Clinical trial NCT03832556: Comparison Between CT and MRI in Preoperative Evaluation of Neurogenic Myositis Ossificans or Neurogenic Para-osteo-arthritis
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
Overall status: COMPLETED
Phase: NA
Conditions: Neurogenic Myositis Ossificans
Neurogenic Para-osteo-arthritis
Keywords: neurogenic myositis ossificans
para-osteo-arthropathy
preoperative evaluation
CT scan
MRI
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Analysis and comparison of accurate topography of heterotopic ossification on the CT and the MRI
timeFrame: through study completion, an average of 2 year
measure: Analysis and comparison of reporting arterial and venous anatomy
timeFrame: through study completion, an average of 2 year
measure: Analysis and comparison of reporting nervous structures
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Performances of MRI for diagnosis of arterial-venous
timeFrame: through study completion, an average of 2 year
measure: Performances of MRI for diagnosis of nervous structures (nerve's location, nerve signal anomalies, signs of suffering and denervation...)
timeFrame: through study completion, an average of 2 year
measure: Rate of incidence of adverse event during surgical operation
timeFrame: through study completion, an average of 2 year
measure: Concordance correlation coefficient
timeFrame: through study completion, an average of 2 year
measure: Characteristic of patients with discordant results
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Garches
country: France
facility: Service d'Imagerie médicale, Hôpital Raymond Poincaré
state: Hauts-de-Seine
Study officials:
affiliation: Service d'Imagerie médicale, Hôpital Raymond Poincaré, Garches
name: Robert Carlier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service d'Imagerie médicale, Hôpital Raymond Poincaré, Garches
name: Raphaël AMAR, Resident
role: STUDY_DIRECTOR
References:
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.