Clinical trial NCT04074733: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bone Fractures
Keywords: ULD
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-08-30
Enrollment: 554
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

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 femur or the extremities, in an emergency situation in adults, once the diagnosis of fracture has been ascertained by the classical standard-dose scanner (gold standard). The statistical analyses will be performed with the help version 9.4 or subsequent versions of SAS software (SAS Institute, Cary, NC, USA) and/or version 3.5.1 or subsequent versions of R software (R Development Core Team (2018). R Foundation for Statistical Computing, Vienna, Austria).

The secondary objectives of this study are to:

A. Compare the diagnostic performances of the two examination methods under study (ULD scan vs. standard X-ray) in the search for bone structure anomalies, damage to the soft tissues, damage to the joints and/or discopathies at the site(s) involved.

B. Compare the diagnostic performances of the two examination methods under study) (ULD scan vs. standard X-ray) in the search for fractures of the site involved. C. Evaluate the diagnostic agreement between two readers (senior radiologist and junior radiologist) for each of the two examination methods under study (ULD scan vs. standard X-ray).

D. Compare the radiologist's self-declared impression of each of the two examination methods under study (ULD scan vs. standard X-ray) in terms of subjective quality: overall image quality, diagnostic quality of the examination method and the level of confidence in the diagnosis made, overall and for each of the two readers (senior and junior).

E. Compare the doses of X-rays administered for each of the two examination methods under study (ULD scan vs. standard X-ray).

F. Compare the interpretation time for each examination method under study (ULD scan vs. standard X-ray), globally and for each of the two readers (senior and junior).

For the evaluation of the diagnostic performances (main objective and secondary objectives A et B), only the senior radiologist's interpretation will be considered.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of at least one fracture in the dorsal spine evaluated with a classical, standard-dose scan (Gold standard)
timeFrame: Day 0
measure: Presence of at least one fracture in the lumbar spine evaluated with a classical, standard-dose scan (Gold standard)
timeFrame: Day 0
measure: Presence of at least one fracture of the pelvis and proximal femurs evaluated with a classical, standard-dose scan (Gold standard)
timeFrame: Day 0
measure: Presence of at least one fracture of the hands / wrists evaluated with a classical, standard-dose scan (Gold standard)
timeFrame: Day 0
measure: Presence of at least one fracture of the feet /ankles evaluated with a classical, standard-dose scan (Gold standard)
timeFrame: Day 0
measure: Presence of at least one fracture in the dorsal spine evaluated with a ULD scan
timeFrame: Day 0
measure: Presence of at least one fracture in the lumbar spine evaluated with a ULD scan
timeFrame: Day 0
measure: Presence of at least one fracture in the pelvis and proximal femurs evaluated with a ULD scan
timeFrame: Day 0
measure: Presence of at least one fracture of the hands / wrists evaluated with a ULD scan
timeFrame: Day 0
measure: Presence of at least one fracture of the feet /ankles evaluated with a ULD scan
timeFrame: Day 0
measure: Presence of at least one fracture of the dorsal spine evaluated with a standard X-ray
timeFrame: Day 0
measure: Presence of at least one fracture of the lumbar spine evaluated with a standard X-ray
timeFrame: Day 0
measure: Presence of at least one fracture of the pelvis and proximal femurs evaluated with a standard X-ray
timeFrame: Day 0
measure: Presence of at least one fracture of the hands / wrists evaluated with a standard X-ray
timeFrame: Day 0
measure: Presence of at least one fracture of the feet /ankles evaluated with a standard X-ray
timeFrame: Day 0
Secondary outcomes:
measure: Presence of an abnormality of the bone structure at the anatomic site(s) concerned evaluated with a classical Gold Standard scan
timeFrame: Day 0
measure: Presence of an abnormality of the soft tissues at the anatomic site(s) concerned evaluated with a classical Gold Standard scan
timeFrame: Day 0
measure: Presence of an abnormality of the joints at the anatomic site(s) concerned evaluated with a classical Gold Standard scan
timeFrame: Day 0
measure: Presence of an abnormality of the invertebral discs at the anatomic site(s) concerned evaluated with a classical Gold Standard scan
timeFrame: Day 0
measure: Presence of an abnormality of the bone structure at the anatomic site(s) concerned evaluated with a ULD scan
timeFrame: Day 0
measure: Presence of an abnormality of the soft tissues at the anatomic site(s) concerned evaluated with a ULD scan
timeFrame: Day 0
measure: Presence of an abnormality of the joints at the anatomic site(s) concerned evaluated with a ULD scan
timeFrame: Day 0
measure: Presence of an abnormality of the invertebral discs at the anatomic site(s) concerned evaluated with a ULD scan
timeFrame: Day 0
measure: Presence of an abnormality of the bone structure at the anatomic site(s) concerned evaluated with a standard X-ray
timeFrame: Day 0
measure: Presence of an abnormality of the soft tissues at the anatomic site(s) concerned evaluated with a standard X-ray
timeFrame: Day 0
measure: Presence of an abnormality of the joints at the anatomic site(s) concerned evaluated with a standard X-ray
timeFrame: Day 0
measure: Presence of an abnormality of the intervertebral discs at the anatomic concerned site(s) evaluated with a standard X-ray
timeFrame: Day 0
measure: Image quality of the ULD scanner and standard X-ray
timeFrame: Day 0
measure: Diagnostic quality of the ULD scanner and standard X-ray
timeFrame: Day 0
measure: Confidence level of the ULD scanner and standard X-ray
timeFrame: Day 0
measure: Effective dose for each exam with the ULD scanner
timeFrame: Day 0
measure: Effective dose for each exam with the standard X-ray
timeFrame: Day 0
measure: Interpretation time for each exam with the ULD scanner
timeFrame: Day 0
measure: Interpretation time for each exam with the standard X-ray
timeFrame: Day 0
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire
state: Gard
city: Saint-Jean
country: France
facility: Clinique de l'Union
state: Haute-Garonne
city: Castelnau-le-Lez
country: France
facility: Clinique du Parc
state: Hérault
city: Mont-de-Marsan
country: France
facility: Centre Hospitalier de Mont-de-Marsan
state: Nouvelle-Aquitaine
Study officials:
affiliation: CHU de Nîmes (Nîmes University Hospital)
name: Ahmed LARBI, Dr.
role: PRINCIPAL_INVESTIGATOR
References: