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

March 15, 2023 updated by: Assistance Publique - Hôpitaux de Paris

Preoperative Evaluation of Neurogenic Myositis Ossificans or Neurogenic Para-osteo-arthritis: Comparison Between Computed Tomography and Magnetic Resonance Imaging in Preoperative Evaluation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Hauts-de-Seine
      • Garches, Hauts-de-Seine, France, 92380
        • Service d'Imagerie médicale, Hôpital Raymond Poincaré

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 2 year
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.
through study completion, an average of 2 year
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.
through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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...)
through study completion, an average of 2 year
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
through study completion, an average of 2 year
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.
through study completion, an average of 2 year
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.
through study completion, an average of 2 year
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.
through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2019

Primary Completion (Actual)

February 7, 2023

Study Completion (Actual)

February 7, 2023

Study Registration Dates

First Submitted

January 25, 2019

First Submitted That Met QC Criteria

February 4, 2019

First Posted (Actual)

February 6, 2019

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-A02783-52

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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