Knee OsteoarthritisNCT06960564
The Effect of Hyaluronic Acid Injection on TNF-Alpha and IL-1β in Knee Osteoarthritis
A study testing Hyaluronic Acid injections in people with Knee Osteoarthritis and Hyaluronic Acid, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Knee Osteoarthritis, Hyaluronic Acid
- What is being tested?
- Hyaluronic Acid injections
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 May 2025to 2 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University, Istanbul Faculty of Medicine
Istanbul
Dicle Rotinda Özdaş Sevgin, +90 530-141-5940, rotindaozdas95@gmail.com
About this study
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
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.
- Conditions
- Knee Osteoarthritis, Hyaluronic Acid
- Being tested
- Hyaluronic Acid injections, Saline -- placebo comparator
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid injectionsDevice
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.
Saline -- placebo comparatorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular hyaluronic acid injection group | Active comparator | Not described Receives: Device: Hyaluronic Acid injections |
| Intra-articular saline injection group | Placebo comparator | Not described Receives: Other: Saline -- placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood and synovial fluid TNF-alpha levels
Measured: Assessments will be made before and 1 week after treatment
Blood and synovial fluid IL-1beta levels
Measured: Assessments will be made before and 1 week after treatment
Blood and synovial fluid TNF-alpha methylation changes
Measured: Assessments will be made before and 1 week after treatment
Blood and synovial fluid IL-1beta methylation changes
Measured: Assessments will be made before and 1 week after treatment
Secondary outcomes (3)
Visual Analogue Scale (VAS)-pain (activity, rest, night)
minimum value : 0 maximum value :10 Higher scores mean worse outcome.
Measured: 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)
Minimum value: 0 maximum value : 96 Higher scores mean worse outcome
Measured: Evaluations will be performed before and 1 month, 3 months and 6 months after treatment
Lequesne Index (pain or discomfort, walking distance, GYA)
Minimum value : 0 maximum value: 24 higher scores mean worse outcome.
Measured: Evaluations will be performed before and 1 month, 3 months and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start12 May 2025
- Primary completion2 Sep 2026 (estimated)
- Study completion2 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Dicle Rotinda Ozdas Sevgin, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960564
- Sponsor's protocol ID
- E-68869993-511.06.01.01-159494
- Status last verified
- Sep 2026
- First submitted
- 28 Apr 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06960564
- Acronym / sponsor ID
- E-68869993-511.06.01.01-159494
- Conditions
- Knee Osteoarthritis, Hyaluronic Acid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 12 May 2025 (actual)
- Primary completion
- 2 Sep 2026 (estimated)
- Study completion
- 2 Sep 2026 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-articular hyaluronic acid injection group | Active comparator | Device: Hyaluronic Acid injections |
| Intra-articular saline injection group | Placebo comparator | Other: Saline -- placebo comparator |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic Acid injectionsIntra-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. | Device | Intra-articular hyaluronic acid injection group |
| Saline -- placebo comparatorIntra-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. | Other | Intra-articular saline injection group |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic Acid injections in people with Knee Osteoarthritis and Hyaluronic Acid, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dicle Rotinda Özdaş Sevgin (+90 530-141-5940, rotindaozdas95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood and synovial fluid TNF-alpha levels (time frame: Assessments will be made before and 1 week after treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.