Early Ultrasound Screening of Heterotopic Ossification After Severe Neurological Trauma

Study Overview
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Brief Summary
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Prospective, bi-centric diagnostic, performance study on a new diagnostic procedure with ultrasounds against a reference diagnostic procedure. The primary objective is to study the performance of ultrasound coupled with clinical examination at 1 week of admission for early screening of heterotopic ossification (HO) in patients admitted to a post intensive care rehabilitation unit (PICRU) after a severe neurologic trauma. The CT scan at 5 weeks of admission is considered as the gold standard. CT scan reader will be blinded to clinical data.

Detailed Description
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Heterotopic ossification still pose the problem of diagnosis and clinical management that is too late and invasive when complications arise. The challenge would be to identify patients at earlier stage of HO development in order to start an early treatment. This study will focus on the performance of ultrasound in the early screening of HO for patients admitted to a post intensive care rehabilitation unit after severe neurological trauma, this population being at high risk of HO. Patient enrollment will be performed only at the PICRU of the Raymond Poincaré Hospital (AP-HP). Another center (the imaging department of the same hospital) will participate in this research for ultrasounds and CT scans, but will not perform any recruitment.

Official Title
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Early Ultrasound Screening of Heterotopic Ossification After Severe Neurological Trauma in a Post-intensive Care Rehabilitation Unit

Conditions
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Heterotopic Ossification

Intervention / Treatment
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* Procedure: Ultrasound
* Procedure: CT scan
* Procedure: Clinical examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ⩾ 18 years; Admitted to a neurological post intensive care rehabilitation unit for the first time; Hospitalized in ICU before being admitted to PICRU for a for traumatic brain injury (initial Glasgow coma scale < 14 and brain radiological abnormalities at the time of admission to ICU and / or a traumatic spinal cord injury (para- or tetraplegia with at least half of key muscles of the 2019 ISNCSCI classification with a strength of less than 3 below the neurological level of the injury at the time of admission to PICRU); Patient's written consent obtained (or from an authorized relative); Affiliation to a social security scheme. Exclusion Criteria: History of moderate or severe traumatic brain injury; History of spinal cord injury (para- or tetraplegia); History of stroke or disabling neurological disease; History of hospitalization in neurological or neurosurgical or traumatological ICU for another reason; Breast-feeding or pregnancy; Under court protection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Newly hospitalized patients<br>Patients admitted for the first time to a post intensive care rehabilitation unit after severe neurological trauma. | Procedure: Ultrasound<br>* Ultrasound examination at 1 week and 5 weeks after admission.<br>Procedure: CT scan<br>* CT scan at 5 weeks after admission. CT scan reader will be blinded to clinical data.<br>Procedure: Clinical examination<br>* Weekly clinical examination from week-2 to week-5.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the ROC (receiver operating characteristic) curve at 1 week | Area under the ROC curve of ultrasound examination at 1 week compared CT scan at 5 weeks for making the diagnosis of HO. | at 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | Sensitivity of ultrasound examination at 1 week for making the diagnosis of HO, the CT scan at 5 weeks of admission being considered as the gold standard. | at 1 week | 
| Specificity | Specificity of ultrasound examination at 1 week for making the diagnosis of HO, the CT scan at 5 weeks of admission being considered as the gold standard. | at 1 week | 
| Positive predictive value and negative predictive value | Positive predictive value and negative predictive value of ultrasound examination at 1 week for making the diagnosis of HO, the CT scan at 5 weeks of admission being considered as the gold standard. | at 1 week | 
| Likelihood-ratio of ultrasound | Likelihood-ratio of ultrasound examination at 1 week for making the diagnosis of HO, the CT scan at 5 weeks of admission being considered as the gold standard. | at 1 week | 
| Area under the ROC curve at 5 weeks | Area under the ROC curve of ultrasound examination at 5 weeks compared with CT scan at 5 weeks for making the diagnosis of HO. | at 5 weeks | 
| Clinical examination | Area under the ROC curve of clinical examination at 1, 2, 3, 4, 5 weeks of admission compared with CT scan at 5 weeks to screen HO. | weekly from week-1 to week-5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heterotopic ossification, post intensive care rehabilitation unit, early screening, ultrasound, neurological trauma