PAAG-OA Treatment for Knee Osteoarthritis

This is a multi-centre, prospective, open-label clinical trial consisting of a main study followed by an extension study. The study will evaluate the effectiveness and safety of intra-articular polyacrylamide hydrogel (PAAG-OA) in subjects with knee OA.

Inclusion criteria

• Signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged ≥ 18 years
• Clinical diagnosis of knee OA according to American College of Rheumatology criteria
• Definite radiographic OA in target knee at mild to severe stage (Kellgren-Lawrence 2-4)
• Stable dose of analgesics for the past four weeks
• Score of 2 or more (0-4 scale) on WOMAC question A1 (pain while walking on flat surface)
• Body Mass Index (BMI) <35
• For females of reproductive potential: use of adequate contraception must be used throughout the trial

Exclusion criteria

• Female participants who are pregnant, lactating or planning pregnancy during the course of the clinical investigation
• Previous intra-articular injection of polyacrylamide gel in the target knee
• Previous intra-articular injection with hyaluronic acid or derivatives in target knee in the previous 6 months
• Significant valgus/varus deformity of the knee, ligamentous laxity or meniscal instability
• Diseases in target knee other than OA
• Intra-articular injection of any substance other than hyaluronic acid (e.g. corticosteroids) in the target knee within the last 3 months
• Acute serious infection of any region that required hospital care or intravenous antibiotic treatment within the last 30 days, or oral antibiotic treatment within the last 14 days
• Skin disease or infections in the area of the injection site
• History of sepsis in any joint or any clinical concern for an infectious process in the target knee
• History of surgery in the target knee within the past 6 months
• Symptomatic osteoarthritis of the hips, spine or ankle, that interferes with the evaluation of the target knee
• Planned surgery on any lower extremity
• Clinically significant venous of lymphatic stasis present in the legs
• Suffering from any unstable or severe cardio-vascular disease
• Any other contraindication to intra-articular injection
• Any foreign material in the target joint
• Any significant medical condition (e.g. significant psychiatric or neurological disorders or active alcohol/drug abuse) that is unstable/poorly controlled or other factors that may interfere with study participation
• Treatment with systemic steroids with daily doses equivalent of >7,5 mg prednisolone
• Significant change in physiotherapy in lower extremities related to OA within the previous month
• Fibromyalgia
• Inflammatory or other disease/condition which may affect the knee joint (e.g. rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis among others)
• Haemophilia
• Any other condition that in the opinion of the investigator puts a potential participant at risk or otherwise precludes participation in the investigation
• Known allergic reactions to antibiotics (azithromycin and moxifloxacin) or local anaesthesia
• Participation in any experimental device study within 6 months prior to enrolment, or participation in an experimental drug study within 1 month prior to enrolment