The Effect of Hyaluronic Acid Injection on TNF-Alpha and IL-1β in Knee Osteoarthritis
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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable knee-osteoarthritis
Started May 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2025
CompletedFirst Posted
Study publicly available on registry
May 7, 2025
CompletedStudy Start
First participant enrolled
May 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2026
CompletedJanuary 9, 2026
June 1, 2025
9 months
April 28, 2025
January 8, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Blood and synovial fluid TNF-alpha levels
Assessments will be made before and 1 week after treatment
Blood and synovial fluid IL-1beta levels
Assessments will be made before and 1 week after treatment
Blood and synovial fluid TNF-alpha methylation changes
Assessments will be made before and 1 week after treatment
Blood and synovial fluid IL-1beta methylation changes
Assessments will be made before and 1 week after treatment
Secondary Outcomes (3)
Visual Analogue Scale (VAS)-pain (activity, rest, night)
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)
Evaluations will be performed before and 1 month, 3 months and 6 months after treatment
Lequesne Index (pain or discomfort, walking distance, GYA)
Evaluations will be performed before and 1 month, 3 months and 6 months after treatment
Study Arms (2)
Intra-articular hyaluronic acid injection group
ACTIVE COMPARATORIntra-articular saline injection group
PLACEBO COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Istanbul Universitylead
- Istanbul University Research Fundcollaborator
Study Sites (1)
Istanbul University, Istanbul Faculty of Medicine
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 28, 2025
First Posted
May 7, 2025
Study Start
May 12, 2025
Primary Completion
January 30, 2026
Study Completion
March 29, 2026
Last Updated
January 9, 2026
Record last verified: 2025-06