- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02829463
MRI of Infrapatellar Fat Pad in Osteoarthritis (IPFP-MRI)
May 7, 2017 updated by: The Third Xiangya Hospital of Central South University
Magnetic Resonance Imaging of Infrapatellar Fat Pad in Osteoarthritis and Controls
In this study, the investigators use the clinical documentation and imaging data of MRI to do research.
Clinical subjects were divided into two groups: osteoarthritis patients and healthy controls without osteoarthritis.
Differences of MRI data were studied between two groups.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In this study, the investigators applied high precision MRI technique (with as less as a slice thickness of 0.35 mm and without inter-slice gap), and calculated not only the IPFP maximal sagittal area and IPFP volume, but also the quantitated signal, and compared the differences between healthy controls and osteoarthritis patients.
This is an observational cross-sectional study without specific interventions to the subjects.
MRI is a regular examination in our hospital.
And all subjects are included for the reasons of osteoarthritis (need MRI) and healthy controls (pain but not osteoarthritis, also need MRI).
The investigator does not assign specific interventions to the subjects of the study.
Study Type
Observational
Enrollment (Actual)
121
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410011
- Jinshen He
-
-
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
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Subjects who come to see doctors requiring knee MRI test.
Description
Inclusion Criteria:
- Patients with clinical knee osteoarthritis;
- The healthy controls who require MRI test.
Exclusion Criteria:
- Contraindications to magnetic resonance imaging;
- Rheumatoid arthritis patients;
- Gout;
- Hemophilic arthritis;
- Subjects who take non-steroidal anti-inflammatory drugs (NSAIDs);
- Subjects who take lipid-lowering agents;
- Subjects who have the history of knee trauma;
- Subjects who have the history of knee operation;
- Subjects who have the disease of musculoskeletal tumor near knee;
- Subjects who have joint loose bodies.
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
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
osteoarthritis patients
3.0 Tesla Magnetic resonance imaging was analyzed.
It's the documentation from the outpatients and inpatients with osteoarthritis.
It's not the intervention the study applied, but the subjects' disease demands.
|
3.0 T Magnetic resonance imaging of knee joints.
It does not harm the subjects.
|
healthy controls
3.0 Tesla Magnetic resonance imaging was analyzed.
It's the documentation from the outpatients and inpatients without osteoarthritis.
It's not the intervention the study applied, but the subjects' non-osteoarthritis knee symptom demands.
|
3.0 T Magnetic resonance imaging of knee joints.
It does not harm the subjects.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Infrapatellar Fat Pad Volume in MRI
Time Frame: collect the data within 24 hours after the subjects did the MRI
|
collect the data within 24 hours after the subjects did the MRI
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jinshen He, MD, Department of Orthopaedic Surgery, Third Xiangya Hospital of Central South University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Pan F, Han W, Wang X, Liu Z, Jin X, Antony B, Cicuttini F, Jones G, Ding C. A longitudinal study of the association between infrapatellar fat pad maximal area and changes in knee symptoms and structure in older adults. Ann Rheum Dis. 2015 Oct;74(10):1818-24. doi: 10.1136/annrheumdis-2013-205108. Epub 2014 May 15.
- Han W, Aitken D, Zhu Z, Halliday A, Wang X, Antony B, Cicuttini F, Jones G, Ding C. Signal intensity alteration in the infrapatellar fat pad at baseline for the prediction of knee symptoms and structure in older adults: a cohort study. Ann Rheum Dis. 2016 Oct;75(10):1783-8. doi: 10.1136/annrheumdis-2015-208360. Epub 2015 Nov 26.
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
October 1, 2015
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
July 7, 2016
First Submitted That Met QC Criteria
July 7, 2016
First Posted (Estimate)
July 12, 2016
Study Record Updates
Last Update Posted (Actual)
June 12, 2017
Last Update Submitted That Met QC Criteria
May 7, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JY201507
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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