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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heterotopic Ossification
• Intervention / Treatment: Procedure: Ultrasound; Procedure: CT scan; Procedure: Clinical examination

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie PAQUEREAU, MD; Phone Number: +33 1 47 10 70 82; Email: julie.paquereau@aphp.fr
• Study Contact Backup: Name: Vincent T. CARPENTIER, MD-MSc; Phone Number: +33 1 47 10 70 82; Email: vincent.carpentier@aphp.fr

Study Locations

• France
  • Garche, France, 92380
    • Recruiting
    • Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Newly hospitalized patients; Patients admitted for the first time to a post intensive care rehabilitation unit after severe neurological trauma.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Fondation Paul Bennetot
• Investigators: Principal Investigator: Julie PAQUEREAU, MD, Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France; Study Director: Vincent T. CARPENTIER, MD, Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: ultrasound; heterotopic ossification; post intensive care rehabilitation unit; early screening; neurological trauma
• Additional Relevant MeSH Terms: Pathologic Processes; Ossification, Heterotopic
• Other Study ID Numbers: APHP210785; IDRCB 2021-A01096-35 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No