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Introduction Osteoarthritis of the carpometacarpal joint of the thumb (CMC-1) is a common problem and surgical treatment is indicated when conservative measures fail to provide sufficient relief. Of the many surgical treatment options, no
Ludwig Maximilians University Munich, Department of Orthopaedic and Trauma Surgery, Musculoskeletal University Center Munich (MUM), Campus Grosshadern, Munich, Germany
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Translational Health Sciences, Bristol Medical School, Musculoskeletal Research Unit, University of Bristol, Southmead Hospital, Bristol, UK
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Centro de Investigación Biomédica en Red de Bioingeniería, Biomateriales y Nanomedicina, CIBER-BBN, Madrid, Spain
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Department of Clinical Medicine, Faculty of Health & Medical Sciences, University of Copenhagen, Copenhagen, Denmark
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The objectives of the 1st EFORT European Consensus on ‘Medical and Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices’ were foremost to focus on patient safety by establishing performance requirements for medical devices.
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The 1st EFORT European Consensus applied an a priori-defined, modified Delphi methodology to produce unbiased, high-quality recommendation statements, confirmed by consensus voting of a European expert panel.
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Intended key outcomes are practical guidelines justified by the current stage of knowledge and based on a broad European Expert Consensus, to maintain innovation and optimisation of orthopaedic devices within the boundaries of MDR 2017/745.
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Twenty-one main research areas of relevance were defined relying on input from the EFORT IPSI WG1 ‘Introduction of Innovation’ recommendations and a related survey.
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A modified Delphi approach with a preparatory literature review and work in small groups were used to prepare answers to the research questions in the form of 32 draft Consensus statements.
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A Consensus Conference in a hybrid format, on-site in the Carl Gustav Carus University of Dresden was organised to further refine the draft statements and define consensus within the complete group of participants by final voting, intended to further quantify expert opinion knowledge.
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The modified Delphi approach provides practical guidelines for hands-on orientation for orthopaedic surgeons, research institutes and laboratories, orthopaedic device manufacturers, patient representatives, Notified Bodies, National Institutes and authorities.
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For the first time, initiated by the EFORT IPSI (WG1 ‘Introduction of Innovation’), knowledge of all related stakeholders was combined in the 1st EFORT European Consensus to develop guidelines and result in a comprehensive set of recommendations.
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handlebars. The resultant force is directed into the palm and metacarpal base. Though these are less critical injuries, the thumb carpometacarpal (CMC) joint is injured approximately 50% of the time and the thumb ulnar collateral ligament is injured 20% of
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prospectively registered on the International Prospective Register of Systematic Reviews (PROSPERO). PubMed, MEDLINE, EMBASE and The Cochrane Library were searched in April 2020 using the terms (thumb CMC or thumb CMCJ or thumb carpometacarpal or
Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands
Center of Research on Psychological and Somatic disorders (CoRPS), Tilburg University, Tilburg, The Netherlands
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Center of Research on Psychological and Somatic disorders (CoRPS), Tilburg University, Tilburg, The Netherlands
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using morphine before total shoulder arthroplasty is predictive for acute postoperative pain, but also in the longer term the relation with complications and/or worse outcome is also reported for osteoarthritis of knees ( 10 ), hips ( 11 ), and the CMC1
