This is a systematic review and meta(regression) analysis to assess the performance of custom triflange acetabular components (CTAC) in total hip arthroplasty (THA) revision surgery. Implant-related complications, failure rate, functional outcomes and implant and surgical technique-related predictors for outcome were assessed.
This systematic review was performed according to PRISMA guidelines and registered with PROSPERO (2020 CRD42020209700). PubMed, Embase, Web of Science, COCHRANE Library and Emcare were searched. Studies on Paprosky type 3A and 3B or AAOS type 3 and 4 acetabular defects with a minimum follow-up of 12 months and cohorts > 10 patients were included.
Thirty-three studies were eligible for inclusion (n = 1235 hips, 1218 patients). The methodological quality of the studies was moderate (AQUILA: 7.4/11 points). Considerable heterogeneity was observed in terms of complications, re-operations and implant failure reporting. The total incidence of implant-related complications was 24%. The incidence of re-operation for any reason was 15%, and the implant failure rate was 12% at a mean of 46.9 months and the post-operative Harris Hip Score improved by a mean of 40 points. Several predictors for outcome were found, such as implant generation, follow-up length and study start date.
The use of CTAC in revision THA has satisfactory complication and implant failure rates. The CTAC technique improves post-operative clinical outcomes and the meta-regression analysis showed that there is a clear association between improvements in the CTAC performance and the evolvement of this technique over time.
Rob G H H NelissenLandelijke Registratie Orthopedische Implantaten (Dutch Arthroplasty Register), ’s Hertogenbosch, The Netherlands Department of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands
The study investigated the existing guidelines on the quality and frequency of the follow-up visits after total hip replacement surgery and assessed the level of evidence of these recommendations.
The review process was carried out according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Additional works were retrieved by direct investigation of the available guidelines of the most important orthopedic societies and regulatory agencies.
The current systematic review of the literature resulted in zero original papers, four guidelines for routine follow-up and three guidelines for special cases. Concerning the quality of evidence behind them, these guidelines were not evidence based but drafted from expert consensus.
The most important finding of this review is the large variation of recommendations in the follow-up schedule after total hip arthroplasty and the lack of evidence-based indications. Indeed, all the above-reported guidelines are the result of a consensus among experts in the field (level of recommendation class D ‘very low’) and not based on clinical studies.
Peter van SchieDepartment of Orthopaedics, Leiden University Medical Centre, Leiden, The Netherlands Department of Biomedical Data Sciences, Medical Decision Making, Leiden University Medical Centre, Leiden, The Netherlands
In order to improve care for total hip and knee arthroplasties (THA/TKA), hospitals may want to compare their performance with hospitals in other countries. Pooling data across countries also enable early detection of infrequently occurring safety issues. We therefore aimed to assess the between-hospital variation and definitions used for revision, readmission, and complications across countries.
PubMed, Embase, Web of Science, Cochrane library, Emcare, and Academic Search Premier were searched from January 2009 to August 2020 for studies reporting on: (i) primary THA/TKA; (ii) revision, readmission, or complications; and (iii) between-hospital variation. Most recent registry reports of Network of Orthopedic Registries of Europe members were also reviewed. Two reviewers independently screened records, extracted data, and assessed the risk of bias using the Integrated quality Criteria for the Review Of Multiple Study designs tool for studies and relevant domains for registries. We assessed agreement for the following domains: (i) outcome definition; (ii) follow-up and starting point; (iii) case-mix adjustment; and (iv) type of patients and hospitals included.
Between-hospital variation was reported in 33 (1 high-quality, 13 moderate-quality, and 19 low-quality) studies and 8 registry reports. The range of variation for revision was 0–33% for THA and 0–27% for TKA varying between assessment within hospital admission until 10 years of follow-up; for readmission, 0–40% and 0–32% for THA and TKA, respectively; and for complications, 0–75% and 0–50% for THA and TKA, respectively. Indicator definitions and methodological variables varied considerably across domains.
The large heterogeneity in definitions and methods used likely explains the considerable variation in between-hospital variation reported for revision, readmission, and complications , making it impossible to benchmark hospitals across countries or pool data for earlier detection of safety issues. It is necessary to collaborate internationally and strive for more uniformity in indicator definitions and methods in order to achieve reliable international benchmarking in the future.
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.
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).
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.
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.
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.
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.
