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New Orthopaedic Implant Management Tool For Computer Assisted Planning Navigation and Simulation From Implant CAD Files To A Standardized XML Based
New Orthopaedic Implant Management Tool For Computer Assisted Planning Navigation and Simulation From Implant CAD Files To A Standardized XML Based
New Orthopaedic Implant Management Tool For Computer Assisted Planning Navigation and Simulation From Implant CAD Files To A Standardized XML Based
To cite this article: S. Sagbo, F. Blochaou, F. Langlotz, C. Vangenot, L.-P. Nolte & G. Zheng
(2005) New orthopaedic implant management tool for computer-assisted planning, navigation,
and simulation: From implant CAD files to a standardized XML-based implant database, Computer
Aided Surgery, 10:5-6, 311-319, DOI: 10.3109/10929080500389803
Abstract
Computer-Assisted Orthopaedic Surgery (CAOS) has made much progress over the last 10 years. Navigation systems have
been recognized as important tools that help surgeons, and various such systems have been developed. A disadvantage of
these systems is that they use non-standard formalisms and techniques. As a result, there are no standard concepts for
implant and tool management or data formats to store information for use in 3D planning and navigation. We addressed
these limitations and developed a practical and generic solution that offers benefits for surgeons, implant manufacturers,
and CAS application developers. We developed a virtual implant database containing geometrical as well as calibration infor-
mation for orthopedic implants and instruments, with a focus on trauma. This database has been successfully tested for
various applications in the client/server mode.
The implant information is not static, however, because manufacturers periodically revise their implants, resulting in the
deletion of some implants and the introduction of new ones. Tracking these continuous changes and keeping CAS systems up
to date is a tedious task if done manually. This leads to additional costs for system development, and some errors are inevi-
tably generated due to the huge amount of information that has to be processed.
To ease management with respect to implant life cycle, we developed a tool to assist end-users (surgeons, hospitals, CAS
system providers, and implant manufacturers) in managing their implants. Our system can be used for pre-operative planning
and intra-operative navigation, and also for any surgical simulation involving orthopedic implants. Currently, this tool allows
addition of new implants, modification of existing ones, deletion of obsolete implants, export of a given implant, and also
creation of backups.
Our implant management system has been successfully tested in the laboratory with very promising results. It makes it
possible to fill the current gap that exists between the CAS system and implant manufacturers, hospitals, and surgeons.
Keywords: CAD files, orthopedic implant management system, XML implant file, XML database, virtual reality, planning,
navigation, simulation, unified interface, computer-aided surgery
Correspondence: Serge Sagbo, MEM Research Center for Orthopaedic Surgery, Institute for Surgical Technology and Biomechanics,
University of Bern, Stauffacherstrasse 78, CH-3014 Bern, Switzerland. Tel: þ41 31 631 59 55. Fax: þ41 31 631 59 60. E-mail:
serge.sagbo@memcenter.unibe.ch
ISSN 1092-9088 print=ISSN 1097-0150 online #2005 Taylor & Francis
DOI: 10.1080=10929080500389803
312 S. Sagbo et al.
interface [8], and could be used with any navigation remains one of the main challenges in orthopedic
application. surgery. Taylor et al. [12] presented the
A database has been established containing various ROBODOC system (Integrated Surgical Systems,
virtual representations of osteosynthesis implants Davis, CA, USA) for performing THR. With this
and anchoring devices for fracture reduction and fix- device, the surgeon plans the surgery from patient-
ation, as well as images of various prostheses for total specific pre-operative data to determine which
joint replacement (knee and hip). This database can implant design and size to use and the desired
be browsed for details of any stored virtual implant. placement of the implant relative to the patient’s
In its current implementation, the provided interface anatomy. Bächler et al. [13] have presented a system
supports the planning and navigation parameters of for computer-aided biological fracture plate fixation
LISS and LC-DCP plates (Synthes, Westchester, using minimally invasive surgical techniques. It was
PA, USA), as well as searching functionalities (allow- proposed to extend this system using a fracture plate
ing search by implant size, manufacturer, bone part, database from different manufacturers and for differ-
or implant type). The system has been successfully ent surgical procedures. In addition, several groups
tested for several computer-assisted orthopedic have proposed techniques for finding the best
surgery applications [7,9]. The aim was to evaluate implant based on virtual fluoroscopy. [2,6,14–18].
