Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
Study NCT ID:
NCT03832556
Status:
COMPLETED
Last Update Posted:
2023-03-16
First Post:
2019-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between CT and MRI in Preoperative Evaluation of Neurogenic Myositis Ossificans or Neurogenic Para-osteo-arthritis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Preoperative Evaluation of Neurogenic Myositis Ossificans or Neurogenic Para-osteo-arthritis: Comparison Between Computed Tomography and Magnetic Resonance Imaging in Preoperative Evaluation
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MON-IRM
Brief 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.
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.
Detailed 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: