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 (ULD-Traumato)

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.

Study Overview

• Status: Recruiting
• Conditions: Bone Fractures
• Intervention / Treatment: Diagnostic test: Patient undergoes a ULD scan; Diagnostic test: Patient undergoes a standard X-ray; Diagnostic test: Patient undergoes a classic-dose scan

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.

• Study Type: Observational
• Enrollment (Anticipated): 554

Contacts and Locations

Study Locations

• France
  • Gard
    • Nîmes, Gard, France, 30029
      • Not yet recruiting
      • Centre Hospitalier Universitaire
      • Contact: Anissa MEGZARI; Email: anissa.megzari@CHU-nimes.fr
      • Principal Investigator: Ahmed LARBI, Dr
      • Sub-Investigator: Joël GREFFIER, PhD
  • Haute-Garonne
    • Saint-Jean, Haute-Garonne, France, 31240
      • Recruiting
      • Clinique de l'Union
      • Contact: Gérard RICHARDI, Dr; Phone Number: 05.8131.59.00; Email: grichardi@rx-infomed.com
  • Hérault
    • Castelnau-le-Lez, Hérault, France, 34170
      • Not yet recruiting
      • Clinique du parc
      • Contact: Eric DECOUX, Dr; Phone Number: 04.67.40.00.80; Email: eric.decoux@groupecrp.fr
  • Nouvelle-Aquitaine
    • Mont-de-Marsan, Nouvelle-Aquitaine, France, 40024
      • Not yet recruiting
      • Centre Hospitalier de Mont-de-Marsan
      • Contact: Abdallah EL BAKKALI, Dr; Phone Number: Tél : 05.58.05.19.00; Email: abdallah.el-bakkali@ch-mdm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with fractures

Diagnostic test: Patient undergoes a ULD scan; 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; Diagnostic test: Patient undergoes a standard X-ray; 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; Diagnostic test: Patient undergoes a classic-dose scan; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of an abnormality of the bone structure at the anatomic site(s) concerned evaluated with a classical Gold Standard scan	YES/NO	Day 0
Presence of an abnormality of the soft tissues at the anatomic site(s) concerned evaluated with a classical Gold Standard scan	YES/NO	Day 0
Presence of an abnormality of the joints at the anatomic site(s) concerned evaluated with a classical Gold Standard scan	YES/NO	Day 0
Presence of an abnormality of the invertebral discs at the anatomic site(s) concerned evaluated with a classical Gold Standard scan	YES/NO	Day 0
Presence of an abnormality of the bone structure at the anatomic site(s) concerned evaluated with a ULD scan	YES/NO	Day 0
Presence of an abnormality of the soft tissues at the anatomic site(s) concerned evaluated with a ULD scan	YES/NO	Day 0
Presence of an abnormality of the joints at the anatomic site(s) concerned evaluated with a ULD scan	YES/NO	Day 0
Presence of an abnormality of the invertebral discs at the anatomic site(s) concerned evaluated with a ULD scan	YES/NO	Day 0
Presence of an abnormality of the bone structure at the anatomic site(s) concerned evaluated with a standard X-ray	YES/NO	Day 0
Presence of an abnormality of the soft tissues at the anatomic site(s) concerned evaluated with a standard X-ray	YES/NO	Day 0
Presence of an abnormality of the joints at the anatomic site(s) concerned evaluated with a standard X-ray	YES/NO	Day 0
Presence of an abnormality of the intervertebral discs at the anatomic concerned site(s) evaluated with a standard X-ray	YES/NO	Day 0
Image quality of the ULD scanner and standard X-ray	By means of a 4-point Likert scale, both the senior and junior radiologists can give their subjective impression of the overall image quality of each of the two examination methods under study (ULD scan vs. standard X-ray) by saying how much they agree or disagree that the overall quality of the image is good enough to detect a fracture. On the Lickert scale, 1- Uninterpretable, 2- Interpretable in spite of a slight technical problem (centering, movement, constant), 3-Completely interpretable in spite of a slight technical problem. 4- No technical problem.	Day 0
Diagnostic quality of the ULD scanner and standard X-ray	Using a 5-point Lickert scale (in which 1= Inacceptable, 2 = Sub-optimal, 3 = Acceptable, 4 = Above average, 5- Excellent) both the senior and junior radiologists will give their subjective impression of the overall diagnostic quality of each of the two examination methods under study (ULD scan vs. standard X-ray).	Day 0
Confidence level of the ULD scanner and standard X-ray	Using a 5-point Lickert scale (1- Very poor, 2- Poor, 3- Fair, 4- Good, 5- Excellent) both the senior and junior radiologists will give their subjective impression of their overall level of confidence in the diagnosis made for each of the two examination methods under study (ULD scan vs. standard X-ray).	Day 0
Effective dose for each exam with the ULD scanner	No. of millisieverts (mSv)	Day 0
Effective dose for each exam with the standard X-ray	No. of millisieverts (mSv)	Day 0
Interpretation time for each exam with the ULD scanner	Measured in minutes	Day 0
Interpretation time for each exam with the standard X-ray	Measured in minutes	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Ahmed LARBI, Dr., CHU de Nîmes (Nîmes University Hospital)

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2019
• Primary Completion (Actual): October 20, 2022
• Study Completion (Anticipated): October 20, 2023

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 28, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: ULD
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease Attributes; Emergencies; Fractures, Bone
• Other Study ID Numbers: PHRCi/2018/AL-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No