Successful use of biosorb osteofixation devices in 165 cranial and maxillofacial cases: a multicenter report.
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.
Ashammakhi
Nureddin
N
Institute of Biomaterials, Tampere University of Technology, Tampere, Finland. Nureddin.Ashammakhi@tut.fi
Renier
Dominique
D
Arnaud
Eric
E
Marchac
Daniel
D
Ninkovic
Milomir
M
Donaway
David
D
Jones
Barry
B
Serlo
Willy
W
Laurikainen
Kari
K
Törmälä
Pertti
P
Waris
Timo
T
D020341:Absorbable Implants; D000293:Adolescent; D000328:Adult; D001672:Biocompatible Materials / Q000009:adverse effects / Q000627:therapeutic use*; D001860:Bone Plates; D001863:Bone Screws; D002648:Child; D002675:Child, Preschool; D019465:Craniofacial Abnormalities / Q000601:surgery*; D003399:Craniotomy / Q000295:instrumentation / Q000379:methods; D004677:Encephalocele / Q000601:surgery; D005062:European Union; D006801:Humans; D007223:Infant; D016268:Internal Fixators; D019344:Lactic Acid / Q000009:adverse effects / Q000627:therapeutic use; D009984:Orthopedic Fixation Devices; D011100:Polyglycolic Acid / Q000009:adverse effects / Q000627:therapeutic use; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011108:Polymers / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D019651:Plastic Surgery Procedures / Q000295:instrumentation; D012886:Skull / Q000601:surgery*
D001672:Biocompatible Materials; D011108:Polymers; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011100:Polyglycolic Acid; D019344:Lactic Acid