National spine surgery registries' characteristics and aims: globally accepted standards have yet to be met. Results of a scoping review and a complementary survey

Simona Pascucci; Francesco Langella; Michela Franzò; Marco Giovanni Tesse; Enrico Ciminello; Alessia Biondi; Eugenio Carrani; Letizia Sampaolo; Gustavo Zanoli; Pedro Berjano; Marina Torre

doi:10.1186/s10195-023-00732-4

National spine surgery registries' characteristics and aims: globally accepted standards have yet to be met. Results of a scoping review and a complementary survey

J Orthop Traumatol. 2023 Sep 16;24(1):49. doi: 10.1186/s10195-023-00732-4.

Authors

Affiliations

¹ Scientific Secretariat of the President's Office, Italian National Institute of Health, Istituto Superiore di Sanità, Viale Regina Elena, 299, 00161, Rome, Italy.
² Department of Mechanical and Aerospace Engineering, La Sapienza University of Rome, Rome, Italy.
³ IRCCS Ospedale Galeazzi-Sant'Ambrogio, Milan, Italy.
⁴ Department of Medico-Surgical Sciences and Biotechnologies, Rome, Italy.
⁵ Orthopaedics Section, Department of Neuroscience and Organs of Sense, Faculty of Medicine and Surgery, University of Bari, AOU Consorziale Policlinico, 70124, Bari, Italy.
⁶ National Centre for Disease Prevention and Health Promotion, Italian National Institute of Health, Rome, Italy.
⁷ Casa Di Cura Santa Maria Maddalena, Occhiobello, Italy.
⁸ Scientific Secretariat of the President's Office, Italian National Institute of Health, Istituto Superiore di Sanità, Viale Regina Elena, 299, 00161, Rome, Italy. marina.torre@iss.it.

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.

Keywords: Back pain; Medical device; Musculoskeletal disease; Registry; Review; Spine.

Publication types

Review

MeSH terms

Databases, Factual
Humans
Patient Reported Outcome Measures*
Physical Examination
Registries
Spinal Diseases* / epidemiology
Spinal Diseases* / surgery