1、Designation: F1829 17Standard Test Method forStatic Evaluation of Anatomic Glenoid Locking Mechanismin Shear1This standard is issued under the fixed designation F1829; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of las
2、t 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 test method covers a method for determining thestatic shear disassembly force of modular anatomic glenoidcomponents
3、used in anatomic total shoulder arthroplasty pros-theses.1.2 Although the methodology described does not replicateall physiological force conditions, it is a means of in vitrocomparison of modular anatomic glenoid component designsand the strength of the retention mechanism between thearticular inse
4、rt and glenoid backing under the stated testconditions.1.3 This test method covers modular glenoid componentscomprised of a separate articular insert and backing. The insertand backing can be fabricated from any combination of thefollowing materials: metal alloys, polymeric materials, com-posite mat
5、erials.1.4 The values 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 establi
6、sh appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.1.6 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment
7、 of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2E4 Practices for Force Verification of Testing MachinesF1378 Specification for Shoulder ProsthesesF2028 Test Methods f
8、or Dynamic Evaluation of GlenoidLoosening or Disassociation3. Terminology3.1 Anatomic Total Shoulder Replacement (TSR) Definitions3.1.1 anatomic total shoulder arthroplasty system,nshoulder implant system that has a concave glenoid com-ponent and a convex humeral component design.3.1.2 anatomic glen
9、oid 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 metallic or composite mate-rial prosthetic portion of a multi-piece anatomic glenoi
10、dcomponent 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 Additional Definitions3.2.1 collar, nflange at the junction of the humeral neckand stem.3.2.2 keel, (or pegs), nsingl
11、e or multiple projections thatprovide resistance to translation or rotation of the glenoidcomponent, or both, by mating with cavities created in theglenoid fossa.3.2.3 neck, nsegment connecting the head and the stem.3.2.4 glenoid plane, nin symmetrical anatomic glenoids,the glenoid plane is defined
12、by joining the two articular edges;1This test method is under the jurisdiction of ASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.22 on Arthroplasty.Current edition approved Dec. 1, 2017. Published January 2018. Originallyapproved i
13、n 1997. Last previous edition approved in 2016 as F1829 16. DOI:10.1520/F1829-17.2For 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
14、 onthe ASTM website.Copyright ASTM International, 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 the
15、Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.1in planar and asymmetric anatomic glenoids, it is defined bythe back (medial) surface.3.2.4.1 DiscussionAlthough the glenoid fossa is not trulya plan
16、ar structure, the terms plane of the glenoid and glenoidplane have both been used in the scientific literature to describethe anatomic orientation of the glenoid.3.2.5 humeral head, nthe bearing member that articulateswith the glenoid.3.2.6 humeral component, nthe prosthetic portion thatreplaces, in
17、 part or in total, the proximal humerus or humeralhead and articulates with the natural glenoid fossa or aprosthetic replacement.3.2.7 humeral stem, nsegment intended for insertionwithin the humeral medullary canal.3.3 Definitions of Terms Specific to This Standard:3.3.1 “d”, noffset distance from t
18、he edge of the glenoidbacking locking mechanism to the centerline of the point offorce application on the articular insert as shown in Fig. 1 andFig. 2.4. Significance and Use4.1 This test method can be used to describe the effects ofmaterials, manufacturing, and design variables on the perfor-mance
19、 of metal or composite-backed anatomic glenoid pros-theses locking mechanisms to resist static shear loading.4.2 The glenoid component is used in shoulder replace-ments and should conform to the criteria specified in Specifi-cation F1378.4.3 The loading of metal or composite-backed anatomicglenoid p
20、rostheses in vivo will, in general, differ from theloading defined in this test method. The results obtained herecannot be used to directly predict in vivo performance.However, this test method is designed to allow for comparisonsbetween different metal or composite-backed anatomic glenoidlocking me
21、chanism designs, when tested under similar circum-stances.4.4 This test method may not be appropriate for all types ofimplant applications. The user is cautioned to consider theappropriateness of the method in view of the materials beingtested and their potential application.4.5 In order for the tes
22、t data on metal or composite-backedanatomic glenoid components to be comparable, reproducible,and capable of being correlated among laboratories, it isessential that uniform procedures be established.5. Apparatus5.1 The test fixture shall be constructed so that the line ofload application is paralle
23、l to the intended axis of the implant(that is, inferior to superior or anterior to posterior).6. Equipment6.1 The tests will be performed on either mechanical orhydraulic load frames with adequate load capacity and thatmeet the criteria of Practices E4.7. Sampling7.1 Aminimum of five samples with th
