Clinical trial NCT06960564: The Effect of Hyaluronic Acid Injection on TNF-Alpha and IL-1β in Knee Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Hyaluronic Acid
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Istanbul University Research Fund
First posted: 2025-05-07
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Blood and synovial fluid TNF-alpha levels
timeFrame: Assessments will be made before and 1 week after treatment
measure: Blood and synovial fluid IL-1beta levels
timeFrame: Assessments will be made before and 1 week after treatment
measure: Blood and synovial fluid TNF-alpha methylation changes
timeFrame: Assessments will be made before and 1 week after treatment
measure: Blood and synovial fluid IL-1beta methylation changes
timeFrame: Assessments will be made before and 1 week after treatment
Secondary outcomes:
measure: Visual Analogue Scale (VAS)-pain (activity, rest, night)
timeFrame: Evaluations will be performed before and 1 month, 3 months and 6 months after treatment
measure: The Western Ontario and McMaster Universities Arthritis Index (WOMAC)- (pain, stiffness, physical function, total score)
timeFrame: Evaluations will be performed before and 1 month, 3 months and 6 months after treatment
measure: Lequesne Index (pain or discomfort, walking distance, GYA)
timeFrame: Evaluations will be performed before and 1 month, 3 months and 6 months after treatment
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Istanbul Faculty of Medicine
Study officials:
References: