ASTM F2028-08
(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
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.
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 glenoid component rocks or pivots following cyclic displacement of the humeral head to opposing glenoid rims (for example, superior-inferior or anterior-posterior). Performance is judged by the tensile displacement opposite each loaded rim after dynamic rocking.
1.2 The same setup can be used to test the locking mechanism of modular glenoid components, for example, for disassociation.
1.3 These test methods cover shoulder replacement designs with monolithic or modular glenoid components for cemented fixation.
1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are provided for information purposes only.
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.
General Information
Relations
Buy Standard
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Please contact ASTM International (www.astm.org) for the latest information.
Designation:F2028–08
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 (ϵ) indicates an editorial change since the last revision or reapproval.
1. Scope replacementofthehumeralhead.Itmayconsistofoneormore
components from one or more materials, for example, either
1.1 These test methods measure how much a prosthetic
all-polyethylene or a metal baseplate with a polymeric insert.
glenoid component rocks or pivots following cyclic displace-
3.1.2 humeral head—theprostheticportionthatreplacesthe
ment of the humeral head to opposing glenoid rims (for
proximal humerus or humeral head and articulates with the
example, superior-inferior or anterior-posterior). Performance
natural glenoid fossa or a prosthetic replacement.
is judged by the tensile displacement opposite each loaded rim
3.1.3 glenoid plane—see Fig. 1. In symmetrical glenoids,
after dynamic rocking.
the glenoid plane is defined by joining the two articular edges;
1.2 The same setup can be used to test the locking mecha-
in planar and asymmetric glenoids, it is defined by the back
nism of modular glenoid components, for example, for disas-
surface.
sociation.
1.3 These test methods cover shoulder replacement designs
with monolithic or modular glenoid components for cemented
fixation.
1.4 The values stated in SI units are to be regarded as the
standard. The values given in parentheses are provided for
information purposes only.
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 appro-
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
2. Referenced Documents
FIG. 1 Glenoid Plane and Load Directions
2
2.1 ASTM Standards:
E4 Practices for Force Verification of Testing Machines
3.1.4 axial load; axial translation—the force and displace-
F1378 Specification for Shoulder Prostheses
ment,respectively,perpendiculartotheglenoidplane;theaxial
F1839 Specification for Rigid Polyurethane Foam for Use
load simulates the net compressive external and muscle forces
as a Standard Material for Testing Orthopaedic Devices
(see Fig. 1).
and Instruments
3.1.5 shear load; shear translation—the force and displace-
ment, respectively, parallel to the glenoid plane, applied, for
3. Terminology
example, in the superior/inferior or anterior/posterior direction
3.1 Definitions:
(see Figs. 1 and 2); the shear load simulates the net shear
3.1.1 glenoid—the prosthetic portion that replaces the gle-
external and active and passive soft tissue forces.
noid fossa of the scapula and articulates with a prosthetic
3.1.6 subluxation load—the peak shear load required for
subluxation,forexample,thepeakresistiveforceattheglenoid
1
These test methods are under the jurisdiction of ASTM Committee F04 on
articular rim opposing movement of the humeral head.
Medical and Surgical Materials and Devices and are the direct responsibility of
3.1.7 subluxation translation—the distance from the gle-
Subcommittee F04.22 on Arthroplasty.
noid origin (see Fig. 2), parallel to the glenoid plane, to the
Current edition approved Feb. 1, 2008. Published February 2008. Originally
point at which the subluxation load occurs.
approved in 2000. Last previous edition approved in 2005 as F2028 – 05. DOI:
10.1520/F2028-08.
3.1.8 superior/inferior (SI)—the SI axis is the longest di-
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
mension of the glenoid (see Fig. 2).
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3.1.9 anterior/posterior (AP)—the AP axis the widest di-
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. mension of the glenoid (see Fig. 2).
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
---------------------- Page: 1 ----------------------
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Please contact ASTM International (www.astm.org) for the latest information.
F2028–08
FIG. 2 Glenoid Axes and Origin
3.1.10 edge displacements—the translation, perpendicular
to the glenoid plane, of a specific point on the outside edge of
the glenoid, when subjected to loading (see Fig. 3).
GLENOID LOOSENING TEST METHOD
4. Summary of Test Method 4.3 The edge displacements of the glenoid are measured
before cycling: a given axial load is first applied perpen
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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:F2028–05 Designation:F2028–08
Standard Test Methods for
Dynamic Evaluation of Glenoid Loosening or
1
Disassociation
This standard is issued under the fixed designation F 2028; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 These test methods measure how much a prosthetic glenoid component rocks or pivots following cyclic displacement of the
humeral head to opposing glenoid rims (for example, superior-inferior or anterior-posterior). Performance is judged by the tensile
displacement opposite each loaded rim after dynamic rocking.
1.2 The same setup can be used to test the locking mechanism of modular glenoid components, for example, for disassociation.
1.3 These test methods cover shoulder replacement designs with monolithic or modular glenoid components for cemented
fixation.
1.4 ThevaluesstatedinSIunitsaretoberegardedasthestandard.Thevaluesgiveninparenthesesareprovidedforinformation
purposes only.
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.
2. Referenced Documents
2
2.1 ASTM Standards:
E 4 Practices for Force Verification of Testing Machines
F 1378 Specification for Shoulder Prostheses
F 1839 Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and
Instruments
3. Terminology
3.1 Definitions:
3.1.1 glenoid—the prosthetic portion that replaces the glenoid fossa of the scapula and articulates with a prosthetic replacement
of the humeral head. It may consist of one or more components from one or more materials, for example, either all-polyethylene
or a metal baseplate with a polymeric insert.
3.1.2 humeral head—the prosthetic portion that replaces the proximal humerus or humeral head and articulates with the natural
glenoid fossa or a prosthetic replacement.
3.1.3 glenoid plane—see Fig. 1. In symmetrical glenoids, the glenoid plane is defined by joining the two articular edges; in
planar and asymmetric glenoids, it is defined by the back surface.
3.1.4 axial load; axial translation—the force and displacement, respectively, perpendicular to the glenoid plane; the axial load
simulates the net compressive external and muscle forces (see Fig. 1).
3.1.5 shear load; shear translation—the force and displacement, respectively, parallel to the glenoid plane, applied, for
example, in the superior/inferior or anterior/posterior direction (see Figs. 1 and 2); the shear load simulates the net shear external
and active and passive soft tissue forces.
3.1.6 subluxation load—the peak shear load required for subluxation, for example, the peak resistive force at the glenoid
articular rim opposing movement of the humeral head.
3.1.7 subluxation translation—the distance from the glenoid origin (see Fig. 2), parallel to the glenoid plane, to the point at
which the subluxation load occurs.
1
These test methods are under the jurisdiction ofASTM Committee F04 on Medical and Surgical Materials and Devices and are the direct responsibility of Subcommittee
F04.22 on Arthroplasty.
Current edition approved Aug.Feb. 1, 2005.2008. Published August 2005.February 2008. Originally approved in 2000. Last previous edition approved in 20022005 as
F 2028 – 025.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM 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 ----------------------
F2028–08
FIG. 2 Glenoid Axes and Origin
FIG. 1 Glenoid Plane and Load Directions
3.1.8 superior/inferior (SI), anterior/posterior (AP)—the SI axis is the longest dimension and theAPaxis the widest dimension
of the glenoid (see superior/inferior (SI)—the SI axis is the longest dimension of the glenoid (see Fig. 2).
3.1.9 anterior/posterior (AP)—the AP axis the widest dimension of the glenoid (see Fig. 2).
3.1.10 edge displacements—the translation, perpendicular to the glenoid plane, of a spec
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.