Hip DiseaseNCT05998720
Application of New Magnetic Resonance UTE Technique in Hip Joint Lesions
An observational study of Hip Disease, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Explore the imaging and quantitative monitoring of hip bone, cartilage and ligament by magnetic resonance UTE technology, combined with QCT and DXA technology, to provide a more accurate basis for clinical evaluation and treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Disease
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 13 Jun 2024
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who meet the inclusion criteria
Who may be able to join
- Patients with past or suspected osteoporosis and bone loss;
- Patients with previous femoral neck fracture;
- Patients with avascular necrosis of femoral head;
- Hip osteoarthritis patients.
Who cannot join
- Patients with metal implants in corresponding parts;
- Claustrophobic.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Radiography department
Zhuhai, Guangdong, 519000
Xiaojun Chen, +8615820587112, 422175400@qq.com
About this study
Official title: Application of New Magnetic Resonance Technique-UTE in Hip Joint Lesions
Explore the imaging and quantitative monitoring of hip bone, cartilage and ligament by magnetic resonance UTE technology, combined with QCT and DXA technology, to provide a more accurate basis for clinical evaluation and treatment.
Read the detailed description
Osteoporosis is a systemic bone metabolism-related disease characterized by decreased bone mass per unit volume, increased bone fragility, decreased bone density, thinning of the bone cortex and changes in bone microstructure. It often occurs in the lumbar spine and hip joint. Femoral neck fracture is a common complication of hip osteoporosis, which seriously affects people's quality of life. UTE technology can clearly image and quantify human cortical bone and cancellous bone, and advanced UTE technology such as STAIR-UTE and UTE-MT have made some progress in the field of osteoporosis. The purpose of this study was to explore UTE technology for imaging and quantitative study of cortical bone, cancellous bone and cartilage of hip joint, and to find more accurate imaging methods for clinical evaluation of hip osteoporosis and other diseases.
- Conditions
- Hip Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| normal group | There are no lesions on the hip. | |
| abnormal group | There are some lesions on the hip. |
What is being measured
The primary outcome is the main question the study is designed to answer.
proton density fat fraction (PDFF)
Magnetic resonance proton density fat fraction
Measured: Baseline (before surgery)
T2 relaxation rate
R2*
Measured: Baseline (before surgery)
Magnetization Transfer Ratio (MTR)
magnetization transfer ratio
Measured: Baseline (before surgery)
T1rho
spin-lattice relaxation in the rotation ame
Measured: Baseline (before surgery)
Secondary outcomes (1)
Subjective rating values
rating values
Measured: Baseline (before surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Jul 2023
- Primary completion13 Jun 2024 (estimated)
- Study completion13 Jun 2024 (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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaolin Li, Study director, Fifth Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998720
- Sponsor's protocol ID
- ZDWY.FSK.025
- Status last verified
- Aug 2023
- First submitted
- 2 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- 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 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of New Magnetic Resonance Technique-UTE in Hip Joint Lesions
- ClinicalTrials.gov ID
- NCT05998720
- Acronym / sponsor ID
- ZDWY.FSK.025
- Conditions
- Hip Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 13 Jun 2024 (estimated)
- Study completion
- 13 Jun 2024 (estimated)
- First posted
- 21 Aug 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.
Explore the imaging and quantitative monitoring of hip bone, cartilage and ligament by magnetic resonance UTE technology, combined with QCT and DXA technology, to provide a more accurate basis for clinical evaluation and treatment.
Detailed description
Osteoporosis is a systemic bone metabolism-related disease characterized by decreased bone mass per unit volume, increased bone fragility, decreased bone density, thinning of the bone cortex and changes in bone microstructure. It often occurs in the lumbar spine and hip joint. Femoral neck fracture is a common complication of hip osteoporosis, which seriously affects people's quality of life. UTE technology can clearly image and quantify human cortical bone and cancellous bone, and advanced UTE technology such as STAIR-UTE and UTE-MT have made some progress in the field of osteoporosis. The purpose of this study was to explore UTE technology for imaging and quantitative study of cortical bone, cancellous bone and cartilage of hip joint, and to find more accurate imaging methods for clinical evaluation of hip osteoporosis and other diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal group | – | –There are no lesions on the hip. |
| abnormal group | – | –There are some lesions on the hip. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who meet the inclusion criteria
Key inclusion criteria (4 listed)
- Patients with past or suspected osteoporosis and bone loss;
- Patients with previous femoral neck fracture;
- Patients with avascular necrosis of femoral head;
- Hip osteoarthritis patients.
Key exclusion criteria (2 listed)
- Patients with metal implants in corresponding parts;
- Claustrophobic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
proton density fat fraction (PDFF)
Time frame: Baseline (before surgery)
Magnetic resonance proton density fat fraction
T2 relaxation rate
Time frame: Baseline (before surgery)
R2*
Magnetization Transfer Ratio (MTR)
Time frame: Baseline (before surgery)
magnetization transfer ratio
T1rho
Time frame: Baseline (before surgery)
spin-lattice relaxation in the rotation ame
1 secondary outcome
Subjective rating values
Time frame: Baseline (before surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 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.
Shaolin Li study director
Fifth Affiliated Hospital, Sun Yat-Sen 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 Disease, run by Fifth Affiliated Hospital, Sun Yat-Sen 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 4 inclusion and 2 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 21 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaojun Chen (+8615820587112, 422175400@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proton density fat fraction (PDFF) (time frame: Baseline (before surgery)). The study lists 4 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 21 Aug 2023.