Actively Recruiting

Phase Not Applicable
Age: 45Years - 75Years
All Genders
ID06960564

Investigation of the Effect of Hyaluronic Acid Injection on Tnf-Alpha and IL-1beta at DNA-Protein Level in Knee Osteoarthritis Patients and Comparison With Clinical Parameters: A Randomised Controlled Trial

Led by Istanbul University · Updated on 2026-01-09

50

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

I

Istanbul University

Lead Sponsor

I

Istanbul University Research Fund

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 45Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Istanbul University, Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

Actively Recruiting

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Research Team

D

Dicle Rotinda Özdaş Sevgin

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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