Hip DiseaseNCT06095219
MRI-based 3D Hip Labrum and Cartilage Morphology in Patients With Hip Deformities Compared to Asymptomatic Volunteers
An observational study of Hip Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Disease
- What is being tested?
- Non- contrast Magnetic Resonance Imaging (MRI) of the hip and Magnetic Resonance Imaging (MRI) of the hip with intra-articular contrast agent
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Jan 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Bern (Inselspital)
Bern, 3010
Jose A. Roshardt, Dr., +41 31 664 04 40, jose.roshardt@insel.ch
About this study
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.
Read the 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.
- Conditions
- Hip Disease
- Being tested
- Non- contrast Magnetic Resonance Imaging (MRI) of the hip, Magnetic Resonance Imaging (MRI) of the hip with intra-articular contrast agent
- Keywords
- Hip dysplasia, Acetabular protrusion, Deep hip, Acetabular retroversion
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non- contrast Magnetic Resonance Imaging (MRI) of the hipOther
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 agentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic volunteers | Healthy individuals without history of hip pain or problems willing to undergo MRI of the hip. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Magnetic Resonance Imaging (MRI) of the hip with intra-articular contrast agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cartilage Surface Area
Difference in hip cartilage surface area (both absolute - mm² and relative - %) between healthy volunteers and patients with hip deformities.
Measured: Within 12 Months after MRI
Cartilage Thickness
Difference in hip cartilage thickness (mm) between healthy volunteers and patients with hip deformities
Measured: 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.
Measured: Within 12 Months after MRI
Cartilage Volume
Difference in hip cartilage volume (mm³) between healthy volunteers and patients with hip deformities.
Measured: Within 12 Months after MRI
Labrum Length
Difference in labrum length (mm) between healthy subjects and patients with hip deformities.
Measured: 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.
Measured: Within 12 Months after MRI
Labrum Volume
Difference in hip labrum volume (mm³) between healthy volunteers and patients with hip deformities.
Measured: Within 12 Months after MRI
Secondary outcomes (1)
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.
Measured: ca. 5 minutes before MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start18 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip DiseaseStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon D. Steppacher, Dr., Principal investigator, University Hospital of Bern (Inselspital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095219
- Sponsor's protocol ID
- 5273
- Other IDs
- 320030_205091
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-based 3D Hip Labrum and Cartilage Morphology in Patients With Hip Deformities Compared to Asymptomatic Volunteers
- ClinicalTrials.gov ID
- NCT06095219
- Acronym / sponsor ID
- 5273
- Conditions
- Hip Disease
- Keywords
- Hip dysplasia, Acetabular protrusion, Deep hip, Acetabular retroversion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic volunteers | – | Other: Non- contrast Magnetic Resonance Imaging (MRI) of the hipHealthy individuals without history of hip pain or problems willing to undergo MRI of the hip. |
| Hip Dysplasia | – | Other: Magnetic Resonance Imaging (MRI) of the hip with intra-articular contrast agentThis group is defined according to the following radiographic parameter: lateral center edge angle (LCE) < 23°. The data was obtained from a retrospective study. |
| cam Deformity | – | Other: Magnetic Resonance Imaging (MRI) of the hip with intra-articular contrast agentThis group is defined according to the following radiographic parameter: alpha angle > 60°. The data was obtained from a retrospective study. |
| Acetabular retroversion | – | Other: Magnetic Resonance Imaging (MRI) of the hip with intra-articular contrast agentThis 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. |
| Acetabular protrusion | – | Other: Magnetic Resonance Imaging (MRI) of the hip with intra-articular contrast agentThis group is defined according to the following radiographic parameter: positive protrusion sign. The data was obtained from a retrospective study. |
| Deep hip | – | Other: Magnetic Resonance Imaging (MRI) of the hip with intra-articular contrast agentThis group is defined according to the following radiographic parameter: LCE angle > 39°. The data was obtained from a retrospective study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non- contrast Magnetic Resonance Imaging (MRI) of the hipAsymptomatic 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. | Other | Asymptomatic volunteers |
| Magnetic Resonance Imaging (MRI) of the hip with intra-articular contrast agentThe 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. | Other | Acetabular protrusion, Acetabular retroversion, Deep hip, Hip Dysplasia, cam Deformity |
Primary outcome
Cartilage Surface Area
Time frame: Within 12 Months after MRI
Difference in hip cartilage surface area (both absolute - mm² and relative - %) between healthy volunteers and patients with hip deformities.
Cartilage Thickness
Time frame: Within 12 Months after MRI
Difference in hip cartilage thickness (mm) between healthy volunteers and patients with hip deformities
Cartilage Orientation
Time frame: Within 12 Months after MRI
Difference in hip cartilage orientation, measured in inclination (°) and anteversion (°), between healthy volunteers and patients with hip deformities.
Cartilage Volume
Time frame: Within 12 Months after MRI
Difference in hip cartilage volume (mm³) between healthy volunteers and patients with hip deformities.
Labrum Length
Time frame: Within 12 Months after MRI
Difference in labrum length (mm) between healthy subjects and patients with hip deformities.
Labrum Area
Time frame: Within 12 Months after MRI
Difference in hip labrum surface area (both absolute - mm² and relative - %) between healthy volunteers and patients with hip deformities.
Labrum Volume
Time frame: Within 12 Months after MRI
Difference in hip labrum volume (mm³) between healthy volunteers and patients with hip deformities.
1 secondary outcome
iHOT 12 Questionnaire
Time frame: ca. 5 minutes before MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon D. Steppacher, Dr. principal investigator
University Hospital of Bern (Inselspital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose A. Roshardt, Dr. (+41316640440, jose.roshardt@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cartilage Surface Area (time frame: Within 12 Months after MRI). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.