NCT04074733

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 developed to reduce the dose of X-rays delivered to the patient. The general purpose of this study is to validate the ULD scanner in case of emergency trauma of the dorsolumbar spine, pelvis and / or extremities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
554

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

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

August 23, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 30, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 21, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2025

Completed
Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

3.9 years

First QC Date

August 23, 2019

Last Update Submit

December 3, 2025

Conditions

Bone Fractures

Keywords

ULD

Outcome Measures

Primary Outcomes (15)

  • Presence of at least one fracture in the dorsal spine evaluated with a classical, standard-dose scan (Gold standard)

    YES/NO

    Day 0

  • Presence of at least one fracture in the lumbar spine evaluated with a classical, standard-dose scan (Gold standard)

    YES/NO

    Day 0

  • Presence of at least one fracture of the pelvis and proximal femurs evaluated with a classical, standard-dose scan (Gold standard)

    YES/NO

    Day 0

  • Presence of at least one fracture of the hands / wrists evaluated with a classical, standard-dose scan (Gold standard)

    YES/NO

    Day 0

  • Presence of at least one fracture of the feet /ankles evaluated with a classical, standard-dose scan (Gold standard)

    YES/NO

    Day 0

  • Presence of at least one fracture in the dorsal spine evaluated with a ULD scan

    YES/NO

    Day 0

  • Presence of at least one fracture in the lumbar spine evaluated with a ULD scan

    YES/NO

    Day 0

  • Presence of at least one fracture in the pelvis and proximal femurs evaluated with a ULD scan

    YES/NO

    Day 0

  • Presence of at least one fracture of the hands / wrists evaluated with a ULD scan

    YES/NO

    Day 0

  • Presence of at least one fracture of the feet /ankles evaluated with a ULD scan

    YES/NO

    Day 0

  • Presence of at least one fracture of the dorsal spine evaluated with a standard X-ray

    YES/NO

    Day 0

  • Presence of at least one fracture of the lumbar spine evaluated with a standard X-ray

    YES/NO

    Day 0

  • Presence of at least one fracture of the pelvis and proximal femurs evaluated with a standard X-ray

    YES/NO

    Day 0

  • Presence of at least one fracture of the hands / wrists evaluated with a standard X-ray

    YES/NO

    Day 0

  • Presence of at least one fracture of the feet /ankles evaluated with a standard X-ray

    YES/NO

    Day 0

Secondary Outcomes (19)

  • Presence of an abnormality of the bone structure at the anatomic site(s) concerned evaluated with a classical Gold Standard scan

    Day 0

  • Presence of an abnormality of the soft tissues at the anatomic site(s) concerned evaluated with a classical Gold Standard scan

    Day 0

  • Presence of an abnormality of the joints at the anatomic site(s) concerned evaluated with a classical Gold Standard scan

    Day 0

  • Presence of an abnormality of the invertebral discs at the anatomic site(s) concerned evaluated with a classical Gold Standard scan

    Day 0

  • Presence of an abnormality of the bone structure at the anatomic site(s) concerned evaluated with a ULD scan

    Day 0

  • +14 more secondary outcomes

Study Arms (1)

Patients with fractures

Diagnostic Test: Patient undergoes a ULD scanDiagnostic Test: Patient undergoes a standard X-rayDiagnostic Test: Patient undergoes a classic-dose scan

Interventions

Patient undergoes a ULD scanDIAGNOSTIC_TEST

The following doses will be applied: 6 mGy.cm for the extremities 50 mGy.cm for the dorsal spine 130 mGy.cm for the lumbar spine 130 mGy.cm for the pelvis

Patients with fractures
Patient undergoes a standard X-rayDIAGNOSTIC_TEST

The following doses will be applied: For the pelvis : front view and profile for the hip. For the dorsal spine : front and profile. For the lumbar spine : front and profile For the extremities : front and profile

Patients with fractures
Patient undergoes a classic-dose scanDIAGNOSTIC_TEST

The following doses will be applied: 6 mGy.cm for the extremities 50 mGy.cm for the dorsal spine 130 mGy.cm for the lumbar spine 130 mGy.cm for the pelvis

Patients with fractures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient presenting at the emergency department patient for trauma of the dorso-lumbar spine, pelvis, proximal femurs, and / or extremities requiring standard X-rays.

You may qualify if:

  • 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

You may not qualify if:

  • Patient participating in a category 1 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Centre Hospitalier Universitaire

Nîmes, Gard, 30029, France

Location

Clinique de l'Union

Saint-Jean, Haute-Garonne, 31240, France

Location

Clinique du Parc

Castelnau-le-Lez, Hérault, 34170, France

Location

Centre Hospitalier de Mont-de-Marsan

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

Location

Menouer TALEB

Alès, France

Location

Related Publications (1)

  • Hamard A, Greffier J, Bastide S, Larbi A, Addala T, Sadate A, Beregi JP, Frandon J. Ultra-low-dose CT versus radiographs for minor spine and pelvis trauma: a Bayesian analysis of accuracy. Eur Radiol. 2021 Apr;31(4):2621-2633. doi: 10.1007/s00330-020-07304-8. Epub 2020 Oct 9.

    PMID: 33034747RESULT

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Ahmed LARBI, Dr.

    CHU de Nîmes (Nîmes University Hospital)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 30, 2019

Study Start

October 21, 2019

Primary Completion

September 12, 2023

Study Completion

September 12, 2025

Last Updated

December 10, 2025

Record last verified: 2025-12

Locations

FR(5)