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

NCT ID: NCT06095219

Last Updated: 2023-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-18

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Asymptomatic volunteers

Healthy individuals without history of hip pain or problems willing to undergo MRI of the hip.

Non- contrast Magnetic Resonance Imaging (MRI) of the hip

Intervention Type OTHER

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.

Magnetic Resonance Imaging (MRI) of the hip with intra-articular contrast agent

Intervention Type OTHER

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.

Magnetic Resonance Imaging (MRI) of the hip with intra-articular contrast agent

Intervention Type OTHER

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.

Magnetic Resonance Imaging (MRI) of the hip with intra-articular contrast agent

Intervention Type OTHER

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.

Magnetic Resonance Imaging (MRI) of the hip with intra-articular contrast agent

Intervention Type OTHER

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.

Magnetic Resonance Imaging (MRI) of the hip with intra-articular contrast agent

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Simon D. Steppacher, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Bern (Inselspital)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital of Bern (Inselspital)

Bern, , Switzerland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jose A. Roshardt, Dr.

Role: CONTACT

+41316640440

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jose A. Roshardt, Dr.

Role: primary

+41 31 664 04 40

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

320030_205091

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

5273

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Painful Post-Operative Hip Study
NCT07066709 NOT_YET_RECRUITING PHASE2
Hip Impingement - Understanding Cartilage Damage
NCT01546493 ACTIVE_NOT_RECRUITING NA