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Trial record 2 of 12 for:    Recruiting, Active, not recruiting Studies | Myositis | France

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

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ClinicalTrials.gov Identifier: NCT03832556
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021


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




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.




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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03832556


Contacts
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Contact: Robert Carlier, MD, PhD +33147107048 robert.carlier@aphp.fr
Contact: Raphaël AMAR, Resident +33147107048 raphaelamar2210@gmail.com

Locations
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France
Service d'Imagerie médicale, Hôpital Raymond Poincaré Recruiting
Garches, Hauts-de-Seine, France, 92380
Contact: Robert Carlier, MD, PhD    +33147107048    robert.carlier@aphp.fr   
Contact: Raphaël AMAR, Resident    +33147107048    raphaelamar2210@gmail.com   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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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

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03832556     History of Changes
Other Study ID Numbers: 2018-A02783-52
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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