Hyaluronic acid injections to reduce knee inflammation and improve symptoms

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

This trial will see if hyaluronic acid knee injections lower inflammatory markers (TNF‑alpha and IL‑1β) and improve pain, function, and quality of life in adults 45–75 with moderate (Kellgren‑Lawrence 2–3) knee osteoarthritis.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 45 Years to 75 Years
• Sex: All
• Sponsor: Istanbul University (other)
• Locations: 1 site (Istanbul)
• Trial ID: NCT06960564 on ClinicalTrials.gov

What this trial studies

Adults aged 45–75 with Kellgren‑Lawrence stage 2–3 knee osteoarthritis and at least three months of pain despite conservative treatment will be enrolled. Participants receive intra‑articular hyaluronic acid injections or a saline placebo and pre‑ and post‑treatment TNF‑alpha and IL‑1β levels will be measured in blood and synovial fluid, along with DNA methylation changes. Patient‑reported pain, functional status, and quality of life will be recorded and correlated with biomarker changes. The trial is conducted at Istanbul University Faculty of Medicine and funded by the Istanbul University Research Fund.

Who should consider this trial

Good fit: Adults 45–75 with symptomatic knee osteoarthritis (Kellgren‑Lawrence stage 2–3), knee pain for more than three months resistant to conservative care, and able to attend visits at the study site are ideal candidates.

Not a fit: Patients with KL stage 1 or 4, secondary or inflammatory arthritis, recent major knee trauma, uncontrolled systemic illness, a bleeding tendency, BMI >40, pregnancy, or recent joint replacement are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the treatment could lower joint inflammation markers and lead to reduced pain and improved function and quality of life for people with moderate knee osteoarthritis.

How similar studies have performed: Previous trials of intra‑articular hyaluronic acid have shown modest symptom improvements for some patients, but effects on TNF‑alpha, IL‑1β, and epigenetic methylation in blood and synovial fluid are not well established.

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

Where this trial is running

Istanbul

• Istanbul University, Istanbul Faculty of Medicine — Istanbul, Turkey (Türkiye) (RECRUITING)

Study contacts

• Study coordinator: Dicle Rotinda Özdaş Sevgin

Conditions: Knee Osteoarthritis, Hyaluronic Acid