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CompletedNCT02829463IPFP-MRIUpdated Jun 12, 2017Results posted

MRI of Infrapatellar Fat Pad in Osteoarthritis

An observational study in Osteoarthritis, sponsored by The Third Xiangya Hospital of Central South University. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2017-06-12.

Sponsored by The Third Xiangya Hospital of Central South University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
121
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Osteoarthritis

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In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 121 is above the median of 100 across 791 observational studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

The Third Xiangya Hospital of Central South University is the lead sponsor of 95 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Subjects who come to see doctors requiring knee MRI test.

Inclusion criteria

  • Patients with clinical knee osteoarthritis;
  • The healthy controls who require MRI test.

Exclusion criteria

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.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
121 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Radiation: Magnetic resonance imaging

  • 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.

    Radiation: Magnetic resonance imaging

Interventions

  • RadiationMagnetic resonance imaging

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

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What researchers measure

Primary outcomes

  1. Infrapatellar Fat Pad Volume in MRI

    Time frame: collect the data within 24 hours after the subjects did the MRI

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Results

Posted Oct 7, 2016

Participant flow

Participant flow — Overall Study
MilestoneOsteoarthritis PatientsHealthy Controls
Started5962
Completed5962
Not completed00

Outcome measures

PrimaryInfrapatellar Fat Pad Volume in MRI
Time frame:
collect the data within 24 hours after the subjects did the MRI
Reported as:
Mean · mm^3
Infrapatellar Fat Pad Volume in MRI
mm^3Osteoarthritis PatientsHealthy Controls
Infrapatellar Fat Pad Volume in MRI25154.96 ± 4865.3729202.39 ± 7242.63

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Osteoarthritis Patients—0/59 (0%)0/59 (0%)
Healthy Controls—0/62 (0%)0/62 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Osteoarthritis PatientsHealthy ControlsTotal
Mean59.6 ± 9.238.8 ± 13.649.9 ± 15.6
Sex: Female, Male
Sex: Female, Male(Participants)Osteoarthritis PatientsHealthy ControlsTotal
Female362965
Male233356
BMI
BMI(kg/(m^2))Osteoarthritis PatientsHealthy ControlsTotal
Median24.7 ± 3.522.6 ± 4.423.6 ± 4.1
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Study locations

1 site
  • Jinshen He
    Changsha, Hunan 410011, China
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References and documents

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. PubMed 24833783 ↗
  • 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. PubMed 26612337 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02829463
Lead sponsor
The Third Xiangya Hospital of Central South University
Responsible party
Sponsor
First posted
Jul 12, 2016
Start date
Oct 2015
Primary completion
Jul 2016
Completion
Jul 2016
Results posted
Oct 7, 2016
Last update
Jun 12, 2017

Study contacts

Jinshen He, MD
principal investigator · Department of Orthopaedic Surgery, Third Xiangya Hospital of Central South University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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