Preoperative Evaluation of Neurogenic Myositis Ossificans or Neurogenic Para-osteo-arthritis: Comparison Between Computed Tomography and Magnetic Resonance Imaging in Preoperative Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Analysis and comparison of accurate topography of heterotopic ossification on the CT and the MRI
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: CT scan (Other)
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.
干预措施: MRI examination (Other)
结局指标
主要结局
Analysis and comparison of accurate topography of heterotopic ossification on the CT and the MRI
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)