NCT04934332

Early Ultrasound Screening of Heterotopic Ossification After Severe Neurological Trauma

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heterotopic Ossification

Interventions

Type	Name	Description
PROCEDURE	Ultrasound	Ultrasound examination at 1 week and 5 weeks after admission.
PROCEDURE	CT scan	CT scan at 5 weeks after admission. CT scan reader will be blinded to clinical data.
PROCEDURE	Clinical examination	Weekly clinical examination from week-2 to week-5.

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2021-06-22
• Last updated: 2023-03-17

Locations

1 site across 1 country: France