The Effect of Hyaluronic Acid Injection on TNF-Alpha and IL-1β in Knee Osteoarthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyaluronic Acid injections, Saline -- placebo comparator.
- Who it may be relevant to
- Registry conditions: Knee Osteoarthritis, Hyaluronic Acid. Basic parameters: 45 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device Hyaluronic Acid injections
Intra-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. - Other Saline -- placebo comparator
Intra-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 outcome measures
- 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 outcome measures (3)
- 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]
- 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]
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Istanbul University, Istanbul Faculty of Medicine — Istanbul
Identifiers
NCT: NCT06960564 · E-68869993-511.06.01.01-159494