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Richard N de Steiger
Richard N de Steiger
Australian Orthopaedic Association National Joint Replacement Registry, SAHMRI, Adelaide, Australia
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Brian R Hallstrom
Brian R Hallstrom
Michigan Arthroplasty Registry Collaborative Quality Initiative University of Michigan, Department of Orthopaedic Surgery, Ann Arbor, Michigan, USA
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Anne Lübbeke
Anne Lübbeke
Geneva Arthroplasty Registry, Geneva University Hospitals Rue Gabrielle-Perret-Gentil 4 CH-1211 Geneva, Switzerland
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Elizabeth W Paxton
Elizabeth W Paxton
Surgical Outcomes and Analysis Unit, Kaiser Permanente National Implant Registries 8954 Rio San Diego Drive, Suite, San Diego, California, USA
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Liza N van Steenbergen
Liza N van Steenbergen
Dutch Arthroplasty Register (Landelijke Registratie Orthopedische Implantaten (LROI)), Bruistensingel 230 | 5232 AD ’s-Hertogenbosch, The Netherlands
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Mark Wilkinson
Mark Wilkinson
Department of Oncology and Metabolism, University of Sheffield, Beech Hill Road, Sheffield, United Kingdom
National Joint Replacement for England, Wales, Northern Ireland, Isle of Man and the States of Guernsey (NJR)
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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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formal policy for the identification of specific prostheses. A post-market surveillance system for medical devices should provide the following functions: readily identify underperforming devices, characterize and disseminate information about real
Claus Varnum
Claus Varnum
The Danish Hip Arthroplasty Register
Department of Orthopaedic Surgery, Vejle Hospital, Vejle, Denmark
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Department of Orthopaedic Surgery, Vejle Hospital, Vejle, Denmark
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Alma Bečić Pedersen
Alma Bečić Pedersen
Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark
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Ola Rolfson
Ola Rolfson
The Swedish Hip Arthroplasty Register
Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
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Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
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Cecilia Rogmark
Cecilia Rogmark
The Swedish Hip Arthroplasty Register
Lund University, Skåne University Hospital, Department of Orthopedics, Malmö, Sweden
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Lund University, Skåne University Hospital, Department of Orthopedics, Malmö, Sweden
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Ove Furnes
Ove Furnes
The Norwegian Arthroplasty Register, Department of Orthopedic Surgery, Haukeland University Hospital, Bergen, Norway
Department of Clinical Medicine, University of Bergen, Bergen, Norway
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Department of Clinical Medicine, University of Bergen, Bergen, Norway
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Geir Hallan
Geir Hallan
The Norwegian Arthroplasty Register, Department of Orthopedic Surgery, Haukeland University Hospital, Bergen, Norway
Department of Clinical Medicine, University of Bergen, Bergen, Norway
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Department of Clinical Medicine, University of Bergen, Bergen, Norway
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Keijo Mäkelä
Keijo Mäkelä
The Finnish Arthroplasty Register
Department of Orthopaedics and Traumatology, Turku University Hospital, Turku, Finland
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Department of Orthopaedics and Traumatology, Turku University Hospital, Turku, Finland
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Richard de Steiger
Richard de Steiger
Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR), Adelaide, Australia
Department of Surgery, Epworth HealthCare, University of Melbourne, Melbourne, Australia
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Department of Surgery, Epworth HealthCare, University of Melbourne, Melbourne, Australia
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Martyn Porter
Martyn Porter
The National Joint Registry of England, Wales, Northern Ireland and Isle of Man
Centre for Hip Surgery, Wrightington Hospital, Wrightington, Wigan and Leigh NHS Trust, Lancashire, United Kingdom
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Centre for Hip Surgery, Wrightington Hospital, Wrightington, Wigan and Leigh NHS Trust, Lancashire, United Kingdom
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Søren Overgaard
Søren Overgaard
The Danish Hip Arthroplasty Register
Orthopaedic Research Unit, Department of Clinical Research, University of Southern Denmark, Odense, Denmark
Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark
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Orthopaedic Research Unit, Department of Clinical Research, University of Southern Denmark, Odense, Denmark
Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark
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recognized that enhanced post-market surveillance would be useful and an initiative called ‘Beyond Compliance’ was introduced in 2012. 58 It was named Beyond Compliance because this was voluntary and beyond the European regulatory requirements. The NJR
M M Morlock
M M Morlock
Institute of Biomechanics, TUHH Hamburg University of Technology, Hamburg, Germany
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E Gomez-Barrena
E Gomez-Barrena
Department of Orthopaedic Surgery and Traumatology, Universidad Autónoma de Madrid, Madrid, Spain
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D C Wirtz
D C Wirtz
Department of Orthopaedics and Traumatology, University Hospital Bonn, Bonn, Germany
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A Hart
A Hart
London Implant Retrieval Centre, Royal National Orthopaedic Hospital, Stanmore, UK
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J P Kretzer
J P Kretzer
Department of Orthopaedic Surgery, Heidelberg University Hospital, Heidelberg, Germany
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Directive issued in 1993. The MDR requires post-market surveillance of all class IIb and III products by the manufacturers, who have to demonstrate the clinical safety of their products on a yearly basis. This will provide a substantially higher level of
Tom Melvin
Tom Melvin
Medical Officer, Health Products Regulatory Authority, Dublin, Republic of Ireland
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Marina Torre
Marina Torre
Engineer, Senior Researcher, Istituto Superiore di Sanità, Rome, Italy
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to their device. The clinical evaluation then informs the extent to which the device manufacturer is required to further examine their device once made available on the market, by means of post-market surveillance (PMS) or post-market clinical follow
Anne Lübbeke
Anne Lübbeke
Division 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
