Repeat Injection of Cingal® for Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Cingal; Cingal; Cingal
Intervention description: Injection into the knee; Injection into the knee; Injection into the knee
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Hyaluronic Acid; Triamcinolone diacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: All subjects enrolled into the Cingal 3-02 follow-on study received an intra-articular injection of Cingal. The three 'arms' of the study were for subjects who received a Cingal, Monovisc, or saline initial injection in the Cingal 13-01 study.
Masking: None (Open Label)
Masking description: Cingal 13-02 was an open label follow-up study. The participants, investigators and outcomes assessors were blinded to the specific study injection subjects had previously received in Cingal 13-01.
Enrollment: 242.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Intra-articular Injection; Hyaluronic Acid; Triamcinolone Hexacetonide

Summary:

      The objective of this study is to evaluate the safety of an injection of Cingal® in subjects
      with Osteoarthritis (OA) of the knee who participated in Cingal 13-01, and who received
      either a Cingal, Monovisc, or saline injection in the 13-01 study. The safety evaluation will
      be done by a through examination of the incidence of adverse events and physical examination
      of the knee.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject completed Cingal 13-01 and is interested in participating in the follow-on
             study

          2. Subject must be willing to abstain from other intra-articular or surgical treatments
             of the index knee for the duration of the study

          3. Subject is willing to discontinue all analgesics except acetaminophen/paracetamol for
             the duration of the study

          4. Subject is willing to use only acetaminophen/paracetamol (up to a maximum of 4.0 grams
             per day per the package insert) for the treatment of joint pain for the duration of
             the study. At least twenty-four hours prior to the injection and each follow-up visit,
             the subject is willing to discontinue use of acetaminophen/paracetamol

          5. Subject is able to understand and comply with the requirements of the study and
             voluntarily provides consent

        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.