Back to resultsComparison Between CT and MRI in Preoperative Evaluation of Neurogenic Myositis Ossificans or Neurogenic Para-osteo-arthritis (MON-IRM)
Primary Purpose
Neurogenic Myositis Ossificans, Neurogenic Para-osteo-arthritis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CT scan
MRI examination
Sponsored by
About this trial
This is an interventional other trial for Neurogenic Myositis Ossificans focused on measuring neurogenic myositis ossificans, para-osteo-arthropathy, preoperative evaluation, CT scan, MRI
Eligibility Criteria
Inclusion Criteria:
- Adult patient with neurogenic para-osteo-arthropathy resulted by prior central nervous system, cerebral or medullar damage
- Deformation with limitation of articular amplitude which could result limitation in rehabilitation care
- An indication of partial or total surgical excision of heterotopic ossification
- Indication of pre-operative assessment by CT scan and MRI, with contrast product injection
- Signed consent of patient obtained after clear and relevant informations given by physician
- Patient covered by social security
Exclusion Criteria:
- Contraindications to an MRI examination: cardiac stimulator, metallic intraocular foreign bodies...
- Contraindications to CT scan
- Contraindications to contrast injection product, such as iodinated or gadolinium-based contrast media
- Impractical venous access
- Severe deformation resulting impossibility to positioning for MRI examination or CT scan
- Patient can not give consent
- Participation to another interventional study
- Patient under guardianship
Sites / Locations
- Service d'Imagerie médicale, Hôpital Raymond Poincaré
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Preoperative evaluation: CT + MRI
Arm Description
Preoperative evaluation by 2 examinations: CT scan and MRI. CT scan with biphasic injection of contrast product; MRI with injection of contrast.
Outcomes
Primary Outcome Measures
Analysis and comparison of accurate topography of heterotopic ossification on the CT and the MRI
Comparison of preoperative diagnostic performances of CT scan and MRI, based on analysis of topography of heterotopic ossification.
On each CT and MRI exam, analysis of accurate topography of heterotopic ossifications relative to the bones, the number of fragments, their relationships with the articular capsule, their mineralization, and the mineralization of the underlying bone.
Analysis and comparison of reporting arterial and venous anatomy
Comparison of preoperative diagnostic performances of CT scan and MRI, based on analysis of reporting arterial and venous anatomy.
On each CT and MRI exam, analysis of vascular (arterial and veinous) relations with the heterotopic ossifications, in the case of contact specify the existence of a gutter or a tunnel, and the vessels permeability or occlusion.
Analysis and comparison of reporting nervous structures
Comparison of preoperative diagnostic performances of CT scan and MRI, based on analysis of reporting nervous structures.
On each CT and MRI exam, analysis of nervous structures relations with the heterotopic ossifications, in the case of contact specify the existence of a gutter or a tunnel, and the the existence of suffering nerve or denervation signs.
Secondary Outcome Measures
Performances of MRI for diagnosis of arterial-venous
Performances of MRI for diagnosis of arterial-venous relation (gutter, stenosis, thrombosis or vascular occlusion, collateral circulation...)
Performances of MRI for diagnosis of nervous structures (nerve's location, nerve signal anomalies, signs of suffering and denervation...)
Rate of incidence of adverse event during surgical operation
The rate of incidence of adverse event during surgical procedure will be calculated.
Concordance correlation coefficient
Concordance correlation coefficient two by two (Gwet concordance coefficient for binary qualitative variables; and W of Kendal concordance coefficient for ordinal qualitative variables or quantitative variables) between results of preoperative MRI and CT and operative report describing arterial-venous relation, and nervous structures.
Characteristic of patients with discordant results
Identify all discordances between CT or MRI and the surgery findings, about topography of heterotopic ossification, vascular relations and nervous structures relations.
Analysis of characteristics of patients with discordant results between preoperative MRI resluts or preoperative CT results relative to the operative report.
Full Information
NCT ID
NCT03832556
First Posted
January 25, 2019
Last Updated
March 15, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03832556
Brief Title
Comparison Between CT and MRI in Preoperative Evaluation of Neurogenic Myositis Ossificans or Neurogenic Para-osteo-arthritis
Acronym
MON-IRM
Official Title
Preoperative Evaluation of Neurogenic Myositis Ossificans or Neurogenic Para-osteo-arthritis: Comparison Between Computed Tomography and Magnetic Resonance Imaging in Preoperative Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 30, 2019 (Actual)
Primary Completion Date
February 7, 2023 (Actual)
Study Completion Date
February 7, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Myositis Ossificans, Neurogenic Para-osteo-arthritis
Keywords
neurogenic myositis ossificans, para-osteo-arthropathy, preoperative evaluation, CT scan, MRI
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preoperative evaluation: CT + MRI
Arm Type
Experimental
Arm Description
Preoperative evaluation by 2 examinations: CT scan and MRI.
