Valutazione Della Performance Diagnostica di MRI 3T Con Tecnica T2 Mapping e Correlazione Intraoperatoria Artroscopica Nella Patologia Condro-labrale Dell'Anca: Studio Interventistico di Validazione di Tecniche Diagnostiche (HPI MRI 3T)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- T2 mapping 3T MRI
研究概览
简要总结
The goal of this observational study is to evaluate the diagnostic performance of the T2 mapping technique of the following 4 MRI scans in detecting hip chondro-labral lesions in comparison with intraoperative arthroscopic findings: 1) basal 3T MRI with T2 mapping technique, 2) 3T MRI with T2 mapping technique and limb traction; 3) 3T arthro-MRI with T2 mapping technique; 4) 3T arthro-MRI with T2 mapping technique and limb traction.
详细描述
This study will evaluate the role of T2 mapping technique in the diagnosis of chondral and labral lesions of the hip. In particular, the following 4 types of MRI scan will be compared to each other and with intraoperative arthroscopic findings:
- Basal 3T MRI without contrast
- 3T MRI with limb traction
- Arthro-RM 3T after intrarticular gadolinium and local anesthetic injection under ultrasound control
- Arthro-RM 3T after intrarticular gadolinium and local anesthetic injection under ultrasound control + limb traction.
The primary endpoint is to:
- assess the diagnostic performance of baseline 3T MRI with T2 mapping technique in terms of sensitivity, specificity, PPV, and NPV in the diagnosis of hip labral lesions, according to Philippon's classification, and chondral lesions according to modified Outerbridge classification,
- compare the diagnostic performance between all the mentioned above scans.
The secondary endpoint is to evaluate the sensitivity, specificity, PPV and NPV of 3T MRI with longitudinal traction of the lower limb in detecting, localizing and grading chondral lesions of the coxo-femoral joint.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic localized chondro-labral lesion requiring arthroscopic treatment
- •Consent to conduct the study
排除标准
- •Patients unable to read or understand the patient information and consent forms;
- •Previous surgery on the same hip;
- •Coxarthrosis ≥ 2 according to Tonnis;
- •Acetabulum and/or proximal femur fractures;
- •Presence of psychological disorders, which might interfere with their ability to undergo the 4 MRI examinations;
- •Known sensitivity to gadolinium;
- •BMI ≥ 30;
- •Current infections;
- •Metabolic disorders;
- •Presence of peripheral neurological disorders such as pudendal neuralgia, peroneal neuralgia, neuralgia sciatica that traction may risk worsening.
结局指标
主要结局
T2 mapping 3T MRI
时间窗: At baseline (Day 0)
* Grade of cartilage lesions according to modified Outerbridge classification; * Grade of labrum lesions according to Philippon's classification; * Localization of cartilage lesions according to the clock system; * Localization of labrum lesions by the ROI (Region Of Interest) method.
Data comparison
时间窗: Within 21 months from beginning of the study
In the postoperative phase, the intraoperative findings will be compared with the preoperative findings of the 4 MRI types by proceeding to calculate their sensitivity, specificity, PPV, NPV in relation to the degree and location of chondro-labral lesions of the hip.
Hip arthroscopy
时间窗: Within 6 months from day 0
* Grade of cartilage lesions according to modified Outerbridge classification; * Grade of labrum lesions according to Philippon's classification; * Localization of cartilage lesions according to the clock system; * Localization of labrum lesions by the ROI (Region Of Interest) method.
次要结局
未报告次要终点