NCT04934332

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 22, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

June 14, 2021

Last Update Submit

March 15, 2023

Conditions

Heterotopic Ossification

Keywords

heterotopic ossificationpost intensive care rehabilitation unitearly screeningultrasoundneurological trauma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Sensitivity

    at 1 week

  • Specificity

    at 1 week

  • Positive predictive value and negative predictive value

    at 1 week

  • Likelihood-ratio of ultrasound

    at 1 week

  • Area under the ROC curve at 5 weeks

    at 5 weeks

  • +1 more secondary outcomes

Study Arms (1)

Newly hospitalized patients

EXPERIMENTAL

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

Procedure: UltrasoundProcedure: CT scanProcedure: Clinical examination

Interventions

UltrasoundPROCEDURE

Ultrasound examination at 1 week and 5 weeks after admission.

Newly hospitalized patients
CT scanPROCEDURE

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

Newly hospitalized patients
Clinical examinationPROCEDURE

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

Newly hospitalized patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Garche, 92380, France

RECRUITING

MeSH Terms

Conditions

Ossification, Heterotopic

Interventions

High-Energy Shock WavesRestraint, Physical

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical PhenomenaBehavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Julie PAQUEREAU, MD

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

    PRINCIPAL INVESTIGATOR

  • Vincent T. CARPENTIER, MD

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

    STUDY DIRECTOR

Central Study Contacts

Julie PAQUEREAU, MD

CONTACT

+33 1 47 10 70 82julie.paquereau@aphp.fr

Vincent T. CARPENTIER, MD-MSc

CONTACT

+33 1 47 10 70 82vincent.carpentier@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2021

First Posted

June 22, 2021

Study Start

March 1, 2022

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

March 17, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)