Abstract

Background

Surgery involving implantable devices is widely used to solve several health issues. National registries are essential tools for implantable device surveillance and vigilance. In 2017, the European Union encouraged Member States to establish “registries and databanks for specific types of devices” to evaluate device safety and performance and ensure their traceability. Spine-implantable devices significantly impact patient safety and public health; spine registries might help improve surgical outcomes. This study aimed to map existing national spine surgery registries and highlight their features and organisational standards to provide an essential reference for establishing other national registries.

Methods

A scoping search was performed using the Embase, PubMed/Medline, Scopus, and Web of Science databases for the terms “registry”, “register”, “implantable”, and all terms and synonyms related to spinal diseases and national registries in publications from January 2000 to December 2020. This search was later updated and finalised through a web search and an ad hoc survey to collect further detailed information.

Results

Sixty-two peer-reviewed articles were included, which were related to seven national spine registries, six of which were currently active. Three additional active national registries were found through the web search. The nine selected national registries were set up between 1998 and 2021. They collect data on the procedure and use patient-reported outcome measures (PROMs) for the follow-up.

Conclusion

Our study identified nine currently active national spine surgery registries. However, globally accepted standards for developing a national registry of spine surgery are yet to be established. Therefore, an international effort to increase result comparability across registries is highly advisable. We hope the recent initiative from the Orthopaedic Data Evaluation Panel (ODEP) to establish an international collaboration will meet these needs.

Details

Title
National spine surgery registries’ characteristics and aims: globally accepted standards have yet to be met. Results of a scoping review and a complementary survey
Author
Pascucci, Simona 1 ; Langella, Francesco 2 ; Franzò, Michela 3 ; Tesse, Marco Giovanni 4 ; Ciminello, Enrico 5 ; Biondi, Alessia 5 ; Carrani, Eugenio 5 ; Sampaolo, Letizia 6 ; Zanoli, Gustavo 7 ; Berjano, Pedro 8 ; Torre, Marina 5   VIAFID ORCID Logo 

 Italian National Institute of Health, Istituto Superiore di Sanità, Scientific Secretariat of the President’s Office, Rome, Italy (GRID:grid.416651.1) (ISNI:0000 0000 9120 6856); La Sapienza University of Rome, Department of Mechanical and Aerospace Engineering, Rome, Italy (GRID:grid.7841.a) 
 IRCCS Ospedale Galeazzi-Sant’Ambrogio, Milan, Italy (GRID:grid.7841.a) 
 Department of Medico-Surgical Sciences and Biotechnologies, Rome, Italy (GRID:grid.7841.a) 
 University of Bari, AOU Consorziale Policlinico, Orthopaedics Section, Department of Neuroscience and Organs of Sense, Faculty of Medicine and Surgery, Bari, Italy (GRID:grid.7644.1) (ISNI:0000 0001 0120 3326) 
 Italian National Institute of Health, Istituto Superiore di Sanità, Scientific Secretariat of the President’s Office, Rome, Italy (GRID:grid.416651.1) (ISNI:0000 0000 9120 6856) 
 Italian National Institute of Health, National Centre for Disease Prevention and Health Promotion, Rome, Italy (GRID:grid.416651.1) (ISNI:0000 0000 9120 6856) 
 Casa Di Cura Santa Maria Maddalena, Occhiobello, Italy (GRID:grid.416651.1) 
 IRCCS Ospedale Galeazzi-Sant’Ambrogio, Milan, Italy (GRID:grid.416651.1) 
Pages
49
Publication year
2023
Publication date
Dec 2023
Publisher
Springer Nature B.V.
ISSN
15909921
e-ISSN
15909999
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2865417004
Copyright
© The Author(s) 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.