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)

NCT06067243 | Withdrawn

• 1 other identifier: CE-AVEC 577/2020/Sper/IOR
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Injuries and Disorders; Hip Arthrosis

Keywords

3T MRI; labral and chondral lesions; hip arthroscopy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

T2 mapping 3T MRI + hip arthroscopy DIAGNOSTIC_TEST

1. 3T MRI 2. hip arthroscopy

HIP MRI-3 T

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Young with symptomatic localized chondro-labral lesion requiring arthroscopic treatment

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Hip Injuries; Disease; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: October 4, 2023
• Study Start: January 1, 2024
• Primary Completion: January 22, 2024
• Study Completion: January 22, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)