1 A substantial and clinically meaningful reduction in pain using the Visual Analog Scale (VAS) was experienced by subjects in the Cartiva group at every follow-up visit through 2 years. Cartiva subjects demonstrated a 93% reduction from a score of 68 at baseline to 5 at 2 years.
2 Functional activities were evaluated using the validated Foot and Ankle Mobility Measure (FAAM). Substantial improvement was observed for Cartiva subjects throughout the 2-year follow-up period with a 168% improvement observed in the sporting activities scale.
3 There was a substantial and clinically important improvement in active dorsiflexon motion in the Cartiva group, restoring motion to levels which are documented in the literature to be needed for normal walking gait while experiencing substantial reduction in pain at 2 years.