Ashammakhi N (1), MD, PhD, FRCSEd, Renier D, MD, Arnaud E (4),
MD, Marchac D (4), MD, Ninkovic M (2), MD, Dunaway
D (3), MD, FRCS, Jones B (3), MD, FRCS,
Serlo W (5), MD, PhD, Laurikainen K, DDS, PhD, Törmälä P (1),
PhD, MDhc, Waris T (1), MD, PhD.
1.Institute of Biomaterials, Tampere
University of Technology, Tampere, Finland
2.
Department
of Plastic and Reconstructive Surgery, University Innsbruck, Austria
3. Craniofacial Unit, Great Ormond Street Hospital for Sick Children,
London, UK
4. Craniofacial Unit, Hopital Necker-Enfants Malades, Paris, France
5. Department of Pediatrics, Oulu University Hospital, Oulu, Finland
Correspondence:
Prof. Nureddin
Ashammakhi, MD, PhD, FRCSEd, Institute of Biomaterials, Tampere University
of Technology, P.O. BOX 589, Hermiankatu 12 B,
FIN-33101 Tampere; Tel. +358 3 3115 2356, Fax +358 3 3115 2250
E-mail:
Nureddin.Ashammakhi@tut.fi
Abstract:
Bioabsorbable osteofixation
devices were developed to avoid problems associated with metals. Bioabsorbable
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-reinforcing (SR)
of bioasorbable materials, it is possible to manufacture ductile osteofixation devices
with ultra high strength. Self-reinforced polyglycolide-co-polylactide
(SR-PLGA) 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 Biosorb 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), or treatment of encephalocoele (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
length of 4, 6 or 8 mm long. Tacks had an outer diameter of 1.5 or
2 mm and length of 4 or 6 mm. Intraoperatively the devices were easy
to handle and
apply and provided stable fixation except in two cases. Postoperative
complications occurred in 13 cases (7.8%), comprising infection (n=6),
bone resorption
(n=4), diabeties insipidus (n=1), delayed skin wound healing (n=2),
and liqurrhoea not related to the implant (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.
Keywords:
Bioabsorbable, Biosorb, Bone, Fixation, Polylactide, Polyglycolide,
Self-reinforced.
|
