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-points and mandated post-marketing studies. 36 Most had not been approved for children. 37 Off-label drug use in children is associated with adverse events 38 and risks may also occur from off-label use of devices. In CORE–MD, the evaluation of evidence
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-of-the-art. Of note, the FDA has currently approved robotic-assisted technology for primary joint arthroplasty, including unicompartmental knee arthroplasty (UKA), THA, and TKA; the technique described here represents an off-label indication. This study was not
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retrieved implants collection and analysis In 2020, the European Federation of Orthopaedics and Traumatology (EFORT) launched an Implant & Patient Safety Initiative addressing the introduction of innovation, the off-label use and mix and match of
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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
Bucharest Emergency Clinical Hospital, Romania
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antibiotic delivery system based on bioactive glass. Until solid data are provided by research into this synthetic biomaterial as an antibiotic delivery system its use for this purpose remains experimental and off-label. 31 – 34 Calcium phosphate
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Department of Trauma & Orthopaedics, University of Leeds, Leeds, United Kingdom of Great Britain and Northern Ireland
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off-label, BMPs have also been investigated in the management of critical bone defects. In a canine ulna model, Salkeld et al. were able to demonstrate that the combination of Rh-BMP 7 with either autograft or allograft lead to faster times to union