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Italian regions, autonomous provinces, and institutions currently enrolled in the Italian arthroplasty registry and procedure adopted for data collection.
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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 dat...
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Introduction
Along with the accumulating reports of autologous concentrated bone marrow (CBM) grafting for osteonecrosis of the femoral head (ONFH), the related medical device, a “point-of-care device” has also been recently developed. However, no study has confirmed the feasibility, safety, and efficiency of CBM grafting using a specific point-of-...
Citations
... The Periprosthetic joint infection (PJI) accounts for 15% of failed total hip arthroplasties (THAs) and for 25% of failed total knee arthroplasties (TKAs) [1]. PJI occurs after 2% of primary THA or TKA [2], which in absolute terms represents approximately 3000 cases in Italy annually [3]. This value is destined to increase following the expected raises in primary procedures performed [2,3]. ...
... PJI occurs after 2% of primary THA or TKA [2], which in absolute terms represents approximately 3000 cases in Italy annually [3]. This value is destined to increase following the expected raises in primary procedures performed [2,3]. Preoperative PJI diagnosis remains a clinical challenge, as there is no uniformly accepted gold standard, particularly when secondary to low virulence organisms or when the individual is immunocompromised. ...
Background: Periprosthetic joint infection (PJI) following total hip and knee arthroplasty remains an extremely challenging and relatively high complication. This study aims to develop, validate and evaluate the use of machine learning (ML) algorithm to predict PJI in patients undergoing revision arthroplasties. Methods: A comprehensive review of patients undergoing hip or knee revision arthroplasty from 1 January 2015 to 31 March 2021 was conducted. Clinical data coming from preoperative patients history, laboratory analysis and demographic characteristics of patients were screened. Final data have been used to train a Logistic Regression model with the aim of predicting PJI preoperatively. Results: 1360 patients were enrolled, 1141 in the aseptic cohort and 219 in the infected cohort were included. ML demonstrated good discriminatory performance in predicting PJI in the selected patients (area under the curve 0.770 ± 0.006 in the training set and 0.720 ± 0.057 in the test set), and identified 3 significant predictors of PJI. Conclusion: ML algorithm trained using preoperative clinical data accurately predicted PJI. The incorporation of ML models into preoperative assessment of patients undergoing prosthetic revision procedures are useful in providing specific risk assessment to aid individualised counselling, shared decision making and presurgical optimization.
... However, managing and establishing these registries can be challenging as data inadequacies and insufficiencies may arise, which require significant investments in terms of finances and human resources to ensure data accuracy and high-quality collection (2). Despite the need for mandatory participation in National Registries to obtain comprehensive data, many countries still rely on voluntary participation, which results in incomplete databases (3). The quality and completeness of such databases can also vary widely, both within and between countries (4). ...
Background and aims
Analysis of mortality from the national health registries and data from a specific central registry dealing with the implantation of pacemakers (REPACE) in Czech patients.
Methods and results
Retrospective observational analysis of pacemakers’ implantation in all Czech patients [ n = 82,791; 47,070 (56.9%) men, 75.9 ± 10.4 years old] between 2010 and 2021. Almost 114,000 pacemakers were implanted between 2010 and 2021, of which 27.9% were single-chamber, 67.4% were dual-chamber and 4.6% were biventricular. The annual number of implantations has been steadily increasing with a 6% annual decline in 2020 with increased mortality and reductions in care provided, likely related to COVID-19. The observed 5-year relative survival was 88.6% (overall survival 60.6%) and the 10-year relative survival was 75.9% (overall survival 32.7%). Causes of death 5ary according to the age of the patient. The highest difference 1n the reported numbers in the REPACE Registry did not exceed 2% in comparison with the National Register of Reimbursed Health Services.
Conclusion
This study followed all Czech patients with pacemaker’s implantation in between 2010 and 2021. The annual number of 1mplantations has been steadily 1ncreasing. Patients with implanted pacemakers had a significantly higher mortality than the average population. Number of patients in the registry corresponded almost perfectly with the National Register of Reimbursed Health Services.
... The Italian Arthroplasty Register reported 29,681 THA procedures (94.7% were primary THA and 84,6% were elective procedures) and 19,402 TKA procedures (94.6 % were primary TKA) during 2020 [2]. The number of THA and TKA procedures has increased on average by 4.2% each year since 2001 [3]. The rising number of hip and knee arthroplasties has allowed the development of advanced and less invasive surgical techniques, the improvement of perioperative course in order to achieve the shortest average length of stay (LOS) for hospitalization and a quicker resumption of daily activities, maintaining a low number of complications. ...
