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 EFORT-EAR.

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 of EAR:

• Registration of all primary and revision operations performed in a defined area.
• 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 revision rate.
• 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 system.

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 results ;
• 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 possible level;
• 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 Arthroplasty Registers;
• 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 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 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

Basic Statements

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 these limitations.
However, it should be made clear that National Arthroplasty Register reports always reflect national circumstances and standards in the public health system concerned.
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.

Evaluation

All datasets are the property of the National Arthroplasty Registers. Therefore, all steps of evaluations on a supranational level require their approval.
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.
Cooperation
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.


Publication

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.