Abstract
Osteochondral articular defects represent a key concern in orthopedic surgery. The objective of this pilot clinical study was to test safety and performance of a newly developed type-I collagen-hydroxyapatite (HA) nanostructural bio-mimetic osteochondral (O.C.) scaffold which reproduces cartilage-subchondral bone morphology. A gradient composite O.C. scaffold, based on type-I collagen-HA, was obtained by nucleating collagen fibrils with hydroxyapatite nanoparticles at physiological conditions. In previous in vitro and animal studies we tested a novel nano-structured three-layer collagen-hydroxyapatite biomaterial for osteochondral reconstruction and obtained good results in terms of both cartilage and bone tissue formation. We observed same macroscopic, histological and radiographic results when implanting scaffold loaded with autologous chondrocytes or scaffold alone. The scaffold was able to induce an in situ regeneration through stem cells coming from the surrounding bone marrow. Thus, we applied this innovative scaffold as a cell-free approach into clinical practice. 30 cases (9F, 21M, mean age 29,3 years) with knee osteochondral lesions were treated with scaffold implantation from January 2007 to July 2007. The lesions size went from 2 cm2 to 6 cm2. All patients achieved minimum 1 year follow up and were clinically evaluated using the International Repair Cartilage Society score. IKDC objective score improved after 1 year showing a normal or nearly normal knee in 80% of patients at 1 year of follow up. Similar results were obtained with the IKDC subjective score and with Tegner score. Cases with previous surgery had the worst results, while associated surgery doesn’t influenced significantly the clinical outcome. 1 case failed and was reoperated. MRI evaluation demonstrated good bone and cartilage formation and only in the failed case no integration of the graft was found. This open one-step surgery was used for the treatment of chondral and osteochondral defects. The results of this technique at short follow-up are very encouraging and show satisfactory results even in big ostechondral defects.
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Marcacci, M., Zaffagnini, S., Kon, E. et al. Maioregen. Arch Ortop Reumatol 120, 35–37 (2009). https://doi.org/10.1007/s10261-009-0051-6
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DOI: https://doi.org/10.1007/s10261-009-0051-6