ASTM F1378-2005 Standard Specification for Shoulder Prosthesis《肩部修复术的标准规范》.pdf

1、Designation: F 1378 05Standard Specification forShoulder Prostheses1This standard is issued under the fixed designation F 1378; 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 indi

2、cates the year of last reapproval. Asuperscript epsilon (e) 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

3、.2 Devices for custom applications are not covered by thisspecification. Modular prostheses are included in this specifi-cation.1.3 The values stated in SI are to be regarded as thestandard. The inch-pound units given in parentheses are forinformation only.2. Referenced Documents2.1 ASTM Standards:2

4、F75 Specification for Cobalt-28Chromium-6MolybdenumAlloy 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-t

5、ions (UNS R30605)F 136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for SurgicalImplant Applications (UNS R56401)F 138 Specification for Wrought 18Chromium-14Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F 562 Specifi

6、cation for Wrought 35Cobalt-35Nickel-2Chromium-10Molybdenum Alloy for Surgical ImplantApplications (UNS R30035)F 563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5 Molybdenum-3.5Tungsten-5Iron Alloyfor Surgical Implant Applications (UNS R30563)F 603 Specification for High-Purity Dense Alum

7、inum Ox-ide for Surgical Implant ApplicationsF 648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF 745 Specification for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant ApplicationsF 74

8、6 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-6MolybdenumAlloy Forgings for Surgical Implants (UNS R31537,R31538, R31539)F 981 Practi

9、ce for Assessment of Compatibility of Bio-Materials (Non-Porous) for Surgical Implants with Respectto Effect of Materials on Muscle and BoneF 983 Practice for Permanent Marking of Orthopaedic Im-plant ComponentsF 1044 Test Method for Shear Testing of Calcium Phos-phate Coatings and Metallic Coatings

10、F 1108 Specification for Titanium-6Aluminum-4VanadiumAlloy Castings for Surgical Implants (UNS R56406)F 1147 Test Method for Tension Testing of Calcium Phos-phate and Metal CoatingsF 1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloy for Surgical Implants (UNS R31537,UNS R31538, and

11、UNS R31539)F 1829 Test Method for Static Evaluation of the GlenoidLocking Mechanism in ShearF 2028 Test Methods for the Dynamic Evaluation of Gle-noid Loosening or Dissociation2.2 ANSI Standard:3ASME B46.119953. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 collarflange at junc

12、tion of neck and stem.3.1.2 glenoid componentthe prosthetic portion that re-places, in part or in total, the glenoid fossa of the scapula andarticulates with the natural humeral head or a prostheticreplacement.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical

13、 Materials and Devices and is the direct responsibility ofSubcommittee F04.22 on Arthroplasty.Current edition approved Oct. 1, 2005. Published October 2005. Originallyapproved in 1992. Last previous edition approved in 2004 as F 1378 04.2For referenced ASTM standards, visit the ASTM website, www.ast

14、m.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 10036.1Copyright ASTM I

15、nternational, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.1.3 headbearing member for articulation with the gle-noid.3.1.4 humeral componentthe prosthetic portion that re-places, in part or in toto, the proximal humerus or humeral headand articulates with the

16、 natural glenoid fossa or a prostheticreplacement.3.1.5 keel, (or pegs)single or multiple projections thatprovide resistance to translation or rotation of the glenoidcomponent, or both, by mating with cavities created in theglenoid fossa.3.1.6 necksegment connecting the head and the stem.3.1.7 rever

17、se design shoulder implantsimplants that havea ball-shaped glenoid component and a concave humeraldesign.3.1.8 stemsegment intended for insertion within the hu-meral medullary canal.4. Classification4.1 ConstrainedA constrained joint prosthesis is used forjoint replacement and resists dislocation of

18、 the prosthesis inmore than one anatomical plane and consists of either a single,flexible, 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 limitstranslat

19、ion and rotation of the prosthesis in one or more planesvia the geometry of its articulating 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 plan

20、es. Its compo-nents have no across-the-joint linkage.5. Materials and Manufacture5.1 The choice 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 adequa

21、te mechanical strengthand durability, corrosion resistance, and biocompatibility.5.1.1 Mechanical StrengthVarious components of shoul-der prostheses have been successfully fabricated from thefollowing materials. However, not all of these materials maypossess sufficient mechanical strength for critic

22、al highly-stressed components. See Specifications F 75, F 90, F 136,F 138, F 562, F 563 (nonbearing use only), F 603, F 648,F 745, F 799, F 1108, and F 1537.5.1.2 Corrosion ResistanceMaterials with limited or nohistory of successful use for orthopedic implant applicationmust be determined to exhibit

23、 corrosion resistance equal to orbetter than one of the materials listed in 5.1.1 when tested inaccordance with Test Method F 746.5.1.3 BiocompatibilityMaterials with limited or no his-tory of successful use for orthopedic implant application mustbe determined to exhibit acceptable biological respon

24、se equalto or better than one of the materials listed in 5.1.1 when testedin accordance with Practices F 748 and F 981.6. Performance Requirements6.1 Wear of Alternative MaterialsIt is important to under-stand the wear performance for articulating surfaces. Any newor different material should not ex

25、ceed the wear rates of thefollowing material couple when tested under physiologicalconditions. The current standard wear couple is CoCrMo alloy(Specification F75) against ultra high molecular weight poly-ethylene (Specification F 648), both having prosthetic qualitysurface finishes according to 8.2.

