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

van Bakelen NB, Vermeulen KM, Buijs GJ, Jansma J, de Visscher JG, Hoppenreijs TJ, Bergsma JE, Stegenga B, Bos RR - PLoS ONE (2015)

Bottom Line: Biodegradable fixation systems could reduce/delete the problems associated with titanium plate removal.This means less surgical discomfort, and a reduction in costs.Health outcomes in the incremental cost-effectiveness ratio (ICER) were bone healing (8 weeks) and plate removal (2 years).

View Article: PubMed Central - PubMed

Affiliation: Department of Oral and Maxillofacial Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.

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.

No MeSH data available.


Related in: MedlinePlus

Results of the cost-effectiveness in the TR-analysis with plate removal as outcome measure.ICERs were calculated for 5000 bootstrap iterations and simulated values of the mean estimates for the costs (-€350) and plate removal (-13.4) differences are presented in the cost-effectiveness plane. The point estimate of the ICER for plate removal within the first 2 years post-operative was €26 (95% CI -€73 to €206), indicating €26 is saved while the percentage of patients with plate removal increases with 1% if titanium plates and screws are replaced by biodegradables.
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pone.0130330.g005: Results of the cost-effectiveness in the TR-analysis with plate removal as outcome measure.ICERs were calculated for 5000 bootstrap iterations and simulated values of the mean estimates for the costs (-€350) and plate removal (-13.4) differences are presented in the cost-effectiveness plane. The point estimate of the ICER for plate removal within the first 2 years post-operative was €26 (95% CI -€73 to €206), indicating €26 is saved while the percentage of patients with plate removal increases with 1% if titanium plates and screws are replaced by biodegradables.

Mentions: Results of the cost-effectiveness analyses are displayed in Figs 2–5. The point estimate of the ICER for bone healing at 8 weeks was -€22 (95% CI -€62 to €15) for the ITT analysis. This means that per percent loss of patients with adequate bone healing, additional cost of €22 are invested if titanium plates and screws are replaced by biodegradables. For bone healing at 8 weeks in the TR analysis the point estimate is €27 (95% CI -€59562 to €64478). In this analysis, both the effect as well as the costs are lower in de biodegradable group.


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

van Bakelen NB, Vermeulen KM, Buijs GJ, Jansma J, de Visscher JG, Hoppenreijs TJ, Bergsma JE, Stegenga B, Bos RR - PLoS ONE (2015)

Results of the cost-effectiveness in the TR-analysis with plate removal as outcome measure.ICERs were calculated for 5000 bootstrap iterations and simulated values of the mean estimates for the costs (-€350) and plate removal (-13.4) differences are presented in the cost-effectiveness plane. The point estimate of the ICER for plate removal within the first 2 years post-operative was €26 (95% CI -€73 to €206), indicating €26 is saved while the percentage of patients with plate removal increases with 1% if titanium plates and screws are replaced by biodegradables.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4507946&req=5

pone.0130330.g005: Results of the cost-effectiveness in the TR-analysis with plate removal as outcome measure.ICERs were calculated for 5000 bootstrap iterations and simulated values of the mean estimates for the costs (-€350) and plate removal (-13.4) differences are presented in the cost-effectiveness plane. The point estimate of the ICER for plate removal within the first 2 years post-operative was €26 (95% CI -€73 to €206), indicating €26 is saved while the percentage of patients with plate removal increases with 1% if titanium plates and screws are replaced by biodegradables.
Mentions: Results of the cost-effectiveness analyses are displayed in Figs 2–5. The point estimate of the ICER for bone healing at 8 weeks was -€22 (95% CI -€62 to €15) for the ITT analysis. This means that per percent loss of patients with adequate bone healing, additional cost of €22 are invested if titanium plates and screws are replaced by biodegradables. For bone healing at 8 weeks in the TR analysis the point estimate is €27 (95% CI -€59562 to €64478). In this analysis, both the effect as well as the costs are lower in de biodegradable group.

Bottom Line: Biodegradable fixation systems could reduce/delete the problems associated with titanium plate removal.This means less surgical discomfort, and a reduction in costs.Health outcomes in the incremental cost-effectiveness ratio (ICER) were bone healing (8 weeks) and plate removal (2 years).

View Article: PubMed Central - PubMed

Affiliation: Department of Oral and Maxillofacial Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.

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.

No MeSH data available.


Related in: MedlinePlus