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

NCT ID: NCT06960564

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-12

Study Completion Date

2026-03-29

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Osteoarthritis Hyaluronic Acid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intra-articular hyaluronic acid injection group

Group Type ACTIVE_COMPARATOR

Hyaluronic Acid injections

Intervention Type DEVICE

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 injection group

Group Type PLACEBO_COMPARATOR

Saline -- placebo comparator

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University Research Fund

UNKNOWN

Sponsor Role collaborator

Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Dicle Rotinda Ozdas Sevgin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul University, Istanbul Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Dicle Rotinda Özdaş Sevgin

Role: CONTACT

+90 530-141-5940

Facility Contacts

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Dicle Rotinda Özdaş Sevgin

Role: primary

+90 530-141-5940

Other Identifiers

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E-68869993-511.06.01.01-159494

Identifier Type: -

Identifier Source: org_study_id

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