MRI-based 3D Hip Labrum and Cartilage Morphology in Patients With Hip Deformities Compared to Asymptomatic Volunteers
2 other identifiers
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 18, 2023
CompletedFirst Submitted
Initial submission to the registry
October 3, 2023
CompletedFirst Posted
Study publicly available on registry
October 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedOctober 23, 2023
October 1, 2023
2 years
October 3, 2023
October 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Cartilage Surface Area
Difference in hip cartilage surface area (both absolute - mm² and relative - %) between healthy volunteers and patients with hip deformities.
Within 12 Months after MRI
Cartilage Thickness
Difference in hip cartilage thickness (mm) between healthy volunteers and patients with hip deformities
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.
Within 12 Months after MRI
Cartilage Volume
Difference in hip cartilage volume (mm³) between healthy volunteers and patients with hip deformities.
Within 12 Months after MRI
Labrum Length
Difference in labrum length (mm) between healthy subjects and patients with hip deformities.
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.
Within 12 Months after MRI
Labrum Volume
Difference in hip labrum volume (mm³) between healthy volunteers and patients with hip deformities.
Within 12 Months after MRI
Secondary Outcomes (1)
iHOT 12 Questionnaire
ca. 5 minutes before MRI
Study Arms (6)
Asymptomatic volunteers
Healthy individuals without history of hip pain or problems willing to undergo MRI of the hip.
Hip Dysplasia
This group is defined according to the following radiographic parameter: lateral center edge angle (LCE) \< 23°. The data was obtained from a retrospective study.
cam Deformity
This group is defined according to the following radiographic parameter: alpha angle \> 60°. The data was obtained from a retrospective study.
Acetabular retroversion
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.
Acetabular protrusion
This group is defined according to the following radiographic parameter: positive protrusion sign. The data was obtained from a retrospective study.
Deep hip
This group is defined according to the following radiographic parameter: LCE angle \> 39°. The data was obtained from a retrospective study.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Bern (Inselspital)
Bern, 3010, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simon D. Steppacher, Dr.
University Hospital of Bern (Inselspital)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2023
First Posted
October 23, 2023
Study Start
January 18, 2023
Primary Completion
December 31, 2024
Study Completion
December 31, 2025
Last Updated
October 23, 2023
Record last verified: 2023-10