NCT01993342

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

1 month

First QC Date

November 8, 2013

Last Update Submit

November 19, 2013

Conditions

Keywords

adipocytokinesosteoarthritisinflammationultrasonography

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Knee inflammation parameters detected by ultrasonography

    three months

  • To determine additional classic parameters of inflammation in synovial fluid as Interleukine 1 beta, Interleukine 6 and tumor necrosis factor alfa

    We determine this inflammatory parameters in one month in all patient at the same time

Study Arms (1)

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: arthrocentesisOther: ultrasonography of the knee

Interventions

The made a diagnostic arthrocentesis to all patient we included

Inflammatory knee osteoarthritis

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

Inflammatory knee osteoarthritis

Eligibility Criteria

Age50 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • aged 50 to 81
  • primary osteoarthritis of the knee
  • synovial effusion in examination
  • patient who have the results in our database

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Parc Tauli Sabadell

Sabadell, Barcelona, 08208, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Synovial fluid

MeSH Terms

Conditions

OsteoarthritisInflammation

Interventions

Arthrocentesis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ParacentesisSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Joan Calvet, Dr

    Hospital Parc Tauli

    PRINCIPAL INVESTIGATOR
  • Cristobal Orellana, Dr

    Hospital Parc Tauli

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 8, 2013

First Posted

November 25, 2013

Study Start

October 1, 2013

Primary Completion

November 1, 2013

Study Completion

March 1, 2014

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations