The Effect of Hyaluronic Acid Injection on TNF-Alpha and IL-1β in Knee Osteoarthritis

Istanbul University

Status: Begins enrollment this month

Conditions: Hyaluronic Acid; Knee Osteoarthritis

Treatments: Other: Saline -- placebo comparator; Device: Hyaluronic Acid injections

Study type: Interventional

Funder types: Other

Identifiers

NCT06960564

E-68869993-511.06.01.01-159494

Details and patient eligibility

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Intra-articular hyaluronic acid injection group

Active Comparator group

Treatment:

Device: Hyaluronic Acid injections

Intra-articular saline injection group

Placebo Comparator group

Treatment:

Other: Saline -- placebo comparator