Hip Injuries and DisordersNCT06067243
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)
An observational study of Hip Injuries and Disorders and Hip Arthrosis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Hip Injuries and Disorders, Hip Arthrosis
- What is being tested?
- T2 mapping 3T MRI + hip arthroscopy
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2024to 22 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Young with symptomatic localized chondro-labral lesion requiring arthroscopic treatment
Who may be able to join
- Patients with symptomatic localized chondro-labral lesion requiring arthroscopic treatment
- Consent to conduct the study
- BMI<30
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Hip Injuries and Disorders, Hip Arthrosis
- Being tested
- T2 mapping 3T MRI + hip arthroscopy
- Keywords
- 3T MRI, labral and chondral lesions, hip arthroscopy
- Medical subject headings
- Hip Injuries, Disease, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T2 mapping 3T MRI + hip arthroscopyDiagnostic test
- 3T MRI
- hip arthroscopy
| Study group | Role | What they receive |
|---|---|---|
| HIP MRI-3 T | Young patients with coxalgia and clinical and imaging suspect for cartilage and/or labral lesion of the hip Receives: Diagnostic Test: T2 mapping 3T MRI + hip arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Within 21 months from beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start1 Jan 2024
- Primary completion22 Jan 2024
- Study completion22 Jan 2024
Why it stopped: No patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Injuries and DisordersStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067243
- Sponsor's protocol ID
- CE-AVEC 577/2020/Sper/IOR
- Status last verified
- Mar 2024
- First submitted
- 5 Sep 2023
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06067243
- Acronym / sponsor ID
- CE-AVEC 577/2020/Sper/IOR
- Conditions
- Hip Injuries and Disorders, Hip Arthrosis
- Keywords
- 3T MRI, labral and chondral lesions, hip arthroscopy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIP MRI-3 T | – | Diagnostic Test: T2 mapping 3T MRI + hip arthroscopyYoung patients with coxalgia and clinical and imaging suspect for cartilage and/or labral lesion of the hip |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young with symptomatic localized chondro-labral lesion requiring arthroscopic treatment
Key inclusion criteria (3 listed)
- Patients with symptomatic localized chondro-labral lesion requiring arthroscopic treatment
- Consent to conduct the study
- BMI<30
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T2 mapping 3T MRI + hip arthroscopy1. 3T MRI 2. hip arthroscopy | Diagnostic test | HIP MRI-3 T |
Primary outcome
T2 mapping 3T MRI
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Injuries and Disorders and Hip Arthrosis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T2 mapping 3T MRI (time frame: At baseline (Day 0)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.