OsteoarthritisNCT01993342
Determination of Adipocytokine in Synovial Fluid of Osteoarthritis Patients
An observational study of Osteoarthritis, run by Parc Taulí Hospital Universitari at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 50 to 81 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- arthrocentesis and ultrasonography of the knee
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2013to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- aged 50 to 81
- primary osteoarthritis of the knee
- synovial effusion in examination
- patient who have the results in our database
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Parc Tauli Sabadell
Sabadell, Barcelona, 08208
Joan Calvet, Dr, 0034937231010 ext. 24065, joan.calvet.fontova@gmail.com
Cristobal Orellana, Dr, 0034937231010 ext. 24065, corellana@tauli.cat
About this study
Official title: Determination of Adipocytokine in Synovial Fluid of Osteoarthritis Patients With Joint Pain and Effusion
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.
- Conditions
- Osteoarthritis
- Being tested
- arthrocentesis, ultrasonography of the knee
- Keywords
- adipocytokines, osteoarthritis, inflammation, ultrasonography
- Medical subject headings
- Osteoarthritis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthrocentesisOther
The made a diagnostic arthrocentesis to all patient we included
ultrasonography of the kneeOther
We explored the affected knee with an ultrasound explanation in order to describe inflammatory changes based on standard examination.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: arthrocentesis; Other: ultrasonography of the knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: We determine adipocytoquines in one month, all patients in the same determination kit
Secondary outcomes (2)
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
Measured: three months
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
Measured: We determine this inflammatory parameters in one month in all patient at the same time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2013 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc Taulí Hospital Universitari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Calvet Fontova, Parc Taulí Hospital Universitari
- Investigators
- Joan Calvet, Dr, Principal investigator, Hospital Parc TauliCristobal Orellana, Dr, Study director, Hospital Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993342
- Sponsor's protocol ID
- Joan03
- Status last verified
- Nov 2013
- First submitted
- 8 Nov 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Adipocytokine in Synovial Fluid of Osteoarthritis Patients With Joint Pain and Effusion
- ClinicalTrials.gov ID
- NCT01993342
- Acronym / sponsor ID
- Joan03
- Conditions
- Osteoarthritis
- Keywords
- adipocytokines, osteoarthritis, inflammation, ultrasonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Parc Taulí Hospital UniversitariUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inflammatory knee osteoarthritis | – | Other: arthrocentesis, Other: ultrasonography of the kneeWe 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. |
Who may qualify
- Ages
- 50 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- aged 50 to 81
- primary osteoarthritis of the knee
- synovial effusion in examination
- patient who have the results in our database
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arthrocentesisThe made a diagnostic arthrocentesis to all patient we included | Other | Inflammatory knee osteoarthritis |
| ultrasonography of the kneeWe explored the affected knee with an ultrasound explanation in order to describe inflammatory changes based on standard examination. | Other | Inflammatory knee osteoarthritis |
Primary outcome
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.
2 secondary outcomes
Knee inflammation parameters detected by ultrasonography
Time frame: three months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Calvet, Dr principal investigator
Hospital Parc Tauli
Cristobal Orellana, Dr study director
Hospital Parc Tauli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Parc Taulí Hospital Universitari at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joan Calvet, Dr (0034 937231010 ext. 24065, joan.calvet.fontova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.