Last updated on August 2019

Treatment of Knee Osteoarthritis With PAAG-OA

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Osteoarthritis of knee
  • Age: Between 40 - 100 Years
  • Gender: Male or Female

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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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