HYMOVIS in Knee Osteoarthritis
Key Inclusion Criteria
- At least 21 years old and not older than 60 years old, with body mass index ≤40
- Diagnosis of knee OA
- Mild to moderate knee OA pain
Key Exclusion Criteria
- Secondary OA of the study joint due to another condition
- Surgery to the study joint within the previous 12 months before screening
- Pregnant or breastfeeding; planned conception
Full Study Name
A Post-Market, Single-Blind, Multicenter, Randomized, Controlled Trial of HYMOVIS Intraarticular Injections in Active Subjects With Knee Osteoarthritis (IRB no. 46218)
This study focuses on active individuals who have osteoarthritis (OA) pain of the knee and who have failed to respond well to previous conservative non-medication therapy and therapy using simple analgesic medications (such as acetaminophen). Researchers will obtain information on the safety and performance of high molecular weight viscoelastic hyaluronan (HYMOVIS), when combined with a physical exercise program, for reducing pain associated with osteoarthritis of the knee. HYMOVIS is approved by the U.S. Food and Drug Administration for injection into the knee joint of patients with osteoarthritis of the knee.
The study aims to determine whether receiving HYMOVIS injections along with a physical exercise program is more effective for pain, symptoms, function in sport and recreation, and/or knee-related quality of life than a physical exercise program alone. Participants will be assigned to one of two study groups: Group A will receive HYMOVIS and perform physical exercises; Group B will only perform physical exercises.
Financial Disclosure: Rodney Gabriel, MD received payment from the company sponsoring this study for serving as a consultant to the sponsor.