Early Ultrasound Screening of Heterotopic Ossification After Severe Neurological Trauma

Heterotopic Ossification Clinical Trial

— POHER II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04934332
• Other study ID #: APHP210785
• Secondary ID: IDRCB 2021-A0109
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: January 2024

Study information

• Verified date: March 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Julie PAQUEREAU, MD
• Phone: +33 1 47 10 70 82
• Email: julie.paquereau[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heterotopic Ossification
• Ossification, Heterotopic

Intervention

Procedure:
• Ultrasound
Ultrasound examination at 1 week and 5 weeks after admission.
• CT scan
CT scan at 5 weeks after admission. CT scan reader will be blinded to clinical data.
• Clinical examination
Weekly clinical examination from week-2 to week-5.

Locations

Country	Name	City	State
France	Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP	Garche

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Fondation Paul Bennetot

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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