Across the globe live 20–33% of people with a painful musculoskeletal condition: that diseases are the second largest contributor to disability worldwide and affect people across the life-course in all regions of the world. While the prevalence of musculoskeletal conditions increases with age – and it is predicted to rise as the global population ages -, younger people are also affected.
In case of hip or knee affections, it is widely reported in the scientific literature that joint replacements improve the patients’ quality of life, restoring joint function and reducing pain.
A significant increase in joint replacement procedures is observed in Italy, as well as in other countries. Procedures have been increasing from 103,000 in 2001 to 190,000 in 2016 (source: Italian Ministry of Health. Hospital Discharge Data 2001-2016). This huge number of procedures and their impact on the public health system drove the health authorities to support implementation of registries aimed at monitoring the use of the implanted devices, tracking the patient in case of failure and optimising the use of available resources.
In the late ‘70s, Scandinavian countries established national arthroplasty registries that have become a solid source of data for health researchers. Following the positive experiences of Scandinavia, since 2000, some Italian regions have independently organised registries for hip, knee, and shoulder arthroplasty, suggesting an extensions of the data collection at a national level. In 2005, all the regions agreed on the need of establishing a national registry organised as federation of regional registries coordinated by the Italian National Institute of Health (Istituto Superiore di Sanità, Iss).
The Iss represents the ideal setting for a centralized data collection because it has a consolidated know-how and it is the seat of many epidemiology registries dedicated to surveillance and monitoring of specific pathologies.
Since 2006, the Italian Ministry of Health – Directorate General of Medical Devices and Pharmaceutical Service – funded a series of studies coordinated by the Iss, first on hip and then on knee, shoulder and ankle replacements, with the aim of:
- analyse and map joint replacements at a national level, and propose a model to collect data
- test that model, based on the routinely collected hospital discharge data integrated by an additional minimum data set
- progressively enroll the regions, evaluating the possibility of introduce the use of Patient Reported Outcome measures to assess the quality of life in subsets of joint replacement patients.
The results achieved by the RIAP supported the inclusion of implanted medical devices registries among the surveillance systems considered by the National Law 17 December 2012 n. 221. However, the process for its coming into force requires the application of the subsequent Decree of the President of the Council of Ministers (DPCM) approved on March 3, 2017. The DPCM is an important policy measure meant to solicit and give birth to the Registry of implantable prostheses (national and regional). Following the DPCM implementation, the Regions will determine the regional reference centre that will guarantee the administrative, technical and IT management of the registry and the data ownership. Based on the DPCM, the choice should take into account any local centre already existing on the territory: the RIAP network can represent a valuable resource to this purpose.
- Musculoskeletal conditions. WHO, Fact sheet, February 2018