ASTM F1714-96(2008)
(Guide)Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
SIGNIFICANCE AND USE
This guide uses a weight-loss method of wear determination for the polymeric components used with hip joint prostheses, using serum or demonstrated equivalent fluid for lubrication, and running under a dynamic load profile representative of the human hip-joint forces during walking (1,2). The basis for this weight-loss method for wear measurement was originally developed (3) for pin-on-disk wear studies (see Practice F 732) and has been extended to total hip replacements (4,5) femoral-tibial knee prostheses (6), and to femoropatellar knee prostheses (6,7).
While wear results in a change in the physical dimensions of the specimen, it is distinct from dimensional changes due to creep or plastic deformation, in that wear generally results in the removal of material in the form of polymeric debris particles, causing a loss in weight of the specimen.
This guide for measuring wear of the polymeric component is suitable for various simulator devices. These techniques can be used with metal, ceramic, carbon, polymeric, and composite counter faces bearing against a polymeric material (for example, polyethylene, polyacetal, and so forth). This weight-loss method, therefore, has universal application for wear studies of total hip replacements that feature polymeric bearings. This weight-loss method has not been validated for high-density material bearing systems, such as metal-metal, carbon-carbon, or ceramic-ceramic. Progressive wear of such rigid bearing combinations generally has been monitored using a linear, variable-displacement transducers or by other profilometric techniques.
SCOPE
1.1 This guide describes a laboratory method using a weight-loss technique for evaluating the wear properties of materials or devices, or both, which are being considered for use as bearing surfaces of human-hip-joint replacement prostheses. The hip prostheses are evaluated in a device intended to simulate the tribological conditions encountered in the human hip joint, for example, use of a fluid such as bovine serum, or equivalent pseudosynovial fluid shown to simulate similar wear mechanisms and debris generation as found in vivo, and test frequencies of 1 Hz or less.
1.2 Since the hip simulator method permits the use of actual implant designs, materials, and physiological load/motion combinations, it can represent a more physiological simulation than basic wear-screening tests, such as pin-on-disk (see Practice F 732) or ring-on-disk (see ISO 6474).
1.3 It is the intent of this guide to rank the combination of implant designs and materials with regard to material wear-rates, under simulated physiological conditions. It must be recognized, however, that there are many possible variations in the in vivo conditions, a single laboratory simulation with a fixed set of parameters may not be universally representative.
1.4 The reference materials for the comparative evaluation of candidate materials, new devices, or components, or a combination thereof, shall be the wear rate of extruded or compression-molded, ultra-high molecular weight (UHMW) polyethylene (see Specification F 648) bearing against standard counter faces [stainless steel (see Specification F 138); cobalt-chromium-molybdenum alloy (see Specification F 75); thermomechanically processed cobalt chrome (see Specification F 799); alumina ceramic (see Specification F 603)], having typical prosthetic quality, surface finish, and geometry similar to those with established clinical history. These reference materials will be tested under the same wear conditions as the candidate materials.
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Designation: F1714 − 96(Reapproved 2008)
Standard Guide for
Gravimetric Wear Assessment of Prosthetic Hip Designs in
1
Simulator Devices
This standard is issued under the fixed designation F1714; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber 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
1.1 This guide describes a laboratory method using a
2.1 ASTM Standards:
weight-loss technique for evaluating the wear properties of
D883Terminology Relating to Plastics
materials or devices, or both, which are being considered for
F75Specification for Cobalt-28 Chromium-6 Molybdenum
use as bearing surfaces of human-hip-joint replacement pros-
Alloy Castings and Casting Alloy for Surgical Implants
theses.Thehipprosthesesareevaluatedinadeviceintendedto
(UNS R30075)
simulate the tribological conditions encountered in the human
F86Practice for Surface Preparation and Marking of Metal-
hip joint, for example, use of a fluid such as bovine serum, or
lic Surgical Implants
equivalent pseudosynovial fluid shown to simulate similar
F136 Specification for Wrought Titanium-6Aluminum-
wear mechanisms and debris generation as found in vivo, and
4VanadiumELI(ExtraLowInterstitial)AlloyforSurgical
test frequencies of 1 Hz or less.
Implant Applications (UNS R56401)
1.2 Sincethehipsimulatormethodpermitstheuseofactual
F138 Specification for Wrought 18Chromium-14Nickel-
implant designs, materials, and physiological load/motion
2.5MolybdenumStainlessSteelBarandWireforSurgical
combinations, it can represent a more physiological simulation
Implants (UNS S31673)
than basic wear-screening tests, such as pin-on-disk (see
F370Specification for Proximal Femoral Endoprosthesis
Practice F732) or ring-on-disk (see ISO 6474).
3
(Withdrawn 2005)
1.3 It is the intent of this guide to rank the combination of
F565PracticeforCareandHandlingofOrthopedicImplants
implant designs and materials with regard to material wear-
and Instruments
rates, under simulated physiological conditions. It must be
F603Specification for High-Purity DenseAluminum Oxide
recognized,however,thattherearemanypossiblevariationsin
for Medical Application
the in vivo conditions, a single laboratory simulation with a
F648Specification for Ultra-High-Molecular-Weight Poly-
fixed set of parameters may not be universally representative.
ethylene Powder and Fabricated Form for Surgical Im-
1.4 The reference materials for the comparative evaluation
plants
of candidate materials, new devices, or components, or a
F732Test Method for Wear Testing of Polymeric Materials
combination thereof, shall be the wear rate of extruded or
Used in Total Joint Prostheses
compression-molded, ultra-high molecular weight (UHMW)
F799Specification for Cobalt-28Chromium-6Molybdenum
polyethylene (see Specification F648) bearing against standard
Alloy Forgings for Surgical Implants (UNS R31537,
counter faces [stainless steel (see Specification F138); cobalt-
R31538, R31539)
chromium-molybdenum alloy (see Specification F75); thermo-
G40Terminology Relating to Wear and Erosion
mechanically processed cobalt chrome (see Specification
2.2 ISO Standard:
F799); alumina ceramic (see Specification F603)], having
ISO6474ImplantsforSurgery–CeramicMaterialsBasedon
typical prosthetic quality, surface finish, and geometry similar
4
Alumina
to those with established clinical history. These reference
materials will be tested under the same wear conditions as the
candidate materials.
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
1
This guide is under the jurisdiction ofASTM Committee F04 on Medical and Standards volume information, refer to the standard’s Document Summary page on
Surgical Materials and Devicesand is the direct responsibility of Subcommittee the ASTM website.
3
F04.22 on Arthroplasty. The last approved version of this historical standard is referenced on
CurrenteditionapprovedJune1,2008.PublishedJuly2008.Originallyapproved www.astm.org.
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in 1996. Last previous edition approved in 2002 as F1714–96 (2002). DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F1714-96R08. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F1714 − 96 (2008)
3. Significance and Use 4.3.3 Load—Ensure that the test load profile is representa-
tive of that which occurs during the patient’s walking cycle,
3.1 This guide uses a weight-loss method of wear dete
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