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Complications of absorbable fixation in maxillofacial surgery: a meta-analysis.

ABSTRACT: 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.

SUBMITTER: Yang L

PROVIDER: S-EPMC3696084 | biostudies-other | 2013

REPOSITORIES: biostudies-other

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Complications of absorbable fixation in maxillofacial surgery: a meta-analysis.

Yang Liya L Xu Meibang M Jin Xiaolei X Xu Jiajie J Lu Jianjian J Zhang Chao C Tian Tian T Teng Li L

PloS one 20130628 6

<h4>Background</h4>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.<h4>Methods</h4>We performed a systematic search of PubMed, Embase, Cochrane Central Regist ...[more]

PMID: 23840705

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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:BackgroundAn alternative to the current gold standard in operative treatment of displaced midshaft clavicle fractures (DMCF) using plate osteosynthesis, is internal fixation by means of intramedullary fixation devices. These devices differ considerably in their specifications and characteristics and an evaluation of their clinical results is warranted. The aim of this systematic review is to generate an overview of functional outcomes and complications in the management of DMCF per available intramedullary device.MethodsA systematic review was conducted to identify all papers reporting functional outcomes, union rates and/or complications using an intramedullary fixation device for the management of midshaft clavicle fractures. Multiple databases and trial registries were searched from inception until February 2020. Meta-analysis was conducted based on functional outcomes and type of complication per type of intramedullary fixation device. Pooled estimates of functional outcomes scores and incidence of complications were calculated using a random effects model. Risk of bias and quality was assessed using the Cochrane risk of bias and ROBINS-I tools. The confidence in estimates were rated and described according to the recommendations of the GRADE working group.ResultsSixty-seven studies were included in this systematic review. The majority of studies report on the use of Titanium Elastic Nails (TEN). At 12 months follow up the Titanium Elastic Nail and Sonoma CRx report an average Constant-Murley score of 94.4 (95%CI 93-95) and 94.0 (95%CI 92-95) respectively (GRADE High). The most common reported complications after intramedullary fixation are implant-related and implant-specific. For the TEN, hardware irritation and protrusion, telescoping or migration, with a reported pooled incidence 20% (95%CI 14-26) and 12% (95%CI 8-18), are most common (GRADE Moderate). For the Rockwood/Hagie Pin, hardware irritation is identified as the most common complication with 22% (95%CI 13-35) (GRADE Low). The most common complication for the Sonoma CRx was cosmetic dissatisfaction in 6% (95%CI 2-17) of cases (GRADE Very low).ConclusionAlthough most studies were of low quality, good functional results and union rates irrespective of the type of device are found. However, there are clear device-related and device-specific complications for each. The results of this systematic review and meta-analysis can help guide surgeons in choosing the appropriate operative strategy, implant and informing their patient.Level of evidenceIV.

Project description:PurposeOur objectives were primarily to review the published literature on complications in neuromuscular scoliosis (NMS) surgery and secondarily, by means of a meta-analysis, to determine the overall pooled rates (PR) of various complications associated with NMS surgery.MethodsPubMed and Embase databases were searched for studies reporting the outcomes and complications of NMS surgery, published from 1997 to May 2011. We focused on NMS as defined by the Scoliosis Research Society's classification. We measured the pooled estimate of the overall complication rates (PR) using a random effects meta-analytic model. This model considers both intra- and inter-study variation in calculating PR.ResultsSystematic review and meta-analysis were performed for 68 cohort and case-control studies with a total of 15,218 NMS patients. Pulmonary complications were the most reported (PR = 22.71 %) followed by implant complications (PR = 12.51 %), infections (PR = 10.91 %), neurological complications (PR = 3.01 %) and pseudoarthrosis (PR = 1.88 %). Revision, removal and extension of implant had highest PR (7.87 %) followed by malplacement of the pedicle screws (4.81 %). Rates of individual studies have moderate to high variability. The studies were heterogeneous in methodology and outcome types, which are plausible explanations for the variability; sensitivity analysis with respect to age at surgery, sample size, publication year and diagnosis could also partly explain this variability. In regard to surgical complications affiliated with various surgical techniques in NMS, the level of evidence of published literature ranges between 2+ to 2-; the subsequent recommendations are level C.ConclusionNMS patients have diverse and high complication rates after scoliosis surgery. High PRs of complications warrant more attention from the surgical community. Although the PR of all complications are affected by heterogeneity, they nevertheless provide valuable insights into the impact of methodological settings (sample size), patient characteristics (age at surgery), and continual advances in patient care on complication rates.

Dataset Information

Complications of absorbable fixation in maxillofacial surgery: a meta-analysis.

Publications

Complications of absorbable fixation in maxillofacial surgery: a meta-analysis.

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