ASTM F3141-17
(Guide)Standard Guide for Total Knee Replacement Loading Profiles
Standard Guide for Total Knee Replacement Loading Profiles
SIGNIFICANCE AND USE
4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3.
4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation or high loading in the soft tissue constraints, whether they are represented physically or virtually.
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
SCOPE
1.1 Motion path, load history and loading modalities all contribute to the wear, degradation and damage of implanted prosthetics. Simulating a variety of functional activities promises more realistic testing for wear and damage mode evaluation. Such activities are often called activities of daily living (ADLs). ADLs identified in the literature include walking, stair ascent and decent, sit-to-stand, stand-to-sit, squatting, kneeling, cross-legged sitting, into bath, out of bath, turning and cutting motions (1-7).2 Activities other than walking gait often involve an extended range of motion and higher imposed loading conditions which have the ability to cause damage and modes of failure other than normal wear (8-10).
1.2 This document provides guidance for functional simulation that could be used to evaluate in vitro the durability of knee prosthetic devices under force control.
1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily living but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in that it attempts to exercise the prosthetic device through a variety of loading and motion conditions such as might be encountered in situ in the human body in order to reveal various damage modes and damage mechanisms that might be encountered throughout the life of the prosthetic device.
1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior posterior shear and medial lateral shear are placed under force control.
1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation and the active musculature acting across the knee.
1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.
1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended to increa...
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Designation:F3141 −17
Standard Guide for
1
Total Knee Replacement Loading Profiles
This standard is issued under the fixed designation F3141; 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 1.5 This document establishes kinetic and kinematic test
conditions for several activities of daily living, including
1.1 Motion path, load history and loading modalities all
walking, turning navigational movements, stair climbing, stair
contribute to the wear, degradation and damage of implanted
descent, and squatting. The kinetic and kinematic test condi-
prosthetics. Simulating a variety of functional activities prom-
tions are expressed as reference waveforms used to drive the
ises more realistic testing for wear and damage mode evalua-
relevant simulator machine actuators. These waveforms repre-
tion. Such activities are often called activities of daily living
sent motion, as in the case of flexion extension, or kinetic
(ADLs).ADLs identified in the literature include walking, stair
signals representing the forces and moments resulting from
ascent and decent, sit-to-stand, stand-to-sit, squatting,
body dynamics, gravitation and the active musculature acting
kneeling, cross-legged sitting, into bath, out of bath, turning
2
across the knee.
and cutting motions (1-7). Activities other than walking gait
often involve an extended range of motion and higher imposed
1.6 This document does not address the assessment or
loading conditions which have the ability to cause damage and
measurement of damage modes, or wear or failure of the
modes of failure other than normal wear (8-10).
prosthetic device.
1.2 This document provides guidance for functional simu-
1.7 This document is a guide.As defined byASTM in their
lation that could be used to evaluate in vitro the durability of
“Form and Style forASTM Standards” book in section C15.2,
knee prosthetic devices under force control.
“Astandard guide is a compendium of information or series of
1.3 Function simulation is defined as the reproduction of
options that does not recommend a specific course of action.
loads and motions that might be encountered in activities of
Guides are intended to increase the awareness of information
daily living but it does not necessarily cover every possible
and approaches in a given subject area. Guides may propose a
type of loading. Functional simulation differs from typical
series of options or instructions that offer direction without
wear testing in that it attempts to exercise the prosthetic device
recommending a definite course of action. The purpose of this
through a variety of loading and motion conditions such as
type of standard is to offer guidance based on a consensus of
might be encountered in situ in the human body in order to
viewpoints but not to establish a standard practice to follow in
reveal various damage modes and damage mechanisms that
all cases.”The intent of this guide is to provide loading profiles
might be encountered throughout the life of the prosthetic
and test procedures to develop testing that might be used for
device.
wear, durability or other types of testing of total knee replace-
1.4 Force control is defined as the mode of control of the
ments.Asnotedinthisdefinition,aguideprovidesguidanceon
test machine that accepts a force level as the set point input and testing,butdoesnotrequirespecifictesting.Thus,forexample,
which utilizes a force feedback signal in a control loop to
if a user is unable to control one mode of force control given
achieve that set point input. For knee simulation, the flexion
in the load profiles, that user is not required to perform that
motion is placed under angular displacement control, internal
mode of loading.
and external rotation is placed under torque control, and axial
1.8 This standard does not purport to address all of the
load, anterior posterior shear and medial lateral shear are
safety concerns, if any, associated with its use. It is the
placed under force control.
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.
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
1.9 This international standard was developed in accor-
Surgical Materials and Devices and is the direct responsibility of Subcommittee
dance with internationally recognized principles on standard-
F04.22 on Arthroplasty.
CurrenteditionapprovedJune1,2017.PublishedJuly2017.Originallyapproved
ization established in the Decision on Principles for the
in2015.Lastprevioused
...
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: F3141 − 15 F3141 − 17
Standard Guide for
1
Total Knee Replacement Loading Profiles
This standard is issued under the fixed designation F3141; 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 Motion path, load history and loading modalities all contribute to the wear, degradation and damage of implanted
prosthetics. Simulating a variety of functional activities promises more realistic testing for wear and damage mode evaluation.
Such activities are often called activities of daily living (ADLs). ADLs identified in the literature include walking, stair ascent and
2
decent, sit-to-stand, stand-to-sit, squatting, kneeling, cross-legged sitting, into bath, out of bath, turning and cutting motions (1-7).
Activities other than walking gait often involve an extended range of motion and higher imposed loading conditions which have
the ability to cause damage and modes of failure other than normal wear (8-10).
1.2 This document provides guidance for functional simulation that could be used to evaluate in vitro the durability of knee
prosthetic devices under force control.
1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily
living but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in
that it attempts to exercise the prosthetic device through a variety of loading and motion conditions such as might be encountered
in situ in the human body in order to reveal various damage modes and damage mechanisms that might be encountered throughout
the life of the prosthetic device.
1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which
utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed
under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior posterior
shear and medial lateral shear are placed under force control.
1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking,
turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are
expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as
in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation
and the active musculature acting across the knee.
1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic
device.
1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A
standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides
are intended to increase the awareness of information and approaches in a given subject area. Guides may propose a series of
options or instructions that offer direction without recommending a definite course of action. The purpose of this type of standard
is to offer guidance based on a consensus of viewpoints but not to establish a standard practice to follow in all cases.” The intent
of this guide is to provide loading profiles and test procedures to develop testing that might be used for wear, durability or other
types of testing of total knee replacements. As noted in this definition, a guide provides guidance on testing, but does not require
specific testing. Thus, for example, if a user is unable to control one mode of force control given in the load profiles, that user is
not required to perform that mode of loading.
1.8 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.
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Sub
...
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