Successful Use of Biosorb Osteofixation Devices in 165 Cranial and Maxillofacial Cases: A Multicenter Report

Abstract

Bioabsorbable osteofixation devices were developed to avoid problems associated with metals. Bioabsorbable devices are mostly made of the polymers polylactide, polyglycolide, and their copolymers [polyglycolide-co-polylactide 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 polyglycolide-co-polylactide 80/20 was selected to make devices (Biosorb PDX) for this study because of its favorable degradation characteristics. The aim of this study was to evaluate the efficacy of using self-reinforced polyglycolide-co-polylactide 80/20 (Biosorb) plates and screws in the fixation of osteotomies in craniomaxillofacial surgery. In a prospective study, 165 patients (161 children and 4 adults) were operated on in four European Union centers (Paris, Innsbruck, London, and Oulu) from May 1, 1998 to January 31, 2002. Indications included correction of dyssynostotic deformities (n = 159), reconstruction of bone defects after trauma (n = 2), tumor removal (n= 2), and treatment of encephalocele (n = 2). Plates used were 0.8, 1, or 1.2 mm thick, and screws had 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. During surgery, the devices were easy to handle and apply and provided stable fixation apart from 2 cases. Postoperative complications occurred in 12 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, self-reinforced polyglycolide-co-polylactide 80/20 (Biosorb) plates and screws can be used safely and with a favorable outcome in corrective cranioplasties, especially in infants and young children.

Bioabsorbable Implants

“…Ashammakhi and colleagues [16] in 2004 used a copolymer of PGA/ PLLA with maxillofacial plates and screws in 165 pediatric patients having no granuloma formations. They did have some complications associated with plating.…”

Minimally Invasive Bioabsorbable Bone Plates for Rigid Internal Fixation of Mandible Fractures

“…Bioabsorbable plates and screws are most often made of the polymers polylactide and polyglycolide, as well as copolymers polyglycolide-co-polylactide and poly(L-lactide-co-D,L-lactide) (P[L/DL]LA). 1 Depending on the material used, most bioabsorbable materials can be eliminated from the body in 8 months to 5 years. 1,2 The current perception is that absorbable bone plates do not provide enough fracture stability to be safely used in the load-bearing regions of most adult patients.…”

“…1 Depending on the material used, most bioabsorbable materials can be eliminated from the body in 8 months to 5 years. 1,2 The current perception is that absorbable bone plates do not provide enough fracture stability to be safely used in the load-bearing regions of most adult patients. Because the materials have low strength, bioabsorbable bone plates tend to be bulky and cumbersome.…”

Biomechanical in vitro evaluation of the effect of cyclic loading on the postoperative fixation stability and degradation of a biodegradable ankle plate

“…[1][2][3][4][5][6][7][8][9] Although biodegradable plates have been successfully used to treat craniomaxillofacial and mandibular fractures and osteotomies, [10][11][12][13][14][15][16] only limited data are available on their use in the treatment of long bone fractures. [17][18][19][20] However, use of biodegradable plates to treat lateral malleolar fractures of the ankle is justified as it could make secondary plate removal unnecessary, thereby saving health care resources.…”