Background: The growth of arthroplasty procedures requires innovative strategies to reduce inpatients Length of Stay (LOS). This study aims to develop a machine learning prediction model that may aid to predict LOS after hip or knee arthroplasties. Methods: A collection of all the clinical notes of patients undergoing elective primary or revision arthroplasty from 1 January 2019 to 31 December 2019 was performed. The hospitalization has been classified as “Short LOS” if it was less than or equal to 6 days and “Long LOS” if it was greater than 7 days. Clinical data coming from pre-operative laboratory analysis, vital parameters, demographic characteristics of patients were screened. Final data have been used to train a Logistic Regression model with the aim of predicting short or long LOS. Results: Final dataset was composed of 1517 patients (795 “LONG”, 722 “SHORT”, p = 0.3196) with a total of 1541 admissions (729 “LONG”, 812 “SHORT”, p < 0.000). Complete model had a prediction efficacy of 78,99% (AUC 0.7899). Conclusions: Machine learning may facilitate day-by-day clinical practice predicting which patients are suitable for a shorter LOS, from those with a longer LOS in which a cautious approach could be recommended.
... coverage) is the first challenge: this data can easily be reached if spinal surgery centres are involved in data collection on a mandatory basis, as voluntary participation usually leads to low rates of coverage and completeness. Making data collection mandatory by law or linking data entry to reimbursements might overcome these issues [40,41]. Coverage data are available for only six registries; among them, the Swedish and Norwegian ones show the best recruitment performance, reaching peaks of 100%. ...
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.
... Although the study 33 did not control for confounding factors, a sound reason for the results difference was that the data we used were not cumulative revision rates for specific implants. Naïve analyses comparing registry countries to non-registry countries only, 32 or comparing the preregistry to the registry revision burden of a specific country only 13 are biased in that the systematic difference between the two country groups, 32 33 the spillover and technological progress effect, 13 32 33 and the systematic change in the registry period of both country categories were not assessed. 32 33 This study has some limitations. ...
Objectives
The association of joint replacement registries with outcomes such as revision burden is uncertain. This study aimed to evaluate whether joint replacement registries are associated with the burden of revision changes while controlling for confounders that could affect the association.
Design
A longitudinal study involving a combination of cross-sectional and time series data from 1980 to 2018. The study was a panel regression analysis using the difference-in-difference method.
Setting
Data from countries with joint replacement registries and countries without joint replacement registries were used. Registry data were obtained from joint replacement registries’ annual reports, while non-registry data were obtained from each included country’s pooled hospitals’ annual revision burden reported in the literature.
Outcome measures
Changes in revision burden from 1980 to 2018 was the outcome measure. The revision burden in the registry periods of registry countries was compared with the non-registry periods of registry and non-registry countries.
Results
Data were obtained from 12 registry periods and 8 non-registry periods. The average difference in revision burden in the registry periods of registry countries relative to the non-registry periods of registry and non-registry countries was statistically significant for hip, −3.80 (95% CI (−2.50 to −5.10); p<0.001) percentage points and knee, −1.63 (95% CI (−1.00 to −2.30); p<0.001) percentage points. This translates to a 19.30%, and 21.85% reduction in revision burden for hip and knee registries, for the whole sampling period.
Conclusion
Joint replacement registries are associated with a significant reduction in the burden of revision. Although revision burden reduces over time even without the registries, the establishment of joint replacement registries is associated with an increased reduction. The establishment of joint replacement registries in non-registry countries would be a worthwhile decision as it will further improve the outcomes of arthroplasty surgeries.
... Furthermore, the lack of incentives renders hospitals little interested in collaborating voluntarily. Some regions have introduced reimbursement schemes linked to the entry of registry data, rapidly achieving remarkable completeness percentages 8 . The issue of overwork for surgeons is a more complex topic. ...
Introduction. Arthroplasty registries are widely recognized as an effective tool, providing a constant flow of data that can guide the clinical practice of orthopedic surgeons. Despite their usefulness, their implementation in Italy has historically proved to be laborious. In fact, many surgeons are unwilling to participate, claiming as reason for this inertia the additional work needed in an already overloaded clinical practice. Material and methods. Five operators from five different hospitals without any previous experience with arthroplasty registries entered all the data relevant to the joint replacements performed in their structures in a dedicated online platform and measured the time needed for any input. The learning curve for each operator was then drawn.Results. After the input of 20 procedures, all operators reached a plateau of about 2-3 minutes to record a single intervention. Conclusions. The modest amount of time required to compile registry data sheet should not represent a limitation for surgeons to enter the information into a national registry.
... In the United States, 370,000 THAs were performed both in 2014 and in 2017 [1]. In Italy, 91,428 THAs were performed in 2014, with an increased rate of 44.5% from 2001 to 2014 [2]. The annual increase in THA incidence was reported worldwide [3] mainly due to the ageing of the population [4]. ...
Background: Patient’s satisfaction after surgery was traditionally assessed by pre, and post-surgical scores and Patient-Reported Outcome Measures (PROMs) scales. Patients treated by Total hip arthroplasty (THA) usually perform well; therefore, it is useful to have a PROMs’ scale with a low ceiling effect as the Forgotten Joint Score-12 (FJS-12). PROMs have to be validated in the local language to be used. This study aims to perform a psychometric validation of the Italian version of FJS-12 in a group of consecutive patients treated by THA.
