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Keith Tucker Orthopaedic Data Evaluation Panel (ODEP), Norwich, UK

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Klaus-Peter Günther University Centre of Orthopedics, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus Dresden, Technische Universität Dresden, Germany

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Per Kjaersgaard-Andersen Department of Orthopaedics, Vejle Hospital, South Danish University, Vejle, Denmark

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Jörg Lützner University Centre of Orthopedics, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus Dresden, Technische Universität Dresden, Germany

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Jan Philippe Kretzer Laboratory of Biomechanics and Implant Research, Clinic for Orthopedics and Trauma Surgery, Heidelberg University Hospital, Heidelberg, Germany

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Rob G.H.H. Nelissen Department of Orthopaedics, Leiden University Medical Center, Leiden, Netherlands

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Toni Lange Center for Evidence-based Healthcare, University Hospital Carl Gustav Carus and Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Germany

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Luigi Zagra IRCCS Istituto Ortopedico Galeazzi, Hip Department, Milan, Italy

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surgeons have the capacity to adapt their practice when they think it is necessary and go ‘off-label’. EFORT consider these issues extremely important; they are all about patient safety which is why they commissioned this appraisal in order to evaluate all

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Antal Imre Department of Orthopaedics, Semmelweis University, Budapest, Hungary

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Sápi Zoltán Department of Pathology and Experimental Cancer Research, Semmelweis University, Budapest

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Szendrői Miklós Department of Orthopaedics, Semmelweis University, Budapest, Hungary

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. They pointed out that denosumab inhibits osteoclast-like giant cells and probably alters the phosphorylation profiles of receptor tyrosine kinases and downstream signalling proteins in the tumourous tissue. Furthermore they performed an off-label

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Francisco Figueroa Clinica Alemana-Universidad del Desarrollo, Santiago, Chile
Hospital Sotero del Rio, Santiago, Chile

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David Figueroa Clinica Alemana-Universidad del Desarrollo, Santiago, Chile

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Rafael Calvo Clinica Alemana-Universidad del Desarrollo, Santiago, Chile

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Alex Vaisman Clinica Alemana-Universidad del Desarrollo, Santiago, Chile
Hospital Padre Hurtado, Santiago, Chile

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João Espregueira-Mendes Clínica do Dragão, Espregueira-Mendes Sports Centre – FIFA Medical Centre of Excellence, Portugal; Dom Henrique Research Centre, Portugal; 3B’s Research Group – Biomaterials, Biodegradables and Biomimetics, University of Minho, Portugal; ICVS/3B’s–PT Government Associate Laboratory, Portugal; Orthopaedics Department of Minho University, Portugal

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Vancomycin presoaked grafts returned to their pre-injury sport compared to their control counterparts. Another important concern are the legal implications involved in this off-label clinical use of Vancomycin. The World Health Organization guideline

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Pernille Bovbjerg Department of Orthopedic Surgery, Odense University Hospital, Odense, Denmark

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Ditte Høgh Department of Orthopedic Surgery, Hospital of Southern Denmark, Odense, Denmark

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Lonnie Froberg Department of Orthopedic Surgery, Odense University Hospital, Odense, Denmark

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Hagen Schmal Department of Orthopedic Surgery, Odense University Hospital, Odense, Denmark
Clinic of Orthopaedic Surgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany

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Moustapha Kassem Department of Endocrinology, Odense University Hospital, Odense, Denmark

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stimulates bone formation by activating osteoblasts. PTH (1-84) has shown the same effect and has been used as an osteoporotic treatment as well. 5 This suggests a positive influence on bone healing, and teriparatide has been used off-label for treatment

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Junbo He Department of Orthopedic Surgery, West China Hospital, Sichuan University, Chengdu, China
These authors contributed equally to this work and should be considered co-first authors

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Tingkui Wu Department of Orthopedic Surgery, West China Hospital, Sichuan University, Chengdu, China
These authors contributed equally to this work and should be considered co-first authors

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Chen Ding Department of Orthopedic Surgery, West China Hospital, Sichuan University, Chengdu, China

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Beiyu Wang Department of Orthopedic Surgery, West China Hospital, Sichuan University, Chengdu, China

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Ying Hong West China School of Nursing, Sichuan University/ Department of Anesthesia and Operation Center, West China Hospital, Sichuan University, Chengdu, China

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Hao Liu Department of Orthopedic Surgery, West China Hospital, Sichuan University, Chengdu, China

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cervical spine Robinson, RA 294 5.0 IV 19 A review of the clinical side effects of bone morphogenetic protein-2 James, AW 293 58.6 NA 20 Increased swelling complications associated with off-label usage of rhBMP-2 in the

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Alan G. Fraser Department of Cardiology, University Hospital of Wales, Cardiff, UK

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Rob G.H.H. Nelissen Department of Orthopaedics, Leiden University Medical Center, Leiden, Netherlands

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Per Kjærsgaard-Andersen Department of Orthopaedics, Vejle Hospital, South Danish University, Vejle, Denmark

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Piotr Szymański Centre of Postgraduate Medical Education, MSWiA Central Clinical Hospital, Warsaw, Poland

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Tom Melvin Healthcare Products Regulatory Authority, Earlsfort Terrace, Dublin 2, Ireland

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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) 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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-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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Xiang-Dong Wu Department of Orthopaedic Surgery, Beijing Jishuitan Hospital, Fourth Clinical College of Peking University, Beijing, China

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Yixin Zhou Department of Orthopaedic Surgery, Beijing Jishuitan Hospital, Fourth Clinical College of Peking University, Beijing, China

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Hongyi Shao Department of Orthopaedic Surgery, Beijing Jishuitan Hospital, Fourth Clinical College of Peking University, Beijing, China

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Dejin Yang Department of Orthopaedic Surgery, Beijing Jishuitan Hospital, Fourth Clinical College of Peking University, Beijing, China

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Sheng-Jie Guo Department of Orthopaedic Surgery, Beijing Jishuitan Hospital, Fourth Clinical College of Peking University, Beijing, China

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Wei Huang Department of Orthopaedic Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China

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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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M M Morlock Institute of Biomechanics, TUHH Hamburg University of Technology, Hamburg, Germany

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E Gomez-Barrena Department of Orthopaedic Surgery and Traumatology, Universidad Autónoma de Madrid, Madrid, Spain

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D C Wirtz Department of Orthopaedics and Traumatology, University Hospital Bonn, Bonn, Germany

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A Hart London Implant Retrieval Centre, Royal National Orthopaedic Hospital, Stanmore, UK

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J P Kretzer Department of Orthopaedic Surgery, Heidelberg University Hospital, Heidelberg, Germany

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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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Daniel Bachman University of Missouri-Kansas City, Kansas City, USA

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Akin Cil University of Missouri-Kansas City, Kansas City, USA

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include distal humeral non-union after a failed attempted ORIF. Relatively preserved cartilage on the radial head and proximal ulna is a pre-requisite for the use of elbow HA. Surgeons should be aware that elbow HA for any indication is an off-label use of

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James Wee Tan Tock Seng Hospital, 11 Jalan Tan Tock Seng, 308433, Singapore

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Gowreeson Thevendran Tan Tock Seng Hospital, 11 Jalan Tan Tock Seng, 308433, Singapore

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. 69 Pertaining to foot and ankle surgery, a novel off-label use of Cerament has been described in a series (Level IV) by Karr, 71 in which vancomycin-impregnated Cerament beads were implanted successfully in the management of patients with

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