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Clinical Trials in Turkey / NCT06960564
Recruiting Not applicable

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

NCT06960564 · tracked via the Priya Life Science Turkey tracker
Sponsor
Istanbul University
Phase
Not applicable
Started
2025-05-12
Last updated
2026-09-03

Condition(s) studied

Knee OsteoarthritisHyaluronic Acid

Investigational drug(s) / intervention(s)

Hyaluronic Acid injectionsSaline -- placebo comparator

Hyaluronic Acid injections: Intra-articular hyaluronic acid will be administered to 30 selected patients. Blood and synovial fluid samples will be collected before HA injection and 1 week after 3 sessions of HA injection with one week interval. Home exercise programme will be given.

Saline -- placebo comparator: Intra-articular saline (SF) will be administered to 20 selected patients. Blood and synovial fluid samples will be collected before and 1 week after 3 session of salin injection with one week interval. Home exercise programme will be given.

Study 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.

Eligibility

Sex
ALL
Min age
45 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Istanbul University, Istanbul Faculty of Medicine Istanbul Turkey (Türkiye) Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06960564 on ClinicalTrials.gov ↗ ← All trials in Turkey