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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02829463
Other study ID # JY201507
Secondary ID
Status Recruiting
Phase N/A
First received July 7, 2016
Last updated July 12, 2016
Start date October 2015
Est. completion date August 2016

Study information

Verified date July 2016
Source The Third Xiangya Hospital of Central South University
Contact Jinshen He, MD
Phone 8613517470997
Email jinshen.he@hotmail.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Radiation:
Magnetic resonance imaging
3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects.

Locations

Country Name City State
China Jinshen He Changsha Hunan

Sponsors (1)

Lead Sponsor Collaborator
The Third Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. 2015 Nov 26. pii: annrheumdis-2015-208360. doi: 10.1136/annrheumdis-2015-208360. [Epub ahead of print] — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Infrapatellar fat pad volume in MRI immediately after the subjects did the MRI Yes
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