• N S Makaram and SimpsonA Hamish R WAHRWProfessor of Orthopaedics and Trauma, Edinburgh Orthopaedics, The University of Edinburgh, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh, EH16 4SU, United Kingdom..
• Specialty Registrar (StR) in Trauma and Orthopaedics, Edinburgh Orthopaedics, The University of Edinburgh, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh, EH16 4SU, United Kingdom. Electronic address: nmakaram@ed.ac.uk.
• Injury. 2023 Oct 1; 54 Suppl 5: 110905110905.

AbstractRecent decades have seen marked advances in the quality of clinical orthopaedic trauma research, and with this has come a rise in the number of randomised clinical trials (RCTs) being conducted in orthopaedic trauma. These trials have been largely valuable in driving evidence-based management of injuries which previously had clinical equipoise. However, though RCTs are traditionally seen as the 'gold standard' of high-quality research, this research method is comprised primarily of two entities, explanatory and pragmatic designs, each with its own strengths and limitations. Most orthopaedic trials lie within a continuum between these designs, with varying degrees of both pragmatic and explanatory features. In this narrative review we provide a summary of the nuances within orthopaedic trial design, the advantages and limitations of such designs, and suggest tools which may aid clinicians in the appropriate selection and evaluation of trial designs.Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.

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