NCT06095219

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

October 3, 2023

Last Update Submit

October 17, 2023

Conditions

Keywords

Hip dysplasiaAcetabular protrusionDeep hipAcetabular retroversion

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.

Other: Non- contrast Magnetic Resonance Imaging (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.

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

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

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

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

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

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.

Asymptomatic volunteers

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 protrusionAcetabular retroversionDeep hipHip Dysplasiacam Deformity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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

RECRUITING

MeSH Terms

Conditions

Hip Dislocation

Interventions

Magnetic Resonance SpectroscopyContrast Media

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesHip Injuries

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesDiagnostic Uses of ChemicalsPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Simon D. Steppacher, Dr.

    University Hospital of Bern (Inselspital)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose A. Roshardt, Dr.

CONTACT

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

Locations