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.

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.

• Authors: 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
• Journal: PloS one (PLoS One) Vol. 10 Issue 7 Pg. e0130330 ( 2015) ISSN: 1932-6203 [Electronic] United States
• PMID: 26192813 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Biocompatible Materials
• Titanium

Topics

• Adolescent
• Adult
• Biocompatible Materials
• Bone Plates
• Bone Screws
• Cost-Benefit Analysis
• Female
• Humans
• Male
• Middle Aged
• Surgery, Oral (economics, methods)
• Titanium
• Treatment Outcome
• Wound Healing
• Young Adult