Table 1 Inclusion and exclusion study criteria according to the protocol body text

Inclusion criteria

• Male and female adults aged 40–72 years

• Radiological diagnosis of tibiofemoral knee osteoarthritis

• Joint pain >35 mm, according to Visual Analogue Scale (range 0–100 mm)

• Radiological severity <4, according to the Ahlbäck scale (range 1–5)

• Body Mass Index between 20 and 30 ^a

• Availability to be examined along the follow-up period

Exclusion criteria

• Bilateral knee osteoarthritis needing infiltration in both knees

• Body Mass Index ≥30 ^b

• Diagnosis of polyarticular disease

• Severe mechanical deformity (bidiaphyseal varus 4° and valgus 16°)

• Previous arthroscopy within last year

• Hyaluronic acid infiltration within last 6 months

• Diagnosis of systemic autoimmune rheumatoid disease (connective tissue diseases and systemic necrotizing vasculitis)

• Uncontrolled diabetes mellitus (glycosylated haemoglobin >7%)

• Blood disorders (thrombopathy, thrombocytopenia, anaemia with haemoglobin <9)

• Ongoing immunosuppressive and/or dicumarinic therapies

• Use of corticosteroids within last 3 months before inclusion in study

• Use of non-steroidal anti-inflammatory drugs within the last 15 days before inclusion in the study