IL-6 Concentration in the Synovial Fluid of Obese Patients is 100% Higher Than the IL-6 Concentration of the Synovial Fluid in Normal Weight PatientsIL6PGNCT05145504
Evaluation of IL-6 in Synovial Fluid in Obese and Normal Weight Patients Suffering From Gonarthrosis During PTA
An observational study of IL-6 Concentration in the Synovial Fluid of Obese Patients is 100% Higher Than the IL-6 Concentration of the Synovial Fluid in Normal Weight Patients, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
Evaluate the concentration of IL-6 in the synovial fluid of obese patients suffering from gonarthrosis during knee arthroplasty surgery Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- IL-6 Concentration in the Synovial Fluid of Obese Patients is 100% Higher Than the IL-6 Concentration of the Synovial Fluid in Normal Weight Patients
- What is being tested?
- Evaluation of IL-6 biomarkers in synovial fluid
- How many people
- 37 participants
- Where
- 1 siteItaly
- Study dates
- 18 Nov 2021to 31 May 2023
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population is made up of obese and normal weight patients, of age, undergoing knee replacement surgery for gonarthrosis
Who may be able to join
- age between 55 and 85 years inclusive,
- Normal weight patients with BMI 18-24.9 included
- Obese patients with BMI ≥ 30
- Patients suffering from gonarthrosis awaiting knee arthroplasty surgery
- Patients awaiting knee replacement surgery
- Patients who agree to sign informed consent
Who cannot join
- Patients under 55 years of age.
- Patients over 85 years of age
- Patients suffering from diabetes mellitus
- Patients who are unable to understand
- Patients with severe neurological disorders or severe disability
- Rheumatoid arthritis patients
- Cancer patients
- Patients on immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Biomarker IL-6 in Synovial Fluid in Obese and Normal Weight Patients Suffering From Gonarthrosis During Knee Arthroplasty Surgery.
Evaluate the concentration of IL-6 in the synovial fluid of obese patients suffering from gonarthrosis during knee arthroplasty surgery
- Being tested
- Evaluation of IL-6 biomarkers in synovial fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of IL-6 biomarkers in synovial fluidDiagnostic test
Evaluation of IL-6 biomarkers in synovial fluid in obese and normal weight patients with gonarthrosis
| Study group | Role | What they receive |
|---|---|---|
| 20 obese patients, with BMI ≥ 30 | Not described Receives: Diagnostic Test: Evaluation of IL-6 biomarkers in synovial fluid | |
| 20 normal weight patients with BMI between 18.5 - 24.9 inclusive | Not described Receives: Diagnostic Test: Evaluation of IL-6 biomarkers in synovial fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate whether the IL-6 concentration in the synovial fluid of obese patients is 100% higher than the IL-6 concentration of the synovial fluid in normal weight patients
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start18 Nov 2021
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IL-6 Concentration in the Synovial Fluid of Obese Patients is 100% Higher Than the IL-6 Concentration of the Synovial Fluid in Normal Weight PatientsStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145504
- Sponsor's protocol ID
- IL6PG
- Acronym
- IL6PG
- Status last verified
- Jul 2023
- First submitted
- 25 Nov 2021
- Last updated
- 2 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Biomarker IL-6 in Synovial Fluid in Obese and Normal Weight Patients Suffering From Gonarthrosis During Knee Arthroplasty Surgery.
- ClinicalTrials.gov ID
- NCT05145504
- Acronym / sponsor ID
- IL6PG / IL6PG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 6 Dec 2021 (actual)
- 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.
Evaluate the concentration of IL-6 in the synovial fluid of obese patients suffering from gonarthrosis during knee arthroplasty surgery
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20 obese patients, with BMI ≥ 30 | – | Diagnostic Test: Evaluation of IL-6 biomarkers in synovial fluid |
| 20 normal weight patients with BMI between 18.5 - 24.9 inclusive | – | Diagnostic Test: Evaluation of IL-6 biomarkers in synovial fluid |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population is made up of obese and normal weight patients, of age, undergoing knee replacement surgery for gonarthrosis
Key inclusion criteria (6 listed)
- age between 55 and 85 years inclusive,
- Normal weight patients with BMI 18-24.9 included
- Obese patients with BMI ≥ 30
- Patients suffering from gonarthrosis awaiting knee arthroplasty surgery
- Patients awaiting knee replacement surgery
Key exclusion criteria (8 listed)
- Patients under 55 years of age.
- Patients over 85 years of age
- Patients suffering from diabetes mellitus
- Patients who are unable to understand
- Patients with severe neurological disorders or severe disability
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 |
|---|---|---|
| Evaluation of IL-6 biomarkers in synovial fluidEvaluation of IL-6 biomarkers in synovial fluid in obese and normal weight patients with gonarthrosis | Diagnostic test | 20 normal weight patients with BMI between 18.5 - 24.9 inclusive, 20 obese patients, with BMI ≥ 30 |
Primary outcome
Evaluate whether the IL-6 concentration in the synovial fluid of obese patients is 100% higher than the IL-6 concentration of the synovial fluid in normal weight patients
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 IL-6 Concentration in the Synovial Fluid of Obese Patients is 100% Higher Than the IL-6 Concentration of the Synovial Fluid in Normal Weight Patients, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 2 Aug 2023. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate whether the IL-6 concentration in the synovial fluid of obese patients is 100% higher than the IL-6 concentration of the synovial fluid in normal weight patients (time frame: 1 day). 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 2 Aug 2023.