Clinical Trials Logo

Clinical Trial Summary

The principal objective of the study is to compare between CT and MRI diagnostic performance (sensibility and specificity) in the preoperative assessment of neurogenic para-osteo-arthritis. The second objectives of the study are: - besides the diagnostic performance (sensibility and specificity), to evaluate the imaging par MRI in visual and descriptive manner heterotopic ossification and connection with vascular and nervous structures. - to study the concordance (two by two) of results of preoperative obtained by MRI and by CT and operative reports. - to study the characteristics of patients with discordant findings (two by two) by MRI, CT scan and operative report.


Clinical Trial Description

This is a study on diagnostic performance, non randomized, versus Gold standard (a prospective multicentric cohort). All eligible patients will be proposed consecutively to participate to the study, to undergo preoperative CT scan and MRI examination as usual procedure. The only additional action in this study will be a neurography sequence of type fluorescence subtraction imaging (FSI) during MRI, permitting to obtain more details in visualization of nerve structure and their relations of the ossifications. The enrollment visit will performed by neuro-orthopaedic surgeon during preoperative consultation. The follow-up visit will be an usual post-operative visit, non-specific for the study. The duration for each participant will compound 1 month (the duration between preoperative imaging and surgical resection) added by up to two months of post-operative follow-up. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03832556
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Completed
Phase N/A
Start date April 30, 2019
Completion date February 7, 2023