24、e load oriented in theinferior-to-superior direction shall be tested per device.7.2 Aminimum of five samples with the load oriented in theanterior-to-posterior direction shall be tested per device.8. Sample and Test Specimen8.1 All articular insert test components shall be representa-tive of final m
25、anufactured implant quality products.8.2 Glenoid backing test components may either be in theform of the final implant or may be a simplified model with theFIG. 1 Schematic of Static Glenoid Locking Strength Inferior-to-Superior DirectionF1829 172exact locking mechanism to be used on the final impla
26、nt. Thematerials and surface shall be representative of implant qualityproducts. All manufacturing processes (including heat treat-ment) should be followed.8.3 All components should be sterilized according to themanufacturers recommendations, if that process could affectthe results.8.4 A new articul
27、ar insert should be used for each test.9. Procedure9.1 Following proper assembly of an insert into a backing,the assembly is attached to the test machine such that the loadis applied in an inferior-to-superior direction (see Fig. 1).9.2 This test is to be performed in air at room temperature.It is p
28、ermissible to perform this test in a simulated physiologi-cal environment if the conditions (that is, temperature,humidity, and fluid) of the test environment are recorded.9.3 Apply a vertical load to the assembly offset at aspecified distance from the locking mechanism.9.4 Load should be applied to
29、 the articular insert with ablunt edge loading applicator.9.5 A constant displacement rate (for example, 25.4 mm/min) should be used and recorded.9.6 Testing of samples shall be terminated when one of thefollowing occurs:9.6.1 The articular insert disengages from the glenoidbacking,9.6.2 The disenga
30、gement force has reached a maximum andcontinues to decrease, or9.6.3 Gross deformation of the insert occurs without dislo-cation of the insert.9.7 Record the load versus displacement and the failuremode. The glenoid backing should be visually inspected fordamage after each test run.9.8 Repeat the pr
31、ocedure with a new insert and with the loadapplied in an anterior-to-posterior direction (see Fig. 2).10. Report10.1 The test report shall include the following:10.1.1 All details (that is, size, thickness, and materials)relevant to the particular implants tested. If the glenoidcomponent is not symm
32、etric then details of the non-symmetryand its relation to the test configuration should be specified,10.1.2 The distance, “d”, between the top of the lockingmechanism and the centerline of the point of load application(see Fig. 1 and Fig. 2),10.1.3 The displacement rate,10.1.4 The maximum load to fa
33、ilure,10.1.5 The failure mode,10.1.6 The indentor loading applicator configuration,10.1.7 The number of glenoid backing test componentsused, and10.1.8 Load displacement curves for each test.11. Precision and Bias11.1 The precision and bias of this test method needs to beestablished. Test results tha
34、t can be used to establish precisionand bias are solicited.12. Keywords12.1 arthroplasty; disassembly; glenoid; modular; orthopae-dic medical devices; shoulder arthroplastyFIG. 2 Schematic of Static Glenoid Locking Strength Anterior-to-Posterior DirectionF1829 173APPENDIX(Nonmandatory Information)X1
35、. RATIONALEX1.1 Aminimum of five test specimens is recommended forthis test method. The investigator should determine if addi-tional specimens are required. Statistical methods that take intoaccount variability in the components being tested may be usedto achieve the desired level of significance.X1
36、.2 This test method is intended to allow the investigatorto compare different glenoid locking mechanism designs assubjected to shear loading. This test method is not intended totest for all modes of failure or loading to which the componentmay be subjected. The investigator should determine if addi-
37、tional test conditions are necessary. It is believed that fatigue,particularly in a rocking motion, is more likely to causedisassembly of the glenoid locking mechanism clinically andwill provide further insight into the glenoid componentsbehavior.X1.3 The size of the glenoid component shall be deter
38、minedby the investigator. In general, the worst case size should bechosen based on evaluation or experience. There may also bea reason why an investigator wishes to test a size that is notworst case. This test method may also be used for this purpose.X1.4 Worst case loading of the glenoid component
39、mayvary, depending on the material, design, and clinical indica-tions. The investigator shall evaluate the possible clinical anddesign-related failure modes and attempt to determine a worstcase condition.X1.5 It is recognized that for some materials the environ-ment may have an effect on the respons
40、e to loading. The testenvironment used and the rationale for that choice shall bedescribed in the test report.X1.6 The loading of metal or composite-backed anatomicglenoid prostheses in vivo will, in general, differ from theloading defined in this test method. The results obtained herecannot be used
41、 to directly predict in vivo performance. Theresults obtained from this test method do not imply that theprosthesis will be clinically successful.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of
42、 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 reviewed every five
43、 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 co
44、mmittee, 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 Conshohocken, PA
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