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

Assistance Publique - Hôpitaux de Paris

Status

Enrolling

Conditions

Heterotopic Ossification

Treatments

Procedure: Ultrasound

Procedure: Clinical examination

Procedure: CT scan

Study type

Interventional

Funder types

Other

Identifiers

NCT04934332

IDRCB 2021-A01096-35 (Other Identifier)

APHP210785

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.