Safety notices and registry outlier data measure different aspects of safety and performance of total knee implants: a comparative study of safety notices and register outliers

Autor: Lotje A Hoogervorst, Yijun Ren, Tom Melvin, Ashley A Stratton-Powell, Anne Lübbeke, Robert E Geertsma, Alan G Fraser, Rob G H H Nelissen, Enrico G Caiani, Perla J Marang-van de Mheen

Publikováno v: Acta Orthopaedica, Vol 95 (2024)

Background and purpose: Safety notices for medical devices such as total knee arthroplasty (TKA) implants may indicate problems in their design or performance that require corrective action to prevent patient harm. Safety notices are often published

Externí odkaz: https://doaj.org/article/490362f2a52e43cda86ea72564fb7102

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

Autor: Reinier W.A. Spek, Lotje A. Hoogervorst, Rob C. Brink, Jan W. Schoones, Derek F.P. van Deurzen, Michel P.J. van den Bekerom

Publikováno v: Clinics in Shoulder and Elbow, Vol 27, Iss 1, Pp 88-107 (2023)

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; scre

Externí odkaz: https://doaj.org/article/1f7165485226437894f43907c7cf8f7e

An open comminuted tibia fracture including a 5 cm tibial bone defect in a child: Successful management using a locking compression plate

Autor: Lotje A. Hoogervorst, Bart W. Oudelaar, Demien Broekhuis

Publikováno v: Trauma Case Reports, Vol 48, Iss , Pp 100944- (2023)

Traumatic bone defects (TBDs), although rare in children, are severe injuries that often represents a challenge for both orthopaedic and trauma surgeons. We present a case of a 6-year-old girl who sustained an open (Gustilo-Anderson type II) comminut

Externí odkaz: https://doaj.org/article/a065ab7b7a0c4ed3a0d3c59d1e74e8c2

Mycetoma caused by Madurella mycetomatis in immunocompromised patients – a case report and systematic literature review

Autor: Lotje A. Hoogervorst, Lindsey S. op de Coul, Arghya Ray, Pieter Bas de Witte, Mark G. J. de Boer

Publikováno v: J Bone Jt Infect

The aim of this study was to review the available literature concerning Madura foot (“mycetoma”) caused by Madurella mycetomatis in immunocompromised patients. With a systematic literature search, we identified only three papers, describing a tot

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1e040f4a2f948f4c45c0d569ca34c915
https://europepmc.org/articles/PMC9752710/

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

Autor: Arjola Bano, Stefan James, Gero Viola, Enrico G. Caiani, Frank Rademakers, Felicitas Kühne, Elizabeth Macintyre, Michael Hahn, Per Kjærsgaard-Andersen, Stephan Windecker, Anett Ruszanov, T Melvin, Richard Holborow, Anne Lubbeke-Wolf, Rob Nelissen, Sabine Ettinger, Jan Szulc, Petra Schnell-Inderst, A G Fraser, Marieke Meijer, Harry van Vugt, Juan Antonio Blasco Amaro, Peter McCulloch, Loredana Simulescu, P Kjærsgaard-Andersen, Chris P Gale, Susana L F Cabaço, Christoph Stettler, Erik Kamenjasevic, Robert E Geertsma, Jantine W P M van Baal, Ola Rolfson, Michèle Meagher, Marina Torre, Sergio Buccheri, P Szymański, Polyxeni Vairami, Cinzia Cappiello, Alan Fraser, Thomas Wejs Møller, Lorenzo Gianquintieri, Joel Jakobsson, Lia Bally, Suzanne Halliday, Aldo P. Maggioni, Hannes Jarke, Christoph Ziskoven, Lotje A. Hoogervorst, Valentina Strammiello, Marianna Mastroroberto, Juan Carlos Rejón Parrilla, Joëlle M Hoebert, Ewout W. Steyerberg, David Epstein, Sarah Wieczorek, Claudia Wild, Jan D'hooge, Alexey Shiryaev, Erman Melikyan, Stefano Del Torso, James R. Smith, Sabina Hoekstra, Paola Laricchiuta, Andre Frenk, Niall MacAleenan, Piotr Szymański, Martin J Landray, Françoise Schlemmer, Elisabetta Zanon, Core-Md Investigators, Perla J Marang-van de Mheen, Amanda Tornsö, Tom Melvin, Ann-Sofie Sonne Holm-Schou, Eugenio Carrani, Kaisa Immonen, Cinzia Ceccarelli, Stefania Ceccarelli, Filippo Boniforti, R G H H Nelissen, Ria Mahon, Adamos Hadjipanayis, Georgios Siontis, Bas B.L. Penning de Vries, Christina Dimopoulou, Robert A. Byrne, Elisabetta Biasin, Maristella Matera, Laurna McGovern, Agnieszka Dobrzynska, Berthold Koletzko, Anton Vedder, P Piscoi, Daniel Prieto Alhambra, Gearóid McGauran, Adrian Ott

Publikováno v: Fraser, A G, Nelissen, R G H H, Kjærsgaard-Andersen, P, Szymański, P, Melvin, T, Piscoi, P & CORE-MD Investigators 2022, ' Improved clinical investigation and evaluation of high-risk medical devices : the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices) ', European Heart Journal-Quality of Care and Clinical Outcomes, vol. 8, no. 3, pp. 249–258 . https://doi.org/10.1093/ehjqcco/qcab059
EFORT Open Reviews, 6(10), 839-849. BRITISH EDITORIAL SOC BONE & JOINT SURGERY
EFORT Open Reviews
Fraser, Alan G; Nelissen, Rob G H H; Kjærsgaard-Andersen, Per; Szymański, Piotr; Melvin, Tom; Piscoi, Paul (2021). Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices). EFORT open reviews, 6(10), pp. 839-849. The British Editorial Society of Bone & Joint Surgery 10.1302/2058-5241.6.210081
Fraser, A G, Nelissen, R G H H, Kjærsgaard-Andersen, P, Szymański, P, Melvin, T & Piscoi, P 2021, ' Improved clinical investigation and evaluation of high-risk medical devices : the rationale and objectives of CORE–MD (Coordinating Research and Evidence for Medical Devices) ', EFORT Open Reviews, vol. 6, no. 10, pp. 839-849 . https://doi.org/10.1302/2058-5241.6.210081

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 Medicin

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4c4cd329458895c5cdcfe189e80c2b53
https://portal.findresearcher.sdu.dk/da/publications/30f5f7b8-aa4a-4b17-926b-6efa3983bc20