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)

NCT ID: NCT06067243

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-01-22

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HIP MRI-3 T

Young patients with coxalgia and clinical and imaging suspect for cartilage and/or labral lesion of the hip

T2 mapping 3T MRI + hip arthroscopy

Intervention Type: DIAGNOSTIC_TEST

1. 3T MRI

2. hip arthroscopy

Interventions

T2 mapping 3T MRI + hip arthroscopy

1. 3T MRI

2. hip arthroscopy

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients with symptomatic localized chondro-labral lesion requiring arthroscopic treatment
• Consent to conduct the study
• BMI<30

Exclusion Criteria

• 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;
• Tumors;
• Metabolic disorders;
• Presence of peripheral neurological disorders such as pudendal neuralgia, peroneal neuralgia, neuralgia sciatica that traction may risk worsening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Ortopedico Rizzoli

Bologna, , Italy

Countries

Italy

Other Identifiers

CE-AVEC 577/2020/Sper/IOR

Identifier Type: -

Identifier Source: org_study_id