ASTM F2385-15
(Practice)Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
SIGNIFICANCE AND USE
4.1 This practice uses clinical radiographs of the hip joint of a patient that has received a total hip replacement to measure the combined effect of plastic deformation and wear at the articular interface which results in three dimensional displacements of the femoral head into the acetabular component.
4.2 This practice addresses the validation of the various computational methods available for measuring the magnitude of creep/wear accruing at the articular surface of THRs.
4.3 This practice addresses the type of radiographic projections needed for an analysis as well as general radiographic parameters needed for obtaining high quality films.
4.4 This practice addresses the criterion for evaluating clinical radiographs for inclusion in a study.
4.5 This practice addresses the conversion of radiographic images to the appropriate digital format needed for the various computer assisted computational methods.
SCOPE
1.1 This practice provides guidance for the measurement of the relative displacement of the femoral head and acetabular component that result from wear and deformation occurring at the articular interface of a total hip replacement from sequential clinical radiographs.
1.2 This practice is primarily intended for use in evaluating patients receiving THRs composed of a polyethylene acetabular component articulating against a metal or ceramic femoral head.
1.3 So-called hard-on-hard articulations such as metal-on-metal and ceramic-on-ceramic THRs are not intended to be directly addressed.
1.4 This practice will focus on computer assisted computational methodologies for measuring relative displacements over time but not to the exclusion of other methodologies.
1.5 This practice describes methods for conducting a radiographic wear/creep study utilizing various computational methods and is not intended to promote or endorse a particular method.
1.6 It is not the intent of this practice to provide detailed instructions in the use of the various computational methods, which is contained in the respective user manuals.
1.7 It is the intent of this practice to enable comparisons of relative displacements occurring in groups of patients receiving different formulations of bearing materials. It must be recognized, however, that there are many possible variations in the in vivo conditions. A single clinical study may not be universally representative.
1.8 This practice is not intended to be a performance standard. It is the responsibility of the user of this practice to characterize the safety and effectiveness of the prosthesis under evaluation.
1.9 The values stated in SI units are to be regarded as the standard, with the exception of angular measurements, which may be reported in either degrees or radians. Additionally, pixel density may also be reported in imperial units.
1.10 The use of this standard may involve the operation of potentially hazardous radiographic equipment and does not purport to address the safety precautions associated with radiography. It is the responsibility of the user of this standard to define and establish appropriate safety practices. The standard does not determine the applicability of regulatory limitations prior to operating radiographic equipment.
1.11 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.
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Designation: F2385 − 15
Standard Practice for
Determining Femoral Head Penetration into Acetabular
Components of Total Hip Replacement Using Clinical
1
Radiographs
This standard is issued under the fixed designation F2385; 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 1.9 The values stated in SI units are to be regarded as the
standard, with the exception of angular measurements, which
1.1 This practice provides guidance for the measurement of
may be reported in either degrees or radians. Additionally,
the relative displacement of the femoral head and acetabular
pixel density may also be reported in imperial units.
component that result from wear and deformation occurring at
the articular interface of a total hip replacement from sequen- 1.10 The use of this standard may involve the operation of
tial clinical radiographs. potentially hazardous radiographic equipment and does not
purport to address the safety precautions associated with
1.2 This practice is primarily intended for use in evaluating
radiography. It is the responsibility of the user of this standard
patients receiving THRs composed of a polyethylene acetabu-
to define and establish appropriate safety practices. The
lar component articulating against a metal or ceramic femoral
standard does not determine the applicability of regulatory
head.
limitations prior to operating radiographic equipment.
1.3 So-called hard-on-hard articulations such as metal-on-
1.11 This standard does not purport to address all of the
metal and ceramic-on-ceramic THRs are not intended to be
safety concerns, if any, associated with its use. It is the
directly addressed.
responsibility of the user of this standard to establish appro-
1.4 This practice will focus on computer assisted computa-
priate safety and health practices and determine the applica-
tional methodologies for measuring relative displacements
bility of regulatory limitations prior to use.
over time but not to the exclusion of other methodologies.
2. Referenced Documents
1.5 This practice describes methods for conducting a radio-
2
graphicwear/creepstudyutilizingvariouscomputationalmeth-
2.1 ASTM Standards:
ods and is not intended to promote or endorse a particular
E177 Practice for Use of the Terms Precision and Bias in
method.
