Background and purpose — The safety and performance of hip and knee prostheses can be assessed by ana-lyzing peer-reviewed literature, registry reports, and safety notices published by national competent authorities/regula-tory agencies, or manufacturers. The percentage of hip and knee prostheses with a safety signal published through any of these data sources is unknown. We aimed to assess the frequency of signals identified for a random sample of 10 hip stems, 10 hip cups, and 10 knee implants. Methods — 3 literature libraries were searched to find safety signals defined as information on patterns/occurrences that may alter the device’s benefit–risk profile, reported in peer-reviewed publications for the randomly selected implants. Annual registry reports from 5 national registries were examined to check whether any of the selected implants had outlier performance. The CORE-MD post-market surveillance (PMS) tool was used to collect all related safety notices from 13 competent authority/regulatory agency websites. Manufacturers’ websites were screened for any reported safety information. Results — Safety signals were identified for 21 of the 30 randomly selected implants: 18 identified by registries, 7 by the CORE-MD PMS tool, and 8 based on literature, with 10 implants identified by multiple sources. There was no systematic pattern in timing of publication with a particular source publishing safety signals earlier than other sources. Conclusion — 70% of the randomly selected hip and knee prostheses had ≥ 1 safety signals published, with registries as the source for the majority. No single source identified all 21 implants with signals, which highlights the need for a comprehensive surveillance strategy to aggregate safety signals from multiple sources.

Background and purpose — The amount of information publicly available from arthroplasty registries is large but could be used more effectively. This project aims to improve the knowledge concerning existing registries to facilitate access, transparency, harmonization, and reporting. Methods — Within the International Society of Arthroplasty Registries (ISAR) we aimed at developing, testing, adopting, and making publicly available a short, standardized registry description with items considered relevant for stakeholders using a cross-sectional study survey. Items were chosen based on a literature review and expert advice, selected by 9 ISAR working group members, tested iteratively in 3 registries, and commented upon by 4 external experts. All 29 ISAR member registries as of July 2023 were invited to participate in the project. Results — Included items covered general descriptive information regarding registries, information related to governance, outcomes, data quality, data access, and registry production. The template was adopted, completed, and made publicly available by 25 of the 29 registries. Of those, 2/3 were national registries. 23 captured both hip and knee arthroplasties and 10 captured shoulder arthroplasties. Most registries had public reporting of data quality, methods, and results. Data was accessible in all but 2 registries, mainly as aggregated data. Important items relevant to registry quality for researchers to consistently indicate in scientific papers include scope, inclusion criteria, outcomes definitions, coverage/completeness, and validation processes. Conclusion — This ISAR initiative implemented a short, standardized description to facilitate appropriate use of orthopedic registry data worldwide relevant for a diverse group of stakeholders including researchers, industry, public health and regulatory agencies.

Introduction: It is unclear if the collar and cuff treatment improve alignment in displaced surgical neck fractures of the proximal humerus. Therefore, this study evaluated if the neckshaft angle and extent of displacement would improve between trauma and onset of radiographically visible callus in non-operatively treated surgical neck fractures (Boileau type A, B, C). Materials and Methods: A consecutive series of patients (≥ 18 years old) were retrospectively evaluated from a level 1 trauma center in Australia (inclusion period: 2016–2020) and a level 2 trauma center in the Netherlands (inclusion period: 2004 to 2018). Patients were included if they sustained a Boileau-type fracture and underwent initial non-operative treatment. The first radiograph had to be obtained within 24 h after the initial injury and the follow-up radiograph(s) 1 week after trauma and before the start of radiographically visible callus. On each radiograph, the maximal medial gap (MMG), maximal lateral gap (MLG), and neck-shaft angle (NSA) were measured. Linear mixed modelling was performed to evaluate if these measurements would improve over time. Results: Sixty-seven patients were included: 25 type A, 11 type B, and 31 type C fractures. The mean age (range) was 68 years (24–93), and the mean number (range) of follow-up radiographs per patient was 1 (1–4). Linear mixed modelling on both MMG and MLG revealed no improvement during follow-up among the three groups. Mean NSA of type A fractures improved significantly from 161° at trauma to 152° at last follow-up (p-value = 0.004). Conclusions: Apart from humeral head angulation improvement in type A, there is no increase nor reduction in displacement among the three fracture patterns. Therefore, it is advised that surgical decision-making should be performed immediately after trauma. Level of clinical evidence: Level IV, retrospective case series.