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临床试验/NCT01796600
NCT01796600已完成不适用

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

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2012年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
2
主要终点
Characterization of the type of fracture using a classification derived from Maurice E. Müller (AO) classification

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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

干预措施: The patients will have a conventional scanner, a reference examination, and a cone-beam scanner Newtom 5G just after the conventional scanner (Device)

结局指标

主要结局

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

时间窗: From the day of the trauma for acute injuries to the first weeks when an occult fracture is suspected

次要结局

  • Tolerability and duration of the exam (for CBCT and MDCT)(Baseline only, the day the scanner is performed)
  • Image quality (for CBCT and MDCT)(Baseline only, the day the scanner is performed)
  • Duration of the exam (for CBCT and MDCT)(Baseline only, the day the scanner is performed)
  • Inter-intra-observer reproducibility(Bseline only, the scanner is performed.)
  • Assessment of soft tissues peripheral to the fracture(Baseline only, the day the scanner is performed.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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