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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB 2021-A01096-35 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Fondation Paul Bennetot | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Newly hospitalized patients | Experimental | Patients admitted for the first time to a post intensive care rehabilitation unit after severe neurological trauma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Procedure | Ultrasound examination at 1 week and 5 weeks after admission. |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie PAQUEREAU, MD | Contact | +33 1 47 10 70 82 | julie.paquereau@aphp.fr | |
| Vincent T. CARPENTIER, MD-MSc | Contact | +33 1 47 10 70 82 | vincent.carpentier@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Julie PAQUEREAU, MD | Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France | Principal Investigator |
| Vincent T. CARPENTIER, MD | Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP | Recruiting | Garche | 92380 | France |
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| ID | Term |
|---|---|
| D009999 | Ossification, Heterotopic |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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| CT scan | Procedure | CT scan at 5 weeks after admission. CT scan reader will be blinded to clinical data. |
|
| Clinical examination | Procedure | Weekly clinical examination from week-2 to week-5. |
|
| 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 |
| Study Director |
| D055585 |
| Physical Phenomena |
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |