Diagnostic Performance of Ultrasound Imaging Technique for Femoral Condyle Cartilage Evaluation and Osteoarthritis (CARTILAGE)
Qualification of Ultrasound Imaging Technique in the Quantitative Evaluation of Cartilaginous Tissue of Femoral Condyle Articulation and Osteoarthritis
研究概览
地位
条件
详细说明
Knee osteoarthritis (OA) is a common degenerative disease of synovial joint becoming more frequent with age. Among techniques have been used to diagnose and classify the severity of knee OA, the imaging techniques, such as ultrasonography (US), provide physical quantitative informations for better understanding and assessing of the pathology of the knee joint.
The present study aim to investigate the diagnostic performance of ultrasonography for femoral condyle cartilage evaluation using MRI and histology analysis as reference tools. To validate this approach, evaluations are conducted to determine, whether the UltraSound Speed Of Sound (US-SOS) propagation is associated with the variation of the arthrosis stage, in order to improve the diagnosis of the surgeon. For this purpose, measurements are conducted using selected human cartilage samples with different stage of OA (early stage and advanced stage).
This research is the first "preclinical" study of a new unlabelled medical device developed by Cartimage Medical SAS. Cartilage is a prospective, monocentric, unrandomized and uncontrolled study. This study doesn't modify the medical care of the patient.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Grenoble、法国、38043
- Orthopedic Surgery Department, University Hospital, Grenoble
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- patient over 18 year old
- knee osteoarthritis which total knee arthroplasty indication
- who have signed a non-objection form.
Exclusion Criteria:
- person who refuse to sign a non-objection form
- person deprived of liberty by judicial or administrative decision
- person under legal protection or unable to express their consent
- person hospitalized for psychiatric care
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Ultrasound assessment
All subject of the study have a knee osteoarthritis (OA) and are going to have a total arthroplasty.
Diagnostic performance of ultrasonography is evaluated on ex vivo cartilage samples (2 samples per patient are selected with different stage of OA : 1 with early stage and 1 with advanced stage).
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Evaluation of the correlation between the Time of Flight (TOF) of ultrasounds between the two interfaces (bone / cartilage and cartilage / water) and the real thickness of the cartilage measured by Magnetic Resonance Imaging (MRI).
大体时间：5 months
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Correlation coefficients between US-TOF measurements and cartilage thickness measurements corresponding to MRI.
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5 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evaluation of the relationship between the propagation velocity of the ultrasound wave in cartilage tissue and the osteoarthritis degree defined by OARSI scale.
大体时间：5 months
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Correlation coefficients between the US propagation velocity measurements and OA progression according to the seven groups of the OARSI scale. Position indicators of US propagation velocity measurements of the 2 groups "early stage" (0 <= OARSI <= 2) and "advanced stage" (3 <= OARSI <= 6). |
5 months
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Evaluation of the relationship between 3D surface reconstruction and defects of cartilage samples from localized ultrasound data and those derived from MRI data
大体时间：5 months
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Correlation coefficient between surface area of samples and defects estimated from ultrasound data and those derived from MRI data. Correlation coefficients between surface volumes of samples and defects estimated from ultrasound data and those derived from MRI data. |
5 months
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Evaluation of correlation between thickness measured by MRI and this measured by histological analysis.
大体时间：5 months
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Correlation coefficients between thickness measurements estimated from MRI data and those estimated from histological data.
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5 months
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合作者和调查者
调查人员
- 首席研究员：Alexandre Moreau -Gaudry, MD, PhD、Clinical Investigation Centre for Innovative Technology Network - University Hospital Grenoble
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 38RC17.074
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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研究美国 FDA 监管的设备产品
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膝骨性关节炎的临床试验
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Universitas SriwijayaPT Bifarma Adiluhung尚未招聘
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First Affiliated Hospital of Wenzhou Medical University尚未招聘
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The Hong Kong Polytechnic UniversityChinese University of Hong Kong; Zhujiang Hospital尚未招聘膝关节骨性关节炎 (Knee OA)
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Ankara Etlik City Hospital主动，不招人