The Effect of Hyaluronic Acid Injection on TNF-Alpha and IL-1β in Knee Osteoarthritis
Recruiting · NCT06960564 · Interventional (participants receive a specific treatment) · Lead sponsor: Istanbul University
View the official record on ClinicalTrials.gov →Interventions studied
Hyaluronic Acid injectionsSaline -- placebo comparator
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.
Who can take part
Age range
45 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Istanbul University, Istanbul Faculty of Medicine - Istanbul, Turkey (Türkiye)