NCT06067243

Diagnostic Performance of 3T MRI T2 Mapping Technique in Chondro-labral Pathology of the Hip, Correlated With Intraoperative Arthroscopic Findings: Interventional Diagnostic Technique Validation Study (HPI MRI 3T)

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)

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. The present study will involve 30 young patients with coxalgia non responding to conservative treatment and referable to a chondro-labrum injury based on clinical and imaging examinations. Patients will undergo RM diagnostic protocol and will receive hip arthroscopy within the next 6 months.

Conditions

• Hip Injuries and Disorders
• Hip Arthrosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	T2 mapping 3T MRI + hip arthroscopy	1. 3T MRI 2. hip arthroscopy

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-01-22
• Completion: 2024-01-22
• First posted: 2023-10-04
• Last updated: 2024-03-20

Locations

1 site across 1 country: Italy