Status:

RECRUITING

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

Lead Sponsor:

Istanbul University

Collaborating Sponsors:

Istanbul University Research Fund

Conditions:

Knee Osteoarthritis

Hyaluronic Acid

Eligibility:

All Genders

45-75 years

Phase:

NA

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 ost...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 12 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 29 2026

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT06960564

Start Date

May 12 2025

End Date

March 29 2026

Last Update

January 9 2026

Active Locations (1)

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Istanbul University, Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)