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

Primary Purpose

Distal Limbs Bones Fractures

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
The patients will have a conventional scanner, a reference examination, and a cone-beam scanner Newtom 5G just after the conventional scanner
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Distal Limbs Bones Fractures focused on measuring distal limbs fracture, acute trauma, imaging, cone beam computed tomography,

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospices Civils de Lyon- hôpital Edouard Herriot

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Conventional and a cone-beam scanner 5G

Arm Description

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

Outcomes

Primary Outcome Measures

Characterization of the type of fracture using a classification derived from Maurice E. Müller (AO) classification

Secondary Outcome Measures

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

Full Information

First Posted
October 30, 2012
Last Updated
May 23, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01796600
Brief Title
Assessment of Distal Limbs Fractures With Cone-Beam CT Newtom 5G
Acronym
FRADICOBE
Official Title
Assessment of Distal Limbs Fractures With Cone-Beam CT Newtom 5G
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Limbs Bones Fractures
Keywords
distal limbs fracture, acute trauma, imaging, cone beam computed tomography,

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional and a cone-beam scanner 5G
Arm Type
Experimental
Arm Description
The patients will have a conventional scanner, a reference examination, and a cone-beam scanner Newtom 5G just after the conventional scanner
Intervention Type
Device
Intervention Name(s)
The patients will have a conventional scanner, a reference examination, and a cone-beam scanner Newtom 5G just after the conventional scanner
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Assessment of soft tissues peripheral to the fracture
Description
Articular fluid, hematoma, tendinous or ligamentous lesions
Time Frame
Baseline only, the day the scanner is performed.
Title
Image quality (for CBCT and MDCT)
Description
0 - Insufficient, 1 - Poor, 2 - Average, 3 - Good, 4 - Excellent
Time Frame
Baseline only, the day the scanner is performed
Title
Tolerability and duration of the exam (for CBCT and MDCT)
Description
Perfect, tolerable, hardly tolerable, intolerable
Time Frame
Baseline only, the day the scanner is performed
Title
Duration of the exam (for CBCT and MDCT)
Description
Perfect, tolerable, hardly tolerable, intolerable
Time Frame
Baseline only, the day the scanner is performed
Title
Inter-intra-observer reproducibility
Description
2 readings for each operator, with consensus reading for disagreements
Time Frame
Bseline only, the scanner is performed.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste PIALAT, MD,PHD
Organizational Affiliation
Hospices Civils de Lyon- Hôpital Edouard Herriot
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon- hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30762657
Citation
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.
Results Reference
result

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

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