Status:

COMPLETED

Diagnostic Performance of the Ultra Low-Dose (ULD) Scanner vs. Diagnostic Performance With Standard X-rays in the Emergency Department Compared With Performance of the Standard Classical-dose Scanner for Trauma of the Dorsolumbar Spine, Pelvis and Extremities

Lead Sponsor:

Centre Hospitalier Universitaire de Nīmes

Conditions:

Bone Fractures

Eligibility:

All Genders

18+ years

Brief Summary

The conventional standard-dose scanner leads to a significantly greater X-ray exposure than the standard X-ray. Recently, technological innovations like the ULD ("Ultra Low Dose") scanner have been de...

Detailed Description

The main purpose of this study is to compare the diagnostic performances of the ULD scanner with those of the standard X-ray when looking for fractures of the dorsolumbar region, the pelvis, proximal ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Patient with a BMI \<40 kg / m²
  • Emergency department patient for trauma of the dorso-lumbar spine, pelvis, proximal femurs, and / or extremities requiring standard radiographs
  • Patient with painful symptomatology causing suspicion of a broken bone
  • Patient or family member / trusted person / family member who has given free and informed consent
  • Patient or family member / trusted person / family member who has signed the consent form
  • Patient beneficiary or affiliate of a health insurance plan
  • Exclusion criteria:
  • Patient participating in a category 1 study
  • Patient in a period of exclusion determined by another study
  • Patient on under juridical protection, under curatorship or under guardianship
  • Patient for whom it is impossible to give informed information
  • Pregnant, parturient or nursing patient
  • Polytraumatised patient
  • Patients in vital emergency requiring urgent scanner

Exclusion

    Key Trial Info

    Start Date :

    October 21 2019

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    September 12 2025

    Estimated Enrollment :

    554 Patients enrolled

    Trial Details

    Trial ID

    NCT04074733

    Start Date

    October 21 2019

    End Date

    September 12 2025

    Last Update

    December 10 2025

    Active Locations (5)

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    Page 1 of 2 (5 locations)

    1

    Centre Hospitalier Universitaire

    Nîmes, Gard, France, 30029

    2

    Clinique de l'Union

    Saint-Jean, Haute-Garonne, France, 31240

    3

    Clinique du Parc

    Castelnau-le-Lez, Hérault, France, 34170

    4

    Centre Hospitalier de Mont-de-Marsan

    Mont-de-Marsan, Nouvelle-Aquitaine, France, 40024

    Diagnostic Performance of the Ultra Low-Dose (ULD) Scanner vs. Diagnostic Performance With Standard X-rays in the Emergency Department Compared With Performance of the Standard Classical-dose Scanner for Trauma of the Dorsolumbar Spine, Pelvis and Extremities | DecenTrialz