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Completed

NCT Number: NCT03832556

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

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.

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Key information

Conditions

Neurogenic Myositis Ossificans Neurogenic Para-osteo-arthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service d'Imagerie médicale, Hôpital Raymond Poincaré

Garches, Hauts-de-Seine, 92380, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT scan

Other

CT scan with biphasic injection of contrast product

MRI examination

Other

MRI with injection of contrast

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: MON-IRM

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 6, 2019
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.