The accuracy of diagnostic Imaging techniques in patients with a suspected Fracture-related Infection (IFI) trial: study protocol for a prospective multicenter cohort study.
Introduction The 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 perfor...
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BMJ Publishing Group
2019-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/9/e027772.full |
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| author | GAM Govaert MGG Hobbelink IHF Reininga P Bosch TC Kwee PA de Jong PC Jutte HC Vogely RAJO Dierckx LPH Leenen AWJM Glaudemans FFA IJpma |
| author_facet | GAM Govaert MGG Hobbelink IHF Reininga P Bosch TC Kwee PA de Jong PC Jutte HC Vogely RAJO Dierckx LPH Leenen AWJM Glaudemans FFA IJpma |
| author_sort | GAM Govaert |
| collection | DOAJ |
| description | Introduction The 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 analysis This 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 dissemination Approval 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 number The IFI trial is registered in the Netherlands Trial Register (NTR7490). |
| format | Article |
| id | doaj-art-abd14652f57943f2bb85cba2176df244 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-abd14652f57943f2bb85cba2176df2442025-08-20T02:32:48ZengBMJ Publishing GroupBMJ Open2044-60552019-09-019910.1136/bmjopen-2018-027772The accuracy of diagnostic Imaging techniques in patients with a suspected Fracture-related Infection (IFI) trial: study protocol for a prospective multicenter cohort study.GAM Govaert0MGG Hobbelink1IHF Reininga2P Bosch3TC Kwee4PA de Jong5PC Jutte6HC Vogely7RAJO Dierckx8LPH Leenen9AWJM Glaudemans10FFA IJpma11Department of Trauma Surgery, Utrecht University, University Medical Center Utrecht, Utrecht, The NetherlandsDepartment of Radiology and Nuclear Imaging, Utrecht University, University Medical Center Utrecht, Utrecht, The NetherlandsDepartment of Trauma Surgery, University of Groningen, University Medical Center Groningen, Groningen, The NetherlandsDepartment of Trauma Surgery, University of Groningen, University Medical Center Groningen, Groningen, The NetherlandsDepartment of Radiology, University of Groningen, University Medical Center Groningen, Groningen, The NetherlandsDepartment of Radiology and Nuclear Imaging, Utrecht University, University Medical Center Utrecht, Utrecht, The NetherlandsDepartment of Orthopaedic Surgery, University of Groningen, University Medical Center Groningen, Groningen, The NetherlandsDepartment of Orthopaedic Surgery, Utrecht University, University Medical Center Utrecht, Utrecht, The NetherlandsDepartment of Nuclear Medicine and Molecular Imaging, University of Groningen, University Medical Center Groningen, Groningen, The NetherlandsDepartment of Trauma Surgery, Utrecht University, University Medical Center Utrecht, Utrecht, The NetherlandsDepartment of Nuclear Medicine and Molecular Imaging, University of Groningen, University Medical Center Groningen, Groningen, The NetherlandsDepartment of Trauma Surgery, University of Groningen, University Medical Center Groningen, Groningen, The NetherlandsIntroduction The 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 analysis This 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 dissemination Approval 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 number The IFI trial is registered in the Netherlands Trial Register (NTR7490).https://bmjopen.bmj.com/content/9/9/e027772.full |
| spellingShingle | GAM Govaert MGG Hobbelink IHF Reininga P Bosch TC Kwee PA de Jong PC Jutte HC Vogely RAJO Dierckx LPH Leenen AWJM Glaudemans FFA IJpma The accuracy of diagnostic Imaging techniques in patients with a suspected Fracture-related Infection (IFI) trial: study protocol for a prospective multicenter cohort study. BMJ Open |
| title | The accuracy of diagnostic Imaging techniques in patients with a suspected Fracture-related Infection (IFI) trial: study protocol for a prospective multicenter cohort study. |
| title_full | The accuracy of diagnostic Imaging techniques in patients with a suspected Fracture-related Infection (IFI) trial: study protocol for a prospective multicenter cohort study. |
| title_fullStr | The accuracy of diagnostic Imaging techniques in patients with a suspected Fracture-related Infection (IFI) trial: study protocol for a prospective multicenter cohort study. |
| title_full_unstemmed | The accuracy of diagnostic Imaging techniques in patients with a suspected Fracture-related Infection (IFI) trial: study protocol for a prospective multicenter cohort study. |
| title_short | The accuracy of diagnostic Imaging techniques in patients with a suspected Fracture-related Infection (IFI) trial: study protocol for a prospective multicenter cohort study. |
| title_sort | accuracy of diagnostic imaging techniques in patients with a suspected fracture related infection ifi trial study protocol for a prospective multicenter cohort study |
| url | https://bmjopen.bmj.com/content/9/9/e027772.full |
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