Heterotopic Ossification
Conditions
Keywords
heterotopic ossification, post intensive care rehabilitation unit, early screening, ultrasound, neurological trauma
Brief summary
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
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.
Interventions
PROCEDUREUltrasound
Ultrasound examination at 1 week and 5 weeks after admission.
PROCEDURECT scan
CT scan at 5 weeks after admission. CT scan reader will be blinded to clinical data.
PROCEDUREClinical examination
Weekly clinical examination from week-2 to week-5.
Sponsors
Fondation Paul Bennetot
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the ROC (receiver operating characteristic) curve at 1 week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specificity | at 1 week | 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. |
| Positive predictive value and negative predictive value | at 1 week | 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. |
| Sensitivity | at 1 week | 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. |
| Area under the ROC curve at 5 weeks | 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. |
| Clinical examination | weekly from week-1 to week-5 | 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. |
| Likelihood-ratio of ultrasound | at 1 week | 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. |
Countries
France
Contacts
Primary ContactJulie PAQUEREAU, MD
Backup ContactVincent T. CARPENTIER, MD-MSc
Outcome results
None listed