integration issues, network access, speed, and usabil- Wu et al. [19] concluded that a CAS procedure
ity. The implant information is not static, however, usually involves different information from different
because manufacturers periodically revise their sources. Therefore, the integration of a CAS,
implants, resulting in the deletion of some implants Computer Aided Design (CAD), and Computer
and the introduction of new ones. Tracking these Aided Manufacture (CAM) interface enables optim-
continuous changes and keeping CAS systems up ization of pre-operative planning, taking into
to date is a tedious task if done manually. This consideration not only medical but also technical
leads to additional costs for system development, boundary conditions.
and some errors are inevitably generated due to the The major weaknesses of these systems are data
huge amount of information that has to be processed. exchange problems, the lack of a standardized
To overcome these limitations and improve the implant storage format, security issues (file corrup-
current implant management process in CAS, we tion, simultaneous access problems), and the lack
designed and developed, on top of our existing of real-time sharing of implant data. Our graphically
Virtual Implant Database, a graphical administration based administration tool for implant management
tool which aims to help surgeons, implant manufac- and the concept of using XML to standardize
turers, and CAS system providers easily administer orthopedic implants using a database is a novel
the implant database. With respect to confidentiality concept in CAS.
and security issues required for medical data, the tool
has been designed with additional security mecha-
Materials and methods
nisms and ergonomic considerations. Moreover, no
database or Structured Query Language (SQL) The work presented here is part of the CARIM
knowledge is needed by the end-users. Our initial (Computer Assisted Reduction and Imaging) project
laboratory tests yielded successful results, and [20]. The aim was to establish a virtual implant data-
improvements are planned, along with more exhaus- base containing geometrical as well as calibration
tive tests involving surgeons, manufacturers, and information for orthopedic implants and instru-
CAS system providers. ments. This should allow different surgical navigation
applications to navigate any number of different types
of implants from this database (Figure 1).
Related work
We constrained our method to respect data
To our knowledge, there has been no research on exchange standard and development formalisms.
providing a virtual implant database as a global and We then used the Unified Modeling Language
generic rapid application development (RAD) frame- (UML) [21] to capture and describe our implant
work. Most of the existing CAS systems are based on domain specification. We used Qt (Trolltech, Oslo,
proprietary file-based solutions for implant manage- Norway) [22] for our graphical user interface (GUI)
ment [10]. Little work has been published dealing development and Coin3D (Systems in Motion,
with implant selection tools or proprietary implant Oslo, Norway) [23] for the 3D object manipulation.
databases. MySql (MySQL AB, Uppsala, Sweden) [24] and
Jaramaz and DiGioia [11], in the context of total Caché database (InterSystems, Cambridge, USA)
hip replacement (THR), proposed techniques for [25] were used for storage. Our customized Implant
choosing the correct implant size. They also showed XML engine was built on top of the Qt Document
that correct implant positioning and alignment Object Model (DOM) library [22]. To achieve the
Orthopaedic implant management tool 313
Figure 1. Virtual implant database: system overview. Various implant types and CAS systems are supported. (color version available online)
goals mentioned above, we adopted the following connect to the database, search implants,
methodology (Figure 2). preview implant parameters (including 2D
images and 3D models), and insert – , update –,
1. Virtual implant database design. All implants are delete and backup implants.
stored in a database containing tables and their 3. Implant XML file structure. A well-defined
relationships, which handle implant planning CAS-compliant XML implant file is generated
and navigation parameters and also various from the implant CAD files. The first part of
virtual representations of osteosynthesis the XML file describes the general parameters
implants and anchoring devices. common to all implants, whereas the second
2. Unified Implant Access Interface. An application part describes the specific parameters for that
programming interface (API) is provided implant type.
