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

Hip Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06095219
• Other study ID #: 5273
• Secondary ID: 320030_205091
• Status: Recruiting
• Start date: January 18, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Jose A. Roshardt, Dr.
• Phone: +41316640440
• Email: jose.roshardt[@]insel.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Hip Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	University Hospital of Bern (Inselspital)	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Cartilage Thickness	Difference in hip cartilage thickness (mm) between healthy volunteers and patients with hip deformities	Within 12 Months after MRI
Primary	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
Primary	Cartilage Volume	Difference in hip cartilage volume (mm³) between healthy volunteers and patients with hip deformities.	Within 12 Months after MRI
Primary	Labrum Length	Difference in labrum length (mm) between healthy subjects and patients with hip deformities.	Within 12 Months after MRI
Primary	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
Primary	Labrum Volume	Difference in hip labrum volume (mm³) between healthy volunteers and patients with hip deformities.	Within 12 Months after MRI
Secondary	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