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Determination of Adipocytokine in Synovial Fluid of Osteoarthritis Patients

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ClinicalTrials.gov Identifier: NCT01993342
Recruitment Status : Unknown
Verified November 2013 by Joan Calvet Fontova, Hospital Parc Taulí, Sabadell.
Recruitment status was:  Recruiting
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Joan Calvet Fontova, Hospital Parc Taulí, Sabadell

Brief Summary:
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.

Condition or disease Intervention/treatment
Osteoarthritis Other: arthrocentesis Other: ultrasonography of the knee

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Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Determination of Adipocytokine in Synovial Fluid of Osteoarthritis Patients With Joint Pain and Effusion
Study Start Date : October 2013
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : March 2014

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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.
Other: arthrocentesis
The made a diagnostic arthrocentesis to all patient we included

Other: ultrasonography of the knee
We explored the affected knee with an ultrasound explanation in order to describe inflammatory changes based on standard examination.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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


Biospecimen Retention:   Samples Without DNA
Synovial fluid


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Ages Eligible for Study:   50 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993342


Contacts
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Contact: Joan Calvet, Dr 0034 937231010 ext 24065 joan.calvet.fontova@gmail.com
Contact: Cristobal Orellana, Dr 0034 937231010 ext 24059 cristobalorellana1@gmail.com

Locations
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Spain
Hospital Parc Tauli Sabadell Recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Joan Calvet, Dr    0034937231010 ext 24065    joan.calvet.fontova@gmail.com   
Contact: Cristobal Orellana, Dr    0034937231010 ext 24065    corellana@tauli.cat   
Principal Investigator: Joan Calvet, Dr         
Sub-Investigator: Cristobal Orellana, Dr         
Sub-Investigator: Maria Garcia-Manrique, Dra         
Sub-Investigator: Noemi Navarro, Dra         
Sponsors and Collaborators
Hospital Parc Taulí, Sabadell
Investigators
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Principal Investigator: Joan Calvet, Dr Hospital Parc Tauli
Study Director: Cristobal Orellana, Dr Hospital Parc Tauli
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Responsible Party: Joan Calvet Fontova, Dr, Hospital Parc Taulí, Sabadell
ClinicalTrials.gov Identifier: NCT01993342    
Other Study ID Numbers: Joan03
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Keywords provided by Joan Calvet Fontova, Hospital Parc Taulí, Sabadell:
adipocytokines
osteoarthritis
inflammation
ultrasonography
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases