NCT03832556

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

April 30, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2023

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

3.8 years

First QC Date

January 25, 2019

Last Update Submit

March 15, 2023

Conditions

Neurogenic Myositis OssificansNeurogenic Para-osteo-arthritis

Keywords

neurogenic myositis ossificanspara-osteo-arthropathypreoperative evaluationCT scanMRI

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (5)

  • Performances of MRI for diagnosis of arterial-venous

    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...)

    through study completion, an average of 2 year

  • Rate of incidence of adverse event during surgical operation

    through study completion, an average of 2 year

  • Concordance correlation coefficient

    through study completion, an average of 2 year

  • Characteristic of patients with discordant results

    through study completion, an average of 2 year

Study Arms (1)

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.

Other: CT scanOther: MRI examination

Interventions

CT scanOTHER

CT scan with biphasic injection of contrast product

Preoperative evaluation: CT + MRI
MRI examinationOTHER

MRI with injection of contrast

Preoperative evaluation: CT + MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Imagerie médicale, Hôpital Raymond Poincaré

Garches, Hauts-de-Seine, 92380, France

Location

Related Publications (1)

  • 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.

    PMID: 34930354DERIVED

Study Officials

  • Robert Carlier, MD, PhD

    Service d'Imagerie médicale, Hôpital Raymond Poincaré, Garches

    PRINCIPAL INVESTIGATOR

  • Raphaël AMAR, Resident

    Service d'Imagerie médicale, Hôpital Raymond Poincaré, Garches

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2019

First Posted

February 6, 2019

Study Start

April 30, 2019

Primary Completion

February 7, 2023

Study Completion

February 7, 2023

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)