ASTM F1223-20
(Test Method)Standard Test Method for Determination of Total Knee Replacement Constraint
Standard Test Method for Determination of Total Knee Replacement Constraint
SIGNIFICANCE AND USE
4.1 This test method, when applied to available products and proposed prototypes, is meant to provide a database of product functionality capabilities (in light of the suggested test regimens) that is hoped will aid the physician in making a more informed total knee replacement (TKR) selection.
4.2 A proper matching of TKR functional restorative capabilities and the recipient's (patient’s) needs is more likely to be provided by a rational testing protocol of the implant in an effort to reveal certain device characteristics pertinent to the selection process.
4.3 The TKR product designs are varied and offer a wide range of constraint (stability). The constraint of the TKR in the in vitro condition depends on several geometrical and kinematic interactions among the implant's components which can be identified and quantified. The degree of TKR's kinematic interactions should correspond to the recipient's needs as determined by the physician during clinical examination.
4.4 For mobile bearing knee systems, the constraint of the entire implant construct shall be characterized. Constraint of mobile bearings is dictated by design features at both the inferior and superior articulating interfaces.
4.5 The methodology, utility, and limitations of constraint/laxity testing are discussed.3, 4 The authors recognize that evaluating isolated implants (that is, without soft tissues) does not directly predict in vivo behavior, but will allow comparisons among designs. Constraint testing is also useful for characterizing implant performance at extreme ranges of motion which may be encountered in vivo at varying frequencies, depending on the patient’s anatomy, pre-operative capability, and post-operative activities and lifestyle.
SCOPE
1.1 This test method may be used to compare the constraint characteristics of total knee replacements (TKRs) with the intent of comparing new designs to existing clinically successful designs or to determine the constraint differences between two similar or dissimilar designs.
1.2 This test method covers the means by which a TKR constraint may be quantified according to motion delineated by the inherent articular design as determined under specific loading conditions in an in-vitro environment.
1.3 Tests deemed applicable to the constraint determination are antero-posterior draw, medio-lateral shear, rotary laxity, valgus-varus rotation, and distraction, as applicable. Also covered is the identification of geometrical parameters of the contacting surfaces which would influence this motion and the means of reporting the test results. (See Practices E4.)
1.4 This test method is not a wear test.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 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:F1223 −20
Standard Test Method for
1
Determination of Total Knee Replacement Constraint
This standard is issued under the fixed designation F1223; 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 This test method may be used to compare the constraint
E4 Practices for Force Verification of Testing Machines
characteristics of total knee replacements (TKRs) with the
F2083 Specification for Knee Replacement Prosthesis
intent of comparing new designs to existing clinically success-
ful designs or to determine the constraint differences between
3. Terminology
two similar or dissimilar designs.
3.1 Definitions—Items in this category refer to the geo-
1.2 This test method covers the means by which a TKR
metricalandkinematicaspectsofTKRdesignsastheyrelateto
constraint may be quantified according to motion delineated by
their human counterparts:
the inherent articular design as determined under specific
3.1.1 anterior curvature, n—a condylar design which is
loading conditions in an in-vitro environment.
generally planar except for a concave—upward region anteri-
orly on the tibial component.
1.3 Tests deemed applicable to the constraint determination
3.1.2 anterior posterior (AP), adj—any geometrical length
are antero-posterior draw, medio-lateral shear, rotary laxity,
aligned with the AP orientation.
valgus-varus rotation, and distraction, as applicable. Also
covered is the identification of geometrical parameters of the
3.1.3 AP displacement, n—the relative linear translation
contacting surfaces which would influence this motion and the
between components in the AP direction.
means of reporting the test results. (See Practices E4.)
3.1.4 AP draw load, n—the force applied to the movable
component with its vector aligned in the AP direction causing
1.4 This test method is not a wear test.
or intending to cause an AP displacement.
1.5 The values stated in SI units are to be regarded as
3.1.5 biconcave, n—a condylar design with pronounced AP
standard. No other units of measurement are included in this
and MLcondylar radii seen as a “dish” in the tibial component
standard.
or a “toroid” in the femoral component.
