- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05998720
Application of New Magnetic Resonance UTE Technique in Hip Joint Lesions
August 17, 2023 updated by: Fifth Affiliated Hospital, Sun Yat-Sen University
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiaojun Chen
- Phone Number: +8615820587112
- Email: 422175400@qq.com
Study Locations
-
-
Guangdong
-
Zhuhai, Guangdong, China, 519000
- Recruiting
- Radiography department
-
Contact:
- Xiaojun Chen
- Phone Number: +8615820587112
- Email: 422175400@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients who meet the inclusion criteria
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with metal implants in corresponding parts;
- Claustrophobic.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
normal group
There are no lesions on the hip.
|
|
abnormal group
There are some lesions on the hip.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
proton density fat fraction (PDFF)
Time Frame: Baseline (before surgery)
|
Magnetic resonance proton density fat fraction
|
Baseline (before surgery)
|
|
T2 relaxation rate
Time Frame: Baseline (before surgery)
|
R2*
|
Baseline (before surgery)
|
|
Magnetization Transfer Ratio (MTR)
Time Frame: Baseline (before surgery)
|
magnetization transfer ratio
|
Baseline (before surgery)
|
|
T1rho
Time Frame: Baseline (before surgery)
|
spin-lattice relaxation in the rotation ame
|
Baseline (before surgery)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective rating values
Time Frame: Baseline (before surgery)
|
rating values
|
Baseline (before surgery)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Shaolin Li, Fifth Affiliated Hospital, Sun Yat-Sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2023
Primary Completion (Estimated)
June 13, 2024
Study Completion (Estimated)
June 13, 2024
Study Registration Dates
First Submitted
August 2, 2023
First Submitted That Met QC Criteria
August 17, 2023
First Posted (Actual)
August 21, 2023
Study Record Updates
Last Update Posted (Actual)
August 21, 2023
Last Update Submitted That Met QC Criteria
August 17, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- ZDWY.FSK.025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hip Disease
-
FH ORTHOTerminatedHip Fractures | Hip DiseaseFrance
-
Zhenjiang First People's HospitalCompletedHip Fractures | Hip DiseaseChina
-
JointMedica Inc.Active, not recruitingOsteoarthritis of the Hip | Degenerative Joint Disease of Hip | Dysplasia; HipUnited States, Bermuda
-
Istituto Ortopedico GaleazziCompleted
-
Yonsei UniversityRecruiting
-
Signature OrthopaedicsThe Cleveland ClinicRecruiting
-
Signature OrthopaedicsThe Cleveland ClinicRecruiting
-
OSF Healthcare SystemUniversity of Illinois College of Medicine at PeoriaCompletedHip Disease
-
Assiut UniversityNot yet recruiting