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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

554 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-21

Study Completion Date

2025-09-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Image Quality Between Ultra-low Dose (ULD) and Standard Dose CT Scans in Detecting Traumatic Brain Injury in the Emergency Room

NCT05210855

Closed Head Injury Penetrating Head Injury

COMPLETED NA

Impact of Unenhanced Computed Tomography (CT) in Elderly Patients Admitted to the Emergency Department With Acute Abdominal Pain

NCT02355483

Abdominal Pain

COMPLETED NA

Application of Mobile DR in the Diagnosis of Bone Trauma in High Cold Environment

NCT05440435

Bone Injury Artificial Intelligence

UNKNOWN

Relevance of Whole-body Computed Tomography Prescription in the Emergency Department : an Identification Tool for Low Risk Patients

NCT05588791

Trauma

RECRUITING

Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR]

NCT03140163

Pneumonia

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bone Fractures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.