This is a multi-center, parallel, double-blind, randomized, placebo-controlled study to evaluate the safety and effectiveness of HYMOVIS, a new viscoelastic hydrogel, for the treatment of osteoarthritis of the knee. A large number of experimental and clinical studies in OA have demonstrated that intra-articular (IA) administration of hyaluranan (HA) may improve the altered rheological properties of synovial fluid, improve signs and symptoms of patients, and in some studies exert protective and reparative effects on the joint structure.
Subjects will undergo intra-articular injections of the study treatment (HYMOVIS or placebo), and subjects will receive a second IA injection 7 days following the first injection and will be followed for up to 180 days after the first treatment. Other study procedures include X-ray, physician assessment, urine pregnancy test, urine drug test, saliva alcohol test and subject questionnaires.
The primary outcome is to evaluate the effectiveness of two 3 mL intra-articular (IA) injections of HYMOVIS in comparison with 3 mL IA injections of Placebo in providing superior pain relief for the treatment of subjects with symptomatic primary osteoarthritis of the knee measured by the Western Ontario and McMaster Universities Arthritis (WOMAC) Pain Subscale.
- Medical history of osteoarthritis symptoms of the knee for at least 6 months
- Ability to speak, read, and write in English
- Willing and able to discontinue using your current pain medications and use only the acetaminophen provided for this study.
- Presence of serious gastrointestinal, renal, hepatic, pulmonary, cardiovascular, or neurological disease that could interfere with the outcome of the study or the subject’s ability to comply with study requirements.
- Have a positive urine drug test for illegal drug substances, non-prescribed controlled substances, or a positive saliva test for alcohol, at screening.
- Are a current candidate for a knee replacement within the next 6 months.
If you qualify for participation in this study, your participation could take approximately 7 months and will require you to make about 8 clinic visits to Tufts Medical Center and daily phone calls to report your medication use.
If you are interested in learning more about this research study, we will schedule a first visit to see if you are eligible to participate. Your first visit will last about 3-4 hours. We will do some tests to determine if you qualify for the study. In addition, you will be scheduled to have an x-ray of your knee.