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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 554 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bone Fractures

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-10-21
• Primary completion: 2023-09-12
• Completion: 2025-09-12
• First posted: 2019-08-30
• Last updated: 2025-12-10

Locations

5 sites across 1 country: France