Clinical trial NCT06095219: MRI-based 3D Hip Labrum and Cartilage Morphology in Patients With Hip Deformities Compared to Asymptomatic Volunteers
Official title: MRI-based 3D Hip Labrum and Cartilage Morphology in Patients With Hip Deformities Compared to Asymptomatic Volunteers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip Disease
Keywords: Hip dysplasia
Acetabular protrusion
Deep hip
Acetabular retroversion
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be publicly advertised in the Bern area. Interested individuals can contact by phone or electronically. Study information will be provided, and appointments will be scheduled for clinical exams and, if deemed necessary based on eligibility criteria, an MRI. Informed consent interviews will be conducted by investigators. MRI procedures will follow, without the use of contrast medium or ionizing radiation. Data for comparison will be obtained from a retrospective study involving 100 patients with hip deformities from the outpatient clinic who underwent direct MR arthrography at 3 Tesla.

Brief summary: In this study, the investigators seek to describe the normal 3D hip joint morphology in asymptomatic volunteers and compare it to various hip joint deformities. Asymptomatic volunteers will be asked to undergo a non-contrast MRI of the hip at 3 Tesla, utilizing a high-resolution morphologic 3D sequence (3D T2 DESS) that enables the segmentation of labrum and cartilage. 3D morphological parameters of the asymptomatic group will subsequently be compared with the 3D morphological parameters of patients with hip deformities, which were collected as part of a previous retrospective study.

Detailed description: Hip deformities can cause hip pain and early onset osteoarthritis in young individuals.

Correcting these deformities typically involves planning with X-rays and MRI images, which offer a limited view of the hip joint's 3D structure. A comprehensive 3D analysis of hip structures, including cartilage, and labrum, would enhance diagnosis and surgery planning. However, 3D hip morphology hasn't been adequately described for distinguishing deformities.

The aim of this study is to describe normal 3D hip joint morphology in healthy participants and compare it to various hip joint deformities (Dysplasia, acetabular protrusion, retroversion, deep hip, and cam deformity).

Asymptomatic volunteers will undergo a non-contrast MRI of the hip at 3 Tesla using high-resolution morphologic 3D sequence (3D T2 DESS), which allows segmentation of labrum and cartilage.

The 3D morphological parameters of the asymptomatic group will then be compared with those of patients with hip deformities, data sourced from a retrospective study that included 100 patients from the outpatient clinic. These patients underwent direct MR arthrography at 3 Tesla in accordance with the institutional routine protocol at the Department of Diagnostic, Interventional, and Pediatric Radiology at Inselspital.

Eligibility criteria: Inclusion criteria:

* Age \> 18 years.
* Signed an informed consent form.
* History free of significant hip pain, with no history of juvenile hip disease, traumatic injuries, inflammatory conditions, or tumors affecting the hip.
* Normal clinical examination of the hip.

Exclusion Criteria:

Individuals who are not considered suitable for MRI (Magnetic Resonance Imaging) for the following reasons:

* Potential pregnancy
* Presence of metal fragments in the eye or elsewhere in the body
* Presence of implants and metallic foreign bodies, such as a pacemaker, heart valve, cerebrospinal fluid shunt, insulin pump, nerve stimulator, or cochlear implant
* Claustrophobia

Primary outcomes:
measure: Cartilage Surface Area
timeFrame: Within 12 Months after MRI
measure: Cartilage Thickness
timeFrame: Within 12 Months after MRI
measure: Cartilage Orientation
timeFrame: Within 12 Months after MRI
measure: Cartilage Volume
timeFrame: Within 12 Months after MRI
measure: Labrum Length
timeFrame: Within 12 Months after MRI
measure: Labrum Area
timeFrame: Within 12 Months after MRI
measure: Labrum Volume
timeFrame: Within 12 Months after MRI
Secondary outcomes:
measure: iHOT 12 Questionnaire
timeFrame: ca. 5 minutes before MRI
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital of Bern (Inselspital)
Study officials:
affiliation: University Hospital of Bern (Inselspital)
name: Simon D. Steppacher, Dr.
role: PRINCIPAL_INVESTIGATOR
References: