CompletedNot Applicable

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

France554 participantsStarted 2019-10-21

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Day 0

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

Timeframe: Day 0

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

Timeframe: Day 0

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

Timeframe: Day 0

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

Timeframe: Day 0

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

Timeframe: Day 0

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

Trial details

NCT IDNCT04074733

SponsorCentre Hospitalier Universitaire de Nīmes

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-09-12

View on ClinicalTrials.gov More Bone Fractures trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Day 0

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

Timeframe: Day 0

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

Timeframe: Day 0

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

Timeframe: Day 0

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

Timeframe: Day 0

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

Timeframe: Day 0

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