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)

Hip Arthrosis Clinical Trial

Official title:
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Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06067243
Study type	Observational
Source	Istituto Ortopedico Rizzoli
Contact
Status	Withdrawn
Phase
Start date	January 1, 2024
Completion date	January 22, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.