The Effect of Hyaluronic Acid Injection on TNF-Alpha and IL-1β in Knee Osteoarthritis
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
Istanbul University
50 participants
May 12, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria12
- 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
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Interventions
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.
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.
Locations(1)
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NCT06960564