treatment of knee osteoarthritis with paag-oa

Conditions: Osteoarthritis, Knee

Summary: this is a multi-center, randomized, double-blind clinical investigation to compare the effectiveness of intra-articular polyacrylamide hydrogel (paag-oa) and a hyaluronic acid, synvisc-one to induce symptomatic benefit in subjects with knee osteoarthritis.

the trial is designed as a multi-center, randomised, controlled, double-blind, and parallel-group trial spanning over 12 months with outcome assessments at baseline, 1, 3, 6 and 12 months incl. follow-up period between 2-5 years. primary endpoint at 6 months. the trial is designed to compare effectiveness and safety of injection of paag-oa and synvisc-one® in participants with knee oa.

Eligibility criteria:
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 ≥ 40 years * clinical diagnosis of knee oa american college of rheumatology criteria confirmed by radiology * definite radiographic oa in the most symptomatic knee (target knee) at mild to moderate-stage (kellgren-lawrence grades 2 or 3) * stable dose of analgesics for the past four weeks * nrs (11 points (0-10) pain intensity numerical rating scale) ≥ 4 in target knee, during the past week when walking * body mass index (bmi) between 20-35 * 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 * contraindications to paag-oa or synvisc-one®, according to ib or instruction for use (ifu) * 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 * other diseases in target knee than osteoarthritis * 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 * infected or severely inflamed knees * history of sepsis in any joint or any clinical concern for a subacute 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 or lymphatic stasis present in the legs * clinically apparent tense effusion or inflammation in the target knee * suffering from any unstable or severe cardio-vascular disease * any contraindication to intra-articular e.g. anticoagulant therapy or clinical concern for potential coagulopathy (e.g. liver disease) * any foreign material in the target joint * any significant medical condition (e.g. significant psychiatric or neurological disorders or active alcohol/drug abuse), any medical condition that is unstable/poorly controlled or other factors that may interfere with study participation * treatment with systemic steroids * history of drug/alcohol abuse, mental dysfunction of other factors limiting their ability to cooperate fully * change in physiotherapy within the previous month * fibromyalgia * inflammatory or other disease/condition which may affect joints (e.g. rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis among others) * haemophilia * any other condition that in the opinion of the investigator put a potential participant at risk or otherwise precludes participation in the trial * known allergic reactions to components of synvisc-one (avian protein) * 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