Reporting Complications in Orthopaedic Trials
Complications in orthopaedic trials are an essential source of information. They may terminate unsuccessful treatment strategies, help to identify potential for development and form the basis for shared decision-making with patients. Therefore, anticipated complications/adverse events should be listed in all study protocols with clear and objective definitions along with appropriate scientific references. In addition, the normal course of healing and rehabilitation including an evidence-based range should be defined. For each complication, a minimum set of information should be documented due to the regulations to allow clinically meaningful evaluation and reporting. It is necessary to follow up a complication until it is resolved. An independent Complication Review Board should review and analyse all information about potential orthopaedic complications.
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