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Early Ultrasound Screening of Heterotopic Ossification After Severe Neurological Trauma

NCT04934332 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-03-17

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Fondation Paul Bennetot

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Julie PAQUEREAU, MD · Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France

  • Vincent T. CARPENTIER, MD · Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2024-01-31
Completion
2024-01-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04934332 on ClinicalTrials.gov