EAR Activities

• Definitions, Objectives:
The EAR is a project by EFORT to support quality control and development of artificial joint implants.

Arthroplasty Registers according to definition of EAR:
Registration of all primary and revision operations performed in a defined area, in revisions at least one component of the implant has to be changed. Central evaluation of the data focusing on survival analysis and influence factors for revision rate.

Definition of implant failure:
Revisions surgery and exchange of the implant or parts of it independent from the period of implantation and reason for revision.

The EAR is based on the successful philosophy of the Scandinavian Arthroplasty Registers, which has to be adapted on national circumstances.


• General Aims of Register Documentation:
• Long term follow up of all artificial joint implants used in a defined area and associated medical products (f. ex. bone cement) concerning revision rate, presented in Kaplan-Meier-analysis.
• Detection of inferior results as soon as possible.
• Publication of Reports and scientific discussion based on validated results
• Vigilance control of implants.
• Presentation of epidemiological data concerning arthroplasty.


• General Aims of the European Arthroplasty Register (EAR):
• Definition of common standards for data collection, data management and evaluations on European level to assure a high level of comparability of national register data.
• Development of register documentation and standardisation on highest level.
• Registration of larger number of different implants in higher number of cases than possible in single national registers.
• Comparison of different countries and different health systems concerning rate of revision.
• Support for national orthopaedic societies in development of National Arthroplasty Registers.
• Development of communication in medical societies and to the industry.
• Improvement of 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 a close cooperation between all departments performing arthroplasty surgery and to set up a register centre.
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 recommended.
To cover all aspects in data collection and to assure efficient publication to all relevant stakeholders a close cooperation between medical societies and public health authorities is recommended.


• Development of Register Documentation and Evaluation:

Basic Statements:
Differences in data handling and statistical procedures as well as differences in the used implants and circumstances in the national health systems lead to differences in the generalisation and comparison of National Arthroplasty Register reports.

A standardisation in data handling and statistical procedures would decrease these problems.
But it has to pointed out clearly, that National Arthroplasty Register reports are reflecting national circumstances and standards in the public health system.
Any generalisation of results to other countries or aggregation of data have to take this aspect into consideration. So results by a National Register will offer more valid information for national issues. National Registers can never be replaced by any other structure without loss on quality level.
On the other hand the volume of datasets concerning a single implant has high influence on the quality of evaluations. In every market there is a high number of implants, which are used in a relatively small amount.
In Sweden (Ref: Annual Report 2002) only 9 out of 158 cup implants and 7 out of 163 stem implants are used more than 100 times a year. Of course these implants are covering the majority of the market, but a high number of implants can not be assessed properly.
Revision implants or implants introduced recently on the market can be found in this group regularly. For these implants it might be reasonable to aggregate datasets from other national registers for quality control issues.

Evaluation:
All datasets are property of the National Arthroplasty Registers, so all steps of evaluations on supranational level need their approval.
For including national datasets in these evaluations first the validation of the national datasets is essential.
For these and other procedures the European Arthroplasty Register Scientific Committee (EAR-Scientific Committee) will decide on guidelines.

The definition of the implant can be updated by using lot number 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 to assess potential failures more in detail, even on level of single lots. This would allow for example 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 soon as possible is a major goal for EAR in the mid term.

Cooperation:
To achieve these goals the inclusion of supranational political organisations like the European Union or the manufacturers will be recommended.
EAR offers its communication platform for negotiations and cooperation.

EAR is supporting the initiative to set up an International Register Society to define worldwide standards and to support publication of interesting Register results worldwide.


• Publication
EFORT-EAR has set up a register section at the EFORT Portal to link worldwide Arthroplasty Register homepages on a single address.
We hope this will offer the enormous amount of information by Arthroplasty Registers in a user friendly way.
http://www.efort.org/E/05/01-50.asp

EAR will support publication activities at national and international congresses concerning Arthroplasty Registers.


• EAR is supporting the development of National Arthroplasty Registers by know how transfer and consulting
• EAR is supporting National Arthroplasty Registers by central service when cooperation is useful and accepted