Background: The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformité Européenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes. Methods: Regional, national and multi-country European cardiovascular (coronary stents and valve repair/replacement) and orthopaedic (hip/knee prostheses) registries were identified using a systematic literature search. Annual reports, peer-reviewed publications, and websites were reviewed to extract publicly available information for 33 items related to structure and methodology in six domains and also for reported outcomes. Results: Of the 20 cardiovascular and 26 orthopaedic registries fulfilling eligibility criteria, a median of 33% (IQR: 14%-71%) items for cardiovascular and 60% (IQR: 28%-100%) items for orthopaedic registries were reported, with large variation across domains. For instance, no cardiovascular and 16 (62%) orthopaedic registries reported patient/ procedure-level completeness. No cardiovascular and 5 (19%) orthopaedic registries reported outlier performances of devices, but each with a different outlier definition. There was large heterogeneity in reporting on items, outcomes, definitions of outcomes, and follow-up durations. Conclusion: European cardiovascular and orthopaedic device registries could improve their potential as data sources for regulatory purposes by reaching consensus on standardised reporting of structural and methodological characteristics to judge the quality of the evidence as well as outcomes.

To create a translated version of the HOOS to fit the Italian population and to test its psychometric properties and validity in hip osteoarthritis (OA) patients undergoing total hip arthroplasty (THA). The HOOS Italian version was developed according to published international guidelines that include preparation, forward translation and reconciliation, backward translation, review and harmonization, and proof reading. The Italian HOOS was administered to 145 patients (mean age 65.7 ± 11.6 years, 34–89, 58.6% women) undergoing THA. The following psychometric properties were evaluated: internal consistency (Cronbach’s alpha); test-retest reliability (Pearson’s r and intra-class correlation coefficient, ICC); convergent validity (Spearman’s rho between HOOS and SF-36); responsiveness (comparison of pre/post-THA scores, Wilcoxon signed rank test). Interpretability (floor and ceiling effects, skewness and kurtosis indexes) and acceptability (time to compiling, missing answers, and autonomy in compilation) were also evaluated. Translation and transcultural adaptation were conducted in accordance with the international recommendation. The translation was deemed understandable and appropriate as to the transcultural adaptation. None of the patients reported to have met any difficulties in reading and understanding the HOOS items. Internal consistency and test-retest reliability were good for each HOOS subscale (Cronbach’s alpha ≥0.7, Pearson’s r and ICC > 0.80). Convergent validity showed the highest correlations (Spearman’s rho > 0.5) between HOOS and SF-36 subscales relating to similar dimensions. As to responsiveness, all HOOS subscales scores improved significantly after THA (p < 0.01). Interpretability was acceptable despite ceiling effect in post-THA assessment. Acceptability was good: HOOS resulted easy and quick to fill out (12 min on average). The HOOS was successfully cross-culturally adapted into Italian. The Italian HOOS showed good psychometric properties therefore it can be useful to assess outcomes in OA patients after THA. This study provided a basis for its use within the Italian Arthroplasty Registry and for future clinical trials.

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.

Purpose Arthroplasty registries have an important role in improving outcomes in joint surgery. As the demand for joint arthroplasty continues to increase, growing attention is being paid to the establishment of national registries, which contribute to the enhancement of the quality of patients' care. Indeed, providing postmarketing surveillance data in terms of safety and effectiveness of medical devices, registries contribute to the best orthopaedic practice and support public health decision making. In this context, a project aimed at implementing a national arthroplasty registry in Italy has appeared to be essential, and the activities performed in the last years have consolidated data collection of hip and knee replacements. Methods Based on a close cooperation among public health institutions, clinicians, and involved stakeholders, the architecture of the registry is built on three pillars: (1) data collected using Hospital Discharge Records (HDRs) integrated by an additional dataset, (2) implants identified and characterized in a dedicated medical devices library, and (3) a federation of regional registries coordinated by a public health institution, the Italian National Institute of Health. Results Besides the organizational structure, statistical analyses on joint arthroplasty from national HDR database (2001–2014) and Italian registry data (2014) are presented. Currently, the institutions participating in the registry on a voluntary basis show 80% of completeness for hip and 58% for knee, and represent approximately 18% of the national volume. Conclusion To make data collection effective, participation should be mandatory and ruled by a national law. Level of Study Level III, observational analytic study. ^† Luisa Leone passed away on October 16th, 2014.

Background and purpose: National joint replacement registries were developed for prospective monitoring of outcomes and post-market surveillance of implants. Increasingly registry data informs practice. However, analysis of a registry can only be as good as the data it captures on the population of interest. We aimed to analyze completeness of reporting of hip and knee replacement procedures for all national registries worldwide.Methods: We analyzed annual reports and data provided following written requests to all active national hip and knee replacement registries. Coverage was defined as the proportion of hospitals in the country that participate in the registry. Procedure completeness was defined as the proportion of procedures successfully captured by the registry.Results: 14 national registries were included, spanning years 2004 to 2022. Coverage was complete in 10. Median procedure completeness for primary hip and knee replacement across all years was 96.5% (interquartile range [IQR] 94.0–97.7%). Median procedure completeness for revisions was 88.5% (IQR 81.0–92.5%). The terminology used and method of calculation of completeness estimates in the registries were variable.Conclusion: National hip and knee replacement registry data generally reflects excellent coverage (full in 10 of 14 registries) and completeness (primary procedures 96.5% and revisions 88.5%) over the last 2 decades.

Before a high-risk medical device is approved for implantation into patients, there should be evidence not only of its performance and safety with a favourable benefit-risk ratio, but also of its clinical efficacy. Regulatory guidance on study methodologies is lacking, however, so the European Commission funded the CORE–MD project (Coordinating Research and Evidence for Medical Devices) to advise regulators on appropriate designs for clinical trials of high-risk devices. The CORE–MD consortium recommends that evaluation should be planned in four stages. Randomised controlled trials should be performed more often, against active comparators reflecting the best available treatment, or using sham interventions with ethical safeguards. Large trials can be managed efficiently using an electronic database or registry. Non-randomised clinical studies can apply objective performance criteria or other validated patient-relevant outcome measures, with adjustments to minimise bias. Full transparency of results from clinical investigations is essential. Proportionate regulation of breakthrough or orphan devices for independently-defined serious unmet needs may involve approval with less evidence, but on condition of subsequent confirmatory studies. These CORE–MD consensus proposals have been submitted to European Union medical device regulators, to be considered as a basis for more transparent and predictable requirements for clinical evidence. The CORE–MD project was funded as a Coordination and Support action from the 10.13039/501100000780 European Union 10.13039/501100007601 Horizon 2020 research and innovation programme, under grant agreement 965246.