Distal Limbs Bones FracturesFRADICOBENCT01796600
Assessment of Distal Limbs Fractures With Cone-Beam CT Newtom 5G
A study testing The patients will have a conventional scanner, a reference examination, and a cone-beam scanner Newtom 5G just after the conventional scanner in people with Distal Limbs Bones Fractures, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
ConeBeam scanner (CBCT) is a widely technique used for dental and maxillofacial imaging. Patients can be set up in a sitting or a laying position in the, Newtom 5G CBCT allowing for an analysis of the distal appendicular skeleton. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Limbs Bones Fractures
- What is being tested?
- The patients will have a conventional scanner, a reference examination, and a cone-beam scanner Newtom 5G just after the conventional scanner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2012to Jun 2013
- Phase
- Interventional
- 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
Who may be able to join
- Patient age 18 years old or above, weight ≤ 160 Kg
- Patient require MDCT for a suspected distal limb fracture or a preoperative assessment
- French spoken an read
- Free and informed consent signed
- Being affiliated to a French social security system or similar.
Who cannot join
- Patients already included in the study for a previous fracture
- Patient with severe pain and reduced spontaneous mobility that could prevent proper positioning for the cone-beam
- Lack of effective contraception (risk of pregnancy) or pregnancy proven data on interrogations
- Patient on protection of the court, under supervision or trusteeship
- Inability to express a consent
- Patients already enrolled in a study with a conflict of interest with this study.
- The presence of osteosynthesis materiel or capital may interfere with image quality. A sample of 3 to 5 patients may be included at the beginning of the study to test the image quality in presence of material.
Trial locations and contacts
1 site in 1 country.
About this study
ConeBeam scanner (CBCT) is a widely technique used for dental and maxillofacial imaging. Patients can be set up in a sitting or a laying position in the, Newtom 5G CBCT allowing for an analysis of the distal appendicular skeleton. The investigators' hypothesis is that the cone-beam scanner could detect and characterize fractures of the extremities similarly to a multidetector CT (MDCT). 150 patients over 18 years requiring a CT scan for a suspected distal limb fracture or a preoperative assessment will be enrolled. The primary endpointis based on the ability of cone-beam scanner to properly characterize the type of fracture using a classification derived from Maurice E. Müller (AO) classification. Secondary endpoints will concern the depiction of the fracture, the assessment of the soft tissues near the fracture, quality of images, inter and intra-operator reproducibility and tolerance of the patient for the examination. Patients will have a MDCT considered as the reference exam, then a CBCT. Exams will be anonymized and read twice by two trained radiologists with 3-6 week intervals. The inter-observer agreement for the diagnosis of fracture type between the two techniques will be evaluated by a kappa coefficient. The evaluation of diagnostic performance will be achieved by studying the sensitivity, specificity, negative predictive value and positive predictive value, and its likelihood ratio. Kappa test will be performed to evaluate the consistency of the characterization of the fracture and the evaluation of soft tissue near the fracture. A Student t test will be performed for paired data if distributions are normal, a Wilcoxon test if not. To assess patient's tolerance, the percentages of (painful, not painful) will be calculated for each technique and will be compared using the Chi2 test (or Fisher's exact test if the chi can not apply).
- Conditions
- Distal Limbs Bones Fractures
- Being tested
- The patients will have a conventional scanner, a reference examination, and a cone-beam scanner Newtom 5G just after the conventional scanner
- Keywords
- distal limbs fracture, acute trauma, imaging, cone beam computed tomography,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The patients will have a conventional scanner, a reference examination, and a cone-beam scanner Newtom 5G just after the conventional scannerDevice
| Study group | Role | What they receive |
|---|---|---|
| Conventional and a cone-beam scanner 5G | Experimental | The patients will have a conventional scanner, a reference examination, and a cone-beam scanner Newtom 5G just after the conventional scanner Receives: Device: The patients will have a conventional scanner, a reference examination, and a cone-beam scanner Newtom 5G just after the conventional scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the type of fracture using a classification derived from Maurice E. Müller (AO) classification
Measured: From the day of the trauma for acute injuries to the first weeks when an occult fracture is suspected
Secondary outcomes (5)
Assessment of soft tissues peripheral to the fracture
Articular fluid, hematoma, tendinous or ligamentous lesions
Measured: Baseline only, the day the scanner is performed.
Image quality (for CBCT and MDCT)
0 - Insufficient, 1 - Poor, 2 - Average, 3 - Good, 4 - Excellent
Measured: Baseline only, the day the scanner is performed
Tolerability and duration of the exam (for CBCT and MDCT)
Perfect, tolerable, hardly tolerable, intolerable
Measured: Baseline only, the day the scanner is performed
Duration of the exam (for CBCT and MDCT)
Perfect, tolerable, hardly tolerable, intolerable
Measured: Baseline only, the day the scanner is performed
Inter-intra-observer reproducibility
2 readings for each operator, with consensus reading for disagreements
Measured: Bseline only, the scanner is performed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startJul 2012
- Primary completionJun 2013
- Study completionJun 2013
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 Distal Limbs Bones FracturesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Baptiste PIALAT, MD,PHD, Principal investigator, Hospices Civils de Lyon- Hôpital Edouard Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796600
- Sponsor's protocol ID
- 2012.710
- Acronym
- FRADICOBE
- Status last verified
- Aug 2025
- First submitted
- 30 Oct 2012
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Dubreuil T, Mouly J, Ltaief-Boudrigua A, Martinon A, Tilhet-Coartet S, Tazarourte K, Pialat JB. Comparison of Cone-Beam Computed Tomography and Multislice Computed Tomography in the Assessment of Extremity Fractures. J Comput Assist Tomogr. 2019 May/Jun;43(3):372-378. doi: 10.1097/RCT.0000000000000843.
