Comparison Between CT and MRI in Preoperative Evaluation of Neurogenic Myositis Ossificans or Neurogenic Para-osteo-arthritis (MON-IRM)

• ClinicalTrials.gov Identifier: NCT03832556
• Recruitment Status: Completed
• First Posted: February 6, 2019
• Last Update Posted: March 16, 2023
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

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.

Condition or disease	Intervention/treatment	Phase
Neurogenic Myositis Ossificans; Neurogenic Para-osteo-arthritis	Other: CT scan; Other: MRI examination	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Preoperative Evaluation of Neurogenic Myositis Ossificans or Neurogenic Para-osteo-arthritis: Comparison Between Computed Tomography and Magnetic Resonance Imaging in Preoperative Evaluation
• Actual Study Start Date: April 30, 2019
• Actual Primary Completion Date: February 7, 2023
• Actual Study Completion Date: February 7, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Preoperative evaluation: CT + MRI; Preoperative evaluation by 2 examinations: CT scan and MRI.; CT scan with biphasic injection of contrast product;; MRI with injection of contrast.	Other: CT scan; CT scan with biphasic injection of contrast product; Other: MRI examination; MRI with injection of contrast

Outcome Measures

Primary Outcome Measures :

1. Analysis and comparison of accurate topography of heterotopic ossification on the CT and the MRI [ Time Frame: through study completion, an average of 2 year ]

   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.

2. Analysis and comparison of reporting arterial and venous anatomy [ Time Frame: through study completion, an average of 2 year ]

   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.

3. Analysis and comparison of reporting nervous structures [ Time Frame: through study completion, an average of 2 year ]

   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 :

1. Performances of MRI for diagnosis of arterial-venous [ Time Frame: through study completion, an average of 2 year ]
   Performances of MRI for diagnosis of arterial-venous relation (gutter, stenosis, thrombosis or vascular occlusion, collateral circulation...)
2. 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 ]
3. Rate of incidence of adverse event during surgical operation [ Time Frame: through study completion, an average of 2 year ]
   The rate of incidence of adverse event during surgical procedure will be calculated.
4. Concordance correlation coefficient [ Time Frame: through study completion, an average of 2 year ]
   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.
5. Characteristic of patients with discordant results [ Time Frame: through study completion, an average of 2 year ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

Service d'Imagerie médicale, Hôpital Raymond Poincaré

Garches, Hauts-de-Seine, France, 92380

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Robert Carlier, MD, PhD; Service d'Imagerie médicale, Hôpital Raymond Poincaré, Garches
• Study Director: Raphaël AMAR, Resident; Service d'Imagerie médicale, Hôpital Raymond Poincaré, Garches

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT03832556
• Other Study ID Numbers: 2018-A02783-52
• First Posted: February 6, 2019
• Last Update Posted: March 16, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:

neurogenic myositis ossificans; para-osteo-arthropathy; preoperative evaluation; CT scan; MRI

Additional relevant MeSH terms:

Arthritis; Myositis; Osteoarthritis; Myositis Ossificans; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Rheumatic Diseases