- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01993342
Determination of Adipocytokine in Synovial Fluid of Osteoarthritis Patients
November 19, 2013 updated by: Joan Calvet Fontova, Hospital Parc Taulí, Sabadell
Determination of Adipocytokine in Synovial Fluid of Osteoarthritis Patients With Joint Pain and Effusion
The purpose of this study is to determine the concentration of different adipocytokine (adiponectin, leptin, resistin, visfatin, osteopontin) and an inflammation classic markers as Interleukine 1 beta, tumor necrosis alfa, interleukine 6 and high sensibility reactive c protein in the synovial fluid of knee osteoarthritis patients, and compare with the inflammation detected with ultrasonography evaluation of the joint.
In last years, some studies appeared focusing on the role of adipocytokines in osteoarthritis and they correlated adipocytokines with cartilage degradation and x-ray degree; in our study we will focused in the importance of adipocytokines in the inflammatory changes more than in joint destruction.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
35
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
-
-
Barcelona
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Sabadell, Barcelona, Spain, 08208
- Recruiting
- Hospital Parc Tauli Sabadell
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Sub-Investigator:
- Noemi Navarro, Dra
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-
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
50 years to 81 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patient with knee osteoarthritis and synovial effusion who attende to a Rheumatologist unit for this problem.
We made the visit and anonimously we kept the results of examination and ultrasonography in our database and we freezed synovial fluid.
Now we will determine the adipocytokines and classic inflammatory parameters in this synovial fluid
Description
Inclusion Criteria:
- aged 50 to 81
- primary osteoarthritis of the knee
- synovial effusion in examination
- patient who have the results in our database
Exclusion Criteria:
- any other rheumatic conditions as rheumatoid arthritis or another inflammatory disease
- secondary knee osteoarthritis
- history of knee surgery
- any conditions that at investigator criteria exclude the patient from study procedures
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Inflammatory knee osteoarthritis
We recruited patients with osteoarthritis and synovial effusion to diagnostic the effusion and to confirm that this this synovial fluid had mechanical characteristics.
Now we are going to determine the adipocytokines and traditional parameters of inflammation in this synovial fluid to correlate it, and we will associate it with the ultrasound explanation of the knee that we have in our database.
|
The made a diagnostic arthrocentesis to all patient we included
We explored the affected knee with an ultrasound explanation in order to describe inflammatory changes based on standard examination.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Determination of adipocytokine levels (adiponectin, leptin, resistin, visfatin, osteopontin) in synovial fluid
Time Frame: We determine adipocytoquines in one month, all patients in the same determination kit
|
We have all the synovial fluid freeze, so now we have to determine the levels of everyone.
|
We determine adipocytoquines in one month, all patients in the same determination kit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee inflammation parameters detected by ultrasonography
Time Frame: three months
|
We performed the ultrasonography evaluation at the same time than the visit were realized, and we have the results in a data base, so we will wait for the adipocytokine results and we will compare with ultrasound evaluation
|
three months
|
|
To determine additional classic parameters of inflammation in synovial fluid as Interleukine 1 beta, Interleukine 6 and tumor necrosis factor alfa
Time Frame: We determine this inflammatory parameters in one month in all patient at the same time
|
We will use classic inflammation parameters to compare with adipocytokine levels
|
We determine this inflammatory parameters in one month in all patient at the same time
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joan Calvet, Dr, Hospital Parc Tauli
- Study Director: Cristobal Orellana, Dr, Hospital Parc Tauli
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, 2013
Primary Completion (Anticipated)
November 1, 2013
Study Completion (Anticipated)
March 1, 2014
Study Registration Dates
First Submitted
November 8, 2013
First Submitted That Met QC Criteria
November 19, 2013
First Posted (Estimate)
November 25, 2013
Study Record Updates
Last Update Posted (Estimate)
November 25, 2013
Last Update Submitted That Met QC Criteria
November 19, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Joan03
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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