Clinical trial NCT06067243: 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)
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)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hip Injuries and Disorders
Hip Arthrosis
Keywords: 3T MRI
labral and chondral lesions
hip arthroscopy
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young with symptomatic localized chondro-labral lesion requiring arthroscopic treatment

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.

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.

Primary outcomes:
measure: T2 mapping 3T MRI
timeFrame: At baseline (Day 0)
measure: Hip arthroscopy
timeFrame: Within 6 months from day 0
measure: Data comparison
timeFrame: Within 21 months from beginning of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References: