An observational study in Hip Disease, sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Insel Gruppe AG, University Hospital Bern · Observational
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.
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.
980 studies on the registry are indexed under Congenital Abnormalities; 177 are open to participants now.
This study's planned enrollment of 60 is below the median of 153 across 446 observational studies indexed under Congenital Abnormalities.
Browse Congenital Abnormalities studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.
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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.
Exclusion Criteria:
Individuals who are not considered suitable for MRI (Magnetic Resonance Imaging) for the following reasons:
Healthy individuals without history of hip pain or problems willing to undergo MRI of the hip.
Other: Non- contrast Magnetic Resonance Imaging (MRI) of the hip
This group is defined according to the following radiographic parameter: lateral center edge angle (LCE) \< 23°. The data was obtained from a retrospective study.
Other: Magnetic Resonance Imaging (MRI) of the hip with intra-articular contrast agent
This group is defined according to the following radiographic parameter: alpha angle \> 60°. The data was obtained from a retrospective study.
Other: Magnetic Resonance Imaging (MRI) of the hip with intra-articular contrast agent
This group is defined according to the following radiographic parameters:positive posterior- wall- sign, positive ischial spine sign, and positive cross- over- sign. The data was obtained from a retrospective study.
Other: Magnetic Resonance Imaging (MRI) of the hip with intra-articular contrast agent
This group is defined according to the following radiographic parameter: positive protrusion sign. The data was obtained from a retrospective study.
Other: Magnetic Resonance Imaging (MRI) of the hip with intra-articular contrast agent
This group is defined according to the following radiographic parameter: LCE angle \> 39°. The data was obtained from a retrospective study.
Other: Magnetic Resonance Imaging (MRI) of the hip with intra-articular contrast agent
Asymptomatic volunteers will undergo a non-contrast MRI of the hip at 3 Tesla. Following this, MRI images will be automatically segmented utilizing a validated artificial intelligence based algorithm to calculate 3D outcome parameters.
The data was derived from a retrospective study involving patients at Inselspital's outpatient clinic who underwent 3 Tesla hip MRI scans with intra-articular contrast agent. A validated artificial intelligence based algorithm was utilized for automated segmentation and the calculation of 3D outcome parameters.
Cartilage Surface Area
Difference in hip cartilage surface area (both absolute - mm² and relative - %) between healthy volunteers and patients with hip deformities.
Time frame: Within 12 Months after MRI
Cartilage Thickness
Difference in hip cartilage thickness (mm) between healthy volunteers and patients with hip deformities
Time frame: Within 12 Months after MRI
Cartilage Orientation
Difference in hip cartilage orientation, measured in inclination (°) and anteversion (°), between healthy volunteers and patients with hip deformities.
Time frame: Within 12 Months after MRI
Cartilage Volume
Difference in hip cartilage volume (mm³) between healthy volunteers and patients with hip deformities.
Time frame: Within 12 Months after MRI
Labrum Length
Difference in labrum length (mm) between healthy subjects and patients with hip deformities.
Time frame: Within 12 Months after MRI
Labrum Area
Difference in hip labrum surface area (both absolute - mm² and relative - %) between healthy volunteers and patients with hip deformities.
Time frame: Within 12 Months after MRI
Labrum Volume
Difference in hip labrum volume (mm³) between healthy volunteers and patients with hip deformities.
Time frame: Within 12 Months after MRI
iHOT 12 Questionnaire
The iHOT-12 is a validated questionnaire for young, active individuals with early hip disease. It covers four domains: symptoms and limitations, sports and recreation, job concerns, and social/emotional aspects. Responses are marked on a 100-mm scale, with the total score as a simple mean ranging from 0 to 100, where 100 represents the best possible quality of life.
Time frame: ca. 5 minutes before MRI
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Insel Gruppe AG, University Hospital Bern