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

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  • N B van Bakelen
  • K M Vermeulen
  • G J Buijs
  • J Jansma
  • J G A M de Visscher
  • Th J M Hoppenreijs
  • J E Bergsma
  • B Stegenga
  • R R M Bos

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. 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

Suggested Citation

  • N B van Bakelen & K M Vermeulen & G J Buijs & J Jansma & J G A M de Visscher & Th J M Hoppenreijs & J E Bergsma & B Stegenga & R R M Bos, 2015. "Cost-Effectiveness of a Biodegradable Compared to a Titanium Fixation System in Maxillofacial Surgery: A Multicenter Randomized Controlled Trial," PLOS ONE, Public Library of Science, vol. 10(7), pages 1-16, July.
    • Handle: RePEc:plo:pone00:0130330
    DOI: 10.1371/journal.pone.0130330
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    1. William C. Black, 1990. "The CE Plane," Medical Decision Making, , vol. 10(3), pages 212-214, August.
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