Resorbable versus titanium plates for facial fractures
Editorial Group: Cochrane Oral Health Group
Published Online: 21 JAN 2009
Assessed as up-to-date: 17 SEP 2008
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
How to Cite
Dorri M, Nasser M, Oliver R. Resorbable versus titanium plates for facial fractures. Cochrane Database of Systematic Reviews 2009, Issue 1. Art. No.: CD007158. DOI: 10.1002/14651858.CD007158.pub2.
- Publication Status: New
- Published Online: 21 JAN 2009
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.
To compare the effectiveness of bioresorbable fixation systems with titanium systems for the management of facial fractures.
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).
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.
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.
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.
Plain language summary
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/).
顎骨的堅性內固定術(rigid internal fixation)為處理顏面部骨折之慣常步驟. 而鈦金屬骨板及骨釘則慣用於此固定術. 而此系統的限制性則造成了後來以生物可吸收材料製成的骨板的發展, 可在某些案例中免去二度手術的必要. 然而, 關於此固定法的穩定度, 將它們分解所需的時間, 以及異物反應(foreign body reaction)的可能性仍然是使用此材料的疑慮.
我們搜尋了以下資料庫: 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.controlledtrials.com (to 20th August 2008).
檢索得到的研究分別獨立由兩位文獻回顧作者篩選. 結果在連續型結果部分以隨機作用模型(randomeffects model)使用平均差來表示, 而二分法的結果則以risk ratio以95%信賴區間來表示. 在臨床及方法論上的異質性是有被探討的.
此搜尋策略檢索到53個潛在符合條件的研究. 沒有任何檢索出來的研究符合我們的納入條件, 所以所有的研究都被排除在此文獻回顧外. 其中有一個研究因我們無法取得它的全文複本所以尚待分類. 有三個尚在進行中的研究被檢索到, 當中有兩個研究在募集到預計受試者數目前就中止了. 有一個研究宣稱其中止試驗的原因是由於可吸收骨板的併發症過高.
本篇文獻回顧表示目前尚沒有有關此回顧主題的隨機控制臨床試驗. 目前並沒有足夠的證據支持可吸收式固定系統相對於傳統鈦金屬系統在顏面部骨折使用上的效果. 本篇回顧的發現, 根據那些半途中止的試驗結果, 並不認為可吸收式骨板如鈦金屬骨板一樣有效. 在未來, 那些尚在進行中的臨床試驗結果可能提供一個可高度信賴的證據給預做決定的臨床醫師及患者參考. 而臨床研究員應該要精確及完善的設計他們的研究, 以符合該研究的目標及目的.
此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。
可吸收式與鈦金屬骨板應用於顏面部骨折: 在創傷患者中, 顏面部骨折伴隨骨頭位移是經常會發生的, 他們可能造成功能及美觀上的問題. 而其處置應該包括復位及固定骨斷端, 以重建該受損骨在功能及美觀上的特有關係. 在傳統上, 使用鈦金屬骨板被用來固定分離的斷塊被認為是標準程序. 最近, 生物性可吸收骨板被引進做為另一種選擇, 因為在某些案例中, 它具有可避免二度手術移除金屬板的優點. 然而, 關於可吸收骨板固定系統的穩定度仍存在著不確定性: 它在體內降解需要的時間, 引起異物反應的可能性, 以及在使用上會遭遇到的一些技術性困難. 本篇文獻回顧的作者並沒有找到任何比較可吸收固定系統與傳統鈦金屬板的隨機控制臨床試驗. 然而, 三個尚在進行中的試驗有被找出, 當中有兩個在試驗完成前就中止了, 其中一個中止的原因是由於可吸收骨板組的併發症過高. 從這些半途中止的研究中, 我們發現可吸收式骨板並不如鈦金屬骨板有效. 更多未來的隨機控制臨床試驗應該要有良好的設計, 並以Consolidated Standards of Reporting Trials (CONSORT) statement為報告的準則. (http://www.consortstatement.org/)