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

Sponsor
Insel Gruppe AG, University Hospital Bern (Other)
Overall Status
Recruiting
CT.gov ID
NCT06095219
Collaborator
(none)
60
1
35.4
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
MRI-based 3D Hip Labrum and Cartilage Morphology in Patients With Hip Deformities Compared to Asymptomatic Volunteers
Actual Study Start Date :
Jan 18, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Cartilage Surface Area [Within 12 Months after MRI]

    Difference in hip cartilage surface area (both absolute - mm² and relative - %) between healthy volunteers and patients with hip deformities.

  2. Cartilage Thickness [Within 12 Months after MRI]

    Difference in hip cartilage thickness (mm) between healthy volunteers and patients with hip deformities

  3. Cartilage Orientation [Within 12 Months after MRI]

    Difference in hip cartilage orientation, measured in inclination (°) and anteversion (°), between healthy volunteers and patients with hip deformities.

  4. Cartilage Volume [Within 12 Months after MRI]

    Difference in hip cartilage volume (mm³) between healthy volunteers and patients with hip deformities.

  5. Labrum Length [Within 12 Months after MRI]

    Difference in labrum length (mm) between healthy subjects and patients with hip deformities.

  6. Labrum Area [Within 12 Months after MRI]

    Difference in hip labrum surface area (both absolute - mm² and relative - %) between healthy volunteers and patients with hip deformities.

  7. Labrum Volume [Within 12 Months after MRI]

    Difference in hip labrum volume (mm³) between healthy volunteers and patients with hip deformities.

Secondary Outcome Measures

  1. iHOT 12 Questionnaire [ca. 5 minutes before MRI]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital of Bern (Inselspital) Bern Switzerland 3010

Sponsors and Collaborators

  • Insel Gruppe AG, University Hospital Bern

Investigators

  • Principal Investigator: Simon D. Steppacher, Dr., University Hospital of Bern (Inselspital)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Insel Gruppe AG, University Hospital Bern
ClinicalTrials.gov Identifier:
NCT06095219
Other Study ID Numbers:
  • 5273
  • 320030_205091
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Insel Gruppe AG, University Hospital Bern
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2023