M17.0
Conditions
Interventions
Group 1: All study patients receive a single intraarticular injection of 1 mL triamcinolone acetonide 40 mg into the index knee joint. The syringe will be removed from the needle and replaced with a s
Sponsors
Belgrade University School of Medicine Institute of Rheumatology
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Male and female patients aged 40-75 years with knee osteoarthritis with the Kellgren-Lawrence (KL) grades III-IV; 2) Average persistent knee pain associated with osteoarthritis for at least 4 weeks with a baseline score of =5 on the Patient’s Assessment of Arthritis Pain by Numeric Rating Scale of 0-10 (NRS);
Exclusion criteria
Exclusion criteria: 1) Surgical interventions in the previous 6 months; 2) Injections to the target joint i.a. with glucocorticosteroids (GC), hyaluronan compounds, platelet rich plasma (PRP) or ACS in the previous 3 months; 3) Rheumatoid arthritis or autoimmune cause of arthritis; 4) Systemic bone or joint illnesses; 5) Active inflammation of predominant patello-femoral disease; 6) Body mass index (BMI) >30); 7) Malignancy; 8) Infection; 9) Pregnancy; 10) Any known conditions that represents a contraindication for the use GCs or ACS (e.g. GCs in Diabetes mellitus).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline of KOOS pain subscale at week 24 comparing ACS and Placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline of KOOS subscales (pain, symptoms, activities of daily living (ADL), sport, quality of life (QoL)) at week 3, 6, 12 and 24 comparing ACS and Placebo. Change from baseline of pain in the last week (average pain, maximum pain, pain at rest) by Numeric Rating Scale (NRS) (0–10) at week 3, 6, 12 and 24 comparing ACS and Placebo. | — |
Countries
Serbia
Contacts
Public ContactNemanja Damjanov
Belgrade University School of Medicine Institute of Rheumatology
Outcome results
None listed