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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)

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06067243
Enrollment
0
Registered
2023-10-04
Start date
2024-01-01
Completion date
2024-01-22
Last updated
2024-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Arthrosis, Hip Injuries and Disorders

Keywords

3T MRI, labral and chondral lesions, hip arthroscopy

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.

Interventions

DIAGNOSTIC_TESTT2 mapping 3T MRI + hip arthroscopy

1. 3T MRI 2. hip arthroscopy

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
T2 mapping 3T MRIAt 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 arthroscopyWithin 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 comparisonWithin 21 months from beginning of the studyIn 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026