Knee Osteoarthritis, Hyaluronic Acid
Conditions
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.
Interventions
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.
Sponsors
Istanbul University Research Fund
Istanbul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Minimum value: 0 maximum value : 96 Higher scores mean worse outcome |
| Lequesne Index (pain or discomfort, walking distance, GYA) | Evaluations will be performed before and 1 month, 3 months and 6 months after treatment | Minimum value : 0 maximum value: 24 higher scores mean worse outcome. |
| Visual Analogue Scale (VAS)-pain (activity, rest, night) | Evaluations will be performed before and 1 month, 3 months and 6 months after treatment | minimum value : 0 maximum value :10 Higher scores mean worse outcome. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactDicle Rotinda Özdaş Sevgin
Outcome results
None listed