ASTM F2028-17
(Test Method)Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
SIGNIFICANCE AND USE
5.1 This test method is intended to investigate the resistance of a glenoid component to loosening. Glenoid loosening is the most common clinical complication in total shoulder arthroplasty (see X1.1). The method assumes that loosening occurs because of edge loading, often called the rocking-horse phenomenon.
5.2 This test method can be used both to detect potential problems and to compare design features. Factors affecting loosening performance include articular geometry, flange geometry, materials, fixation design, bone quality, and surgical technique.
SCOPE
1.1 These test methods measure how much a prosthetic anatomic glenoid component rocks or pivots following cyclic displacement of the humeral head to opposing glenoid rims (for example, superior-inferior or anterior-posterior). Motion is quantified by the tensile displacement opposite each loaded rim after dynamic rocking. Similarly, these test methods measure how much a prosthetic reverse glenoid component rocks or pivots following cyclic articulation with a mating humeral liner. Motion is quantified by the magnitude of displacement measured before and after cyclic loading.
1.2 The same setup can be used to test the locking mechanisms of modular glenoid components, for example, disassociation of both anatomic and reverse shoulder components.
1.3 These test methods cover shoulder replacement designs with monolithic or modular glenoid components for cemented fixation as well as reverse glenoid components for uncemented fixation.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F2028 − 17
Standard Test Methods for
Dynamic Evaluation of Glenoid Loosening or
1
Disassociation
This standard is issued under the fixed designation F2028; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
2
2.1 ASTM Standards:
1.1 These test methods measure how much a prosthetic
E4 Practices for Force Verification of Testing Machines
anatomic glenoid component rocks or pivots following cyclic
F1378 Specification for Shoulder Prostheses
displacementofthehumeralheadtoopposingglenoidrims(for
F1839 Specification for Rigid Polyurethane Foam for Use as
example, superior-inferior or anterior-posterior). Motion is
a Standard Material for Testing Orthopaedic Devices and
quantifiedbythetensiledisplacementoppositeeachloadedrim
Instruments
after dynamic rocking. Similarly, these test methods measure
how much a prosthetic reverse glenoid component rocks or
3. Terminology
pivots following cyclic articulation with a mating humeral
3.1 Anatomic Total Shoulder Replacement (TSR) Definitions
liner. Motion is quantified by the magnitude of displacement
3.1.1 anatomic total shoulder arthroplasty system,
measured before and after cyclic loading.
n—shoulder implant system that has a concave glenoid com-
1.2 The same setup can be used to test the locking mecha- ponent and a convex humeral component design.
nisms of modular glenoid components, for example, disasso-
3.1.2 anatomic glenoid component, n—the concave pros-
ciation of both anatomic and reverse shoulder components.
thetic portion that replaces, in part or in total, the glenoid fossa
of the scapula and articulates with the natural humeral head or
1.3 These test methods cover shoulder replacement designs
a prosthetic replacement.
with monolithic or modular glenoid components for cemented
3.1.3 glenoid backing, n—the metallic or composite mate-
fixation as well as reverse glenoid components for uncemented
rial prosthetic portion of a multi-piece anatomic glenoid
fixation.
component that attaches to the scapula.
1.4 The values stated in SI units are to be regarded as
3.1.4 glenoid liner, n—the polymeric prosthetic portion of a
standard. No other units of measurement are included in this
multiple-piece anatomic glenoid component that articulates
standard.
with the humeral head.
1.5 This standard does not purport to address all of the
3.2 Reverse TSR Definitions
safety concerns, if any, associated with its use. It is the
3.2.1 reverse total shoulder arthroplasty system,
responsibility of the user of this standard to establish appro-
n—shoulder implant system that has a convex glenoid compo-
priate safety and health practices and determine the applica-
nent and a concave humeral component design.
bility of regulatory limitations prior to use.
3.2.2 reverse glenoid component, n—the convex prosthetic
1.6 This international standard was developed in accor-
portion that replaces the glenoid fossa of the scapula and
dance with internationally recognized principles on standard-
articulates with a concave prosthetic replacement of the hu-
ization established in the Decision on Principles for the
meral head in reverse total shoulder arthroplasty applications.
Development of International Standards, Guides and Recom-
The reverse glenoid may consist of one or more components
mendations issued by the World Trade Organization Technical
from one or more materials; most commonly, the reverse
Barriers to Trade (TBT) Committee.
glenoid is composed of a metal glenosphere that is modularly
connected to a metal glenoid baseplate which is fixed to the
glenoid fossa.
1
These test methods are under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and are the direct responsibility of
2
Subcommittee F04.22 on Arthroplasty. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Dec. 1, 2017. Published January 2018. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2000. Last previous edition approved in 2014 as F2028 – 14. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2028-17. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F2028 − 17
3.2.3 glenoid baseplate, n—the nonarticular portion of the
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2028 − 14 F2028 − 17
Standard Test Methods for
Dynamic Evaluation of Glenoid Loosening or
1
Disassociation
This standard is issued under the fixed designation F2028; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 These test methods measure how much a prosthetic anatomic glenoid component rocks or pivots following cyclic
displacement of the humeral head to opposing glenoid rims (for example, superior-inferior or anterior-posterior). Motion is
quantified by the tensile displacement opposite each loaded rim after dynamic rocking. Similarly, these test methods measure how
much a prosthetic reverse glenoid component rocks or pivots following cyclic articulation with a mating humeral liner. Motion is
quantified by the magnitude of displacement measured before and after cyclic loading.
1.2 The same setup can be used to test the locking mechanisms of modular glenoid components, for example, disassociation
of both anatomic and reverse shoulder components.
1.3 These test methods cover shoulder replacement designs with monolithic or modular glenoid components for cemented
fixation as well as reverse glenoid components for uncemented fixation.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory
limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2
2.1 ASTM Standards:
E4 Practices for Force Verification of Testing Machines
F1378 Specification for Shoulder Prostheses
F1839 Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and
Instruments
3. Terminology
3.1 Anatomic Total Shoulder Replacement (TSR) Definitions
3.1.1 anatomic total shoulder arthroplasty system, n—shoulder implant system that has a concave glenoid component and a
convex humeral component design.
3.1.2 anatomic glenoid component, n—the concave prosthetic portion that replaces, in part or in total, the glenoid fossa of the
scapula and articulates with the natural humeral head or a prosthetic replacement.
3.1.3 glenoid backing, n—the metallic or composite material prosthetic portion of a multi-piece anatomic glenoid component
that attaches to the scapula.
3.1.4 glenoid liner, n—the polymeric prosthetic portion of a multiple-piece anatomic glenoid component that articulates with the
humeral head.
1
These test methods are under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and are the direct responsibility of Subcommittee
F04.22 on Arthroplasty.
Current edition approved March 1, 2014Dec. 1, 2017. Published July 2014January 2018. Originally approved in 2000. Last previous edition approved in 20122014 as
ε1
F2028 – 08F2028 – 14.(2012) . DOI: 10.1520/F2028-14.10.1520/F2028-17.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2028 − 17
3.2 Definitions:Reverse TSR Definitions
3.2.1 anatomicreverse total shoulder arthroplasty, arthroplasty system, n—shoulder implant system that has a concaveconvex
glenoid component and a convexconcave humeral component design.
3.1.1.1 anatomic glenoid, n—the concave prosthetic portion that replaces the glenoid fossa of the scapula and articulates with
a convex prosthetic replacement of the humeral head in anatomic total shoulder arthroplasty applications. It may consist of one
or more components from one or more materials, for examp
...
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