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临床试验/NCT03210584
NCT03210584已完成不适用

Multimodal Evaluation of Cartilage Lesions of Patellofemoral Joint

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
1
主要终点
Evaluation and comparison of histologic analysis, 9,4 Tesla MRI, FFOCT and ultrasound-based navigation system for cartilage lesions analysis of patellofemoral joint.

研究概览

简要总结

Evaluation and comparison of histological analysis, 9,4 tesla MRI, Full-Field Optical Coherence Tomography (FFOCT) and ultrasound-based navigation system for cartilage degeneration analysis of patellofemoral joint.

详细描述

Knee osteoarthritis (OA) is a common and debilitating chronic degenerative disease of the articular cartilage. Despite recent progress in the field of cartilage imaging, no routinely used clinical imaging modality has the ability to evaluate and monitor changes in cartilage degeneration. This observationnal, pilot, prospective, non randomized, uncontrolled, monocentric study aim to compare three of the most innovative imaging systems, namely the 9,4 Tesla MRI, the FFOCT (Full-Field Optical Coherence Tomography) and the ultrasound-based navigation system in order to image healthly to severely degraded human cartilage samples. All methods will be cross-correlated and compared with histological data considered as the gold standard.

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

入选标准

  • Over 18 years of age
  • Knee prosthetic surgery indication with cartilage excision.

排除标准

  • Subjects who refuse to sign a non-objection form

结局指标

主要结局

Evaluation and comparison of histologic analysis, 9,4 Tesla MRI, FFOCT and ultrasound-based navigation system for cartilage lesions analysis of patellofemoral joint.

时间窗: 6 months

Correlation between Osteoarthritis Research Society International (OARSI) grades performed for different modalities

次要结局

  • Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual qualitative information parameter.(6 months)
  • Evaluation of navigation ultrasound in early osteoarthritis evaluation using visual qualitative information parameter.(6 months)
  • Inter-observer robustness analysis of the OARSI classification(6 months)
  • Evaluation of 9,4 Tesla MRI reconstructions in early osteoarthritis evaluation using visual qualitative information parameter obtained from the Average Pathlength Maps (APM).(6 months)
  • Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual quantitative information parameter.(6 months)
  • Evaluation of of 9,4 Tesla MRI reconstruction in early osteoarthritis evaluation using visual quantitative information parameter obtained for the Average Pathlength Maps.(6 months)
  • Evaluation of navigation ultrasound in early osteoarthritis evaluation using visual quantitative information parameter.(6 months)
  • Intra-observer robustness analysis of the OARSI classification(6 months)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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