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Bioasorbable osteofixation used devices in 165 cranial and maxillofacial cases: a multicenter report

Ashammakhi N., Renier D., Arnaud E., Marchac D., Ninkovic M., Donaway D., Jones B., Serlo W., Laurikainen K., Törmälä P., Waris T.

Inżynieria Biomateriałów

2004

R. 7, nr 38-42

13-13

Bioasorbable osteofixation devices were developed to avoid problems associated with metals. Bioasorbable devices are mostly made of the polymers polylactide (PLA), polyglycolide (PGA) and their copolymers (PLGA and P(L/DL)LA). Using the technique of self-reinforcement of bioabsorbable materials, it is possible to manufacture osteofixation devices with ultra high strength. Self-reinforced (SR) polyglycolide-co-polylactide (SR-PLGA) 80/20 was selected to make devices (Biosorb TM PDX) for this study because of its favorable degradation characteristics. The aim of this study was to evaluate the efficacy of using SR-PLGA (Biosorb TM) plates and screws in the fixation of osteotomies in craniomaxillofacial (CMF) surgery. In a prospective study, 165 patients (161 children and 4 adults) were operated on in four EU centers (Paris, Innsbruck, London and Oulu) from May 1st, 1998 to January 31st, 2002. Indications included correction of dyssynostotic deformities (n=159), reconstruction of bone defects following trauma (n=2), tumor removal (n=2), and treatment of encephalocoele (n=2). Plates used were 0.8, 1 or 1,2 mm thick and screws has an outer (thread) diameter of 1.5 or 2 mm and a length of 4, 6 or 8 mm. Tacks had an outer diameter of 1.5 or 2 mm and a length of 4 or 6 mm. Intraoperatively the devices were easy to handle and apply and provided stable fixation apart from two cases (7.3%), comprising infection (n=6), bone resorption (n=4), diabetes insipidus (n=1), delayed skin wound healing/skin slough (n=2), and liquorrhea (n=1). Accordingly, SR-PLGA 80/20 (Biosorb) plates and screws can be used safely and with favorable outcome in corrective cranioplasties, especially in infants and young children.