ASTM Test Methods
E691 Practice for Conducting an Interlaboratory Study to
1.6 It is not the intent of this practice to provide detailed
Determine the Precision of a Test Method
instructions in the use of the various computational methods,
which is contained in the respective user manuals.
3. Terminology
1.7 It is the intent of this practice to enable comparisons of
3.1 All radiographic terminology is consistent with the
relativedisplacementsoccurringingroupsofpatientsreceiving
referenced standards, unless otherwise stated.
different formulations of bearing materials. It must be
recognized, however, that there are many possible variations in
3.2 Definitions:
the in vivo conditions. A single clinical study may not be
3.2.1 radiostereometric analysis (RSA)—a method devel-
universally representative.
oped by Goren Selvik for measuring relative motion between
3
two parts from clinical radiographs (1). This method utilizes
1.8 This practice is not intended to be a performance
in vivo tantalum beads, an external reference cage, and two
standard. It is the responsibility of the user of this practice to
x-ray generators which take two exposures simultaneously.
characterizethesafetyandeffectivenessoftheprosthesisunder
evaluation.
1 2
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Surgical Materials and Devices and is the direct responsibility of Subcommittee contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
F04.22 on Arthroplasty. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Nov. 1, 2015. Published December 2015. Originally the ASTM website.
3
approved in 2004. Last previous edition approved in 2010 as F2385 – 04(2010). The boldface numbers in parentheses refer to the list of references at the end of
DOI: 10.1520/F2385-15. this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2385 − 15
There are several commercially available software/hardware It utilizes a model based edge matching method for determin-
packages for RSA analysis. ing the center of the markers (4).
3.
...
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: F2385 − 04 (Reapproved 2010) F2385 − 15
Standard Test Method Practice for
Determining Femoral Head Penetration into Acetabular
Components of Total Hip Replacement Using Clinical
1
Radiographs
This standard is issued under the fixed designation F2385; 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 This test method provides guidance for the measurement of the relative displacement of the femoral head and acetabular
component that result from wear and deformation occurring at the articular interface of a total hip replacement from sequential
clinical radiographs.
1.2 This test method is primarily intended for use in evaluating patients receiving THRs composed of a polyethylene acetabular
component articulating against a metal or ceramic femoral head.
1.3 So-called hard-on-hard articulations such as metal-on-metal and ceramic-on-ceramic THRs are not intended to be directly
addressed.
1.4 This test method will focus on computer assisted computational methodologies for measuring relative displacements over
time but not to the exclusion of other methodologies.
1.5 This test method describes methods for conducting a radiographic wear/creep study utilizing various computational methods
and is not intended to promote or endorse a particular method.
1.6 It is not the intent of this test method to provide detailed instructions in the use of the various computational methods, which
is contained in the respective user manuals.
1.7 It is the intent of this test method to enable comparisons of relative displacements occurring in groups of patients receiving
different formulations of bearing materials. It must be recognized, however, that there are many possible variations in the in vivo
conditions. A single clinical study may not be universally representative.
1.8 This test method is not intended to be a performance standard. It is the responsibility of the user of this test method to
characterize the safety and effectiveness of the prosthesis under evaluation.
1.9 The values stated in SI units are to be regarded as the standard, with the exception of angular measurements, which may
be reported in either degrees or radians.
1.10 The use of this standard may involve the operation of potentially hazardous radiographic equipment and does not purport
to address the safety precautions associated with radiography. It is the responsibility of the user of this standard to define and
establish appropriate safety practices. The standard does not determine the applicability of regulatory limitations prior to
operating radiographic equipment.
1.11 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:
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
1
This test method practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.22 on Arthroplasty.
Current edition approved Aug. 15, 2010Nov. 1, 2015. Published October 2010December 2015. Originally approved in 2004. Last previous edition approved in 20042010
as F2385 – 04.F2385 – 04(2010). DOI: 10.1520/F2385-04R10.10.1520/F2385-15.
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 ----------------------
F2385 − 15
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
3. Terminology
3.1 All radiographic terminology is consistent with the referenced standards, unless otherwise stated.
3.2 Definitions:
3.2.1 radiostereometric analysis (RSA)—a method developed by Goren Selvik for measuring relative motion between two parts
3
from clinical radiographs (1). This method utilizes in vivo tantalum beads, an external r
...
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