Preclinical and Clinical Cases of New Absorbable Composite Interference Screws in Osteoarticular Surgery
The objective of this study deals with preclinical and clinical cases of absorbable composite interference screws of next generation in osteoarticular surgery. These implants are made of resorbable polymers PLA either amorphous or semi-cristalline, associated with granules of microporous biphasic calcium phosphate ceramic. A preclinical study was performed on goats in femoral and tibial epiphysis during 4 and 6 months. Histological and histomorphometric results were obtained by micro CT, light and scanning electron microscopy. The comparative statistical in vivo study of the kinetics of resorption and bone regeneration have shown the superiority of the composite compared to control (polymer alone). Thus the presence of Biphasic Calcium Phosphate granules in the composite has a major role for bone regeneration at the expense of the implant (buffering effect and properties of osteoconduction). An observational and functional study involving 10 patients, with a follow-up from 17 to 33 months (mean 25.7), was performed. Data were analyzed according to Good Clinical Practice and International Conference on Harmonisation. Clinical observations have revealed no complications and no serious event was reported; quantitative functional indices confirm the good observational results. The clinical study supports the functionality and performance of this new composite with properties of osteoconduction related to the osteogenicity of microporous biphasic calcium phosphate granules in the field of knee ligament fixation.
Kunio Ishikawa and Yukihide Iwamoto
A. P. Uzel et al., "Preclinical and Clinical Cases of New Absorbable Composite Interference Screws in Osteoarticular Surgery", Key Engineering Materials, Vols. 529-530, pp. 325-330, 2013