Dynamic Ultrasonography VS MRI in the Evaluation of Meniscal Lesions in Patients With an Indication for Arthroscopy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Diagnostic sensitivity of Dynamic Ultrasonography assessment
研究概览
简要总结
This is a diagnostic, open-label, single-center interventional study.
This study aims to evaluate the diagnostic accuracy of dynamic ultrasonography for meniscal injuries in patients with an indication for arthroscopy, and to compare it with the study in MRI.
详细描述
Patients admitted for ACL injury and indication for arthroscopy will be included in a study involving the evaluation of the diagnostic accuracy of dynamic ultrasound compared with MRI.
A total of 254 patients will be included, who after providing their signed informed consent to participate in the study, will undergo dynamic ultrasound. After giving signed consent to participate in the study, the patient will undergo the ultrasound evaluation for assessment of possible meniscal injury; Radiological examinations in the patient's possession or from the patient's medical record will be collected during or before the diagnostic investigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an indication for knee arthroscopy with:
- •Age between 18 and 60 years;
- •Unilateral involvement;
- •Presence of symptomatology such that dynamic ultrasound examination is precluded;
- •Ability and consent of patients to actively participate in the study;
排除标准
- •Patients unable to express consent;
- •Patients with malignant neoplasms;
- •Patients with rheumatic diseases;
- •Patients with diabetes;
- •Patients with metabolic disorders of the thyroid gland;
- •Patients abusing alcoholic beverages, drugs or medications;
- •Body Mass Index > 35;
- •Pregnant or lactating women;
研究组 & 干预措施
Dynamic Ultrasonography assessment
Patients admitted for ACL injury and indication for arthroscopy will have dynamic ultrasound evaluation that will be compared with an MRI.
干预措施: Dynamic Ultrasonography assessment (Diagnostic Test)
结局指标
主要结局
Diagnostic sensitivity of Dynamic Ultrasonography assessment
时间窗: baseline
Baseline ultrasonography evaluation for assessment of possible meniscal injury. The ultrasound examination will be compared with an MRI using the arthroscopy result as the gold standard.
Diagnostic specificity of Dynamic Ultrasonography assessment
时间窗: baseline
Baseline ultrasonography evaluation for assessment of possible meniscal injury. The ultrasound examination will be compared with an MRI using the arthroscopy result as the gold standard.
次要结局
未报告次要终点