PubMed 30762657
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Distal Limbs Fractures With Cone-Beam CT Newtom 5G
- ClinicalTrials.gov ID
- NCT01796600
- Acronym / sponsor ID
- FRADICOBE / 2012.710
- Conditions
- Distal Limbs Bones Fractures
- Keywords
- distal limbs fracture, acute trauma, imaging, cone beam computed tomography,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Feb 2013 (estimated)
- 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.
ConeBeam scanner (CBCT) is a widely technique used for dental and maxillofacial imaging. Patients can be set up in a sitting or a laying position in the, Newtom 5G CBCT allowing for an analysis of the distal appendicular skeleton. The investigators' hypothesis is that the cone-beam scanner could detect and characterize fractures of the extremities similarly to a multidetector CT (MDCT). 150 patients over 18 years requiring a CT scan for a suspected distal limb fracture or a preoperative assessment will be enrolled. The primary endpointis based on the ability of cone-beam scanner to properly characterize the type of fracture using a classification derived from Maurice E. Müller (AO) classification. Secondary endpoints will concern the depiction of the fracture, the assessment of the soft tissues near the fracture, quality of images, inter and intra-operator reproducibility and tolerance of the patient for the examination. Patients will have a MDCT considered as the reference exam, then a CBCT. Exams will be anonymized and read twice by two trained radiologists with 3-6 week intervals. The inter-observer agreement for the diagnosis of fracture type between the two techniques will be evaluated by a kappa coefficient. The evaluation of diagnostic performance will be achieved by studying the sensitivity, specificity, negative predictive value and positive predictive value, and its likelihood ratio. Kappa test will be performed to evaluate the consistency of the characterization of the fracture and the evaluation of soft tissue near the fracture. A Student t test will be performed for paired data if distributions are normal, a Wilcoxon test if not. To assess patient's tolerance, the percentages of (painful, not painful) will be calculated for each technique and will be compared using the Chi2 test (or Fisher's exact test if the chi can not apply).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conventional and a cone-beam scanner 5G | Experimental | Device: The patients will have a conventional scanner, a reference examination, and a cone-beam scanner Newtom 5G just after the conventional scannerThe patients will have a conventional scanner, a reference examination, and a cone-beam scanner Newtom 5G just after the conventional scanner |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient age 18 years old or above, weight ≤ 160 Kg
- Patient require MDCT for a suspected distal limb fracture or a preoperative assessment
- French spoken an read
- Free and informed consent signed
- Being affiliated to a French social security system or similar.
Key exclusion criteria (7 listed)
- Patients already included in the study for a previous fracture
- Patient with severe pain and reduced spontaneous mobility that could prevent proper positioning for the cone-beam
- Lack of effective contraception (risk of pregnancy) or pregnancy proven data on interrogations
- Patient on protection of the court, under supervision or trusteeship
- Inability to express a consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The patients will have a conventional scanner, a reference examination, and a cone-beam scanner Newtom 5G just after the conventional scanner | Device | Conventional and a cone-beam scanner 5G |
Primary outcome
Characterization of the type of fracture using a classification derived from Maurice E. Müller (AO) classification
Time frame: From the day of the trauma for acute injuries to the first weeks when an occult fracture is suspected
5 secondary outcomes
Assessment of soft tissues peripheral to the fracture
Time frame: Baseline only, the day the scanner is performed.
Image quality (for CBCT and MDCT)
Time frame: Baseline only, the day the scanner is performed
Tolerability and duration of the exam (for CBCT and MDCT)
Time frame: Baseline only, the day the scanner is performed
Duration of the exam (for CBCT and MDCT)
Time frame: Baseline only, the day the scanner is performed
Inter-intra-observer reproducibility
Time frame: Bseline only, the scanner is performed.
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 4 Sep 2025.
- Results publication: PubMed 30762657Dubreuil T, Mouly J, Ltaief-Boudrigua A, Martinon A, Tilhet-Coartet S, Tazarourte K, Pialat JB. Comparison of Cone-Beam Computed Tomography and Multislice Computed Tomography in the Assessment of Extremity Fractures. J Comput Assist Tomogr. 2019 May/Jun;43(3):372-378. doi: 10.1097/RCT.0000000000000843.
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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.
Jean-Baptiste PIALAT, MD,PHD principal investigator
Hospices Civils de Lyon- Hôpital Edouard Herriot
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The patients will have a conventional scanner, a reference examination, and a cone-beam scanner Newtom 5G just after the conventional scanner in people with Distal Limbs Bones Fractures, run by Hospices Civils de Lyon 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 5 inclusion and 7 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 4 Sep 2025. 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?
Characterization of the type of fracture using a classification derived from Maurice E. Müller (AO) classification (time frame: From the day of the trauma for acute injuries to the first weeks when an occult fracture is suspected). 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 NCT01796600, 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 4 Sep 2025.