Qualification of Ultrasound Imaging Technique in the Quantitative Evaluation of Cartilaginous Tissue of Femoral Condyle Articulation and Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
This study investigates the potential of the ultrasound imaging technique to diagnose the severity of knee osteoarthritis (OA). In parallel, measurements will also be conducted using Magnetic Resonance Imaging (MRI) and histology analysis as reference tools.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient over 18 year old
- •knee osteoarthritis which total knee arthroplasty indication
- •who have signed a non-objection form.
排除标准
- •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
结局指标
主要结局
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).
时间窗: 5 months
Correlation coefficients between US-TOF measurements and cartilage thickness measurements corresponding to MRI.
次要结局
- Evaluation of the relationship between 3D surface reconstruction and defects of cartilage samples from localized ultrasound data and those derived from MRI data(5 months)
- Evaluation of correlation between thickness measured by MRI and this measured by histological analysis.(5 months)
- Evaluation of the relationship between the propagation velocity of the ultrasound wave in cartilage tissue and the osteoarthritis degree defined by OARSI scale.(5 months)