Dataset Information

Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial.

ABSTRACT:

Background

Biodegradable fixation systems could reduce or eliminate problems associated with titanium removal of implants in a second operation.

Aim

The aim of this study was to compare the long-term (i.e. >5 years postoperatively) clinical performance of a titanium and a biodegradable system in oral and maxillofacial surgery.

Materials and methods

The present multicenter Randomized Controlled Trial (RCT) was performed in four hospitals in the Netherlands. Patients treated with a bilateral sagittal split osteotomy (BSSO) and/or a Le Fort-I osteotomy, and those treated for fractures of the mandible, maxilla, or zygoma were included from December 2006 to July 2009. The patients were randomly assigned to either a titanium (KLS Martin) or a biodegradable group (Inion CPS).

Results

After >5 years postoperatively, plate removal was performed in 22 of the 134 (16.4%) patients treated with titanium and in 23 of the 87 (26.4%) patients treated with the biodegradable system (P = 0.036, hazard ratio (HR) biodegradable (95% CI) = 2.0 (1.05-3.8), HR titanium = 1). Occlusion, VAS pain scores, and MFIQ showed good and (almost) pain free mandibular function in both groups.

Conclusion

In conclusion, the performance of the Inion CPS biodegradable system was inferior compared to the KLS Martin titanium system regarding plate/screws removal in the abovementioned surgical procedures.

Trial registration

http://controlled-trials.com ISRCTN44212338.

SUBMITTER: Gareb B

PROVIDER: S-EPMC5426637 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial.

Gareb B B van Bakelen N B NB Buijs G J GJ Jansma J J de Visscher J G A M JGAM Hoppenreijs Th J M TJM Bergsma J E JE van Minnen B B Stegenga B B Bos R R M RRM

PloS one 20170511 5

<h4>Background</h4>Biodegradable fixation systems could reduce or eliminate problems associated with titanium removal of implants in a second operation.<h4>Aim</h4>The aim of this study was to compare the long-term (i.e. >5 years postoperatively) clinical performance of a titanium and a biodegradable system in oral and maxillofacial surgery.<h4>Materials and methods</h4>The present multicenter Randomized Controlled Trial (RCT) was performed in four hospitals in the Netherlands. Patients treated ...[more]

PMID: 28493922

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Project description:BackgroundBiodegradable fixation systems could reduce/delete the problems associated with titanium plate removal. This means less surgical discomfort, and a reduction in costs.AimThe aim of the present study was to compare the cost-effectiveness between a biodegradable and a titanium system in Maxillofacial surgery.Materials and methodsThis 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).ResultsIn 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 discussionThe 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 registrationControlled-Trials.com ISRCTN 44212338.

Project description:To guide the selection of osteosynthesis systems, this study compared the mechanical properties of biodegradable and titanium osteosynthesis systems. SonicPins Rx and xG were subjected to pull-out tests. Additionally, 15 biodegradable (Inion CPS 2.0 and 2.5 mm; LactoSorb 2.0 mm; Macropore 2.0 mm; Polymax 2.0 mm; BioSorb FX 2.0 mm; ResorbX 2.1 mm; Osteotrans-MX 2.0 mm with plate thicknesses 1.0 and 1.4 mm; SonicWeld Rxplate/Rxpins, xGplate/Rxpins and xGplate/xGpins 2.1 mm without and with tapping the burr hole) and six titanium (CrossDrive (2006), CrossDrive (2018), MaxDrive; all 1.5 and 2.0 mm) straight, four-hole osteosynthesis systems were evaluated. All systems were subjected to tensile, bending and torsion tests. Pull-out loads of the SonicPins were comparable (P = 0.423). Titanium systems' tensile loads were higher than biodegradable systems (P < 0.001). CrossDrive (2018) and MaxDrive systems' tensile and torsional stiffness were lower, accompanied with higher ductility, than corresponding CrossDrive (2006) systems (P < 0.001). Bending stiffness of 1.5 mm titanium systems was comparable to, and of the 2.0 mm systems higher than, all biodegradable systems (P < 0.001). Regarding biodegradable systems, Inion CPS 2.5 mm had highest tensile load and torsional stiffness, SonicWeld 2.1 mm highest tensile stiffness, and BioSorbFX 2.0 mm highest bending stiffness (P < 0.001). On the basis of the results of this study, the CrossDrive (2018) and MaxDrive 1.5 mm titanium systems are recommended for midface fractures (e.g., zygomatic or maxillary fractures) and osteotomies (e.g., Le Fort I osteotomy), and the CrossDrive (2018) and MaxDrive 2.0 mm titanium systems for mandibular fractures and osteotomies when a titanium osteosynthesis system is used. When there is an indication for a biodegradable osteosynthesis system, the SonicWeld 2.1 mm or BioSorbFX 2.0 mm are recommended for midface fractures and osteotomies, and the Inion CPS 2.5 mm biodegradable system for mandibular osteotomies and non-load bearing mandibular fractures, especially when high torsional forces are expected (e.g., mandibular symphysis fractures).

Project description:The use of titanium during maxillofacial fixation is limited due to its palpability, mutagenic effects and interference with imaging, which lead to the requirement for subsequent removal. The use of a biologically absorbable fixation material will potentially eliminate these limitations. In this meta-analysis, we analyzed the complications of absorbable fixation in maxillofacial surgery.We performed a systematic search of PubMed, Embase, Cochrane Central Register of Systematic Reviews and Cochrane Central Register of Controlled Trials for trials published through December 2012. Data extracted from literature were analyzed with Review manager 5.0.24.Relevant data was extracted from 20 studies (1673 participants) and revealed that patients in the absorbable group had significantly more complications than those in the titanium group (RR = 1.20; 95% CI: 1.02-1.42; P = 0.03) in all enrolled maxillofacial surgeries. For bimaxillary operation subgroup, the absorbable fixation group did not have a significant increase in complications when compared with the titanium group (RR = 1.89; 95% CI: 0.85-4.22; P = 0.12). There was no significant difference observed between the absorbable and titanium groups receiving a bilateral sagittal split ramus osteotomy (BSSRO) (RR = 1.45; 95% CI: 0.84-2.48; P = 0.18) and Le Fort I osteotomy (RR = 0.65; 95% CI: 0.34-1.23; P = 0.18). The combined results of the five trials revealed that the absorbable group had a significantly lower rate of complications compared to the titanium group (RR = 0.71; 95% CI: 0.52-0.97; P = 0.03) in fracture fixation.This meta-analysis shows that absorbable fixation systems used for fixation in maxillofacial surgery do not have adequate safety profiles. Subgroup indicated the safety of absorbable fixation systems was superior during fracture fixation. The absorbable fixation systems tend to have a similar favorable safety profile as titanium fixation during Le Fort I, bimaxillary operation and BSSRO.

Dataset Information

Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial.

Background

Aim

Materials and methods

Results

Conclusion

Trial registration

Publications

Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial.

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