswith the humeral head.3.2 Reverse TSR Definitions3.2.1 reverse to

19、tal shoulder arthroplasty system,nshoulder implant system that has a convex glenoid compo-nent and a concave humeral component design.3.2.2 reverse glenoid component, nthe convex prostheticportion that replaces the glenoid fossa of the scapula andarticulates with a concave prosthetic replacement of

20、the hu-meral head in reverse total shoulder arthroplasty applications.The reverse glenoid may consist of one or more componentsfrom one or more materials; most commonly, the reverseglenoid is composed of a metal glenosphere that is modularlyconnected to a metal glenoid baseplate which is fixed to th

21、eglenoid fossa.3.2.3 glenoid baseplate, nthe nonarticular portion of thereverse glenoid component that modularly connects to theglenosphere and is commonly fixed to the glenoid fossa of thescapula using bone screws without the use of cement.3.2.4 glenosphere, nthe convex prosthetic articular por-tio

22、n of the reverse glenoid component that articulates with theconcave prosthetic replacement of the proximal humerus orhumeral head (for example, the humeral liner).3.2.5 glenosphere thickness, nthe height of the truncatedsection of the sphere which composes the glenosphere. Notethat the difference be

23、tween the glenosphere articular radius andthickness defines the medial/lateral position of the glenoidcenter of rotation (see Fig. 1). The glenosphere thickness couldalso be affected by the geometric relationship between theglenosphere and the glenoid baseplate.3.2.6 humeral liner, nthe concave pros

24、thetic portion of thereverse humeral component that replaces the proximal humerusor humeral head and articulates with the convex prostheticreplacement of the glenoid (for example, the glenosphere).3.3 Definitions Common to Anatomic and Reverse TSRs3.3.1 collar, nflange at the junction of the humeral

25、 neckand stem.3.3.2 keel (or pegs), nsingle or multiple projections thatprovide resistance to translation or rotation of the glenoidcomponent, or both, by mating with cavities created in theglenoid fossa.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York

26、, NY 10036.FIG. 1 Glenosphere ThicknessF1378 1723.3.3 neck, nsegment connecting the head and the stem.3.3.4 glenoid plane, nin symmetrical anatomic glenoids,the glenoid plane is defined by joining the two articular edges;in planar and asymmetric anatomic glenoids, it is defined bythe back (medial) s

27、urface. For a reverse shoulder it is definedas the plane created by the face of the glenoid baseplate (seeFig. 2).3.3.4.1 DiscussionAlthough the glenoid fossa is not trulya planar structure, the terms plane of the glenoid and glenoidplane have both been used in the scientific literature to describet

28、he anatomic orientation of the glenoid.3.3.5 humeral head, nthe bearing member that articulateswith the glenoid.3.3.6 humeral component, nthe prosthetic portion thatreplaces, in part or in total, the proximal humerus or humeralhead and articulates with the natural glenoid fossa or aprosthetic replac

29、ement.3.3.7 humeral stem, nsegment intended for insertionwithin the humeral medullary canal.4. Classification4.1 ConstrainedA constrained joint prosthesis is used forjoint replacement and resists dislocation of the prosthesis inmore than one anatomical plane and consists of either a single,flexible,

30、 across-the-joint component or more than one compo-nent linked together or affined.4.2 Partially ConstrainedA semi-constrained joint pros-thesis is used for partial or total joint replacement and limitstranslation and rotation of the prosthesis in one or more planesvia the geometry of its articulati

31、ng surfaces. It has no across-the-joint linkages.4.3 UnconstrainedAn unconstrained joint prosthesis isused for partial or total joint replacement and restricts mini-mally prosthesis movement in one or more planes. Its compo-nents have no across-the-joint linkage.5. Materials and Manufacture5.1 The c

32、hoice of materials is understood to be a necessarybut not sufficient ensurance of function of the device madefrom them.All devices conforming to this specification shall befabricated from materials, with adequate mechanical strengthand durability, corrosion resistance, and biocompatibility.5.1.1 Mec

33、hanical StrengthVarious components of shoul-der prostheses have been successfully fabricated from thefollowing materials. However, not all of these materials maypossess sufficient mechanical strength for critical highly-stressed components. See Specifications F75, F90, F136, F138,F562, F563 (nonbear

34、ing use only), F603, F648, F745, F799,F1108, and F1537.5.1.2 Corrosion ResistanceMaterials with limited or nohistory of successful use for orthopedic implant applicationshall be determined to exhibit corrosion resistance equal to orbetter than one of the materials listed in 5.1.1 when tested inaccor

