The Effect of Hyaluronic Acid Injection on TNF-Alpha and IL-1β in Knee Osteoarthritis
Key facts
- Who runs it
- Istanbul University
- Where
- Türkiye1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 50 people, planned
- Started
- 12 May 2025
- Planned end
- 2 Sept 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Hyaluronic Acid injections
- Saline -- placebo comparator
- Record updated
- 3 September 2026
Who can take part
- Age
- 45 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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.)
- History of total knee or hip arthroplasty within 1 year
- History of intra-articular injection within the last 6 months
- Presence of allergy to hyaluronic acid products
- Patients with Hb less than 11 g/dl and Plt less than 150.000
- Patients with KL stage 1 and 4 OA
- Major knee trauma within the last 1 year
- BMI >40
- Pregnancy
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 45 and 75 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Intra-articular hyaluronic acid injection groupExisting treatment, for comparison
Treatment: Hyaluronic Acid injections
- Intra-articular saline injection groupPlacebo, for comparison
Treatment: Saline -- placebo comparator
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Fit questions
- Built from NCT06960564, who can take part
- Record updated
- 3 September 2026