Study TPX-100-5: Significant reduction in femoral bone shape change 12 months after IA TPX-100 correlates with tibiofemoral cartilage stabilization

Abstract

Purpose: Bone shape changes occur as part of normal aging in the knee. However, the rate of change and degree of pathologic deformation of bone is strikingly increased in knee OA. Based on data from the Osteoarthritis Initiative, pathologic three-dimensional (3D) changes in the femur have been shown to precede measurable thinning of tibiofemoral cartilage and to predict progression of OA, including total knee arthroplasty. Study TPX-100-5 was designed to compare 3D femoral shape changes in knees 6 and 12 months after IA TPX-100 or placebo in subjects with bilateral moderate to severe knee OA, and to analyze relationships between cartilage thickness and bone shape change from baseline to 12-month follow up.