Early Ultrasound Screening of Heterotopic Ossification After Severe Neurological Trauma — POHER II  

Heterotopic Ossification Clinical Trial

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

Status Recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Heterotopic Ossification
• Ossification, Heterotopic

• NCT number: NCT04934332
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Julie PAQUEREAU, MD
• Phone: +33 1 47 10 70 82
• Email: julie.paquereau@aphp.fr
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Completion date: January 2024