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Completed

NCT Number: NCT01796600

Assessment of Distal Limbs Fractures With Cone-Beam CT Newtom 5G

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon- hôpital Edouard Herriot

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

The patients will have a conventional scanner, a reference examination, and a cone-beam scanner Newtom 5G just after the conventional scanner

Device

Primary outcomes

  1. 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

Secondary outcomes

  1. Assessment of soft tissues peripheral to the fracture

    Time frame: Baseline only, the day the scanner is performed.

    Articular fluid, hematoma, tendinous or ligamentous lesions

  2. Image quality (for CBCT and MDCT)

    Time frame: Baseline only, the day the scanner is performed

    0 - Insufficient, 1 - Poor, 2 - Average, 3 - Good, 4 - Excellent

  3. Tolerability and duration of the exam (for CBCT and MDCT)

    Time frame: Baseline only, the day the scanner is performed

    Perfect, tolerable, hardly tolerable, intolerable

  4. Duration of the exam (for CBCT and MDCT)

    Time frame: Baseline only, the day the scanner is performed

    Perfect, tolerable, hardly tolerable, intolerable

  5. Inter-intra-observer reproducibility

    Time frame: Bseline only, the scanner is performed.

    2 readings for each operator, with consensus reading for disagreements

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: FRADICOBE

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 22, 2013
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.