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Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK
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Christophe Combescure
Christophe Combescure
Division of Clinical Epidemiology, Geneva University Hospitals and University of Geneva, Switzerland
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Christophe Barea
Christophe Barea
Division of Orthopaedic Surgery & Traumatology, Geneva University Hospitals and University of Geneva, Switzerland
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Amanda Inez Gonzalez
Amanda Inez Gonzalez
Division of Orthopaedic Surgery & Traumatology, Geneva University Hospitals and University of Geneva, Switzerland
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Keith Tucker
Keith Tucker
Chair Orthopaedic Data Evaluation Panel, UK
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Per Kjærsgaard-Andersen
Per Kjærsgaard-Andersen
Center for Adult Hip and Knee Reconstruction, Department of Orthopaedics, South Danish University, Vejle Hospital, Denmark
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Tom Melvin
Tom Melvin
School of Medicine, Trinity College Dublin, Ireland
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Alan G Fraser
Alan G Fraser
Department of Cardiology, University Hospital of Wales, Cardiff, UK
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Rob Nelissen
Rob Nelissen
Department of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands
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James A Smith
James A Smith
Centre 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
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National Institute for Health Research Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford, UK
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. Under the MDR, post-market surveillance is expected to be proactive and continuous, with clinically meaningful comparator(s) and clinically relevant endpoints (risks and benefits). The evidence identified in this review would often not have met those
Martyn Porter
Martyn Porter
The National Joint Registry of England, Wales, Northern Ireland and the Isle of Man, UK
Centre for Hip Surgery, Wrightington Hospital, UK
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Centre for Hip Surgery, Wrightington Hospital, UK
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Richard Armstrong
Richard Armstrong
The National Joint Registry of England, Wales, Northern Ireland and the Isle of Man, UK
Head of Health Registries, Northgate Public Services, Peoplebuilding 2, Hemel Hempstead, Hertfordshire, England
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Head of Health Registries, Northgate Public Services, Peoplebuilding 2, Hemel Hempstead, Hertfordshire, England
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Peter Howard
Peter Howard
The National Joint Registry of England, Wales, Northern Ireland and the Isle of Man, UK
Royal Derby Hospital, Derby, UK
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Royal Derby Hospital, Derby, UK
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Matthew Porteous
Matthew Porteous
The National Joint Registry of England, Wales, Northern Ireland and the Isle of Man, UK
West Suffolk NHS Foundation Trust, UK
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West Suffolk NHS Foundation Trust, UK
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J. Mark Wilkinson
J. Mark Wilkinson
The National Joint Registry of England, Wales, Northern Ireland and the Isle of Man, UK
University of Sheffield, Sheffield, UK
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University of Sheffield, Sheffield, UK
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post-market surveillance. Transparency and accountability The NJR is funded as part of the NHS. This leads to inevitable tensions between the politicians who want all outcome data to be published, and the surgeons who have concerns about the
Andrew Carr
Andrew Carr
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
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the increased use of post-market surveillance and intends to fortify the 510(k) system. This falls significantly short of the Institute of Medicine’s recommendation to eliminate the 510(k) route. The US system will improve device recall and will
Mustafa S. Rashid
Mustafa S. Rashid
Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK
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Yves Tourné
Yves Tourné
Institut Grenoblois de Chirurgie du Pied, Echirolles, France
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Kar H. Teoh
Kar H. Teoh
Princess Alexandra Hospital, Harlow, UK
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the chances of union. Utilizing a large post-market surveillance registry database, Zura et al reported an overall healing rate for all fractures sustained < 90 days prior to LIPUS treatment as 96% (4032/4190). 13 However, this cohort excluded
Anne Lübbeke
Anne Lübbeke
Division of Orthopaedic Surgery and Traumatology, Geneva University Hospitals and University of Geneva, Switzerland
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK
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Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK
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Andrew J Carr
Andrew J Carr
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK
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Pierre Hoffmeyer
Pierre Hoffmeyer
Division of Orthopaedic Surgery and Traumatology, Geneva University Hospitals and University of Geneva, Switzerland
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industry dedicated to providing high-performance implants. 13 The registry is seen as an essential tool of post-market surveillance and clinical control that justifies improvements in materials, design and concepts. In their view the downside is that
Alan G. Fraser
Alan G. Fraser
Department of Cardiology, University Hospital of Wales, Cardiff, UK
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Rob G.H.H. Nelissen
Rob G.H.H. Nelissen
Department of Orthopaedics, Leiden University Medical Center, Leiden, Netherlands
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Per Kjærsgaard-Andersen
Per Kjærsgaard-Andersen
Department of Orthopaedics, Vejle Hospital, South Danish University, Vejle, Denmark
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Piotr Szymański
Piotr Szymański
Centre of Postgraduate Medical Education, MSWiA Central Clinical Hospital, Warsaw, Poland
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Tom Melvin
Tom Melvin
Healthcare Products Regulatory Authority, Earlsfort Terrace, Dublin 2, Ireland
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Paul Piscoi
Paul Piscoi
Health Technology Unit B6, Directorate General for Health (DG SANTE), European Commission, Brussels, Belgium
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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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important difference; and what follow-up intervals would be recommended for assessing PROMs for specific interventions. A systematic review will assess how PROMs have been used in trials and studies for regulatory purposes and post-market surveillance, and
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