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

Primary Purpose

Heterotopic Ossification

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Ultrasound

CT scan

Clinical examination

About this trial

This is an interventional diagnostic trial for Heterotopic Ossification focused on measuring heterotopic ossification, post intensive care rehabilitation unit, early screening, ultrasound, neurological trauma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Newly hospitalized patients

Arm Description

Patients admitted for the first time to a post intensive care rehabilitation unit after severe neurological trauma.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT04934332

First Posted

June 14, 2021

Last Updated

March 15, 2023

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Fondation Paul Bennetot

1. Study Identification

Unique Protocol Identification Number

NCT04934332

Brief Title

Early Ultrasound Screening of Heterotopic Ossification After Severe Neurological Trauma

Acronym

POHER II

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2022 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Fondation Paul Bennetot

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heterotopic Ossification

Keywords

heterotopic ossification, post intensive care rehabilitation unit, early screening, ultrasound, neurological trauma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Newly hospitalized patients

Arm Type

Experimental

Arm Description

Patients admitted for the first time to a post intensive care rehabilitation unit after severe neurological trauma.

Intervention Type

Procedure

Intervention Name(s)

Ultrasound

Intervention Description

Ultrasound examination at 1 week and 5 weeks after admission.

Intervention Type

Procedure

Intervention Name(s)

CT scan

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Clinical examination

Intervention Description

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

Primary Outcome Measure Information:

Title

Area under the ROC (receiver operating characteristic) curve at 1 week

Description

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 Outcome Measure Information:

Title

Sensitivity

Description

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

Title

Specificity

Description

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

Title

Positive predictive value and negative predictive value

Description

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

Title

Likelihood-ratio of ultrasound

Description

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

Title

Area under the ROC curve at 5 weeks

Description

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

Title

Clinical examination

Description

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.

Time Frame

weekly from week-1 to week-5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Julie PAQUEREAU, MD

Phone

+33 1 47 10 70 82

julie.paquereau@aphp.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Vincent T. CARPENTIER, MD-MSc

Phone

+33 1 47 10 70 82

vincent.carpentier@aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julie PAQUEREAU, MD

Organizational Affiliation

Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Vincent T. CARPENTIER, MD

Organizational Affiliation

Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Garche

ZIP/Postal Code

92380

Country

France

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Early Ultrasound Screening of Heterotopic Ossification After Severe Neurological Trauma

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