Background:

Several devices for obtaining dynamic fixation of the syndesmosis have been introduced in recent years, but their efficacy has been tested in only a few randomized controlled trials (RCTs), without demonstrating any clear benefit over the traditional static fixation with screws.

Purpose:

To perform a level 1 meta-analysis of RCTs to investigate the complications, subjective outcomes, and functional results after dynamic or static fixation of acute syndesmotic injuries.

Study Design:

Meta-analysis of RCTs.

Methods:

A systematic literature search was performed of the Medline/PubMed, Cochrane Central Register of Controlled Trials, and Embase electronic databases, as well as ClinicalTrials.gov for unpublished studies. Eligible studies were RCTs comparing dynamic fixation and static fixation of acute syndesmosis injuries. A meta-analysis was performed, while bias and quality of evidence were rated according to the Cochrane Database questionnaire and the Grading of Recommendations Assessment, Development and Evaluation guidelines.

Results:

Dynamic fixation had a significantly reduced relative risk (RR = 0.55, P = .003) of complications—in particular, the presence of inadequate reduction at the final follow-up (RR = 0.36, P = .0008) and the clinical diagnosis of recurrent diastasis or instability (RR = 0.10, P = .03). The effect was more evident when compared with permanent screws (RR = 0.10, P = .0001). The reoperation rate was similar between the groups (RR = 0.64, P = .07); however, the overall risk was reduced after dynamic fixation as compared with static fixation with permanent screws (RR = 0.24, P = .007). The American Orthopaedic Foot & Ankle Society score was significantly higher among patients treated with dynamic fixation—6.06 points higher (P = .005) at 3 months, 5.21 points (P = .03) at 12 months, and 8.60 points (P < .00001) at 24 months—while the Olerud-Molander score was similar. The visual analog scale for pain score was reduced at 6 months (–0.73 points, P = .003) and 12 months (–0.52 points, P = .005), and ankle range of motion increased by 4.36° (P = .03) with dynamic fixation. The overall quality of evidence ranged from “moderate” to “very low,” owing to a substantial risk of bias, heterogeneity, indirectness of outcome reporting, and evaluation of a limited number of patients.

Conclusion:

The dynamic fixation of syndesmotic injuries was able to reduce the number of complications and improve clinical outcomes as compared with static screw fixation—especially malreduction and clinical instability or diastasis—at a follow-up of 2 years. A lower risk of reoperation was found with dynamic fixation as compared with static fixation with permanent screws. However, the lack of patients or personnel blinding, treatment heterogeneity, small samples, and short follow-up limit the overall quality of this evidence.

中文翻译：

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与螺钉固定术相比，动态稳定的椎间盘融合症损伤减少了并发症和再次手术：一项随机对照试验的荟萃分析。

背景：

近年来已经引入了几种用于动态固定椎间盘融合的装置，但是仅在一些随机对照试验（RCT）中对它们的功效进行了测试，但并未证明其优于传统的使用螺钉进行静态固定的明显好处。

目的：

进行RCT的1级荟萃分析，以研究动态或静态固定急性下颌联合损伤后的并发症，主观结果和功能结果。

学习规划：

随机对照试验的荟萃分析。

方法：

系统地检索了Medline / PubMed，Cochrane对照试验中央注册簿和Embase电子数据库以及ClinicalTrials.gov进行未发表的研究。符合条件的研究是比较急性联合症损伤的动态固定和静态固定的RCT。进行了荟萃分析，同时根据Cochrane数据库问卷和“建议评估，制定和评估指南分级”对偏倚和证据质量进行了评估。

结果：

动态固定可显着降低并发症的相对风险（RR = 0.55，P = .003），尤其是在最终随访时降低的风险不充分（RR = 0.36，P = .0008）和临床诊断为复发性腹泻或不稳定（RR = 0.10，P = .03）。与永久螺钉相比，效果更明显（RR = 0.10，P = .0001）。两组之间的再手术率相似（RR = 0.64，P = .07）；但是，与使用永久性螺钉进行静态固定相比，动态固定后的总体风险有所降低（RR = 0.24，P= .007）。在动态固定治疗的患者中，美国骨科足踝学会评分显着更高-3个月时高6.06分（P = .005），12个月时高5.21分（P = .03），而8.60分（P <。 00001）在24个月时-而Olerud-Molander得分相似。疼痛评分的视觉模拟量表在6个月（–0.73点，P = .003）和12个月（–0.52点，P = .005）时降低，踝关节活动范围增加了4.36°（P= .03）并带有动态注视。由于存在很大的偏见，异质性，结果报告的间接性和评估有限的患者的风险，证据的总体质量从“中等”到“非常低”。

结论：

在两年的随访中，与静态螺钉固定（尤其是复位不良，临床不稳定或腹泻相比）相比，采用动态固定术治疗结缔组织损伤能够减少并发症的发生并改善临床效果。与使用永久性螺钉的静态固定相比，动态固定的再手术风险更低。但是，缺乏患者或人员盲目性，治疗异质性，样本量少和随访时间短限制了该证据的整体质量。