title: Cost-Effectiveness of a Biodegradable Compared to a Titanium Fixation System in Maxillofacial Surgery: A Multicenter Randomized Controlled Trial.
abstract: BACKGROUND
  Biodegradable fixation systems could reduce/delete the problems associated with titanium plate removal. This means less surgical discomfort, and a reduction in costs.
  
  
  OBJECTIVE
  The aim of the present study was to compare the cost-effectiveness between a biodegradable and a titanium system in Maxillofacial surgery.
  
  
  METHODS
  This multicenter RCT was performed in the Netherlands from December 2006 to July 2009. Included were 230 patients who underwent a bilateral sagittal split osteotomy (BSSO), a Le Fort-I osteotomy, or a bi-maxillary osteotomy and those treated for fractures of the mandible, maxilla, or zygoma. The patients were randomly assigned to a titanium group (KLS Martin) or to a biodegradable group (Inion CPS). Costs were assessed from a societal perspective. Health outcomes in the incremental cost-effectiveness ratio (ICER) were bone healing (8 weeks) and plate removal (2 years).
  
  
  RESULTS
  In 25 out of the 117 patients who were randomized to the biodegradable group, the maxillofacial surgeon made the decision to switch to the titanium system intra-operatively. This resulted in an Intention-To-Treat (ITT-)analysis and a Treatment-Received (TR-) analysis. Both analyses indicated that operations performed with titanium plates and screws had better health outcomes. In the TR-analysis the costs were lower in the biodegradable group, in the ITT-analysis costs were lower in the titanium group.
  
  
  CONCLUSIONS
  The difference in costs between the ITT and the TR analyses can be explained by the intra-operative switches: In the TR-analysis the switches were analysed in the titanium group. In the ITT-analysis they were analysed in the biodegradable group. Considering the cost-effectiveness the titanium system is preferable to the biodegradable system in the regular treatment spectrum of mandibular, Le Fort-I, and zygomatic fractures, and BSSO's, Le Fort-I osteotomies and bimaxillary osteotomies.
  
  
  BACKGROUND
  Controlled-Trials.com ISRCTN 44212338.
authors.affiliation: Department of Oral and Maxillofacial Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.
authors.forename: N B
authors.initials: NB
authors.lastname: van Bakelen
authors.affiliation: Department of Epidemiology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.
authors.forename: K M
authors.initials: KM
authors.lastname: Vermeulen
authors.affiliation: Department of Oral and Maxillofacial Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.
authors.forename: G J
authors.initials: GJ
authors.lastname: Buijs
authors.affiliation: Department of Oral and Maxillofacial Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.
authors.forename: J
authors.initials: J
authors.lastname: Jansma
authors.affiliation: Department of Oral and Maxillofacial Surgery, Medical Centre Leeuwarden, Leeuwarden, The Netherlands.
authors.forename: J G A M
authors.initials: JG
authors.lastname: de Visscher
authors.affiliation: Department of Oral and Maxillofacial Surgery, Rijnstate Hospital Arnhem, Arnhem, The Netherlands.
authors.forename: Th J M
authors.initials: TJ
authors.lastname: Hoppenreijs
authors.affiliation: Department of Oral and Maxillofacial Surgery, Amphia Hospital Breda, Breda, The Netherlands.
authors.forename: J E
authors.initials: JE
authors.lastname: Bergsma
authors.affiliation: Department of Oral and Maxillofacial Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands; UMCG Center for Dentistry and Oral Hygiene, Department of Oral Health Care & Clinical Epidemiology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.
authors.forename: B
authors.initials: B
authors.lastname: Stegenga
authors.affiliation: Department of Oral and Maxillofacial Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.
authors.forename: R R M
authors.initials: RR
authors.lastname: Bos
mesh_terms: D000293:Adolescent; D000328:Adult; D001672:Biocompatible Materials; D001860:Bone Plates; D001863:Bone Screws; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013515:Surgery, Oral / Q000191:economics* / Q000379:methods*; D014025:Titanium; D016896:Treatment Outcome; D014945:Wound Healing; D055815:Young Adult
chemical_list: D001672:Biocompatible Materials; D014025:Titanium