Neurogenic Myositis Ossificans Clinical Trial
— MON-IRMOfficial title:
Preoperative Evaluation of Neurogenic Myositis Ossificans or Neurogenic Para-osteo-arthritis: Comparison Between Computed Tomography and Magnetic Resonance Imaging in Preoperative Evaluation
| Verified date | March 2023 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 23 |
| Est. completion date | February 7, 2023 |
| Est. primary completion date | February 7, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Service d'Imagerie médicale, Hôpital Raymond Poincaré | Garches | Hauts-de-Seine |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Analysis and comparison of accurate topography of heterotopic ossification on the CT and the MRI | 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 | |
| Primary | Analysis and comparison of reporting arterial and venous anatomy | 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 | |
| Primary | Analysis and comparison of reporting nervous structures | 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 | Performances of MRI for diagnosis of arterial-venous | 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 | |
| Secondary | Performances of MRI for diagnosis of nervous structures (nerve's location, nerve signal anomalies, signs of suffering and denervation...) | through study completion, an average of 2 year | ||
| Secondary | Rate of incidence of adverse event during surgical operation | The rate of incidence of adverse event during surgical procedure will be calculated. | through study completion, an average of 2 year | |
| Secondary | Concordance correlation coefficient | 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 | |
| Secondary | Characteristic of patients with discordant results | 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 |