The Effect of Hyaluronic Acid Injection on TNF-Alpha and IL-1β in Knee Osteoarthritis

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis; Hyaluronic Acid

• Registration Number: NCT06960564
• Lead Sponsor: Istanbul University

Brief Summary

In this study, the effect of intra-articular HA injection therapy on pre- and post-treatment TNF-alpha and IL-1beta levels and methylation changes in blood and synovial fluid in patients with knee osteoarthritis will be determined and compared with the placebo group. In addition, the effects of HA injection on pain, functional status and quality of life will be evaluated and these effects will be related to changes in TNF-alpha and IL-1-beta.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-28
• Study First Submitted QC: 2025-05-05
• Study First Posted: 2025-05-07
• Study Start: 2025-05-12
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-11
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Diagnosis of knee osteoarthritis according to ACR (American College of Rheumatology) criteria
• Knee pain for more than 3 months
• Presence of knee pain resistant to conservative treatment for at least 3 months
• To be between the ages of 45-75
• Kellgren-Lawrence stage 2-3 gonarthrosis detected in the available knee direct radiographs of the patients

Exclusion Criteria

• Patients with KL stage 1 and 4 OA
• Systematic diseases (severe cardiovascular disease, severe renal failure, severe hepatic failure, uncontrolled diabetes, cancer, immunosuppression, haematological diseases, systemic bone diseases)
• Bleeding tendency (acquired or inherited) [lNR>2 in a patient on Coumadin],
• Infection (systemic or local)
• Secondary knee osteoarthritis (inflammatory joint disease, post-traumatic, post-infectious, etc.)
• Major knee trauma within the last 1 year
• BMI >40
• History of total knee or hip arthroplasty within 1 year
• Pregnancy
• History of intra-articular injection within the last 6 months
• Patients with Hb less than 11 g/dl and Plt less than 150.000
• Presence of allergy to hyaluronic acid products

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Blood and synovial fluid TNF-alpha levels	Assessments will be made before and 1 week after treatment
Blood and synovial fluid IL-1beta levels	Assessments will be made before and 1 week after treatment
Blood and synovial fluid TNF-alpha methylation changes	Assessments will be made before and 1 week after treatment
Blood and synovial fluid IL-1beta methylation changes	Assessments will be made before and 1 week after treatment

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)-pain (activity, rest, night)	Evaluations will be performed before and 1 month, 3 months and 6 months after treatment	minimum value : 0 maximum value :10 Higher scores mean worse outcome.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)- (pain, stiffness, physical function, total score)	Evaluations will be performed before and 1 month, 3 months and 6 months after treatment	Minimum value: 0 maximum value : 96 Higher scores mean worse outcome
Lequesne Index (pain or discomfort, walking distance, GYA)	Evaluations will be performed before and 1 month, 3 months and 6 months after treatment	Minimum value : 0 maximum value: 24 higher scores mean worse outcome.

Trial Locations

Locations (1)

Istanbul University, Istanbul Faculty of Medicine; 🇹🇷 Istanbul, Turkey