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aspects of these practices and to produce guidance for the benefit of patients, surgeons, manufacturers and regulators. In this article we will attempt to clarify and suggest recommendations around the issues of off-label, including discussing the mixing
Department of Biomedical Data Sciences, Medical Decision Making, Leiden University Medical Centre, Leiden, The Netherlands
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example, a previous study showed that a change in definition within the same surgical context increased the occurrence of adverse outcomes from 7 to 27% ( 20 ). Similarly, data from one study where the complication rate is defined as the case-mix
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insertion has evolved significantly since its inception. ‘First-generation’ technique included simple hand mixing, finger packing, and hand insertion of cement. Early basic and clinical studies showed significant improvements in the fixation strength of
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sessions, discussions and controversies presented to an attentive audience. Lately, hybrid meetings have come in fashion created with a mix of in-person and virtual and lately in-person meetings have come back. What a relief it is to hear a ‘real’ speaker
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and traumatology journal with a mix of original articles, reviews and sounding boards. It was a print publication distributed widely to all members of the societies participating in EFORT, representing more than 40 000 potential readers throughout
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significantly higher rate of one or more complications and major systemic complications for operations involving a trainee compared with ones with no involvement. 5 However, the cohorts in each group were subject to unknown case-mix and unknown levels of
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4 92 – 94 . ( https://doi.org/10.1016/j.jacme.2014.02.004 ) 18. Grissinger M . Key vulnerabilities in the surgical environment: container Mix-ups and syringe swaps . P and T 2018 43 129 – 167 . 19. Harby SA & Kohaf NA . Accidental
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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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expect surgeons to use all components of the same manufacturer, almost all included registries report off-label mix-and-match prostheses, except for the GAR. The NAR and RAR reported that these mix-and-match prostheses consist of the use of BHR acetabular
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Department of Biomechanical Engineering, University of Twente, Enschede, The Netherlands
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Dept. of Orthopaedics, Radboud University Medical Center, Nijmegen, The Netherlands
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Dept. of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands
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components) ( Table 1 ). For bone cement, the name of bone cement, the manufacturer, type of cement, viscosity, whether the cement contains any antibiotics and use of a vacuum cement mixing system are collected ( Table 2 ). In 2014, the process described
Bucharest Emergency Clinical Hospital, Romania
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Available configuration Preloaded antibiotic Approved antibiotics for mixing Suggested optimal elution time (> MIC) Stimulan® calcium sulphate hemihydrate beads (3 mm, 4.8 mm, 6 mm); paste; bullets (7 mm; 9 mm) – Vancomycin