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

ConditionsKnee OsteoarthritisHyaluronic Acid
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-75
SponsorIstanbul University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hyaluronic Acid injections

    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.

  • Saline -- placebo comparator

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Intra-articular hyaluronic acid injection groupActive comparator 1 intervention
Group B: Intra-articular saline injection groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Blood and synovial fluid TNF-alpha levels

Time frame
Assessments will be made before and 1 week after treatment
2

Blood and synovial fluid IL-1beta levels

Time frame
Assessments will be made before and 1 week after treatment
3

Blood and synovial fluid TNF-alpha methylation changes

Time frame
Assessments will be made before and 1 week after treatment
4

Blood and synovial fluid IL-1beta methylation changes

Time frame
Assessments will be made before and 1 week after treatment

Secondary outcomes

1

Visual Analogue Scale (VAS)-pain (activity, rest, night)

minimum value : 0 maximum value :10 Higher scores mean worse outcome.

Time frame
Evaluations will be performed before and 1 month, 3 months and 6 months after treatment
2

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

Time frame
Evaluations will be performed before and 1 month, 3 months and 6 months after treatment
3

Lequesne Index (pain or discomfort, walking distance, GYA)

Minimum value : 0 maximum value: 24 higher scores mean worse outcome.

Time frame
Evaluations will be performed before and 1 month, 3 months and 6 months after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istanbul University

Lead sponsor

Istanbul University - Cerrahpasa

Collaborator

Source ClinicalTrials.gov
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