Wounds and Injuries, HandsULD ENCT04832490
ULD-E (Ultra Low Dose Extremities)
An observational study of Wounds and Injuries, Hands and Wounds and Injuries, Wrists, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries, Hands, Wounds and Injuries, Wrists, Wounds and Injuries, Feet
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2018to 1 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Major patients consulting in the emergency room of the Nîmes University Hospital during working hours
- Extremity Trauma: Hands/wrists Feet/ankles
Who cannot join
- opposition to trial participation
- Minor patients
- Polytraumatized patient with body scanner considered
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Results of ULD CT-scan for Extremity in Emergency Room
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.
Read more
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.
Read the detailed description
The study included all consecutive adult patients who consulted for trauma to the extremities, i.e. hands and wrists, feet and ankles, in the emergency department between February and August 2018. Patients included had undergone digital radiography and ULD-CT for a diagnosis of trauma during weekdays, during working hours (9am-6pm), excluding weekends and holidays. Patients with severe polytrauma requiring a whole body CT scan and patients for whom digital radiography was not the first imaging modality performed were not included in the study.
ULD-CT images were acquired using a Somatom Definition AS+ CT-scan (Siemens Healthineers). Acquisition parameters were as follows: beam collimation of 64×0.6 mm; field of view of 500 mm; pitch factor of 0.85; rotation time of 1.0 s. The tube voltage was fixed at 80 kVp, and the tube current was set at 12 mAs for hands and wrists and at 15 mAs for feet and ankles. Both the automatic adjustment of tube voltage (CARE kV) and the automatic tube current modulation (CARE Dose4D) were disabled. The images were reconstructed in transverse plane of 1-mm thickness and 0.7mm overlapping, and raw data were reconstructed using the level 4 of the SAFIRE® (Sinogram Affirmed Iterative Reconstruction) algorithm. The reconstruction kernels used were "moderately smooth" (I30f) for soft tissue exploration and "strongly sharp" (I70f) for bone exploration for all locations.
Imaging interpretation Image analysis and interpretation were performed retrospectively in a blinded manner by two radiologists, a junior reader with a 3-year experience (TA, reader 1) and a senior reader with a 11-year experience (FS, reader 2). The two radiologists separately analyzed all radiographs after image anonymization and randomization of the reading rank. To limit interpretation biases, a period of 4 weeks was observed before interpretation of the ULD-CT images. They were analyzed separately by the two same radiologists, in the same blinded manner than radiographs, also after randomization of the reading rank. The images were visualized on GE Healthcare Centricity Picture Archiving and Communication System (PACS); all ULD-CT images were read in multiplanar 3-mm reconstructed slices.
- Conditions
- Wounds and Injuries, Hands, Wounds and Injuries, Wrists, Wounds and Injuries, Feet, Wounds and Injuries, Ankles
- Medical subject headings
- Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
presence or not of fracture
number of fractures detected after consensus interpretation of the two readers
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start1 Feb 2018
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wounds and Injuries, HandsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Larbi, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832490
- Sponsor's protocol ID
- Local 2018/AL
- Acronym
- ULD E
- Status last verified
- Apr 2021
- First submitted
- 23 Mar 2021
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35919065
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Results of ULD CT-scan for Extremity in Emergency Room
- ClinicalTrials.gov ID
- NCT04832490
- Acronym / sponsor ID
- ULD E / Local 2018/AL
- Conditions
- Wounds and Injuries, Hands, Wounds and Injuries, Wrists, Wounds and Injuries, Feet, Wounds and Injuries, Ankles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study included all consecutive adult patients who consulted for trauma to the extremities, i.e. hands and wrists, feet and ankles, in the emergency department between February and August 2018. Patients included had undergone digital radiography and ULD-CT for a diagnosis of trauma during weekdays, during working hours (9am-6pm), excluding weekends and holidays. Patients with severe polytrauma requiring a whole body CT scan and patients for whom digital radiography was not the first imaging modality performed were not included in the study.
ULD-CT images were acquired using a Somatom Definition AS+ CT-scan (Siemens Healthineers). Acquisition parameters were as follows: beam collimation of 64×0.6 mm; field of view of 500 mm; pitch factor of 0.85; rotation time of 1.0 s. The tube voltage was fixed at 80 kVp, and the tube current was set at 12 mAs for hands and wrists and at 15 mAs for feet and ankles. Both the automatic adjustment of tube voltage (CARE kV) and the automatic tube current modulation (CARE Dose4D) were disabled. The images were reconstructed in transverse plane of 1-mm thickness and 0.7mm overlapping, and raw data were reconstructed using the level 4 of the SAFIRE® (Sinogram Affirmed Iterative Reconstruction) algorithm. The reconstruction kernels used were "moderately smooth" (I30f) for soft tissue exploration and "strongly sharp" (I70f) for bone exploration for all locations.
Imaging interpretation Image analysis and interpretation were performed retrospectively in a blinded manner by two radiologists, a junior reader with a 3-year experience (TA, reader 1) and a senior reader with a 11-year experience (FS, reader 2). The two radiologists separately analyzed all radiographs after image anonymization and randomization of the reading rank. To limit interpretation biases, a period of 4 weeks was observed before interpretation of the ULD-CT images. They were analyzed separately by the two same radiologists, in the same blinded manner than radiographs, also after randomization of the reading rank. The images were visualized on GE Healthcare Centricity Picture Archiving and Communication System (PACS); all ULD-CT images were read in multiplanar 3-mm reconstructed slices.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Major patients consulting in the emergency room of the Nîmes University Hospital during working hours
- Extremity Trauma: Hands/wrists Feet/ankles
Key exclusion criteria (3 listed)
- opposition to trial participation
- Minor patients
- Polytraumatized patient with body scanner considered
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
presence or not of fracture
Time frame: 1 year
number of fractures detected after consensus interpretation of the two readers
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Derived from this study: PubMed 35919065Addala 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds and Injuries, Hands and Wounds and Injuries, Wrists, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence or not of fracture (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04832490, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2021.