NCT06960564 The Effect of Hyaluronic Acid Injection on TNF-Alpha and IL-1β in Knee Osteoarthritis
| NCT ID | NCT06960564 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istanbul University |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-05-12 |
| Primary Completion | 2026-09-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-05-12 with a primary completion date of 2026-09-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06960564 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 75 Years, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06960564 currently recruiting?
Yes, NCT06960564 is actively recruiting participants. Contact the research team at rotindaozdas95@gmail.com for enrollment information.
Where is the NCT06960564 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT06960564 clinical trial?
NCT06960564 is sponsored by Istanbul University. The trial plans to enroll 50 participants.