between the database and the client appli- 4. Customized implant XML engine. A custom
cations and acts as a communication channel XML engine (XMLImplantReader and
[8]. This layer provides main functionalities to XMLImplantWriter) has been developed and
helps in loading XML files in the database or Each implant table is organized in two parts: the
exporting implants from the database to a first part contains fields describing the generic par-
given XML file. ameters common to all implants (e.g., the implant
5. Graphical user interface. An advanced GUI allows name, description, manufacturer, etc.), whereas the
the end-users (CAS system providers, hospital, second part describes specific parameters with
and manufacturers) to manage implants. Our respect to implant category (Figure 3). The novelty
system workflow is organized in three stages: of our concept is that we created generic objects to
first, the user carries out actions while clicking handle various implant types. The information
buttons in the interface. These actions are refor- required to add implants to our database depends
mulated in SQL requests in the interface layer. on the implant category and type (e.g., plate, screw,
The requests are then sent to the database nail, etc.).
server, which treats them and returns the The implant manufacturers provided us with the
results of the requests. Each step will be following:
described in more detail in the following sections.
. Implant geometry (3D model, shape descrip-
tion, and principal dimensions);
Virtual implant database design
. Reference points used for navigation:
We used the entity –relationship principle [26] (the W For implants where holes are important
core principle of relational database systems) to (e.g., plates), we used information such as
design the tables and relationships that describe our the center, axis, and orientation of each hole;
orthopedic implant domain. We first designed the W For spherical implants with a center (e.g., hip
implant category table which handles the various cups), we used the geometrical center and
implant categories routinely used by surgeons geometrical axis;
during orthopedic operations: plates, screws, and W For implants with an alignment plane (e.g.,
nails for trauma surgery; hip and knee components hip stems), we used points defining the align-
for prosthetic operations. ment plane or alignment axis.
System interface design and implementation We used specific tools such as VoloView (Auto-
desk, San Rafael, CA, USA) to extract the relevant
Our implant database system is composed of three
planning and navigation information and to provide
main parts: the implant data storage component,
this as input to our developed tool. XML implant
the core processing component, and the published
files are then generated and inserted in our database.
interface (Figure 4). The storage component
handles the structure, relationships, and rules
between implants (e.g., which plate can be used Customized implant XML engine
with which screw). The implementation has been To transfer implant data from XML files to a
done on top of a well-known database management database, we need to map the XML document
system (MySQL database system and Caché schema (DTD, XML Schemas, etc.) to the database
system). The core processing component manages schema. The data transfer software is then built on
network, data processing, and security issues. The top of this mapping [27]. We first parse and check
published interface will allow any CAS application the validity (syntax checking and well-formed
to access implants easily. It acts as a communication validity) of the given XML implants files using our
channel between the implant database and the CAS customized implant reader engine. XMLImplant-
applications or end-users. Two actions are necessary Reader opens XML files and builds in memory the
to access implants: connection with a valid login and corresponding document tree. The output of our
search for the best-fitting implant or insert/update/ XML reader is a collection of implant objects with
delete if administration rights have been granted. their attributes that can be manipulated to insert
data in the database.
XML implant file design We also developed a writer component, XML
ImplantWriter, which reads data from the database,
Three-dimensional CAD files do not provide a struc- builds in memory the corresponding implant object,
tured, easy-to-process, and interchangeable standard and generates an implant file according to the
that can be handled by CAS developers (for implant implant category and type.
planning and navigation) without a tedious and
manual conversion process. To overcome this
GUI for implant management
problem, we chose to use Virtual Reality Modeling
Language (VRML) for 3D implant mesh represen- One of the main advantages of our system is that the
tation and Autocad DXF format for 2D engineering end-users do not need to know about the underlying
drawings. To ease inter-operability between CAS design and implementation techniques. SQL knowl-
systems and to allow exchange of data and expertise edge is not required either: users can easily manage
among the medical research community, we designed their implants without typing SQL requests. The
a structured XML implant file with reference to user’s interaction with the system can be summarized
several viewing modalities (2D image, 3D model, in three stages (Figure 6):
etc.). This XML file is currently generated based
on information received from implant manufacturers 1. The user carries out actions through the graphi-
and is dependent on implant type (Figure 5). cal interface.
