Evaluation of IL-6 in Synovial Fluid in Obese and Normal Weight Patients Suffering From Gonarthrosis During PTA (IL6PG)

July 31, 2023 updated by: Istituto Ortopedico Galeazzi

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20161
        • IRCCS Istituto Ortopedico Galeazzi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The population is made up of obese and normal weight patients, of age, undergoing knee replacement surgery for gonarthrosis

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
20 obese patients, with BMI ≥ 30
Diagnostic test: Evaluation of IL-6 biomarkers in synovial fluid
Evaluation of IL-6 biomarkers in synovial fluid in obese and normal weight patients with gonarthrosis
20 normal weight patients with BMI between 18.5 - 24.9 inclusive
Diagnostic test: Evaluation of IL-6 biomarkers in synovial fluid
Evaluation of IL-6 biomarkers in synovial fluid in obese and normal weight patients with gonarthrosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Galeazzi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2021

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

November 25, 2021

First Submitted That Met QC Criteria

November 25, 2021

First Posted (Actual)

December 6, 2021

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IL6PG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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