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
On behalf of the CORE–MD Investigators (see Appendix)
On behalf of the CORE–MD Investigators (see Appendix)Alan Fraser, Piotr Szymański, Chris Gale, Aldo Maggioni, Elisabetta Zanon, Christina Dimopoulou, Cinzia Ceccarelli, Polyxeni Vairami, Anett Ruszanov, Per Kjærsgaard-Andersen, Rob Nelissen, Adrian Ott, Elizabeth Macintyre, Loredana Simulescu, Marieke Meijer, Berthold Koletzko, Sarah Wieczorek, Adamos Hadjipanayis, Stefano Del Torso, Perla Marang-van de Mheen, Lotje Hoogervorst, Ewout W. Steyerberg, Bas Penning De Vries, Peter McCulloch, Martin Landray, Daniel Prieto Alhambra, James Smith, Anne Lubbeke-Wolf, Stefan James, Sergio Buccheri, Robert Byrne, Laurna McGovern, Stephan Windecker, Andre Frenk, Georgios Siontis, Christoph Stettler, Arjola Bano, Lia Bally, Frank E. Rademakers, Jan D‘hooge, Anton Vedder, Elisabetta Biasin, Erik Kamenjasevic, Petra Schnell-Inderst, Felicitas Kühne, Ola Rolfson, Joel Jakobsson, Amanda Tornsö, Enrico G. Caiani, Lorenzo Gianquintieri, Cinzia Cappiello, Maristella Matera, Tom Melvin, Niall MacAleenan, Ria Mahon, Michèle Meagher, Gearóid McGauran, Thomas Wejs Møller, Ann-Sofie Sonne Holm-Schou, Jan Szulc, Robert E. Geertsma, Jantine W.P.M. van Baal, Joëlle M. Hoebert, Susana L.F. Cabaço, Paola Laricchiuta, Marina Torre, Filippo Boniforti, Eugenio Carrani, Stefania Ceccarelli, Claudia Wild, Sabine Ettinger, Juan Antonio Blasco Amaro, Juan Carlos Rejón Parrilla, Agnieszka Dobrzynska, David Epstein, Valentina Strammiello, Hannes Jarke, Kaisa Immonen, Françoise Schlemmer, Sabina Hoekstra, Marianna Mastroroberto, Christoph Ziskoven, Michael Hahn, Erman Melikyan, Richard Holborow, Suzanne Halliday, Alexey Shiryaev, Gero Viola, Harry van Vugt
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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, while authorising the placing on the market of medical devices is decentralised to independent ‘conformity assessment’ organisations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the Medical Device Directive, 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.
Cite this article: EFORT Open Rev 2021;6:839-849. DOI: 10.1302/2058-5241.6.210081
Berend W. SchreursLandelijke Registratie Orthopedische Implantaten (Dutch Arthroplasty Register), ’s Hertogenbosch, The Netherlands Dept. of Orthopaedics, Radboud University Medical Center, Nijmegen, The Netherlands
Rob G. H. H. NelissenLandelijke Registratie Orthopedische Implantaten (Dutch Arthroplasty Register), ’s Hertogenbosch, The Netherlands Dept. of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands
In the Dutch Arthroplasty Register (LROI), the product and batch number of prosthetic components and cement are registered for traceability. Registration of the product number provides opportunities to extend the information about a specific prosthesis. All product numbers used from the beginning of the registration in 2007 were characterized to develop and maintain an implant library.
The Scientific Advisory Board developed a core-set that contains the most important characteristics needed to form an implant library. The final core-set contains the brand name, type, coating and material of the prosthesis. In total, 35 676 product numbers were classified, resulting in a complete implant library of all product numbers used in the LROI.
To improve quality of the data and increase convenience of registration, the LROI implemented barcode scanning for data entry into the database. In 2017, 82% of prosthetic components and cement stickers had a GS1 barcode. The remaining product stickers used HIBCC barcodes and custom-made barcodes.
With this implant library, implants can be grouped for analyses at group level, e.g. evaluation of the effect of a material of a prosthesis on survival of the implant. Apart from that, the implant library can be used for data quality control within the LROI database.
The implant library reduces the registration burden and increases accuracy of the database. Such a system will facilitate new designs (learning from the past) and thus improve implant quality and ultimately patient safety.
Cite this article: EFORT Open Rev 2019;4 DOI: 10.1302/2058-5241.4.180063
Anne LübbekeDivision of Orthopaedic Surgery & Traumatology, Geneva University Hospitals and University of Geneva, Switzerland Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK
James A SmithCentre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK National Institute for Health Research Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford, UK
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.
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.
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.
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.
Jorge Arias de la TorreDepartament de Salut, Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS), Barcelona, Spain CIBER Epidemiología y Salud Pública (CIBERESP), Madrid, Spain Instituto de Biomedicina (IBIOMED). Universidad de León, León, Spain
Anne LübbekeDivision of Orthopaedic Surgery and Traumatology, Geneva University Hospitals, Geneva, Switzerland Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
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.
Eleven registries of the Network of Orthopaedic Registries of Europe (NORE) participated totalling 54 434 resurfacings and 58 498 large stemmed MoM THRs.
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.
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.
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
Søren OvergaardDepartment of Orthopaedic Surgery and Traumatology, Copenhagen University Hospital, Copenhagen, Denmark Department of Clinical Medicine, Faculty of Health & Medical Sciences, University of Copenhagen, Copenhagen, Denmark
Thomas M GruppAesculap AG Research & Development & Medical Scientific Affairs, Tuttlingen, Germany Department of Orthopaedic and Trauma Surgery, Ludwig Maximilians University Munich, Musculoskeletal University Center Munich (MUM), Campus Grosshadern, Munich, Germany
Anne LübbekeDivision of Surgery and Traumatology, Geneva University Hospitals and University of Geneva, Switzerland Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK
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.
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.
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.
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.
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.
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.