• BMJ open · Sep 2019

    The accuracy of diagnostic Imaging techniques in patients with a suspected Fracture-related Infection (IFI) trial: study protocol for a prospective multicenter cohort study.

    • Gam Govaert, Mgg Hobbelink, Ihf Reininga, P Bosch, T C Kwee, P A de Jong, P C Jutte, H C Vogely, Rajo Dierckx, Lph Leenen, Awjm Glaudemans, and Ffa IJpma.
    • Department of Trauma Surgery, Utrecht University, University Medical Center Utrecht, Utrecht, The Netherlands g.a.m.govaert@umcutrecht.nl.
    • BMJ Open. 2019 Sep 8; 9 (9): e027772.

    IntroductionThe optimal diagnostic imaging strategy for fracture-related infection (FRI) remains to be established. In this prospective study, the three commonly used advanced imaging techniques for diagnosing FRI will be compared. Primary endpoints are (1) determining the overall diagnostic performances of white blood cell (WBC) scintigraphy, fluorodeoxyglucose positron emission tomography (FDG-PET) and magnetic resonance imaging (MRI) in patients with suspected FRI and (2) establishing the most accurate imaging strategy for diagnosing FRI.Methods And AnalysisThis study is a non-randomised, partially blinded, prospective cohort study involving two level 1 trauma centres in The Netherlands. All adult patients who require advanced medical imaging for suspected FRI are eligible for inclusion. Patients will undergo all three investigational imaging procedures (WBC scintigraphy, FDG-PET and MRI) within a time frame of 14 days after inclusion. The reference standard will be the result of at least five intraoperative sampled microbiology cultures, or, in case of no surgery, the clinical presence or absence of infection at 1 year follow-up. Initially, the results of all three imaging modalities will be available to the treating team as per local protocol. At a later time point, all scans will be centrally reassessed by nuclear medicine physicians and radiologists who are blinded for the identity of the patients and their clinical outcome. The discriminative ability of the imaging modalities will be quantified by several measures of diagnostic accuracy.Ethics And DisseminationApproval of the study by the Institutional Review Board has been obtained prior to the start of this study. The results of this trial will be disseminated by publication of peer-reviewed manuscripts, presentation in abstract form at scientific meetings and data sharing with other investigators through academically established means.Trial Registration NumberThe IFI trial is registered in the Netherlands Trial Register (NTR7490).© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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