35、dance with Test Method F746.5.1.3 BiocompatibilityMaterials with limited or no historyof successful use for orthopedic implant application must bedetermined to exhibit acceptable biological response equal toor better than one of the materials listed in 5.1.1 when tested inaccordance with Practices F

36、748 and F981.6. Performance Requirements6.1 Wear of Alternative MaterialsIt is important to under-stand the wear performance for articulating surfaces. Any newor different material should not exceed the wear rates of thefollowing material couple when tested under physiologicalconditions. The current

37、 standard wear couple is CoCrMo alloy(Specification F75) against ultra high molecular weight poly-ethylene (Specification F648), both having prosthetic qualitysurface finishes in accordance with 8.2.NOTE 1In situations where the pin-on-flat test may not be consideredappropriate, other test methods m

38、ay be considered.6.2 Range of Motion of Shoulder Prosthesis Prior toImplantationFlexion shall be equal to or greater than 90.FIG. 2 Glenoid Plane and Force DirectionsF1378 173Abduction shall be equal to or greater than 90. Internalrotation shall be equal to or greater than 90. External rotationshall

39、 be equal to or greater than 45. Extension shall be equalto or greater than 45.6.3 Porous metal coatings shall be tested according to TestMethod F1044 (shear strength) and Test Method F1147 (tensilestrength).6.4 Guidelines for In-Vitro Laboratory Testing:6.4.1 Implant testing should reflect current

40、clinical failuresand potential failure modes particular to the implant. Thesetests may be directed towards subluxation, glenoid loosening,insert dissociation from a metal backing, and humeral headdissociation. To facilitate such testing, several references onshoulder forces have been compiled.5-7Bas

41、ed upon the workby Anglin et al5and Poppen et al,6the normal shoulder jointreaction forces are on the order of 1 to 2 times body weightwith the directions of loading being given in Figure 3 of thestudy by Anglin et al.5In the design of shoulder implants, thisbackground information of the forces and

42、their directions maybe helpful in determining worst-case shoulder joint forces.However, these joint reaction forces are based upon normalsubjects. In order to generate pass/fail criterion (that is, forces,angles, and number of cycles) for a particular shoulderprosthesis, one should take into conside

43、ration the anticipatedpatient population, the worst-case physiological loads andangles, an appropriate safety factor, and the potential forunsupported surfaces.6.4.2 All anatomic modular implants should be tested inaccordance with Test Method F1829.6.4.3 All prosthetic glenoid components shall be ca

44、pable ofwithstanding sustained static and dynamic physiological forcesof up to 1 times body weight (per 6.4.1) without compromiseof their function for the intended use and environment. Allimplants should be tested for loosening for a clinically relevantnumber of cycles. It has been suggested by Angl

45、in et al7that100 000 cycles is a suitable number of cycles. A larger numberof cycles may be required for worst-case situations. Onemethod for testing anatomic and reverse glenoid components isTest Method F2028.7. Dimensions7.1 Dimensions of anatomic shoulder joint replacementcomponents shall be as d

46、esignated in Figs. 3-5.8. Finish and Product Marking8.1 Items conforming to this specification shall be finishedand marked in accordance with Practice F86, where applicable.8.2 Articulating Surface Finishes:8.2.1 Metallic Bearing SurfaceThe main bearing surfaceshall have a surface finish no rougher

47、than 0.10 m roughnessaverage, Ra, with a cutoff length of 0.25 mm, when measuredaccording to the principles given in ASME B46.11995.8.2.2 Polymeric Bearing Surface (if used)The main bear-ing surface shall have a surface finish no rougher than 2 mroughness, Ra, with a cut-off length of 0.8 mm, when m

48、easuredaccording to the priniciples given in ASME B46.11995.8.3 In accordance with Practices F86 and F983, itemsconforming to this specification shall be marked as follows inorder of priority where space permits: manufacturer, material,lot number, catalog number, and size. Additional informationmay

49、include a designation for left or right and front.5Anglin, C., Wyss, U. P., Pichora, D. R., “Glenohumeral Contact Forces,”Proceedings of the Institution of Mechanical Engineers. Part HJournal ofEngineering in Medicine, 214 (6), 2000, pp. 637644.6Poppen, N. K., Walker, P.S., “Forces at the Glenohumeral Joint in Abduction,”Clinical Orthopaedics right or left, if applicable).8.4 If one of the components is not radiographically opaque,it is strongly encouraged that it shall contain a marker wire orother means of radiographic detection located a