ASTM_F_2028_-_14.pdf

Designation:F202814Standard Test Methods forDynamic Evaluation of Glenoid Loosening orDisassociation1This standard is issued under the fixed designation F2028;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 indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 These test methods measure how much a prostheticanatomic glenoid component rocks or pivots following cyclicdisplacement of the humeral head to opposing glenoid rims(forexample,superior-inferior or anterior-posterior).Motion isquantified by the tensile displacement opposite each loaded rimafter dynamic rocking.Similarly,these test methods measurehow much a prosthetic reverse glenoid component rocks orpivots following cyclic articulation with a mating humeralliner.Motion is quantified by the magnitude of displacementmeasured before and after cyclic loading.1.2 The same setup can be used to test the locking mecha-nisms of modular glenoid components,for example,disasso-ciation of both anatomic and reverse shoulder components.1.3 These test methods cover shoulder replacement designswith monolithic or modular glenoid components for cementedfixation as well as reverse glenoid components for uncementedfixation.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 establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2E4 Practices for Force Verification of Testing MachinesF1378 Specification for Shoulder ProsthesesF1839 Specification for Rigid Polyurethane Foam for Use asa Standard Material for Testing Orthopaedic Devices andInstruments3.Terminology3.1 Definitions:3.1.1 anatomic total shoulder arthroplasty,nshoulder im-plant that has a concave glenoid component and a convexhumeral component design.3.1.1.1 anatomic glenoid,nthe concave prosthetic portionthat replaces the glenoid fossa of the scapula and articulateswith a convex prosthetic replacement of the humeral head inanatomic total shoulder arthroplasty applications.It may con-sist of one or more components from one or more materials,forexample,either all-polyethylene or a metal baseplate with apolymeric insert.3.1.1.2 humeral head,nthe convex prosthetic portion thatreplaces the proximal humerus or humeral head and articulateswith the natural glenoid fossa or an anatomic prostheticreplacement.3.1.2 reverse total shoulder arthroplasty,nshoulder im-plants that have a convex glenoid component and a concavehumeral component design.3.1.2.1 glenoid baseplate,nthe nonarticular portion of thereverse glenoid component that modularly connects to theglenosphere and is usually fixed to the glenoid fossa of thescapula using bone screws without the use of cement.3.1.2.2 glenosphere,nthe convex prosthetic articular por-tion of the reverse glenoid component that articulates with theconcave prosthetic replacement of the proximal humerus orhumeral head(for example,the humeral liner).3.1.2.3 glenosphere thickness,nthe height of the truncatedsection of the sphere which composes the glenosphere.Notethat the difference between 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 relation between the gleno-sphere and the glenoid baseplate.3.1.2.4 humeral liner,nthe concave prosthetic portion ofthe reverse humeral component that replaces the proximal1These test methods are under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and are the direct responsibility ofSubcommittee F04.22 on Arthroplasty.Current edition approved March 1,2014.Published July 2014.Originallyapproved in 2000.Last previous edition approved in 2012 as F2028 08(2012)1.DOI:10.1520/F2028-14.2For 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 onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 humerus or humeral head and articulates with the convexprosthetic replacement of the glenoid(for example,the gleno-sphere).3.1.2.5 reverse glenoid,nthe convex prosthetic portionthat replaces the glenoid fossa of the scapula and articulateswith a concave prosthetic replacement of the humeral head inreverse total shoulder arthroplasty applications.The reverseglenoid may consist of one or more components from one ormore materials;most commonl