Determination of Adipocytokine in Synovial Fluid of Osteoarthritis Patients

Osteoarthritis Clinical Trial

Official title:

Determination of Adipocytokine in Synovial Fluid of Osteoarthritis Patients With Joint Pain and Effusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01993342
• Other study ID #: Joan03
• Status: Recruiting
• Phase: N/A
• First received: November 8, 2013
• Last updated: November 19, 2013
• Start date: October 2013
• Est. completion date: March 2014

Study information

• Verified date: November 2013
• Source: Hospital Parc Taulí, Sabadell
• Contact: Joan Calvet, Dr
• Phone: 0034 937231010
• Email: joan.calvet.fontova[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: March 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 81 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Other:
• arthrocentesis
The made a diagnostic arthrocentesis to all patient we included
• ultrasonography of the knee
We explored the affected knee with an ultrasound explanation in order to describe inflammatory changes based on standard examination.

Locations

Country	Name	City	State
Spain	Hospital Parc Tauli Sabadell	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Parc Taulí, Sabadell

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of adipocytokine levels (adiponectin, leptin, resistin, visfatin, osteopontin) in synovial fluid	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	No
Secondary	Knee inflammation parameters detected by ultrasonography	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	No
Secondary	To determine additional classic parameters of inflammation in synovial fluid as Interleukine 1 beta, Interleukine 6 and tumor necrosis factor alfa	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	No