The ACTIVE(Advanced Cartilage Treatment with Injectable-hydrogel Validation of the Effect) study investigates safety and performance of a novel dextran-tyramine hydrogel implant for treatment of small cartilage defects in the knee (0.5-2.0cm2). The hydrogel is composed of a mixture of natural polymer conjugates that are mixed intra-operatively and which cross-link in situ through a mild enzymatic reaction, providing a cell-free scaffold for cartilage repair. The ACTIVE study is split into a safety (n=10) and a performance cohort (n=36). The Knee Injury and Osteoarthritis Outcome Score (KOOS), pain (numeric rating scale, NRS), Short-Form Health Survey (SF-36) were compared at baseline and 3, 6, and 12 months after surgery. The primary performance hypothesis is an average change in the KOOS from baseline to 12 months (ΔKOOS) greater than a minimal clinically important change (MIC) of 10. No statistical tests were performed as these are preliminary data on a smaller portion of the total study.Introduction
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