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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01906281
Other study ID # Joan01
Secondary ID
Status Recruiting
Phase N/A
First received July 5, 2013
Last updated November 7, 2013
Start date July 2013
Est. completion date December 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

Adipocytokines play an important role in joint inflammation in patients with knee osteoarthritis as measured by ultrasound and high sensitivity protein-C reactive. Adipocytokines could be the link between osteoarthritis and cardiovascular risk factors more prevalent in these patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 105
Est. completion date December 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients over 50 years old with symptomatic knee osteoarthritis.

Exclusion Criteria:

- Patients with secondary osteoarthritis of the knee

- Any other rheumatologic condition.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Other:
Blood analyse, arthrocentesis, ultrasound examination


Locations

Country Name City State
Spain Hospital Parc Tauli Sabadell Barcelona
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 adipocytokine level We will determine the adipocytokine level at the end of inclusion period between 12-18 months 18 months No
Secondary Ultrasound inflammatory exploration of the knee we evaluate the presence of synovial fluid with ultrasound evaluation in the visit of the patient. Ultrasound evaluation will be performed by two Rheumatologists. 18 months No
Secondary Ultrasound of carotid artery We will evaluate patients with ultrasound exploration in order to describe the presence of atheromatous disease in the visit of the patient 18 months No
Secondary Cardiovascular risk factors We evaluate the prevalence of cardiovascular risk factors in the symptomatic knee osteoarthritis patients, and the relationship with adipocytokines. We will evaluate blood analyse levels of cholesterol, glycemia. 18months No
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