Repeat Injection of Cingal® for Osteoarthritis of the Knee
Osteoarthritis of the Knee
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Osteoarthritis, Intra-articular Injection, Hyaluronic Acid, Triamcinolone Hexacetonide
Eligibility Criteria
Inclusion Criteria:
- Subject completed Cingal 13-01 and is interested in participating in the follow-on study
- Subject must be willing to abstain from other intra-articular or surgical treatments of the index knee for the duration of the study
- Subject is willing to discontinue all analgesics except acetaminophen/paracetamol for the duration of the study
- 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
- Subject is able to understand and comply with the requirements of the study and voluntarily provides consent
Exclusion Criteria:
- Subject received an intra-articular injection or underwent a surgical procedure of the index knee since the study injection in Cingal 13-01
- 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.
- 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.
- Subject has a contraindication to IA injections, aspiration of the index knee, corticosteroids, hyaluronan, or acetaminophen/paracetamol.
- Subject is pregnant or breastfeeding or a woman of child bearing potential who refuses to use effective contraception during the course of the study.
- Subject participated in a research study other than Cingal 13-01 within 60 days of consent.
Sites / Locations
- Medical Plus s.r.o.
- Belvaros-Lipotvaros, Orthopedic Outpatient Clinic
- Semmelweis University, Department of Orthopaedics
- Uzsoki Hospital, Department of Traumatology
- Jutrix Healthcare Services Ltd.
- Medidea Bt.
- G&V Pharma-Med Bt.
- NZOZ Medi-Spatz
- ARTIMED Niepubliczny Zaklad Opieki Zdrowotnej w Kielcach
- CenterMed Krakow Sp. z o.o.
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Cingal/Cingal
Cingal/Monovisc
Cingal/Saline
Subjects who had received an injection of Cingal in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.
Subjects who had received an injection of Monovisc in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.
Subjects who had received an injection of Saline in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.