1.6 This standard does not purport to address all of the
3.1.6 bearing surface, n—those regions of the component
safety concerns, if any, associated with its use. It is the
which are intended to contact its counterpart for load transmis-
responsibility of the user of this standard to establish appro-
sion.
priate safety, health, and environmental practices and deter-
3.1.7 condyle, n—entity designed to emulate the joint
mine the applicability of regulatory limitations prior to use.
anatomy and used as a bearing surface primarily for transmis-
1.7 This international standard was developed in accor-
sion of the joint reaction force with geometrical properties
dance with internationally recognized principles on standard-
which tend to govern the general kinematics of the TKR.
ization established in the Decision on Principles for the
3.1.8 distraction, n—the separation of the femoral compo-
Development of International Standards, Guides and Recom-
nent(s) from the tibial component(s) in the z-direction.
mendations issued by the World Trade Organization Technical
3.1.9 femoralsideconstraint,n—thatconstraintprovidedby
Barriers to Trade (TBT) Committee.
the superior articulating interfaces, determined by fixing the
inferior surface of the mobile bearing component during
testing.
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
2
F04.22 on Arthroplasty. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved June 15, 2020. Published August 2020. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1989. Last previous edition approved in 2014 as F1223 – 14. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F1223-20. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F1223−20
3.1.10 flexion angle, n—the angulation of the femoral com- 3.1.26 superior articulating interfaces, n—any interface in
ponent (about an axis parallel
...
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: F1223 − 14 F1223 − 20
Standard Test Method for
1
Determination of Total Knee Replacement Constraint
This standard is issued under the fixed designation F1223; 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 covers the establishment of a database of total knee replacement (TKR) motion characteristics may be used
to compare the constraint characteristics of total knee replacements (TKRs) with the intent of developing guidelines for the
assignment of constraint criteria to TKR designs. (See the Rationale incomparing new designs to existing clinically successful
designs or to determine the constraint differences Appendix X1.)between two similar or dissimilar designs.
1.2 This test method covers the means by which a TKR constraint may be quantified according to motion delineated by the
inherent articular design as determined under specific loading conditions in an in vitroin-vitro environment.
1.3 Tests deemed applicable to the constraint determination are antero-posterior draw, medio-lateral shear, rotary laxity,
valgus-varus rotation, and distraction, as applicable. Also covered is the identification of geometrical parameters of the contacting
surfaces which would influence this motion and the means of reporting the test results. (See Practices E4.)
1.4 This test method is not a wear test.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.7 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
F2083 Specification for Knee Replacement Prosthesis
3. Terminology
3.1 Definitions—Items in this category refer to the geometrical and kinematic aspects of TKR designs as they relate to their
human counterparts:
1
This test method 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 May 15, 2014June 15, 2020. Published June 2014August 2020. Originally approved in 1989. Last previous edition approved in 20122014 as
F1223 – 08 (2012).F1223 – 14. DOI: 10.1520/F1223-14.10.1520/F1223-20.
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 ----------------------
F1223 − 20
3.1.1 anterior curvature, n—a condylar design which is generally planar except for a concave—upward region anteriorly on the
tibial component.
3.1.2 anterior posterior (AP),n—adj—any geometrical length aligned with the AP orientation.
3.1.3 AP displacement, n—the relative linear translation between components in the AP direction.
3.1.4 AP draw load, n—the force applied to the movable component with its vector aligned in the AP direction causing or
intending to cause an AP displacement.
3.1.5 biconcave, n—a condylar design with pronounced AP and ML condylar radii seen as a “dish” in the tibial component or a
“toroid” in the femoral component.
3.1.6 bearing surface, n—those regions of the component which are intended to contact its counterpart for load transmission.
3.1.7 condyles,condyle, n—entity designed to emulate the joint anatomy and used as a bearing surface primarily for transmission
of the joint reaction force with geometrical properties which tend to govern the general kinematics of the TKR.
3.1.8 distraction,
...
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