200 patients were randomized to evaluate the effect of lateral wedge insoles on improving symptoms and slowing structural disease progression of knee osteoarthritis (OA). Patients wore either full length 5 degree lateral wedged insoles or flat control insoles daily for 12 months. Results indicated that there were no significant between-group differences regarding changes in overall pain or medial tibial cartilage volume. Lateral wedge insoles did not lead to any symptomatic or structural benefits over flat control insoles for medial knee OA. In addition, more instances of self-reported problems and discomfort were reported with lateral wedge insolesgroup compared to control insoles.