Repeat Injection of Cingal® for Osteoarthritis of the Knee

Exclusion Criteria

• •1. Subject received an intra-articular injection or underwent a surgical procedure of the index knee since the study injection in Cingal 13-01
• •2. Subject is taking medication at the time of consent which could interfere with the treatment procedure, healing and/or assessments. This includes but is not limited to oral or injectable anticoagulant treatments, anti-aggregant platelet treatment and opioid analgesics. Low dose aspirin used for cardiovascular protection is allowed if a stable regimen is maintained for the duration of the study.
• •3. Subjects who had an oral, intramuscular, intravenous, rectal suppository or topical (excluded in index knee only) corticosteroid within 30 days of signing the ICF are excluded. Topical corticosteroid use at any site other than the index knee is allowed.
• •4. Subject has a contraindication to IA injections, aspiration of the index knee, corticosteroids, hyaluronan, or acetaminophen/paracetamol.
• •5. Subject is pregnant or breastfeeding or a woman of child bearing potential who refuses to use effective contraception during the course of the study.
• •6. Subject participated in a research study other than Cingal 13-01 within 60 days of consent.