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- Author: Anne Lübbeke x
- General Orthopaedics x
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Since improving the patient’s condition is the ultimate goal of clinical care and research, this review of research methodology focuses on outcomes in the musculoskeletal field.
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This paper provides an overview of conceptual models, different types of outcomes and commonly assessed outcomes in orthopaedics as well as epidemiological and statistical aspects of outcomes determination, measurement and interpretation.
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Clinicians should determine the outcome(s) most important to patients and/or public health in collaboration with the patients, epidemiologists/statisticians and other stakeholders.
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Key points in outcome choice are to evaluate both the benefit and harm of a health intervention, and to consider short- and longer-term outcomes including patient-reported outcomes.
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Outcome estimation should aim at identifying a clinically important difference (not the same as a statistically significant difference), at presenting measures of effects with confidence intervals and at taking the necessary steps to minimize bias.
Cite this article: EFORT Open Rev 2018;3 DOI: 10.1302/2058-5241.3.170064
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK
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Clinical registries are health information systems, which have the mission to collect multidimensional real-world data over the long term, and to generate relevant information and actionable knowledge to address current serious healthcare problems.
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This article provides an overview of clinical registries and their relevant stakeholders, focussing on registry structure and functioning, each stakeholder’s specific interests, and on their involvement in the registry’s information input and output.
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Stakeholders of clinical registries include the patients, healthcare providers (professionals and facilities), financiers (government, insurance companies), public health and regulatory agencies, industry, the research community and the media.
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The article discusses (1) challenges in stakeholder interaction and how to strengthen the central role of the patient, (2) the importance of adding cost reporting to enable informed value choices, and (3) the need for proof of clinical and public health utility of registries.
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In its best form, a registry is a mission-driven, independent stakeholder–registry team collaboration that enables rapid, transparent and open-access knowledge generation and dissemination.
Cite this article: EFORT Open Rev 2019;4 DOI: 10.1302/2058-5241.4.180077
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
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National Institute for Health Research Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford, UK
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National Institute for Health Research Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford, UK
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Medical devices are a very important but largely under-recognized and fragmented component of healthcare.
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The limited regulation of the past and the lack of systematic rigorous evaluation of devices leading to numerous high-profile failures will now be replaced by stricter legal requirements and more transparent evaluation processes.
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This constitutes an unprecedented opportunity, but it also uncovers urgent needs in landscaping, methodology development, and independent comprehensive assessment of device risks and benefits for individual patients and society, especially in the context of increasingly complex devices.
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We argue that an academic discipline of ‘medical device science’ is well placed to lead and coordinate the efforts necessary to achieve much needed improvement in the medical device sector.
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Orthopaedics and traumatology could contribute and benefit considerably as one of the medical specialties with the highest use of medical devices.
Cite this article: EFORT Open Rev 2021;6:160-163. DOI: 10.1302/2058-5241.6.200094
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National Joint Replacement for England, Wales, Northern Ireland, Isle of Man and the States of Guernsey (NJR)
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Recent concerns surrounding joint replacements that have a higher than expected rate of revision have led to stricter controls by regulatory authorities with regards to the introduction of new devices into the marketplace.
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Implant post-market surveillance remains important, and joint replacement registries are ideally placed to perform this role. This review examined if and how joint replacement registries identified outlier prostheses, outlined problems and suggested solutions to improve post-market surveillance.
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A search was performed of all joint replacement registries that had electronic or published reports detailing the outcomes of joint replacement. These reports were examined for registry identification of outlier prostheses. Five registries publicly identified outlier prostheses in their reports and the methods by which this was performed, and three others had internal reports.
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Identification of outlier prostheses is one area that may improve overall joint replacement outcomes; however, further research is needed to determine the optimum methods for identification, including the threshold, the comparator and the numbers required for notification of devices.
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Co-operation of registries at a global level may lead to earlier identification of devices and thereby further improve the results of joint replacement.
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Total joint arthroplasty is performed to decreased pain, restore function and productivity and improve quality of life.
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One-year implant survivorship following surgery is nearly 100%; however, self-reported satisfaction is 80% after total knee arthroplasty and 90% after total hip arthroplasty.
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Patient-reported outcomes (PROs) are produced by patients reporting on their own health status directly without interpretation from a surgeon or other medical professional; a PRO measure (PROM) is a tool, often a questionnaire, that measures different aspects of patient-related outcomes.
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Generic PROs are related to a patient’s general health and quality of life, whereas a specific PRO is focused on a particular disease, symptom or anatomical region.
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While revision surgery is the traditional endpoint of registries, it is blunt and likely insufficient as a measure of success; PROMs address this shortcoming by expanding beyond survival and measuring outcomes that are relevant to patients – relief of pain, restoration of function and improvement in quality of life.
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PROMs are increasing in use in many national and regional orthopaedic arthroplasty registries.
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PROMs data can provide important information on value-based care, support quality assurance and improvement initiatives, help refine surgical indications and may improve shared decision-making and surgical timing.
