Cost-Effectiveness of a Biodegradable Compared to a Titanium Fixation System in Maxillofacial Surgery: A Multicenter Randomized Controlled Trial.

Autor:	van Bakelen NB; Department of Oral and Maxillofacial Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., Vermeulen KM; Department of Epidemiology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., Buijs GJ; Department of Oral and Maxillofacial Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., Jansma J; Department of Oral and Maxillofacial Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., de Visscher JG; Department of Oral and Maxillofacial Surgery, Medical Centre Leeuwarden, Leeuwarden, The Netherlands., Hoppenreijs TJ; Department of Oral and Maxillofacial Surgery, Rijnstate Hospital Arnhem, Arnhem, The Netherlands., Bergsma JE; Department of Oral and Maxillofacial Surgery, Amphia Hospital Breda, Breda, The Netherlands., Stegenga B; 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., Bos RR; Department of Oral and Maxillofacial Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.
Jazyk:	angličtina
Zdroj:	PloS one [PLoS One] 2015 Jul 20; Vol. 10 (7), pp. e0130330. Date of Electronic Publication: 2015 Jul 20 (Print Publication: 2015).
DOI:	10.1371/journal.pone.0130330
Abstrakt:	Background: Biodegradable fixation systems could reduce/delete the problems associated with titanium plate removal. This means less surgical discomfort, and a reduction in costs. Aim: The aim of the present study was to compare the cost-effectiveness between a biodegradable and a titanium system in Maxillofacial surgery. Materials and 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. Conclusion and Discussion: 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. Trial Registration: Controlled-Trials.com ISRCTN 44212338.
Databáze:	MEDLINE
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