Biodegradable fixation systems could reduce or delete the problems associated with metallic systems, since removal is not necessary. The aim of this study was to establish the effectiveness and safety of biodegradable plates and screws as potential alternatives to metallic ones. This multi-center randomized controlled trial was conducted from December 2006 to July 2009. Included were patients who underwent mandibular and/or Le Fort I osteotomies and those with fractures of the mandible, maxilla, and zygoma. The patients were assigned to a titanium control group (KLS Martin) or to a biodegradable test group (Inion CPS). The primary outcome measure was 'bone healing 8 weeks post-operatively'. The Intention-To-Treat (ITT) analysis of 113 patients in the titanium group and 117 patients in the biodegradable group yielded a significant difference (p < 0.001), primarily because in 25 patients (21%) who were randomized to the biodegradable group, the surgeon made the decision to switch to titanium intra-operatively. Despite this 'inferior' primary outcome result, biodegradable plates and screws could be safely used when it was possible to apply them. The benefits of using biodegradable systems (fewer plate removal operations) should be confirmed during a follow-up of minimally 5 years (Controlled-trials.com ISRCTN number 44212338).
BackgroundBiodegradable fixation systems could reduce or eliminate problems associated with titanium removal of implants in a second operation.AimThe 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 methodsThe 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).ResultsAfter >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.ConclusionIn 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 registrationhttp://controlled-trials.com ISRCTN44212338.
Titanium osteosynthesis is currently the fixation system of choice in maxillofacial traumatology.Biodegradable osteosynthesis systems have the ability to degrade in the human body. The aim of this study was to conduct a systematic review, with meta-and trial sequential analyses, to assess the efficacy and morbidity of biodegradable versus titanium osteosyntheses after maxillofacial trauma. MEDLINE, EMBASE, and CENTRAL were searched for randomized controlled trials, and prospective and retrospective controlled studies. Five time periods were studied: perioperative, short-term (0-4 weeks), intermediate (6-12 weeks), long-term (>12 weeks) and overall follow-up. After screening 3542 records, 24 were included. All had a high risk of performance and detection bias due to the nature of the interventions. Meta-analysis showed no differences in efficacy and morbidity between biodegradable and titanium osteosyntheses. Risk of perioperative screw breakage was significantly higher (RR 17.13, 95% CI: 2.19;34.18) and the symptomatic plate removal rate lower in the biodegradable group (RR 0.11; 95% CI 0.02;0.57), which was confirmed by the trial sequential analysis. The quality of evidence ranged from very low to moderate. Based on both narrative review and meta-analyses, current evidence shows that biodegradable osteosyntheses are a viable alternative to titanium osteosyntheses when applied in the treatment of maxillofacial trauma with similar efficacy but significantly lower symptomatic plate removal rates. Perioperative screw breakage occurred significantly more often in the biodegradable compared to the titanium group.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.