Study of Cingal® and Triamcinolone Hexacetonide for the Relief of Knee Osteoarthritis Pain

Inclusion Criteria

• Subject is 40-75 years old.
• Body Mass Index (BMI) ≤ 40 kg/m2.
• Subject has Kellgren-Lawrence (K-L) severity grade II or III in the Index knee as determined by X-Ray. Contralateral knee: K-L severity grade 0, I or II.
• Subject has had at least two signs and at least two symptoms of OA disease (based on the European League Against Rheumatism (EULAR) recommendations for diagnosing knee OA) in the Index knee for at least 6 months despite conservative treatment (weight reduction, physical therapy, pain medications, etc.). The EULAR signs and symptoms are as follows:
• Signs: crepitus, restricted movement and bony enlargement
• Symptoms: persistent knee pain, limited morning stiffness and reduced function
• Subject must be willing to abstain from other IA treatments of the knee for the duration of the study.
• Subject is willing to discontinue all analgesics including nonsteroidal anti-inflammatory drugs (NSAIDs), except acetaminophen before the treatment injection and through the completion of the study. NSAIDs should be discontinued through the Screening period.
• Subject is willing to use only acetaminophen (up to a maximum of 3.0 grams per day) for the treatment of joint pain for the duration of the study. At least forty-eight hours prior to the Baseline Visit and each follow-up visit, the Subject is willing to discontinue use of acetaminophen
• Subject is willing to maintain a stable dose of oral glucosamine and/or chondroitin sulfate products throughout the study, if taken prior to signing ICF.
• Subject is able to understand and comply with the requirements of the study and voluntarily provides consent.

Baseline Inclusion Criteria 24 Subject has a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain-sub-score ≥ 50 mm and ≤ 90 mm in the affected knee and ≤ 30 mm in the contralateral knee on a 100 mm Visual Analog Scale (VAS) scale.

Exclusion Criteria

• Subject received an IA injection of Hyaluronic Acid (HA) and/or steroid in either knee within 6 months of signing the ICF. A Subject will be excluded if they are planning to receive an HA or steroid injection (other than the study injection) in either knee during the course of this study.
• Subject had an arthroscopy of either knee within 3 months of signing the ICF.
• Subject had an open surgical procedure of either knee or hip or any surgery of the spine within 12 months of signing ICF. Subject plans to have knee, hip or spine surgery within the study period.
• Subject has intra-articular trauma to the Index knee. Subject has concurrent multi-system or multi-limb trauma.
• Subject has evidence or medical history of the following diseases in the Index knee: septic arthritis; inflammatory joint disease; history of Reiter's syndrome; gout; chondrocalcinosis associated with recurrent episodes of acute synovitis of the knee consistent with pseudogout; osteochondritis dissecans, Paget disease of the bone; ochronosis; acromegaly; hemochromatosis; primary osteochondromatosis; known history of Wilson disease; heritable disorders or collagen gene mutations.
• Subject has a history of cartilage repair surgery in the Index knee within 3 years of signing the ICF.
• Subject has a history of Anterior cruciate ligament (ACL) repair, reconstruction or injury in the Index knee within 3 years of signing the ICF.
• Subject has X-Ray findings of acute fractures, severe bone loss, avascular necrosis, severe bone or joint deformity in the Index knee.
• Subject has significant varus or valgus deformity greater than 8 degrees in either knee.
• Subject has a clinically apparent tense effusion of the Index knee.
• Subject has knee instability in either knee per the Investigator's assessment.
• Subject requires consistent use of an assistive device (e.g. wheelchair, walker, etc.) Occasional use of a cane is acceptable.
• Subject has medical condition(s) which could affect study assessments or may adversely affect the safety