Frequency of safety signals from scientific reports, manufactures, registers, and other sources for a random selection of hip and knee prostheses

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

Ten technical aspects of baseplate fixation in reverse total shoulder arthroplasty for patients without glenoid bone loss: a systematic review

The aim of this systematic review was to collect evidence on the following 10 technical aspects of glenoid baseplate fixation in reverse total shoulder arthroplasty (rTSA): screw insertion angles; screw orientation; screw quantity; screw length; screw type; baseplate tilt; baseplate position; baseplate version and rotation; baseplate design; and anatomical safe zones. Five literature libraries were searched for eligible clinical, cadaver, biomechanical, virtual planning, and finite element analysis studies. Studies including patients >16 years old in which at least one of the ten abovementioned technical aspects was assessed were suitable for analysis. We excluded studies of patients with: glenoid bone loss; bony increased offset-reversed shoulder arthroplasty; rTSA with bone grafts; and augmented baseplates. Quality assessment was performed for each included study. Sixty-two studies were included, of which 41 were experimental studies (13 cadaver, 10 virtual planning, 11 biomechanical, and 7 finite element studies) and 21 were clinical studies (12 retrospective cohorts and 9 case-control studies). Overall, the quality of included studies was moderate or high. The majority of studies agreed upon the use of a divergent screw fixation pattern, fixation with four screws (to reduce micromotions), and inferior positioning in neutral or anteversion. A general consensus was not reached on the other technical aspects. Most surgical aspects of baseplate fixation can be decided without affecting fixation strength. There is not a single strategy that provides the best outcome. Therefore, guidelines should cover multiple surgical options that can achieve adequate baseplate fixation

Large simple randomized controlled trials—from drugs to medical devices: lessons from recent experience

: Randomized controlled trials (RCTs) are the cornerstone of modern evidence-based medicine. They are considered essential to establish definitive evidence of efficacy and safety for new drugs, and whenever possible they should also be the preferred method for investigating new high-risk medical devices. Well-designed studies robustly inform clinical practice guidelines and decision-making, but administrative obstacles have made it increasingly difficult to conduct informative RCTs. The obstacles are compounded for RCTs of high-risk medical devices by extra costs related to the interventional procedure that is needed to implant the device, challenges with willingness to randomize patients throughout a trial, and difficulties in ensuring proper blinding even with sham procedures. One strategy that may help is to promote the wider use of simpler and more streamlined RCTs using data that are collected routinely during healthcare delivery. Recent large simple RCTs have successfully compared the performance of drugs and of high-risk medical devices, against alternative treatments; they enrolled many patients in a short time, limited costs, and improved efficiency, while also achieving major impact. From a task conducted within the CORE-MD project, we report from our combined experience of designing and conducting large pharmaceutical trials during the COVID-19 pandemic, and of planning and coordinating large registry-based RCTs of cardiovascular devices. We summarize the essential principles and utility of large simple RCTs, likely applicable to all interventions but especially in order to promote their wider adoption to evaluate new medical devices

Pooling data for primary total knee implants across national registries:is the same implant used in multiple registries and for the same patient group? An observational study

Background and purpose — Pooling data on the performance of total knee (TK) implants across registries is only possible if the same TK implant is used across multiple registries and if used in patients with similar characteristics. We assessed to what extent specific TK implants: (i) are used across multiple registries or only in a single registry; and (ii) differ in patient characteristics between registries. Methods — All primary TK implants implanted between January 2020 and December 2021 in the Danish, Dutch, German, and Italian registries were included. We determined the number of registries using a specific TK implant (based on combined femoral-tibial component brand name and fixation/congruency/mobile bearing insert/patella usage). Patient characteristics (age/body mass index [BMI]/sex/ diagnosis osteoarthritis) were compared across registries for TK implants used in ≥ 2 registries ≥ 100 times. Results — 813 different TK implants (577,351 procedures) were used across the 4 registries, of which 53 TK implants (7%) were used in 1 registry (8,000 procedures). 760 different TK implants (569,351 procedures; 99%) were used in ≥ 2 registries of which 47 different TK implants (393,954 procedures; 68%) were used in ≥ 2 registries and ≥ 100 times. Statistically and clinically significant differences in age for the same TK implant across registries were observed for 29 TK implants (62%) and 3 TK implants (6%), respectively; for other characteristics these were for BMI 30 (64%) and 0 (0%) TK implants; for male proportion 23 (49%) and 17 (36%) TK implants; and for diagnosis of osteoarthritis 42 (89%) and 34 (72%) TK implants, respectively. Conclusion — Most specific TK implants and TK procedures were used across multiple registries, but they were often used in patients with different characteristics. This has an impact on comparing implant performances between registries.</p

