Arthroplasty Registry of Slovenia

The National Arthroplasty Registry of Slovenia (RES) is a registry aimed at monitoring implanted artificial hip and knee joints within the territory of the Republic of Slovenia. By tracking each artificial joint (endoprosthesis), we seek to determine the lifespan of a specific type of artificial joint (the time from insertion to revision). This way, we can select endoprostheses for implantation that are more suitable for our patients.

At the initiative of the leadership of the Slovenian Orthopaedic Society of Slovenian Medical Association (ZOSZD) and with the assistance of experts from the European Arthroplasty Registry of the European Federation of National Associations of Orthopaedics and Traumatology (EAR-EFORT), the Minister of Health established a working group in 2009 to establish the arthroplasty registry. In the working group, we defined the set of data collected in the RES. The set of data is in line with European recommendations. In 2010, the establishment of RES was halted due to a lack of funds and also due to unregulated legislation.

In 2013, within the framework of the European project PARENT, coordinated by the Slovenian National Institute of Public Health (NIJZ), an initiative was made to revive RES. NIJZ, with the consent of ZOSZD, partnered with the Valdoltra Orthopaedic Hospital (OBV). The final product of this pilot project was the RES application for hip endoprostheses in OpenEHR format.

To regulate the legal and financial status of the RES registry, ZOSZD and OBV jointly applied to the Health Council (ZS) of the Ministry of Health on June 26, 2017, for the approval of the new state health program RES. The Extended Professional Collegium for Orthopedics also provided a positive opinion on the professional justification of the application in its entirety. On December 8, 2017, we received a request for application supplementation. All the requested supplements were submitted by ZOSZD and OB Valdoltra to ZS on November 14, 2018, and again on April 12, 2019. On March 9, 2020, the Health Council issued a resolution stating that The National Arthroplasty Registry of Slovenia (RES) is meaningful from a medical perspective and acceptable from a financial perspective. The Health Council approves the application and places it on the ranked list of applications for inclusion in the General Agreement. Funding from the General Agreement started on October 1, 2019.

With the amendment to the Act on Data Collections in the Field of Health Care (ZZPPZ-B), published in the Official Gazette No. 34 on May 4, 2018, the Valdoltra Orthopaedic Hospital was designated as the manager of The National Arthroplasty Registry of Slovenia (RES). This provided RES with a legal basis for its operation.

Since its establishment in January 2019, all entities performing knee and hip arthroplasty activities in the Republic of Slovenia have been obliged to provide data on performed operations. This data is prescribed on designated forms and then digitized. The data is either transmitted directly to the database in electronic form or on paper in an agreed standard format that the manager obtains from healthcare providers. The manager can also obtain relevant data for the database from all other databases based on the connecting unique identifier number (EMŠO) or the number of the insured person - the Institute for Health Insurance of the Republic of Slovenia (ZZZS) number.

The RES database is maintained for:

• Monitoring the survival of inserted hip and knee endoprostheses,
• Ensuring quality control of endoprosthetic surgeries,
• Facilitating rapid detection of lower-quality endoprostheses,
• Indirectly reducing the costs of primary and revision surgeries for hip and knee endoprostheses,
• Serving as a basis for clinical and epidemiological studies, professional analyses and providing data for the Central Registry of Patient Data (CRPP).

The RES contains basic data about the patient who has had an endoprosthesis of the hip or knee joint or its part inserted or removed. Additionally, the RES includes data about the provider, data about the implanted parts of the endoprosthesis, data about the surgery, and data about any previous surgery in case of removal of a previously inserted endoprosthesis or its part. On July 14, 2021, the Ministry of Health added to RES the collection of quality-of-life Patient Reported Outcome Measures (PROMs) questionnaires, specifically the Oxford Hip and Oxford Knee Score and EQ-5D-5L questionnaires. Preoperative forms are collected in paper form by individual hospitals. Digitization is carried out concurrently with the digitalization of the RES registry itself, as patients are prompted to complete quality-of-life questionnaires over the phone or in writing 6 and 12 months after surgery. The data in the RES is stored permanently.