The European Arthroplasty Register (EAR) is a voluntary cooperation of
independent National Arthroplasty Registers.
EAR is an EFORT project organised in the EFORT-affiliated scientific society
Definitions and Objectives
The European Arthroplasty Register (EAR) is a project by EFORT to support
quality control and the development of artificial joint implants.
Goals and organisation of Arthroplasty Registers according to definition
- Registration of all primary and revision operations performed in a
- Definition of Revision:
At least one component of the implant has to be changed.
- Central evaluation
of the data focusing on survival analysis and influence factors for
- Definition of Implant Failure:
Revision surgery and exchange of the implant or parts of it independent
of the period of implantation and reason for revision.
The European Arthroplasty Register (EAR) is based on the successful philosophy
of the Scandinavian Arthroplasty Registers, which has to be adapted to
the particular national circumstances of each individual country’health
General Aims of Register Documentation
- Long-term follow-up of all artificial joint implants used in a defined
area and associated medical products (e.g. bone cement) concerning the
revision rate, presented using Kaplan-Meier analysis;
- Detection of inferior results as early as possible;
- Publication of Reports and scientific discussion based on validated
- Vigilance control of implants;
- Presentation of epidemiological data concerning arthroplasty.
General Aims of the European Arthroplasty Register (EAR)
- To define of common standards for data collection, data management
and evaluations at European level to ensure a high level of comparability
of national register data;
- To develop of register documentation and standardisation on the highest
- To perform supranational evaluations of implants when useful;
- To compare different countries and different health systems with respect
to rate of revision;
- To support National Orthopaedic Societies in the development of National
- To develop communication in medical societies and with the industry;
- To improve communication concerning register reports
Organisation of National Arthroplasty Registers
The basic and crucial characteristic of National Registers is the aim
to cover all patients and surgical procedures.
To achieve this goal, it is essential to build up close cooperation among
all departments performing arthroplasty surgery, and to set up a register
To assign revision surgery to a specific patient and a primary operation,
it is necessary to document individual personal data like social insurance
codes. To deal with this kind of sensible data, legal support is required.
To cover all aspects in data collection and to assure efficient publication
to all relevant stakeholders, close cooperation between medical societies
and public health authorities is recommended.
Development of Register Documentation and Evaluation
Differences in data handling and statistical procedures, as well as differences
with regard to the implants used and the specific circumstances in the
various national health systems lead to differences in generalisation
and comparison of National Arthroplasty Register reports.
Standardisation in data handling and statistical procedures would reduce
However, it should be made clear that National Arthroplasty Register reports
always reflect national circumstances and standards in the public health
This aspect must be taken into account in any generalisation of results
for other countries or aggregation of data. Thus, results of a National
Register by definition offer more valid information for national issues.
National Registers can never be replaced by any other structure without
loss on the data quality level.
On the other hand, the volume of datasets concerning a single implant
highly influences the quality of evaluations. In every market there are
a significant number of implants that are used in relatively small quantities.
In Sweden (Ref: Annual Report 2002), for example, only 9 out of 158 cup
implants and 7 out of 163 stem implants are used more often than 100 times
a year. Of course these implants cover the majority of the market, but
a large number of implants cannot be assessed properly. Revision implants
or implants recently introduced on the market are regularly found in this
group. For these implants it may be reasonable to aggregate datasets from
other national registers for outcome measurement and quality control issues.
All datasets are the property of the National Arthroplasty Registers.
Therefore, all steps of evaluations on a supranational level require
Validation of national datasets is a prerequisite for their inclusion
in such evaluations. The European Arthroplasty Register Scientific Committee
(EAR Scientific Committee) is going to decide
on guidelines for these and other procedures.
Implant definition and identification can be based on lot numbers and
standardised catalogue numbers (i.e. EAN numbers). EAR is in negotiations
to set up a standardised list covering the entire market.
Implant tracking based on this advanced system would allow more detailed
assessment of potential failures, even on the level of single lots. This
would, for example, allow for the detection of problems in the manufacturing
process or raw materials.
Based on this level of data, the development of an early warning system
to detect increased numbers of revisions as early as possible is a major
medium-term goal of EAR.
To achieve these goals, it is advisable to involve supranational political
organisations like the European Union and the manufacturers in the process.
EAR offers its communication platform for negotiations and cooperation.
EAR endorses the initiative to set up an International Society of Arthroplasty
Registeries (ISAR) to define worldwide standards and to support the publication
of interesting Register results worldwide.
EFORT-EAR has set up a register section at the EFORT Portal to link worldwide
Arthroplasty Register homepages at a single address. This makes the enormous
amount of information provided by Arthroplasty Registers accessible in
an easy and user-friendly way.
Apart from its own publications, EAR supports Arthroplasty Registers’
publication activities at national and international congresses.
In addition, EAR supports the development of National Arthroplasty Registers
by know-how transfer and consulting, as well as by providing central services
when useful and accepted.