ASTM F2978-13
(Guide)Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging
Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging
SIGNIFICANCE AND USE
5.1 Magnetic resonance imaging is ideally suited to image MOM hip arthroplasty due to its superior soft tissue contrast, multiplanar capabilities and lack of ionizing radiation. MR imaging is the most accurate imaging modality for the assessment of peri-prosthetic osteolysis and wear-induced synovitis (17-19).
5.2 Before scanning a patient with a specific implant, the MR practitioner shall confirm that the device is MR Conditional and that the scan protocol to be used satisfies the conditions for safe scanning for the specific implant.
5.3 This guide can be used to identify the following adverse events.
5.3.1 Osteolysis—Magnetic resonance imaging is superior to conventional radiographs and CT in the assessment of peri-prosthetic osteolysis and has been shown to be the most accurate method to locate and quantify the extent of peri-prosthetic osteolysis (17, 18). On MR imaging, osteolysis appears as well marginated intraosseous intermediate to slightly increased signal intensity lesions that contrast with the high signal intensity of the intramedullary fat. A characteristic line of low signal intensity surrounds the area of focal marrow replacement, distinguishing the appearance of osteolysis from tumoral replacement of bone or infection (20).
5.3.2 Component Loosening—While the data are preliminary, MR imaging can identify circumferential bone resorption that may indicate component loosening. Loosening may result from osteolysis, circumferential fibrous membrane formation or poor osseous integration of a non-cemented component. On MR imaging, component loosening typically manifests as circumferential increased signal intensity at the metallic-bone or cement-bone interface on fat-suppressed techniques (19). The finding of circumferential fibrous membrane formation or osteolysis also indicates potential loosening; this is in contrast to a well-fixed component, with high signal intensity fatty marrow directly opposed to the implant interface.
5.3.3 Wear-...
SCOPE
1.1 This guide describes the recommended protocol for magnetic resonance imaging (MRI) studies of patients implanted with metal-on-metal (MOM) devices to determine if the periprosthetic tissues are likely to be associated with an adverse local tissue reaction (ALTR). Before scanning a patient with a specific implant, the MR practitioner shall confirm that the device is MR Conditional and that the scan protocol to be used satisfies the conditions for safe scanning for the specific implant. This guide assumes that the MRI protocol will be applied to MOM devices while they are implanted inside the body. It is also expected that standardized MRI safety measures will be followed during the performance of this scan protocol.
1.2 This guide covers the clinical evaluation of the tissues surrounding MOM hip replacement devices in patients using MRI. This guide is applicable to both total and resurfacing MOM hip systems.
1.3 The protocol contained in this guide applies to whole body magnetic resonance equipment, as defined in section 2.2.103 of IEC 60601-2-33, Ed. 3.0, with a whole body radiofrequency (RF) transmit coil as defined in section 2.2.100. The RF coil should have quadrature excitation.
1.4 The values stated in SI units are to be regarded as standard.
1.5 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. The user may consider all precautions and warnings provided in the MR system and hip implant labeling prior to determining the applicability of these protocols.
General Information
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2978 − 13
Guide to
Optimize Scan Sequences for Clinical Diagnostic Evaluation
of Metal-on-Metal Hip Arthroplasty Devices using Magnetic
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Resonance Imaging
This standard is issued under the fixed designation F2978; 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
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2.1 ASTM Standards:
1.1 This guide describes the recommended protocol for
A340 Terminology of Symbols and Definitions Relating to
magnetic resonance imaging (MRI) studies of patients im-
Magnetic Testing
planted with metal-on-metal (MOM) devices to determine if
F2503 Practice for Marking Medical Devices and Other
the periprosthetic tissues are likely to be associated with an
Items for Safety in the Magnetic Resonance Environment
adverselocaltissuereaction(ALTR).Beforescanningapatient
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2.2 IEC Standard:
with a specific implant, the MR practitioner shall confirm that
IEC 60601-2-33, Ed. 3.0 Medical Electrical Equipment—
the device is MR Conditional and that the scan protocol to be
Part 2: Particular Requirements for the Safety of Magnetic
used satisfies the conditions for safe scanning for the specific
Resonance Equipment for Medical Diagnosis, 2010
implant. This guide assumes that the MRI protocol will be
applied to MOM devices while they are implanted inside the
3. Terminology
body.ItisalsoexpectedthatstandardizedMRIsafetymeasures
3.1 Definitions—For the purposes of this standard the
will be followed during the performance of this scan protocol.
following definitions shall apply:
1.2 This guide covers the clinical evaluation of the tissues
3.1.1 Magnetic Resonance Imaging (MRI)—diagnostic im-
surrounding MOM hip replacement devices in patients using
aging technique that uses static and time varying magnetic
MRI. This guide is applicable to both total and resurfacing
fields to provide tomographic images of tissue by the magnetic
MOM hip systems.
resonance of nuclei.
3.1.2 MR - Conditional—an item that has been demon-
1.3 The protocol contained in this guide applies to whole
stratedtoposenoknownhazardsinaspecificMRenvironment
body magnetic resonance equipment, as defined in section
with specified conditions of use. Field conditions that define
2.2.103 of IEC 60601-2-33, Ed. 3.0, with a whole body
the specified MR environment include field strength, spatial
radiofrequency(RF)transmitcoilasdefinedinsection2.2.100.
gradient, dB/dt (time rate of change of the magnetic field),
The RF coil should have quadrature excitation.
radiofrequency (RF) fields, and specific absorption rate (SAR).
1.4 The values stated in SI units are to be regarded as
Additional conditions, including specific configurations of the
standard.
item, may be required (Practice F2503).
1.5 This standard does not purport to address all of the
3.1.3 Metal-on-Metal (MOM) hip replacement—a hip ar-
safety concerns, if any, associated with its use. It is the throplasty device in which the articulating surfaces of the
responsibility of the user of this standard to establish appro- femoral head and the acetabular cup are fabricated from metal.
priate safety and health practices and determine the applica-
4. Summary of Protocol
bility of regulatory limitations prior to use. The user may
consider all precautions and warnings provided in the MR
4.1 Surface coil fast spin echo (FSE) sequences of the
system and hip implant labeling prior to determining the
affected hip in three planes and a larger field-of-view (FOV)
applicability of these protocols.
short tau inversion recovery (STIR) sequence to include both
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or
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This guide is under the jurisdiction of ASTM Committee F04 on Medical and contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Surgical Materials and Devices and is the direct responsibility of Subcommittee Standards volume information, refer to the standard’s Document Summary page on
F04.22 on Arthroplasty. the ASTM website.
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Current edition approved Dec. 1, 2013. Published May 2014. DOI: 10.1520/ Available from International Electrotechnical Commission (IEC), 3, rue de
F2978-13. Varembé, P.O. Box 131, CH-1211 Geneva 20, Switzerland, http://www.iec.ch.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F2978 − 13
hips and the surrounding pelvis are recommended. A large magnetic field (B ); therefore, imaging at field strengths
0
FOVsequence of the entire pelvis should be included to assess greater than 1.5 T should be avoided when possible.
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