Biocompatibility testing of novel starch-based materials with potential application in orthopaedic surgery: a preliminary study

This paper describes an extensive biocompatibility evaluation of biodegrada ble starch-based materials aimed at orthopaedic applications as temporary b one replacement/fixation implants. For that purpose, a polymer (starch/ethy lene vinyl alcohol blend, SEVA-C) and a composite of SEVA-C reinforced with hydroxyapatite (HA) particles, were evaluated in both in vitro and in vivo assays. For the in vitro analysis cell culture methods were used. The in v ivo tissue reactions were evaluated in an intramuscular acid intracortical bone implantation model on goats, using light and scanning electron microsc opy. A computerized image analysis system was used to obtain histomorphomet ric data regarding bone contact and remodelling after 6 and 12 weeks of imp lantation. In both in vitro and in vivo models, the SEVA-C-based materials did not induce adverse reactions, which in addition to their bone-matching mechanical properties makes them promising materials for bone replacement/f ixation. (C) 2001 Elsevier Science Ltd. All rights reserved.