Methods: Each patient completed both the Italian version of FJS-12 and Western Ontario and McMaster University Osteoarthritis Index (WOMAC) in preoperative evaluation, after two weeks and 1 month, 3 months and 6 months postoperative follow-up. The reliability, internal consistency, test-retest reliability, and measurement error were evaluated.
Results: 53 patients were included. Cronbach’s α between 0.6 and 0.9 indicated good internal consistency for the FJS-12. The test-retest reliability was acceptable. The Pearson correlation coefficient between the FJS-12 and WOMAC was 0.238 (P=0.087) at baseline, r = 0.637 (P < 0.001) at 1 month, r = 0.490 (P < 0.001) at 3 months and r = 0.572 (P < 0.001) at 6 months. The ceiling effect was above the acceptable range (15%) for FJS-12 in 1 month (26.4%) and WOMAC in 6 months follow-up (24.5%).
Conclusions: An excellent test-retest reliability, a good internal consistency, and a good validity by medium-high correlation with the WOMAC were assessed for FJS-12. However, the responsiveness for the FJS-12 score was not assessed.
... Istituto Superiore di Sanità (ISS, i.e. Italian National Institute of Health) started working on the Italian Arthroplasty Registry (RIAP) project in the 2006 (Torre et al. 2017) with the ambitious target of collecting and analysing anagraphic and surgery data in order to perform specific analyses on the arthroplasty prostheses devices. In order to reach this crucial goal, patients, hospitalisations and registry-specific information have to be integrated from two main data sources: ...
Italian Arthroplasty Registry (Registro Italiano ArtroProtesi, RIAP) faces important data integration challenges in collecting a huge quantity of data from different sources. This paper discusses the introduction of both an ontology and a central relational database supporting the described process, focusing on the main advantages and benefits coming from this structured knowledge representation applied to the arthroplasty.
In particular, the ontology has the main role of conceptualising the RIAP domain by introducing a proposal to standardise the semantics of the involved concepts, relationships and attributes in order to improve the registry data quality, while the central database has the target of speeding up the process of data collection and processing.
... In these patients, TKA is an effective option that can provide considerable pain relief and functional gain. The annual rate of TKA procedures has risen steadily worldwide over the last 20 years [1,2], and continuous growth is further expected, thus implying a significant economic burden on the national health systems [3]. This trend reflects the increased incidence of knee OA in the general population, whose prevalence has almost doubled since the midtwentieth century [4]. ...
IntroductionThis study aimed to estimate separately in women and men the number of Total knee arthroplasty (TKA) procedures performed in Italy from 2001 to 2016, exploring specific gender-related characteristics and trends.Materials and methodsData of this study were collected from the National Hospital Discharge Reports (NHDR) reported at the Italian Ministry of Health in the years between 2001 and 2016. The information included in this archive are the patient’s sex, age, the year when the surgical procedure was performed and the length of the hospitalization.ResultsBetween the years 2001 and 2016, a total of 848,863 TKAs have been performed in Italy. TKAs in women passed from 20,719 in 2001 to 49,320 in 2016 showing an increase of 138%, while TKAs in men passed from 6631 in 2001 to 23,601 in 2016 showing an increase of 256%. From the age of 50 onwards, there was a prevalence of procedures in women, from 63.2% in the 50–54 group to 85.7% in the 100 + group. Conversely, under the age of 50, there was a higher percentage of surgeries performed in males, 57.1% on a total of 16,434 TKA surgeries carried out in this age group.Conclusions
This study showed that TKA is growing and heavily affecting the female population (70.6% of all TKAs) between 2001 and 2016. However, under 50 years old there was a higher percentage of surgeries performed in males (57.1%). The average number of days of hospitalization in females was higher than in males.
... Moreover, RIPI will adopt the same architecture of data collection process of RIAP, based on electronic Hospital Discharge Records (e-HDR) routinely collected in all Italian hospitals. Associated with a minimum dataset of additional variables (MDS), these provide crucial data that make it possible to perform outcome studies, assess device safety and assure its traceability [10]. Therefore, the conceptual and organizational heritage of RIAP will be transferred into a comprehensive system of several registries (one for each implantable prosthesis). ...
Medical device registries are major tools for public health, able to provide early warning systems for increasing the patient safety. We are now at the forefront of a final legal and procedural step to design the Regulation of the Italian Implantable Prostheses Registry (RIPI) and to make data collection mandatory. This can ensure prostheses traceability, recall of patients and fuel biomedical and epidemiological research. Data completeness will be greatly improved when the Regulation is issued. At that time, rules for accessing data and subjects/entities allowed to access the Registry will be clearly defined. Therefore, the Regulation content is crucial, with no chance to fail in its design. The thorough expertise gained at the Italian National Institute of Health (Istituto Superiore di Sanità) by the Italian Arthroplasty Registry in terms of scientific, technical and privacy management may represent a prototypical model for other registries. Our aim is to identify a few key issues to shape a far-reaching Regulation that might permit the flexible and dynamic functioning of RIPI providing suggestions for other registries at national and international level.
