MRI-based 3D Hip Labrum and Cartilage Morphology in Patients With Hip Deformities Compared to Asymptomatic Volunteers

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Disease
• Intervention / Treatment: Other: Non- contrast Magnetic Resonance Imaging (MRI) of the hip; Other: Magnetic Resonance Imaging (MRI) of the hip with intra-articular contrast agent

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Jose A. Roshardt, Dr.; Phone Number: +41316640440; Email: jose.roshardt@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • University Hospital of Bern (Inselspital)
    • Contact: Jose A. Roshardt, Dr.; Phone Number: +41 31 664 04 40; Email: jose.roshardt@insel.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Asymptomatic volunteers; 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; 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.
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.	Other: Magnetic Resonance Imaging (MRI) of the hip with intra-articular contrast agent; 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.
cam Deformity; 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; 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.
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.	Other: Magnetic Resonance Imaging (MRI) of the hip with intra-articular contrast agent; 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.
Acetabular protrusion; 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; 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.
Deep hip; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	ca. 5 minutes before MRI

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Simon D. Steppacher, Dr., University Hospital of Bern (Inselspital)

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Hip dysplasia; Acetabular protrusion; Deep hip; Acetabular retroversion
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 5273 (Other Identifier: Oregon Clinical & Translational Research Institute); 320030_205091 (Other Grant/Funding Number: Swiss National Science Foundation (SNSF))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No