Neurogenic Myositis OssificansMON-IRMNCT03832556
Comparison Between CT and MRI in Preoperative Evaluation of Neurogenic Myositis Ossificans or Neurogenic Para-osteo-arthritis
A study testing CT scan and MRI examination in people with Neurogenic Myositis Ossificans and Neurogenic Para-osteo-arthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Myositis Ossificans, Neurogenic Para-osteo-arthritis
- What is being tested?
- CT scan and MRI examination
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2019to 7 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Imagerie médicale, Hôpital Raymond Poincaré
Garches, Hauts-de-Seine, 92380
About this study
Official title: 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.
Read the 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.
- Being tested
- CT scan, MRI examination
- Keywords
- neurogenic myositis ossificans, para-osteo-arthropathy, preoperative evaluation, CT scan, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanOther
CT scan with biphasic injection of contrast product
MRI examinationOther
MRI with injection of contrast
| Study group | Role | What they receive |
|---|---|---|
| Preoperative evaluation: CT + MRI | Experimental | Preoperative evaluation by 2 examinations: CT scan and MRI.
* CT scan with biphasic injection of contrast product;
* MRI with injection of contrast. Receives: Other: CT scan; Other: MRI examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 2 year
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.
Measured: through study completion, an average of 2 year
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.
Measured: through study completion, an average of 2 year
Secondary outcomes (5)
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...)
Measured: 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...)
Measured: through study completion, an average of 2 year
Rate of incidence of adverse event during surgical operation
The rate of incidence of adverse event during surgical procedure will be calculated.
Measured: through study completion, an average of 2 year
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.
Measured: through study completion, an average of 2 year
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.
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start30 Apr 2019
- Primary completion7 Feb 2023
- Study completion7 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurogenic Myositis OssificansStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Carlier, MD, PhD, Principal investigator, Service d'Imagerie médicale, Hôpital Raymond Poincaré, GarchesRaphaël AMAR, Resident, Study director, Service d'Imagerie médicale, Hôpital Raymond Poincaré, Garches
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832556
- Sponsor's protocol ID
- 2018-A02783-52
- Acronym
- MON-IRM
- Status last verified
- Mar 2023
- First submitted
- 25 Jan 2019
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34930354
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Evaluation of Neurogenic Myositis Ossificans or Neurogenic Para-osteo-arthritis: Comparison Between Computed Tomography and Magnetic Resonance Imaging in Preoperative Evaluation
- ClinicalTrials.gov ID
- NCT03832556
- Acronym / sponsor ID
- MON-IRM / 2018-A02783-52
- Keywords
- neurogenic myositis ossificans, para-osteo-arthropathy, preoperative evaluation, CT scan, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 7 Feb 2023 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative evaluation: CT + MRI | Experimental | Other: CT scan, Other: MRI examinationPreoperative evaluation by 2 examinations: CT scan and MRI. * CT scan with biphasic injection of contrast product; * MRI with injection of contrast. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scanCT scan with biphasic injection of contrast product | Other | Preoperative evaluation: CT + MRI |
| MRI examinationMRI with injection of contrast | Other | Preoperative evaluation: CT + MRI |
Primary outcome
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.
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.
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.
5 secondary outcomes
Performances of MRI for diagnosis of arterial-venous
Time frame: 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
Rate of incidence of adverse event during surgical operation
Time frame: through study completion, an average of 2 year
Concordance correlation coefficient
Time frame: through study completion, an average of 2 year
Characteristic of patients with discordant results
Time frame: through study completion, an average of 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Derived from this study: PubMed 34930354Amar 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Carlier, MD, PhD principal investigator
Service d'Imagerie médicale, Hôpital Raymond Poincaré, Garches
Raphaël AMAR, Resident study director
Service d'Imagerie médicale, Hôpital Raymond Poincaré, Garches
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT scan and MRI examination in people with Neurogenic Myositis Ossificans and Neurogenic Para-osteo-arthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03832556, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.