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Off-label use is frequently practiced in primary and revision arthroplasty, as there may be indications for the application of implants for purposes outside the one the manufacturers intended.
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Under certain circumstances, patients may benefit from selective application of mix & match. This can refer to primary hip arthroplasty (if evidence suggests that the combination of devices from different manufacturers has superior results) and revision hip or knee arthroplasty (when the exchange of one component only is necessary and the invasiveness of surgery can be reduced).
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Within the EFORT ‘Implant and Patient Safety Initiative’, evidence- and consensus-based recommendations have been developed for the safe application of off-label use and mix & match in primary as well as revision hip and knee arthroplasty.
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Prior to the application of a medical device for hip or knee arthroplasty off-label and within a mix & match situation, surgeons should balance the risks and benefits to the patient, obtain informed consent, and document the decision process appropriately.
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Nevertheless, it is crucial for surgeons to only combine implants that are compatible. Mismatch of components, where their sizes or connections do not fit, may have catastrophic effects and is a surgical mistake.
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Surgeons must be fully aware of the features of the components that they use in off-label indications or during mix & match applications, must be appropriately trained and must audit their results.
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Considering the frequent practice of off-label and mix & match as well as the potential medico-legal issues, further research is necessary to obtain more data about the appropriate indications and outcomes for those procedures.
Cite this article: EFORT Open Rev 2021;6:982-1005. DOI: 10.1302/2058-5241.6.210080
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