Development of a minimum checklist to assess the quality of evidence produced using registry data for the evaluation of medical device safety and performance

Funding: This work was supported by the European Union Horizon 2020 Research and Innovation Program (grant number 965246) and was part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project.Objectives Medical device registries in Europe report limited information about their structure and methodological characteristics. This hinders their utility for evaluation of medical device safety and performance under the Medical Device Regulation. This study aimed to define a minimum checklist of items necessary for regulators to assess the quality of evidence produced using registry data for the evaluation of medical device safety and performance.Design A three-round Delphi panel.Setting A task within the Coordinating Research and Evidence for Medical Devices project.Participants 101 experts in the medical device community (healthcare professionals, methodologists, registry experts, regulators, and assessors from notified bodies) were invited.Interventions Based on a literature review and expert advice, 27 items relating to the quality of registry data and the analysis of medical device safety and performance were selected. In round 1, participants selected which items were required for a minimum checklist. They could also propose new items. Items selected by ≥70% of participants indicated consensus. Remaining items were discussed in round 2, resulting in a final checklist that was ranked by participants for importance (round 3).Main outcome measures Consensus of items to be included in the minimum checklist.Results 51 experts participated in round 1, achieving consensus on 18 (67%) items and suggesting 12 items. After discussion in round 2, 5 additional items were selected, resulting in a final set of 15 data quality items and 8 data analysis items. The most important items were ‘completeness of procedures’ (data quality) and ‘definition of outcome analyzed’” (quality of analysis).Conclusions Reporting all items from the minimum checklist will facilitate judgment of the utility of registry data to evaluate medical devices during post-market surveillance.Peer reviewe

Large simple randomized controlled trials-from drugs to medical devices: lessons from recent experience

Randomized controlled trials (RCTs) are the cornerstone of modern evidence-based medicine. They are considered essential to establish definitive evidence of efficacy and safety for new drugs, and whenever possible they should also be the preferred method for investigating new high-risk medical devices. Well-designed studies robustly inform clinical practice guidelines and decision-making, but administrative obstacles have made it increasingly difficult to conduct informative RCTs. The obstacles are compounded for RCTs of high-risk medical devices by extra costs related to the interventional procedure that is needed to implant the device, challenges with willingness to randomize patients throughout a trial, and difficulties in ensuring proper blinding even with sham procedures. One strategy that may help is to promote the wider use of simpler and more streamlined RCTs using data that are collected routinely during healthcare delivery. Recent large simple RCTs have successfully compared the performance of drugs and of high-risk medical devices, against alternative treatments; they enrolled many patients in a short time, limited costs, and improved efficiency, while also achieving major impact. From a task conducted within the CORE-MD project, we report from our combined experience of designing and conducting large pharmaceutical trials during the COVID-19 pandemic, and of planning and coordinating large registry-based RCTs of cardiovascular devices. We summarize the essential principles and utility of large simple RCTs, likely applicable to all interventions but especially in order to promote their wider adoption to evaluate new medical devices

Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)

: In the European Union (EU) the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, whereas authorizing the placing on the market of medical devices is decentralized to independent 'conformity assessment' organizations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the medical device directives, from the 1990s. Uncertainties about clinical evidence requirements, among other reasons, led to the EU Medical Device Regulation (2017/745) that has applied since May 2021. It provides general principles for clinical investigations but few methodological details-which challenges responsible authorities to set appropriate balances between regulation and innovation, pre- and post-market studies, and clinical trials and real-world evidence. Scientific experts should advise on methods and standards for assessing and approving new high-risk devices, and safety, efficacy, and transparency of evidence should be paramount. The European Commission recently awarded a Horizon 2020 grant to a consortium led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, that will review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources. The CORE-MD project (Coordinating Research and Evidence for Medical Devices) will run until March 2024; here we describe how it may contribute to the development of regulatory science in Europe

CORE-MD Review

Orthopedic and cardiovascular medical device registries in Europe: a systematic revie

CORE-MD Review

Orthopedic and cardiovascular medical device registries in Europe: a systematic revie

Achieving consensus on items needed to assess the quality and analysis of registry data for the regulatory evaluation of medical device performances during post-market surveillance: which items are the minimum requirements?

Delphi Panel CORE-M