ISO 16087:2013
(Main)Implants for surgery — Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants
Implants for surgery — Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants
ISO 16087:2013 provides requirements for the clinical assessment of migration of orthopaedic implants with roentgen stereophotogrammetric analysis (RSA).
Implants chirurgicaux — Analyse stéréophotogrammétrique Roentgen pour l'évaluation de la migration des implants orthopédiques
General Information
Buy Standard
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 16087
First edition
2013-10-01
Implants for surgery — Roentgen
stereophotogrammetric analysis
for the assessment of migration of
orthopaedic implants
Implants chirurgicaux — Analyse stéréophotogrammétrique
Roentgen pour l’évaluation de la migration des implants
orthopédiques
Reference number
©
ISO 2013
© ISO 2013
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms and definitions . 1
3 Measurement . 3
3.1 Size of markers . 3
3.2 Virtual markers . 3
3.3 Number and distribution of markers . 4
3.4 Mean error of rigid body fitting . 4
3.5 Condition number . 4
3.6 Three-dimensional implant models . 4
4 Radiographic arrangement . 4
5 Calibration cages and reference plates . 4
6 Radiographs . 5
6.1 General . 5
6.2 Double examinations . 5
7 Software . 5
8 Coordinate systems . 5
8.1 Global coordinate system . 5
8.2 Implant coordinate system . 5
8.3 Reference rigid body . 6
9 Migration . 6
9.1 Translations . 6
9.2 Rotations . 6
10 Maximum total point motion . 7
10.1 General . 7
10.2 Signed versus unsigned values. 8
11 Validation . 8
11.1 Accuracy . 8
11.2 Precision . 8
12 Practical issues . 8
12.1 Weight bearing . 8
12.2 Follow-up intervals . 9
12.3 Radiation dose . 9
12.4 Exclusion of patients . 9
13 Standardised output . 9
Annex A (informative) Relevant formulae .11
Bibliography .12
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received. www.iso.org/patents
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 4,
Bone and joint replacement.
iv © ISO 2013 – All rights reserved
Introduction
[1]
Since its introduction in 1974, roentgen stereophotogrammetric analysis (RSA) has been widely
used to assess migration of orthopaedic implants. It is a highly accurate method of quantifying
three-dimensional migration between an implant and the bone it is fixed in. RSA is also used in other
applications such as measuring migration between bone fragments in e.g. bone fracture studies, and
measuring wear of implants. These applications are not within the scope of this International Standard.
Several studies have found implant migration to be predictive of long-term implant survival and, for
most devices, measurement over two years might therefore provide a surrogate outcome measure with
[2][3]
relatively low numbers of subjects, e.g. less than 50 patients in each group in randomized studies.
[4]
A smaller number of subjects can be used in these studies as a consequence of the high accuracy of
the measurement technique. Because of this, RSA is an important technique in early clinical trials for
screening new joint replacement prostheses.
However, results from these early clinical trials are difficult to compare as different studies report
their results in different formats. To facilitate comparison of outcome reported from different research
groups and because the results are obtained using different methodological procedures, there is a need
for standardization of RSA investigations.
The RSA method described in this International Standard requires the use of X-rays and exposes the
patient to a greater X-ray exposure dose with its associated health risk. For this reason, it is neither
the intention of this International Standard to recommend the routine use of RSA nor to add to existing
regulatory requirements. Rather it is the intention that when RSA is used in a standardized manner, the
results can be as useful and as widely applicable as possible.
INTERNATIONAL STANDARD ISO 16087:2013(E)
Implants for surgery — Roentgen
stereophotogrammetric analysis for the assessment of
migration of orthopaedic implants
CAUTION — The RSA method described in this International Standard requires the use of X-rays
and exposes the patient to a greater X-ray exposure dose with its associated health risk. Careful
consideration of the benefits and drawbacks of this method on a case by case basis is advisable.
1 Scope
This International Standard provides requirements for the clinical assessment of migration of
orthopaedic implants with roentgen stereophotogrammetric analysis (RSA).
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
absolute movement
movement of a rigid body relative to a fixed reference rigid body
2.2
accuracy
closeness of agreement between a measured quantity value and a true quantity value of a measurand
2.3
bias
estimate of a systematic measurement error
2.4
biplanar technique
RSA technique where two X-ray cassettes/films/sensors are set at an angle to each other
2.5
calibration cage
calibration box
reference frame used to create a three-dimensional coordinate system, with definition of position and
orientation, and to determine the position of the two roentgen foci
2.6
condition number
calculated number used to assess the distribution of markers
Note 1 to entry: High condition numbers indicate poor marker distribution, while low condition numbers indicate
appropriate marker distribution.
Note 2 to entry: See Annex A, which establishes the methodology to determine the condition number associated
with the marker distribution.