26、NOTE 1In situations where the pin-on-flat test may not be consideredappropriate, other test methods may be considered.6.2 Range of Motion of Shoulder Prosthesis Prior toImplantationFlexion shall be equal to or greater than 90.Abduction shall be equal to or greater than 90. Internalrotation shall be

27、equal to or greater than 90. External rotationshall 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 F 1044 (shear strength) and Test Method F 1147(tensile strength).6.4 Guidelines for In-Vitro Laboratory

28、Testing:6.4.1 Implant testing should reflect current 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 r

29、eferences onshoulder forces have been compiled.4, 5, 6Based upon the workby Anglin et al4and Poppen et al,5the 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.4In the design of shoulde

30、r implants, thisbackground information of the forces and 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 pa

31、rticular shoulder pros-thesis, one should take into consideration the anticipatedpatient population, the worst-case physiological loads andangles, an appropriate safety factor, and the potential forunsupported surfaces.6.4.2 All modular implants should be tested in accordancewith Test Method F 1829.

32、6.4.3 All prosthetic glenoid components shall be capable 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 rele

33、vantnumber of cycles. It has been suggested by Anglin et al6that100 000 cycles is a suitable number of cycles. A larger number4Anglin, C., Wyss, U. P., Pichora, D. R., “Glenohumeral Contact Forces,”Proceedings of the Institution of Mechanical Engineers. Part HJournal ofEngineering in Medicine, 214 (

34、6), 2000, pp. 637644.5Poppen, 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 radiographic opaque, itis strongly encouraged that it shall contain a marker wire orother means of radiographic d

35、etection. It may be located at themanufacturers discretion.9. Labeling9.1 The dimensions shown in Figs. 1-3 shall be included inthe product labeling.9.2 The material(s) used for the implant shall be specifiedon the package labels and inserts.10. Keywords10.1 arthroplasty; glenoid; humeral; prosthese

36、s; hemi-shoulder replacement; total shoulder replacementNOTEA modular connection may be included in this device.FIG. 1 Humeral Collarless DesignF1378053APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 The objectives of this specification are the provisionof guidelines for the manufacture and use

37、of the componentsfor total shoulder replacement. Total shoulder replacementparts are intended for use in a patient who is skeletally mature,under conditions of imposed dynamic loads, in a corrosiveenvironment, and virtually continuous motion at the bearingsurfaces. Laboratory tests to accurately sim

38、ulate imposedloads, aggressive electrolytes, and complex constituents ofbody fluids have not been usefully accelerated at the presenttime for a complete joint evaluation. Long-term projections ofsatisfactory performance over many decades can be suggestedbut not accurately predicted using available s

39、creening proce-dures. This specification identifies those factors considered tobe important to assure a satisfactory useful prosthetic life. It ishere recognized that failure of an arthroplasty can occur, evenwhile the components are intact. This is true owing to theNOTEA modular connection may be i

40、ncluded in this device.FIG. 2 Humeral Collared DesignNOTE 1If the glenoid component is not symmetric about the trans-verse plane, a minimum and maximum component width shall bespecified.NOTE 2A modular connection may be included in this device.FIG. 3 Glenoid ComponentsF1378054composite nature of the

41、 arthroplasty procedure, which includesthe implant, cement if any, and the physiological environment.X1.2 Under applicable documents and materials, the listreflects the current state of the art. It is recognized that shouldmaterials not now included appear and be proved acceptable,they shall be inse

42、rted in the process of revision.X1.2.1 Performance ConsiderationsComponent perfor-mance should be considered with regard to patient anatomy. Itis well recognized that physical stresses resulting from eventsor activities out of the ordinary range, as in accidents orespecially vigorous sports, predict

43、ably exceed allowable stresslevels in any component design. It is also recognized here thatother forms of arthroplasty failure are known to occur, relatedprimarily to patient factors, such as osteoporosis, Pagetsdisease, misuse and disuse, and others.X1.2.1.1 No device specific wear test is specifie

44、d in thisspecification. It is felt that at this time wear is not a major issuein existing or potential implant designs, that presently there areno techniques available to do device specific wear tests and thatthis consideration is already partly covered in 6.1.X1.2.1.2 The range of motion parameters

45、 are specified asminimum values so that the implant itself does not restrictpatient shoulder motion and thus allow potential dislocation orloosing of the implant. Initially the minimum range of motionparameters were larger but they were decreased to those givenin 6.2.X1.2.2 DimensionsThe method of d

46、imensional measure-ment must be sought to conform with industry practice and,whenever possible, on an international basis.X1.2.3 Finish and MarkingsDimensions and tolerancesare as described by ANSI documents for sphericity, concen-tricity, and surface finish.X1.2.3.1 The manufacturers trademark must

47、 appear legiblyon each of the components. It is desirable to have completeinformation, where space is available to do so, including size,orientation if any, and catalog number with date.X1.3 This specification was revised in 2004 to includereverse design shoulder implants.ASTM International takes no

48、 position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. 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 respons

49、ibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed 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 theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known t