Istanbul University, Istanbul Faculty of Medicine
Istanbul, Turkey (Türkiye)
Location status: Recruiting
Recruiting
NCT Number: NCT06960564
The Effect of Hyaluronic Acid Injection on TNF-Alpha and IL-1β in Knee Osteoarthritis
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
45 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Hyaluronic Acid injections
DeviceIntra-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
OtherIntra-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.
Primary outcomes
-
Blood and synovial fluid TNF-alpha levels
Time frame: Assessments will be made before and 1 week after treatment
-
Blood and synovial fluid IL-1beta levels
Time frame: Assessments will be made before and 1 week after treatment
-
Blood and synovial fluid TNF-alpha methylation changes
Time frame: Assessments will be made before and 1 week after treatment
-
Blood and synovial fluid IL-1beta methylation changes
Time frame: Assessments will be made before and 1 week after treatment
Secondary outcomes
-
Visual Analogue Scale (VAS)-pain (activity, rest, night)
Time frame: Evaluations will be performed before and 1 month, 3 months and 6 months after treatment
minimum value : 0 maximum value :10 Higher scores mean worse outcome.
-
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)- (pain, stiffness, physical function, total score)
Time frame: Evaluations will be performed before and 1 month, 3 months and 6 months after treatment
Minimum value: 0 maximum value : 96 Higher scores mean worse outcome
-
Lequesne Index (pain or discomfort, walking distance, GYA)
Time frame: Evaluations will be performed before and 1 month, 3 months and 6 months after treatment
Minimum value : 0 maximum value: 24 higher scores mean worse outcome.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Istanbul University
Other
Collaborators
- Istanbul University Research Fund
Registry information
Official study 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
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- May 7, 2025
- Registry last updated
- Jan 9, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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