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)

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.

Study Overview

• Status: Withdrawn
• Conditions: Hip Arthrosis; Hip Injuries and Disorders
• Intervention / Treatment: 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 Type: Observational

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Istituto Ortopedico Rizzoli
    • Contact: Dante Dallari, MD; Phone Number: 0516366; Email: dante.dallari@ior.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Young with symptomatic localized chondro-labral lesion requiring arthroscopic treatment

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
T2 mapping 3T MRI	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.	At baseline (Day 0)
Hip arthroscopy	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.	Within 6 months from day 0
Data comparison	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.	Within 21 months from beginning of the study

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): January 22, 2024
• Study Completion (Actual): January 22, 2024

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 4, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: hip arthroscopy; 3T MRI; labral and chondral lesions
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip; Hip Injuries
• Other Study ID Numbers: CE-AVEC 577/2020/Sper/IOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No