ASTM F2028-02
(Test Method)Standard Test Methods for the Dynamic Evaluation of Glenoid Loosening or Disassociation
Standard Test Methods for the Dynamic Evaluation of Glenoid Loosening or Disassociation
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 The test method covers shoulder replacement designs with both monolithic and modular humeral and glenoid components with either cemented or noncemented 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.
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Designation:F2028–02
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 3.1.3 glenoid plane—see Fig. 1. In symmetric glenoids, the
plane is defined by joining the two articular edges; in planar
1.1 These test methods measure how much a prosthetic
and asymmetric glenoids, it is defined by the back surface.
glenoid component rocks or pivots following cyclic displace-
ment 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 mecha-
nism of modular glenoid components, for example, for disas-
sociation.
1.3 The test method covers shoulder replacement designs
with both monolithic and modular humeral and glenoid com-
ponents with either cemented or noncemented 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.
FIG. 1 Glenoid Plane and Load Directions
2. Referenced Documents
2.1 ASTM Standards:
2
E4 Practices for Force Verification of Testing Machines
3.1.4 axial load; axial translation—the force and displace-
3
F 1378 Specification for Shoulder Prostheses
ment,respectively,perpendiculartotheglenoidplane;theaxial
F 1839 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).
3
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
replacementofthehumeralhead.Itmayconsistofoneormore
subluxation,forexample,thepeakresistiveforceattheglenoid
components from one or more materials, for example, either
articular rim opposing movement of the humeral head.
all-polyethylene or a metal baseplate with a polymeric insert.
3.1.7 subluxation translation—the distance from the gle-
3.1.2 humeral head—theprostheticportionthatreplacesthe
noid origin (see Fig. 2), parallel to the glenoid plane, to the
proximal humerus or humeral head and articulates with the
point at which the subluxation load occurs.
natural glenoid fossa or a prosthetic replacement.
3.1.8 superior/inferior (SI), anterior/posterior (AP)—the SI
axis is the longest dimension and the AP axis the widest
dimension of the glenoid (see Fig. 2).
1
These test methods are under the jurisdiction of ASTM Committee F04 on
3.1.9 edge displacements—the translation, perpendicular to
Medical and Surgical Materials and Devices and are the direct responsibility of
the glenoid plane, of a specific point on the outside edge of the
Subcommittee F04.22 on Arthroplasty.
Current edition approved Nov. 10, 2002. Published December 2002. Originally
glenoid, when subjected to loading (see Fig. 3).
e1
approved in 2000. Last previous edition approved in 2000 as F 2028 – 00 .
2
Annual Book of ASTM Standards, Vol 03.01.
3
Annual Book of ASTM Standards, Vol 13.01.
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F2028–02
FIG. 2 Glenoid Axes and Origin
FIG. 3 Biaxial Testing Apparatus
GLENOID LOOSENING TEST METHOD
4. Summary of Test Method feasible as a result of the large displacements, quick speeds,
and deformable polyethylene.)
4.1 The prosthetic glenoid component is fixed into a bone
4.4 The humeral head is cycled to 90 % of the subluxation
substitute using the normal surgical technique.
distance for a fixed number of cycles.
4.2 The subluxation translation is determined experimen-
4.5 Theedgedisplacements(4.3)areeitherrepeatedfollow-
tally on additional components. This is accomplished, using a
ing the cycling or measured continuously during the cycling.
biaxial apparatus (see Fig. 3). by applying an axial load
perpendicular to the glenoid, then translating the humeral head
5. Significance and Use
parallel to the glenoid plane until encounteri
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