CT scan with biphasic injection of contrast product;
MRI with injection of contrast.
Intervention Type
Other
Intervention Name(s)
CT scan
Intervention Description
CT scan with biphasic injection of contrast product
Intervention Type
Other
Intervention Name(s)
MRI examination
Intervention Description
MRI with injection of contrast
Primary Outcome Measure Information:
Title
Analysis and comparison of accurate topography of heterotopic ossification on the CT and the MRI
Description
Comparison of preoperative diagnostic performances of CT scan and MRI, based on analysis of topography of heterotopic ossification.
On each CT and MRI exam, analysis of accurate topography of heterotopic ossifications relative to the bones, the number of fragments, their relationships with the articular capsule, their mineralization, and the mineralization of the underlying bone.
Time Frame
through study completion, an average of 2 year
Title
Analysis and comparison of reporting arterial and venous anatomy
Description
Comparison of preoperative diagnostic performances of CT scan and MRI, based on analysis of reporting arterial and venous anatomy.
On each CT and MRI exam, analysis of vascular (arterial and veinous) relations with the heterotopic ossifications, in the case of contact specify the existence of a gutter or a tunnel, and the vessels permeability or occlusion.
Time Frame
through study completion, an average of 2 year
Title
Analysis and comparison of reporting nervous structures
Description
Comparison of preoperative diagnostic performances of CT scan and MRI, based on analysis of reporting nervous structures.
On each CT and MRI exam, analysis of nervous structures relations with the heterotopic ossifications, in the case of contact specify the existence of a gutter or a tunnel, and the the existence of suffering nerve or denervation signs.
Time Frame
through study completion, an average of 2 year
Secondary Outcome Measure Information:
Title
Performances of MRI for diagnosis of arterial-venous
Description
Performances of MRI for diagnosis of arterial-venous relation (gutter, stenosis, thrombosis or vascular occlusion, collateral circulation...)
Time Frame
through study completion, an average of 2 year
Title
Performances of MRI for diagnosis of nervous structures (nerve's location, nerve signal anomalies, signs of suffering and denervation...)
Time Frame
through study completion, an average of 2 year
Title
Rate of incidence of adverse event during surgical operation
Description
The rate of incidence of adverse event during surgical procedure will be calculated.
Time Frame
through study completion, an average of 2 year
Title
Concordance correlation coefficient
Description
Concordance correlation coefficient two by two (Gwet concordance coefficient for binary qualitative variables; and W of Kendal concordance coefficient for ordinal qualitative variables or quantitative variables) between results of preoperative MRI and CT and operative report describing arterial-venous relation, and nervous structures.
Time Frame
through study completion, an average of 2 year
Title
Characteristic of patients with discordant results
Description
Identify all discordances between CT or MRI and the surgery findings, about topography of heterotopic ossification, vascular relations and nervous structures relations.
Analysis of characteristics of patients with discordant results between preoperative MRI resluts or preoperative CT results relative to the operative report.
Time Frame
through study completion, an average of 2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patient with neurogenic para-osteo-arthropathy resulted by prior central nervous system, cerebral or medullar damage
Deformation with limitation of articular amplitude which could result limitation in rehabilitation care
An indication of partial or total surgical excision of heterotopic ossification
Indication of pre-operative assessment by CT scan and MRI, with contrast product injection
Signed consent of patient obtained after clear and relevant informations given by physician
Patient covered by social security
Exclusion Criteria:
Contraindications to an MRI examination: cardiac stimulator, metallic intraocular foreign bodies...
Contraindications to CT scan
Contraindications to contrast injection product, such as iodinated or gadolinium-based contrast media
Impractical venous access
Severe deformation resulting impossibility to positioning for MRI examination or CT scan
Patient can not give consent
Participation to another interventional study
Patient under guardianship
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Carlier, MD, PhD
Organizational Affiliation
Service d'Imagerie médicale, Hôpital Raymond Poincaré, Garches
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raphaël AMAR, Resident
Organizational Affiliation
Service d'Imagerie médicale, Hôpital Raymond Poincaré, Garches
Official's Role
Study Director
Facility Information:
Facility Name
Service d'Imagerie médicale, Hôpital Raymond Poincaré
City
Garches
State/Province
Hauts-de-Seine
ZIP/Postal Code
92380
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34930354
Citation
Amar R, Thiry T, Salga M, Safa D, Chetrit A, Gatin L, Carlier RY. Comparison of magnetic resonance imaging and computed tomography for bone assessment of neurogenic heterotopic ossification of the hip: a preliminary study. J Orthop Surg Res. 2021 Dec 20;16(1):725. doi: 10.1186/s13018-021-02869-6.
Results Reference
derived
Learn more about this trial
Comparison Between CT and MRI in Preoperative Evaluation of Neurogenic Myositis Ossificans or Neurogenic Para-osteo-arthritis
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