IL6PG: Evaluation of Biomarker IL-6 in Synovial Fluid in Obese and Normal Weight Patients Suffering From Gonarthrosis During Knee Arthroplasty Surgery.

• Sponsor: Istituto Ortopedico Galeazzi (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05145504
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 22
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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	Diagnostic Test: Evaluation of IL-6 biomarkers in synovial fluid

Study Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Evaluation of Biomarker IL-6 in Synovial Fluid in Obese and Normal Weight Patients Suffering From Gonarthrosis During Knee Arthroplasty Surgery.
• Actual Study Start Date: Nov 18, 2021
• Actual Primary Completion Date: Nov 25, 2021
• Anticipated Study Completion Date: Sep 18, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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 [1 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

age between 55 and 85 years inclusive, Normal weight patients with BMI 18-24.9 included Obese patients with BMI ≥ 30 Patients with gonarthrosis awaiting knee replacement surgery Patients awaiting knee replacement surgery Patients who agree to sign informed consent

Exclusion Criteria:

Patients less than 55 years of age. Patients over 85 years of age Patients with diabetes mellitus Patients who are unable to understand and want Patients with severe neurological disorders or with severe disabilities Rheumatoid arthritis patients Cancer patients Patients on immunosuppressive therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Istituto Ortopedico Galeazzi	Milan		Italy	20161

Sponsors and Collaborators

• Istituto Ortopedico Galeazzi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Istituto Ortopedico Galeazzi
• ClinicalTrials.gov Identifier: NCT05145504
• Other Study ID Numbers: IL6PG
• First Posted: Dec 6, 2021
• Last Update Posted: Dec 6, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoarthritis, Knee; Body Weight

Study Results

No Results Posted as of Dec 6, 2021