Resorbable versus titanium plates for facial fractures: Cochrane systematic review
Rigid internal fixation of the jaw bones is a routine procedure for the management of facial fractures. Titanium plates and screws are routinely used for this purpose. The limitations of this system has led to the development of plates manufactured from bioresorbable materials which, in some cases, omits the necessity for the second surgery. However, concerns remain about the stability of fixation and the length of time required for their degradation and the possibility of foreign body reactions.Objectives
To compare the effectiveness of bioresorbable fixation systems with titanium systems for the management of facial fractures.Search methods
We searched the following databases: The Cochrane Oral Health Group's Trials Register (to 20th August 2008), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2008, Issue 3), MEDLINE (1950 to 20th August 2008), EMBASE (from 1980 to 20th August 2008), http://www.clinicaltrials.gov/ and http://www.controlled-trials.com (to 20th August 2008).Selection criteria
Randomised controlled trials comparing resorbable versus titanium fixation systems used for facial fractures.Data collection and analysis
Retrieved studies were independently screened by two review authors. Results were to be expressed as random-effects models using mean differences for continuous outcomes and risk ratios for dichotomous outcomes with 95% confidence intervals. Heterogeneity was to be investigated including both clinical and methodological factors.Main results
The search strategy retrieved 53 potentially eligible studies. None of the retrieved studies met our inclusion criteria and all were excluded from this review. One study is awaiting classification as we failed to obtain the full text copy. Three ongoing trials were retrieved, two of which were stopped before recruiting the planned number of participants. In one study, the excess complications in the resorbable arm was declared as the reason for stopping the trial.Authors' conclusions
This review illustrates that there are no published randomised controlled clinical trials relevant to this review question. There is currently insufficient evidence for the effectiveness of resorbable fixation systems compared with conventional titanium systems for facial fractures. The findings of this review, based on the results of the aborted trials, do not suggest that resorbable plates are as effective as titanium plates. In future, the results of ongoing clinical trials may provide high level reliable evidence for assisting clinicians and patients for decision making. Trialists should design their studies accurately and comprehensively to meet the aims and objectives defined for the study.
Dorri Mojtaba, Oliver Richard
Resorbable versus titanium plates for facial fractures
Facial fractures with bone displacement are a frequent occurrence in individuals who have suffered trauma. They may cause functional and cosmetic problems. The management should include repositioning and immobilising the fractured bones to restore the functional and cosmetic properties of injured bone(s). Conventionally, titanium plates are used to immobilise the displaced segments and are recognised as the 'gold standard'. Recently, bioresorbable plates have been introduced as an alternative with the advantage of omitting, in some cases, the necessity for the second operation to remove the metal plate. However, there are uncertainties about the stability of resorbable fixations, the length of time required for their resorption, the possibility of foreign body reactions, and with some of the technical difficulties experienced with resorbable plates. The review authors did not identify any randomised controlled trial comparing the effectiveness of resorbable fixations with conventional titanium plates. However, three ongoing trials were identified two of which were stopped before completion mainly because of, in one trial, the complications in the resorbable group. The findings of these aborted trials do not suggest that resorbable plates are as effective as titanium plates. Further randomised controlled trials should be well designed and reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement (http://www.consort-statement.org/).
Implications for practice
There are no published randomised controlled clinical trials relevant to this review question. In the absence of any high level reliable evidence clinicians should base their decisions on clinical experience, individual circumstances and in conjunction with patients' preferences where appropriate. However, the results of ongoing clinical trials may be helpful in providing high level reliable evidence for assisting clinicians and patients for decision making. The findings of this review, based on the results of the aborted trials, do not suggest that resorbable plates are as effective as titanium plates.
Implications for research
The results of this systematic review confirm the necessity for methodologically sound trials that are reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement (http://www.consort-statement.org/). It is recognised that it is unethical to complete trials when there are early complications in the intervention group. Further basic studies should investigate the reasons for the failures of resorbable plates and also methods to overcome these failures. Trials should be accurately designed to minimise the possibility of being stopped before meeting the aims and objectives defined for the study. It would be beneficial if future randomised controlled trials for this research question could provide comprehensive information on all variables indicated in this review.Get full text at The Cochrane Library
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