2.7
crossing line error
shortest distance between the two X-rays projecting the centre of a marker in the two RSA images
2.8
double examinations
two RSA examinations of the same patient within an interval of several minutes
...
INTERNATIONAL ISO
STANDARD 16087
First edition
2013-10-01
Implants for surgery — Roentgen
stereophotogrammetric analysis
for the assessment of migration of
orthopaedic implants
Implants chirurgicaux — Analyse stéréophotogrammétrique
Roentgen pour l’évaluation de la migration des implants
orthopédiques
Reference number
©
ISO 2013
© ISO 2013
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms and definitions . 1
3 Measurement . 3
3.1 Size of markers . 3
3.2 Virtual markers . 3
3.3 Number and distribution of markers . 4
3.4 Mean error of rigid body fitting . 4
3.5 Condition number . 4
3.6 Three-dimensional implant models . 4
4 Radiographic arrangement . 4
5 Calibration cages and reference plates . 4
6 Radiographs . 5
6.1 General . 5
6.2 Double examinations . 5
7 Software . 5
8 Coordinate systems . 5
8.1 Global coordinate system . 5
8.2 Implant coordinate system . 5
8.3 Reference rigid body . 6
9 Migration . 6
9.1 Translations . 6
9.2 Rotations . 6
10 Maximum total point motion . 7
10.1 General . 7
10.2 Signed versus unsigned values. 8
11 Validation . 8
11.1 Accuracy . 8
11.2 Precision . 8
12 Practical issues . 8
12.1 Weight bearing . 8
12.2 Follow-up intervals . 9
12.3 Radiation dose . 9
12.4 Exclusion of patients . 9
13 Standardised output . 9
Annex A (informative) Relevant formulae .11
Bibliography .12
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received. www.iso.org/patents
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 4,
Bone and joint replacement.
iv © ISO 2013 – All rights reserved
Introduction
[1]
Since its introduction in 1974, roentgen stereophotogrammetric analysis (RSA) has been widely
used to assess migration of orthopaedic implants. It is a highly accurate method of quantifying
three-dimensional migration between an implant and the bone it is fixed in. RSA is also used in other
applications such as measuring migration between bone fragments in e.g. bone fracture studies, and
measuring wear of implants. These applications are not within the scope of this International Standard.
Several studies have found implant migration to be predictive of long-term implant survival and, for
most devices, measurement over two years might therefore provide a surrogate outcome measure with
[2][3]
relatively low numbers of subjects, e.g. less than 50 patients in each group in randomized studies.
[4]
A smaller number of subjects can be used in these studies as a consequence of the high accuracy of
the measurement technique. Because of this, RSA is an important technique in early clinical trials for
screening new joint replacement prostheses.
However, results from these early clinical trials are difficult to compare as different studies report
their results in different formats. To facilitate comparison of outcome reported from different research
groups and because the results are obtained using different methodological procedures, there is a need
for standardization of RSA investigations.
The RSA method described in this International Standard requires the use of X-rays and exposes the
patient to a greater X-ray exposure dose with its associated health risk. For this reason, it is neither
the intention of this International Standard to recommend the routine use of RSA nor to add to existing
regulatory requirements. Rather it is the intention that when RSA is used in a standardized manner, the
results can be as useful and as widely applicable as possible.
INTERNATIONAL STANDARD ISO 16087:2013(E)
Implants for surgery — Roentgen
stereophotogrammetric analysis for the assessment of
migration of orthopaedic implants
CAUTION — The RSA method described in this International Standard requires the use of X-rays
and exposes the patient to a greater X-ray exposure dose with its associated health risk. Careful
consideration of the benefits and drawbacks of this method on a case by case basis is advisable.
1 Scope
This International Standard provides requirements for the clinical assessment of migration of
orthopaedic implants with roentgen stereophotogrammetric analysis (RSA).
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
absolute movement
movement of a rigid body relative to a fixed reference rigid body
2.2
accuracy
closeness of agreement between a measured quantity value and a true quantity value of a measurand
2.3
bias
estimate of a systematic measurement error
2.4
biplanar technique
RSA technique where two X-ray cassettes/films/sensors are set at an angle to each other
2.5
calibration cage
calibration box
reference frame used to create a three-dimensional coordinate system, with definition of position and
orientation, and to determine the position of the two roentgen foci
2.6
condition number
calculated number used to assess the distribution of markers
Note 1 to entry: High condition numbers indicate poor marker distribution, while low condition numbers indicate
appropriate marker distribution.
Note 2 to entry: See Annex A, which establishes the methodology to determine the condition number associated
with the marker distribution.
2.7
crossing line error
shortest distance between the two X-rays projecting the centre of a marker in the two RSA images
2.8
double examinations
two RSA examinations of the same patient within an interval of several minutes
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.