Early Ultrasound Screening of Heterotopic Ossification After Severe Neurological Trauma

Assistance Publique - Hôpitaux de Paris80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Heterotopic Ossification

Interventions

UltrasoundPROCEDURE

Ultrasound examination at 1 week and 5 weeks after admission.

CT scanPROCEDURE

CT scan at 5 weeks after admission. CT scan reader will be blinded to clinical data.

Clinical examinationPROCEDURE

Weekly clinical examination from week-2 to week-5.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP

Garche, France

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: at 1 week

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Central Contacts

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

Data from ClinicalTrials.gov

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