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临床试验/NCT01771393
NCT01771393已完成不适用

Performance of Cone-beam Computed Tomography (CT) Compared to Multidetector CT for Arthrography of the Wrist, Ankle, Elbow and Knee

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2012年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
69
试验地点
2
主要终点
cartilage damage thickness

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 limbs distal joints. Our hypothesis is that the cone-beam scanner could detect and characterize chondral lesions the cartilage similarly to a multidetector CT (MDCT). 100 patients over 18 years requiring arthroscanner of the wrist, ankle, elbow or knee will be enrolled The primary endpoint based on the ability of cone-beam scanner to detect cartilage lesions. Secondary endpoints will concern the depiction of the joint lesions, quality of the images, tolerability of the exams and inter- intra-operator reproducibility. After arthrography, patients will have a MDCT considered as the reference exam, and a CBCT on a randomized order. Exams will be anonymized and read twice by two trained radiologists with 3-6 week intervals. The inter-observer agreement for the diagnosis of cartilage lesion 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 depiction of the lesions. 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
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

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 knee or ankle or elbow or wrist arthroscanner
  • 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 ARCOBE study
  • 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.

结局指标

主要结局

cartilage damage thickness

时间窗: participants will be followed for the duration of the arthrography CT , an expected average of 2 hours

0- normal, 1- Linear cartilage tear, 2- focal ulceration of less than 50% of the cartilage thickness, 3-: - focal ulceration of greater than 50% of the cartilage thickness, 4- Full thickness ulceration of the cartilage

次要结局

  • cartilage damage measurements(participants will be followed for the duration of the arthrography CT , an expected average of 2 hours)
  • Image quality (for CBCT and MDCT)(participants will be followed for the duration of the arthrography CT , an expected average of 2 hours)
  • Tolerability of the exam (for CBCT and MDCT)(participants will be followed for the duration of the arthrography CT , an expected average of 2 hours)
  • Duration of the exam (for CBCT and MDCT)(participants will be followed for the duration of the arthrography CT , an expected average of 2 hours)
  • Subchondral bone lesion (for CBCT and MDCT)(participants will be followed for the duration of the arthrography CT , an expected average of 2 hours)
  • Lesion of intrinsic ligament (for CBCT and MDCT)(participants will be followed for the duration of the arthrography CT , an expected average of 2 hours)
  • Osteochondroma (for CBCT and MDCT)(participants will be followed for the duration of the arthrography CT , an expected average of 2 hours)
  • Meniscal lesion (for arthrography CBCT and MDCT of the knee)(participants will be followed for the duration of the arthrography CT , an expected average of 2 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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