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There are several practical considerations that need to be considered when implementing PROMs collection, as the undertaking itself may be expensive, a burden to the patient, as well as being time and labour intensive.
Cite this article: EFORT Open Rev 2019;4 DOI: 10.1302/2058-5241.4.180080
Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK
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National Institute for Health Research Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford, UK
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Purpose
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The objective of this systematic review was to give an overview of clinical investigations regarding hip and knee arthroplasty implants published in peer-reviewed scientific medical journals before entry into force of the EU Medical Device Regulation in May 2021.
Methods
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We systematically reviewed the medical literature for a random selection of hip and knee implants to identify all peer-reviewed clinical investigations published within 10 years before and up to 20 years after regulatory approval. We report study characteristics, methodologies, outcomes, measures to prevent bias, and timing of clinical investigations of 30 current implants. The review process was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
Results
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We identified 2912 publications and finally included 151 papers published between 1995 and 2021 (63 on hip stems, 34 on hip cups, and 54 on knee systems). We identified no clinical studies published before Conformité Européene (CE)-marking for any selected device, and no studies even up to 20 years after CE-marking in one-quarter of devices. There were very few randomized controlled trials, and registry-based studies generally had larger sample sizes and better methodology.
Conclusion
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The peer-reviewed literature alone is insufficient as a source of clinical investigations of these high-risk devices intended for life-long use. A more systematic, efficient, and faster way to evaluate safety and performance is necessary. Using a phased introduction approach, nesting comparative studies of observational and experimental design in existing registries, increasing the use of benefit measures, and accelerating surrogate outcomes research will help to minimize risks and maximize benefits.
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CIBER Epidemiología y Salud Pública (CIBERESP), Madrid, Spain
Instituto de Biomedicina (IBIOMED). Universidad de León, León, Spain
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Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
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The purpose of this paper is to determine the prevalence of metal-on-metal (MoM) total hip replacement (THR) in European registries, to assess the incidence of revision surgery and to describe the national follow-up guidelines for patients with MoM THR including resurfacings.
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Eleven registries of the Network of Orthopaedic Registries of Europe (NORE) participated totalling 54 434 resurfacings and 58 498 large stemmed MoM THRs.
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The resurfacings and stemmed large head MoM had higher pooled revision rates at five years than the standard total hip arthroplasties (THA): 6.0%, 95% confidence interval (CI) 5.3 to 6.8 for resurfacings; 6.9%, 95% CI 4.4 to 9.4 for stemmed large head MoM; and 3.0%, 95% CI 2.5 to 3.6 for conventional THA.
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The resurfacings and stemmed large head MoM had higher pooled revision rates at ten years than the standard THAs: 12.1%, 95% CI 11.0 to 13.3 for resurfacings; 15.5%, 95% CI 9.0 to 22 for stemmed large head MoM; and 5.1%, 95% CI 3.8 to 6.4 for conventional THA.
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Although every national registry reports slightly different protocols for follow-up, these mostly consist of annual assessments of cobalt and chromium levels in blood and MRI (MARS) imaging.
Cite this article: EFORT Open Rev 2019;4 DOI: 10.1302/2058-5241.4.180078
Department of Clinical Medicine, Faculty of Health & Medical Sciences, University of Copenhagen, Copenhagen, Denmark
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Department of Orthopaedic and Trauma Surgery, Ludwig Maximilians University Munich, Musculoskeletal University Center Munich (MUM), Campus Grosshadern, Munich, Germany
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Technical University Delft, Delft, the Netherlands
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Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK
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With the implementation of the new MDR 2017/745 by the European Parliament, more robust clinical and pre-clinical data will be required due to a more stringent approval process.
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The EFORT Implant and Patient Safety Initiative WG1 ‘Introduction of Innovation’, combined knowledge of orthopaedic surgeons, research institutes, orthopaedic device manufacturers, patient representatives and regulatory authorities to develop a comprehensive set of recommendations for the introduction of innovations in joint arthroplasty within the boundaries of MDR 2017/745.
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Recommendations have been developed to address key questions about pre-clinical and clinical requirements for the introduction of new implants and implant-related instrumentation with the participation of a steering group, invited by the EFORT Board in dialogue with representatives from European National Societies and Speciality Societies.
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Different degrees of novelty and innovation were described and agreed on in relation to when surgeons can start, using implants and implant-related instrumentation routinely.
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Before any clinical phase of a new implant, following the pre-market clinical investigation or the equivalent device PMCF pathway, it is a common understanding that all appropriate pre-clinical testing (regulatory mandatory and evident state of the art) – which has to be considered for a specific device – has been successfully completed.
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Once manufacturers receive the CE mark for a medical device, it can be used in patients routinely when a clinical investigation has been conducted to demonstrate the conformity of devices according to MDR Article 62 or full equivalence for the technical, biological and clinical characteristics has been demonstrated (MDR, Annex XIV, Part A, 3.) and a PMCF study has been initiated.
