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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

Tracking Information
First Submitted Date November 8, 2013
First Posted Date November 25, 2013
Last Update Posted Date November 25, 2013
Study Start Date October 2013
Estimated Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 19, 2013)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 19, 2013)
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Determination of Adipocytokine in Synovial Fluid of Osteoarthritis Patients
Official Title Determination of Adipocytokine in Synovial Fluid of Osteoarthritis Patients With Joint Pain and Effusion
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Synovial fluid
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
Condition Osteoarthritis
Intervention
  • 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.
Study Groups/Cohorts 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.
Interventions:
  • Other: arthrocentesis
  • Other: ultrasonography of the knee
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 19, 2013)
35
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2014
Estimated Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years to 81 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT01993342
Other Study ID Numbers Joan03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Joan Calvet Fontova, Hospital Parc Taulí, Sabadell
Study Sponsor Hospital Parc Taulí, Sabadell
Collaborators Not Provided
Investigators
Principal Investigator: Joan Calvet, Dr Hospital Parc Tauli
Study Director: Cristobal Orellana, Dr Hospital Parc Tauli
PRS Account Hospital Parc Taulí, Sabadell
Verification Date November 2013