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

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 Overview

• Status: Completed
• Conditions: Distal Limbs Bones Fractures
• Intervention / Treatment: Device: The patients will have a conventional scanner, a reference examination, and a cone-beam scanner Newtom 5G just after the conventional scanner

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69003
    • Hospices Civils de Lyon- Hôpital Edouard Herriot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conventional and a cone-beam scanner 5G; The patients will have a conventional scanner, a reference examination, and a cone-beam scanner Newtom 5G just after the conventional scanner	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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Characterization of the type of fracture using a classification derived from Maurice E. Müller (AO) classification	From the day of the trauma for acute injuries to the first weeks when an occult fracture is suspected

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of soft tissues peripheral to the fracture	Articular fluid, hematoma, tendinous or ligamentous lesions	Baseline only, the day the scanner is performed.
Image quality (for CBCT and MDCT)	0 - Insufficient, 1 - Poor, 2 - Average, 3 - Good, 4 - Excellent	Baseline only, the day the scanner is performed
Tolerability and duration of the exam (for CBCT and MDCT)	Perfect, tolerable, hardly tolerable, intolerable	Baseline only, the day the scanner is performed
Duration of the exam (for CBCT and MDCT)	Perfect, tolerable, hardly tolerable, intolerable	Baseline only, the day the scanner is performed
Inter-intra-observer reproducibility	2 readings for each operator, with consensus reading for disagreements	Bseline only, the scanner is performed.

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Jean-Baptiste PIALAT, MD,PHD, Hospices Civils de Lyon- Hôpital Edouard Herriot

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: October 30, 2012
• First Submitted That Met QC Criteria: February 19, 2013
• First Posted (Estimate): February 22, 2013

Study Record Updates

• Last Update Posted (Actual): May 28, 2019
• Last Update Submitted That Met QC Criteria: May 23, 2019
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: distal limbs fracture, acute trauma, imaging, cone beam computed tomography,
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 2012.710