Results
We have successfully achieved the initial goals for the
implant management tool. We developed a GUI-
based application that, in a semi-automatic manner,
helps surgeons, implant manufacturers, and CAS
system developers to continuously keep their systems
up to date for clinical use. In doing this, we also devel-
oped a new XML implant standard that eases inter-
operability and data sharing and provides a close link
between manufacturers, CAS system providers, and
surgeons. The main functionalities provided are
available components (hip cup, stem, head, etc.). tool is built on top of a virtual implant database, we
Our advanced search functionality is intended to first provided an overview of this new concept and pre-
provide a filter combination based on existing sented our new implant management concept centered
relationships, constraints, and clinical rules between around the presented administration tool. After evalu-
implants. For the case shown in Figure 7, the ation of existing database management systems, we
search starts by selecting the anatomy part (e.g., designed and deployed a multi-platform implant data-
tibia, femur, etc.). As a result, only implants designed base that addressed the current limitations of existing
for those specific anatomy parts are displayed. We CAS systems with regard to the way in which implants
can then apply a precise filter such as implant are managed. Our implant interface provides CAS
manufacturer or implant category. Depending on applications with simultaneous communication and
the implant type, we can iteratively continue the search algorithms for implants. The delivered solution
filtering process using criteria such as desired is manufacturer- and CAS-system-independent. Our
implant length, plate hole number, etc. While click- tests show that our concept enables and facilitates the
ing on a plate in the result list, our system automati- rapid integration of orthopedic surgical devices into
cally finds the fixation devices (e.g., screws) that can planning and navigation systems [7–9], thanks to the
be used with this plate. Two- and three-dimensional standard communication interface provided between
views are also provided for visual feedback. the CAS and the implant management systems. We
Delete obsolete implant from database. The function currently support osteosynthesis plates [9], screws,
delete allows users to remove obsolete implants from nails and hip prostheses (stems, cups, and heads). Inte-
the database. The workflow is similar to the backup gration of knee prosthesis components is ongoing. The
functionality described above, with the difference delivered solution can be used on Linux, Windows,
that the selected implants will be deleted from the and Solaris operating systems.
database. Validation tests have been successfully carried out
with long-bone fracture-reduction planning software
and digital template planning software (both deve-
Discussion loped at our Institute). The intention of the tests
We have presented a graphically based implant was to evaluate integration issues, network access,
management tool for use with a computer-assisted speed, and usability of our system within CAS
orthopedic planning and navigation system. As this systems (Figure 8). Moreover, a virtual implant
Figure 7. Advanced search finds the best plates and the corresponding fixation devices.
318 S. Sagbo et al.
Figure 8. Integration tests with CAS: a 3D implant model (left) or a 2D implant contour image of a LISS plate (right) is selected from our
database. [Left: X. Dong and V. Vitanis, 2003; Right: C. Anderegg, 2003.] (color version available online)
browser system was developed for multi-purpose systems, expert systems, knowledge-based
demonstrations (Figure 9). systems, and data mining techniques.
During this project, several lessons have been
learned from a clinical and software design point of Conclusion
view. This project is still under development, and
Our proposed solution is a new concept that
the following additional features and research topics
addresses the limitations of existing CAS systems
will be addressed in the near future:
with regard to orthopedic implant management.
. Improving the GUI for routine use by adding Compared with existing solutions, our approach has
additional functionalities, such as ‘undo’, after many advantages: data reusability, security mechan-
a delete action. isms, a robust database system, client/server archi-
. Processing more implants using our tool and tecture, ease of use, and a framework for RAD
making quantitative performance measurements. which allows CAS application developers to focus
. Investigating the fully automatic process by more on surgical procedures.
linking our system with CAD tools and directly The implant management tool presented here is a
processing implant data (e.g., by integrating a new application that addresses the current limitations
DXF parser in our design) and storing the and fills the gaps between the hospital’s available
implant files in a native XML database. CAS system implants and the implants provided by
. Validation of surgical efficiency in collaboration the manufacturers. Laboratory tests of the system’s
with surgeons, manufacturers, and CAS usability and efficiency have been successful. Some
developers. improvements are planned to allow for fully auto-
. Improvement of search functionalities, addition mated implant XML file generation directly from
of intelligence by exploring rules-based database CAD files received from implant manufacturers.