ULD-E (Ultra Low Dose Extremities)

NCT04832490 | Completed

• 1 other identifier: Local 2018/AL
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

extremity trauma is a frequent reason for emergency room visits. There is an increase in the use of CT scanners in extremity trauma, due to a greater sensitivity of detection than X-rays, particularly for "occult fractures" and for the organization of treatment, particularly surgical treatment. As the number of CT scans increases, the reduction of the delivered dose has become a subject of interest. Among the many methods used, the use of iterative reconstruction has enabled a substantial reduction in the delivered dose without compromising image quality: low-dose and ultra-low-dose protocols (effective dose equivalent to the effective dose of the Diagnostic Reference Levels of radiographs from the same region of interest) have been developped, but have not yet been evaluated in extremity trauma. The subject of our feasibility study is to evaluate the diagnostic performance of ultra-low dose CT compared to radiographs in patients consulting for extremity trauma in the emergency room. The recent implementation in our department of a scanner dedicated to low-dose explorations as well as the optimization of protocols has allowed the realization of ultra-low-dose scans since June 2017.

Conditions

Wounds and Injuries, Hands; Wounds and Injuries, Wrists; Wounds and Injuries, Feet; Wounds and Injuries, Ankles

Outcome Measures

Primary Outcomes (1)

• presence or not of fracture

  number of fractures detected after consensus interpretation of the two readers

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study included all consecutive adult patients consulting for trauma of the extremities, i.e. hands and wrists and feet and ankles, at the emergency department. Patients included had underwent both digital radiography and ULD-CT for trauma diagnosis during week days, within working hours (9am-6pm), excluding week-ends and public holidays. Patients with severe polytraumas requiring a whole body-scan and patients for whom digital radiography was not the first imaging modality performed were not included in the study.

You may qualify if:

• Major patients consulting in the emergency room of the Nîmes University Hospital during working hours
• Extremity Trauma: Hands/wrists Feet/ankles

You may not qualify if:

• opposition to trial participation
• Minor patients
• Polytraumatized patient with body scanner considered

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Takieddine ADDALA

Nîmes, France

Location

Related Publications (1)

• Addala TE, Greffier J, Hamard A, Snene F, Bobbia X, Bastide S, Belaouni A, de Forges H, Larbi A, de la Coussaye JE, Beregi JP, Claret PG, Frandon J. Early results of ultra-low-dose CT-scan for extremity traumas in emergency room. Quant Imaging Med Surg. 2022 Aug;12(8):4248-4258. doi: 10.21037/qims-21-848.

  PMID: 35919065 DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: hospital practitioner

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 5, 2021
• Study Start: February 1, 2018
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: April 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)