The purpose of this study is to assess the safety and efficacy of the SL-1002 injectable formulation, compared to placebo, for the treatment of knee pain associated with osteoarthritis. The study will be conducted in two parts referred to as Phase A and Phase B. In Phase A of the study, there will be a total of 3 dosing groups of subjects. Phase B of the study will enroll a single group of subjects. This study will last approximately 26 weeks, which includes a screening period that includes 2 visits. After the first two screening visits and the study drug treatment visit (Day 0), the subject will be required to return to the study site for 7 additional study visits at approximately 2 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, and 6 months after the study drug treatment is administered on Day 0.
This implant has already been tested and been approved by the FDA and is already in use routinely in total ankle replacements within the United States. We are conducting this study to gain further knowledge about the implant. In order to do this, x-rays which have been taken as part of your routine care will be reviewed. Any additional x-rays conducted during the period of the research will also be reviewed. We are also interested in measuring improvements in patient-reported information related to quality of life and pain following implantation over a 10-year period.
Twelve patients with osteoarthritis of the knee will undergo Geniculate Artery Embolization for treatment of knee pain. Prior to the procedure, patients will undergo MRI imaging of the affected knee which will include contrast enhanced images and dynamic contrast enhanced images. The MRI will measure the degree of abnormal blood flow in the synovial lining of the knee joint as well as change in the knee joint structure found in osteoarthritis. Patients will be followed at 1, 6, and 12 months after the procedure, and knee pain as well as medication usage will be assessed at each interval. At the 6-month visit, patients will undergo a second MRI with contrast that will be used to compare the changes in blood flow and knee joint structure.
The purpose of this study is to create and maintain a registry, which is a database (a searchable collection of information) about children, adolescents and young adults with pediatric onset of rheumatic diseases. This data may help in the evaluation of the safety and benefit of medications that are prescribed to patients who have rheumatic diseases.