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

NCT ID: NCT03832556

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2023-02-07

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.

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.

Conditions

Neurogenic Myositis Ossificans; Neurogenic Para-osteo-arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CT scan

Intervention Type: OTHER

CT scan with biphasic injection of contrast product

MRI examination

Intervention Type: OTHER

MRI with injection of contrast

Interventions

CT scan

CT scan with biphasic injection of contrast product

Intervention Type: OTHER

MRI examination

MRI with injection of contrast

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Carlier, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Service d'Imagerie médicale, Hôpital Raymond Poincaré, Garches

Raphaël AMAR, Resident

Role: STUDY_DIRECTOR

Service d'Imagerie médicale, Hôpital Raymond Poincaré, Garches

Locations

Service d'Imagerie médicale, Hôpital Raymond Poincaré

Garches, Hauts-de-Seine, France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 34930354 (View on PubMed)

Other Identifiers

2018-A02783-52

Identifier Type: -

Identifier Source: org_study_id