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)

Sponsor

Istituto Ortopedico Rizzoli (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06067243

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Injuries and Disorders Hip Arthrosis	Diagnostic Test: T2 mapping 3T MRI + hip arthroscopy

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Anticipated Study Start Date :

Mar 1, 2024

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
HIP MRI-3 T Young patients with coxalgia and clinical and imaging suspect for cartilage and/or labral lesion of the hip	Diagnostic Test: T2 mapping 3T MRI + hip arthroscopy 3T MRI hip arthroscopy

Arm

Intervention/Treatment

HIP MRI-3 T

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

Diagnostic Test: T2 mapping 3T MRI + hip arthroscopy

3T MRI hip arthroscopy

Outcome Measures

Primary Outcome Measures

T2 mapping 3T MRI [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.
Hip arthroscopy [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.
Data comparison [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.