Improving Non-Invasive Diagnosis and Grading of Cartilage Defects in the Knee - Accuracy of Ultra High Field 7-Tesla MRI as Compared With Arthroscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Modified Whole-Organ Magnetic Resonance Imaging Score (WORMS)
研究概览
简要总结
The investigators propose to prospectively evaluate the accuracy of a novel 7-Tesla (7T) knee MRI protocol for the detection and grading of cartilage lesions in the knee, which is a significant limitation of current MRI techniques.
详细描述
The investigators hypothesize that 7T MRI will be ~ 80% sensitive for detection of cartilaginous lesions. This will be tested in a prospective multi-reader study of 100 patients who are scheduled to have knee arthroscopy. Patients will have two MRIs of the knee: one standard of care and one experimental 7T MRI. Subjects will visit at one time point prior to scheduled knee arthroscopy, for a session time of ~1-2 hours for a single 7T MRI scan.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Confirmed Knee Symptomatology
- •Scheduled Arthroscopic Treatment of Knee
- •Adult (equal or greater than 18 years of age)
排除标准
- •Active infections
- •Less than 18 years of age
结局指标
主要结局
Modified Whole-Organ Magnetic Resonance Imaging Score (WORMS)
时间窗: baseline
* Modified Whole-Organ Magnetic Resonance Imaging Score (WORMS) of the knee is a validated instrument utilized to grade structural abnormalities found in MRI. * Only the cartilage sub-score of the full WORMS will be scored in the study. Cartilage will be scored on a range from 0-6 for 6 different regional subdivisions for a minimum score of 0 and maximum score of 36. A lower score is considered a better outcome, with a score of 0 equating to normal thickness and signal of cartilage.
次要结局
未报告次要终点
研究者
Patrick McCulloch,MD
Principal Investigator
The Methodist Hospital Research Institute