HipNCT05754905
High-resolution CE-MRA of Children's Hip Joint
An observational study of Hip and Vessels; Anomaly, run by Children's Hospital of Chongqing Medical University at 1 site in China.
Trial summary
The goal of this observational study is to learn about the feasibility of enhanced three-dimensional water-selective cartilage (3D-WATSc) sequence in displaying the vessels of children's hip by magnetic resonance. Read more about this study
- Who is it for?
- Ages 6 months to 14 years
- Conditions the study is for
- Hip, Vessels; Anomaly, Magnetic Resonance
- What is being tested?
- Magnetic resonance examination
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Jan 2023
- 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 6 months to 14 years
- All sexes
- Child
Study population: Children with hip disease from 2021-2022 in Children's Hospital of Chongqing Medical University
Who may be able to join
- Children aged 6 months-14 years who are diagnosed as hip disease after screening by pediatric orthopedic surgeon in Children's Hospital of Chongqing Medical University during the study period. The hip disease contain developmental dysplasia of the hip, Perthes disease, infection of the hip, inflammation of the hip, fracture of the hip, and Meyer's dysplasia.
Who cannot join
- patients with bilateral hip joint disease; patients with claustrophobia;Patients with metal implants (such as pacemaker implantation)
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014
About this study
Official title: High-resolution Contrast-enhanced Magnetic Mesonance Angiography of Children's Hip Joint
The goal of this observational study is to learn about the feasibility of enhanced three-dimensional water-selective cartilage (3D-WATSc) sequence in displaying the vessels of children's hip by magnetic resonance. The main questions it aims to answer are:
- Could the images of enhanced 3D-WATSc sequence show the healthy side hip joint vessels in children?
- Could the images of enhanced 3D-WATSc sequence show the vascular disease of the suffering side hip joint in children?
Read more
Participants with unilateral hip disease will undergo the magnetic resonance examination including enhanced 3D-WATSc sequence. The pelvic plain film and magnetic resonance images will be collected and analysed.
Researchers will compare the images of of the normal side with the images of the abnormal side to see if the enhanced 3D-WATSc sequence images could show the vascular disease of the suffering side hip joint in children?
- Conditions
- Hip, Vessels; Anomaly, Magnetic Resonance, Three-dimensional Water-selective Cartilage (3D-WATSc)
- Being tested
- Magnetic resonance examination
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance examinationOther
the two groups are underwent magnetic resonance examination including enhanced 3D-WATSc sequence
| Study group | Role | What they receive |
|---|---|---|
| Normal hip joint | The normal side of patients with hip joint disease Receives: Other: Magnetic resonance examination | |
| Abnormal hip joint | The abnormal side of patients with hip joint disease Receives: Other: Magnetic resonance examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
The medial circumflex femoral artery (MCFA) and lateral circumflex femoral artery (LCFA) of the bilateral hip joint
Morphology of the MCFA and LCFA of the bilateral hip joint
Measured: 1 day (Magnetic resonance examination end time)
The branches of the MCFA and/or LCFA around the bilateral femoral neck
Morphology of MCFA and/or LCFA branches around the bilateral femoral neck
Measured: 1 day (Magnetic resonance examination end time)
The vessels of secondary ossification center and/or cartilaginous vascular canal in bilateral femoral head
Morphology of the vessels and cartilaginous vascular canal in bilateral femoral head
Measured: 1 day (Magnetic resonance examination end time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start1 Jan 2021
- Primary completion30 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HipStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuxi Su, Children's Hospital of Chongqing Medical University
- Investigators
- Yuxi Su, M.D., Study chair, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754905
- Sponsor's protocol ID
- CQMU-2023-2
- Status last verified
- Feb 2023
- First submitted
- 23 Feb 2023
- Last updated
- 6 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-resolution Contrast-enhanced Magnetic Mesonance Angiography of Children's Hip Joint
- ClinicalTrials.gov ID
- NCT05754905
- Acronym / sponsor ID
- CQMU-2023-2
- Conditions
- Hip, Vessels; Anomaly, Magnetic Resonance, Three-dimensional Water-selective Cartilage (3D-WATSc)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Children's Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 6 Mar 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.
The goal of this observational study is to learn about the feasibility of enhanced three-dimensional water-selective cartilage (3D-WATSc) sequence in displaying the vessels of children's hip by magnetic resonance. The main questions it aims to answer are:
- Could the images of enhanced 3D-WATSc sequence show the healthy side hip joint vessels in children?
- Could the images of enhanced 3D-WATSc sequence show the vascular disease of the suffering side hip joint in children?
Participants with unilateral hip disease will undergo the magnetic resonance examination including enhanced 3D-WATSc sequence. The pelvic plain film and magnetic resonance images will be collected and analysed.
Researchers will compare the images of of the normal side with the images of the abnormal side to see if the enhanced 3D-WATSc sequence images could show the vascular disease of the suffering side hip joint in children?
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal hip joint | – | Other: Magnetic resonance examinationThe normal side of patients with hip joint disease |
| Abnormal hip joint | – | Other: Magnetic resonance examinationThe abnormal side of patients with hip joint disease |
Who may qualify
- Ages
- 6 months to 14 years
- Sex
- All
- Age groups
- Child
- Study population
- Children with hip disease from 2021-2022 in Children's Hospital of Chongqing Medical University
Key inclusion criteria (1 listed)
- Children aged 6 months-14 years who are diagnosed as hip disease after screening by pediatric orthopedic surgeon in Children's Hospital of Chongqing Medical University during the study period. The hip disease contain developmental dysplasia of the hip, Perthes disease, infection of the hip, inflammation of the hip, fracture of the hip, and Meyer's dysplasia.
Key exclusion criteria (1 listed)
- patients with bilateral hip joint disease; patients with claustrophobia;Patients with metal implants (such as pacemaker implantation)
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 |
|---|---|---|
| Magnetic resonance examinationthe two groups are underwent magnetic resonance examination including enhanced 3D-WATSc sequence | Other | Abnormal hip joint, Normal hip joint |
Primary outcome
The medial circumflex femoral artery (MCFA) and lateral circumflex femoral artery (LCFA) of the bilateral hip joint
Time frame: 1 day (Magnetic resonance examination end time)
Morphology of the MCFA and LCFA of the bilateral hip joint
The branches of the MCFA and/or LCFA around the bilateral femoral neck
Time frame: 1 day (Magnetic resonance examination end time)
Morphology of MCFA and/or LCFA branches around the bilateral femoral neck
The vessels of secondary ossification center and/or cartilaginous vascular canal in bilateral femoral head
Time frame: 1 day (Magnetic resonance examination end time)
Morphology of the vessels and cartilaginous vascular canal in bilateral femoral head
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Yuxi Su, M.D. study chair
Children's Hospital of Chongqing Medical University
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 and Vessels; Anomaly, run by Children's Hospital of Chongqing Medical University at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Mar 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The medial circumflex femoral artery (MCFA) and lateral circumflex femoral artery (LCFA) of the bilateral hip joint (time frame: 1 day (Magnetic resonance examination end time)). The study lists 3 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 6 Mar 2023.