OsteoarthritisIPFP-MRINCT02829463
MRI of Infrapatellar Fat Pad in Osteoarthritis
An observational study of Osteoarthritis, run by The Third Xiangya Hospital of Central South University at 1 site in China.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- How many people
- 121 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Jul 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects who come to see doctors requiring knee MRI test.
Who may be able to join
- Patients with clinical knee osteoarthritis;
- The healthy controls who require MRI test.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Osteoarthritis
- Being tested
- Magnetic resonance imaging
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingRadiation
3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Radiation: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infrapatellar Fat Pad Volume in MRI
Measured: collect the data within 24 hours after the subjects did the MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startOct 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinshen He, MD, Principal investigator, Department of Orthopaedic Surgery, Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829463
- Sponsor's protocol ID
- JY201507
- Acronym
- IPFP-MRI
- Status last verified
- May 2017
- First submitted
- 7 Jul 2016
- Last updated
- 12 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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 24833783Han 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging of Infrapatellar Fat Pad in Osteoarthritis and Controls
- ClinicalTrials.gov ID
- NCT02829463
- Acronym / sponsor ID
- IPFP-MRI / JY201507
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Posted 7 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| osteoarthritis patients | – | Radiation: Magnetic resonance imaging3.0 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. |
| healthy controls | – | Radiation: Magnetic resonance imaging3.0 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who come to see doctors requiring knee MRI test.
Key inclusion criteria (2 listed)
- Patients with clinical knee osteoarthritis;
- The healthy controls who require MRI test.
Key exclusion criteria (10 listed)
- Contraindications to magnetic resonance imaging;
- Rheumatoid arthritis patients;
- Gout;
- Hemophilic arthritis;
- Subjects who take non-steroidal anti-inflammatory drugs (NSAIDs);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imaging3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects. | Radiation | healthy controls, osteoarthritis patients |
Primary outcome
Infrapatellar Fat Pad Volume in MRI
Time frame: collect the data within 24 hours after the subjects did the MRI
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24833783Pan 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.
- Background: PubMed 26612337Han 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinshen He, MD principal investigator
Department of Orthopaedic Surgery, Third Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by The Third Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infrapatellar Fat Pad Volume in MRI (time frame: collect the data within 24 hours after the subjects did the MRI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02829463, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.