Osteochondral regeneration with a novel aragonite-hyaluronate biphasic scaffold: up to 12-month follow-up study in a goat model

BACKGROUND: The regeneration of articular hyaline cartilage remains an elusive goal despite years of research. Recently, an aragonite-hyaluronate (Ar-HA) biphasic scaffold has been described capable of cartilage regeneration over a 6-month follow-up period. This study was conducted in order to assess the fate of the regenerated osteochondral tissue in a 12-month-long validated caprine model. HYPOTHESIS/PURPOSE: The hypothesis was that the implantation of the Ar-HA implant leads to tissue regeneration and maturation. STUDY DESIGN: A two-arm caprine model of a critical osteochondral defect compares the fate of acute osteochondral defects (group A) to Ar-HA implanted defects (group B). METHODS: Critical 6 mm in diameter and 10-mm in depth osteochondral defects were created in the load-bearing medial femoral condyle of 20 mature goats and randomized into two groups. In group A (n = 6), a blood clot spontaneously filled the defect; in group B (n = 14), a single Ar-HA implant reconstructed the defect. The animals were sacrificed after either 6 or 12 months. Parameters assessed included clinical evaluation, x-rays, micro-CT, ultrasound and histology at both time points, and specimen high-field magnetic resonance imaging with T2 mapping at the 12-month time point. RESULTS: In most group A animals, the defects were not reconstructed (1/3 at 6 months, and 0/3 at 12 months). Defects in group B were mostly reconstructed (5/7 at 6 months and 6/7 at 12 months). Group A defects were either empty or contained fibrous repair tissue; while group B filling was compatible with hyaline cartilage and normal bone. CONCLUSION: Ar-HA scaffolds implanted in critical osteochondral defects result in hyaline cartilage formation and subchondral bone regeneration. The results improved at the 12-month time point compared to the 6-month time point, indicating a continuous maturation process without deterioration of the repair tissue. CLINICAL RELEVANCE: Osteochondral defects are common in humans; the results of the current study suggest that an acellular Ar-HA scaffold might induce cartilage and subchondral bone regeneration.