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

NCT ID: NCT05145504

Last Updated: 2023-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-18

Study Completion Date

2023-05-31

Brief Summary

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Evaluate the concentration of IL-6 in the synovial fluid of obese patients suffering from gonarthrosis during knee arthroplasty surgery

Detailed Description

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Conditions

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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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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20 obese patients, with BMI ≥ 30

Evaluation of IL-6 biomarkers in synovial fluid

Intervention Type DIAGNOSTIC_TEST

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

Evaluation of IL-6 biomarkers in synovial fluid

Intervention Type DIAGNOSTIC_TEST

Evaluation of IL-6 biomarkers in synovial fluid in obese and normal weight patients with gonarthrosis

Interventions

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Evaluation of IL-6 biomarkers in synovial fluid

Evaluation of IL-6 biomarkers in synovial fluid in obese and normal weight patients with gonarthrosis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Istituto Ortopedico Galeazzi

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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IL6PG

Identifier Type: -

Identifier Source: org_study_id

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