NCT02829463

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
3 months until next milestone

Results Posted

Study results publicly available

October 7, 2016

Completed
Last Updated

June 12, 2017

Status Verified

May 1, 2017

Enrollment Period

9 months

First QC Date

July 7, 2016

Results QC Date

August 13, 2016

Last Update Submit

May 7, 2017

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Infrapatellar Fat Pad Volume in MRI

    collect the data within 24 hours after the subjects did the MRI

Study Arms (2)

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

Magnetic resonance imagingRADIATION

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

healthy controlsosteoarthritis patients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects who come to see doctors requiring knee MRI test.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinshen He

Changsha, Hunan, 410011, China

Location

Related Publications (2)

  • 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.

    PMID: 24833783BACKGROUND

  • 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.

    PMID: 26612337BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Results Point of Contact

Title
Dr. Jinshen He
Organization
Third Xiangya Hospital of Central South University
jinshen.he@hotmail.com
8613517470997

Study Officials

  • Jinshen He, MD

    Department of Orthopaedic Surgery, Third Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2016

First Posted

July 12, 2016

Study Start

October 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

June 12, 2017

Results First Posted

October 7, 2016

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)