Evaluation of Meniscal Extrusion by Dynamic Ultrasonography in Patients With Ostearthritis and Comparison With Magnetic Resonance Imaging Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 2
- 主要终点
- Meniscal extrusion
研究概览
简要总结
This is a diagnostic, open-label, single-center interventional study. The aim of the study is to evaluate the relationship between medial and lateral meniscus extrusion determined by dynamic ultrasound study and bone edema assessed by MRI study in patients with knee OA.
As a secondary objective, the correlation of the above parameters with the patient's symptomatology assessed by subject clinical questionnaires will be evaluated.
详细描述
Patients with a diagnosis of knee OA will be included in a study involving evaluation of the correlation between meniscal extrusion assessed by dynamic ultrasonography and bone edema assessed on MRI. A total of 202 patients will be included, who, after providing their signed informed consent to participate in the study, will undergo dynamic ultrasonography. After giving signed consent to participate in the study, the patient will undergo the following examinations::
- ultrasound evaluation for assessment of possible meniscal extrusion;
- At the same time as the ultrasound examination, subjective questionnaires will be administered to patients.Recent radiological examinations of the patients 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years;
- •Signs and symptoms of degenerative pathology of knee cartilage;
- •Patients with Radiographic (X-ray or MRI) signs of OA (K-L grade 0-4);
- •Cooperative patients with pain that does not prevent orthostatism
- •Ability and consent of patients to actively participate in clinical follow-up;
- •Recently performed MRI (maximum 1 month).
排除标准
- •Patients unable to express consent;
- •Patients undergoing intra-articular infiltration of other substance in the previous 6 months;
- •Patients undergoing knee surgery in the previous 12 months;
- •Patients with malignant neoplasms;
- •Patients with rheumatic diseases;
- •Patients with a history of total/subtotal meniscectomy;
- •Patients with symptomatology such that a dynamic examination in orthostatism is not possible;
- •Patients abusing alcoholic beverages, drugs or medications;
- •Body Mass Index > 40;
- •Pregnant or lactating women;
- •Patients with axis deviation > 5°.
研究组 & 干预措施
Ultrasonographic evaluation
Ultrasonographic evaluation for assessment of possible meniscal extrusion
干预措施: Ultrasonographic evaluation (Diagnostic Test)
结局指标
主要结局
Meniscal extrusion
时间窗: baseline
Meniscal extrusion in clinostatism and orthostatism, assessed in millimeters (mm) or percent meniscal extrusion relative to tibial margin, and difference between the two measurements
次要结局
- Tegner Activity Level Scale(baseline)
- EQ-VAS(baseline)
- IKDC-Subjective Score (Subjective International Knee Documentation Committee)(baseline)
- VAS-dolore (Visual Analogue Scale)(baseline)
- KOOS Score ( Knee Injury and Osteoarthritis Outcome score)(baseline)
- Objective parameters - Circumferences(baseline)
- Objective parameters- Range of Motion(baseline)