钢板固定与非手术治疗移位型锁骨中段骨折：一项随机对照试验的荟萃分析
Plate Fixation Versus Nonoperative Treatment for Displaced Midshaft Clavicular Fractures: A Meta-Analysis of Randomized Controlled Trials.
作者信息
Woltz Sarah, Krijnen Pieta, Schipper Inger B
机构信息
1Department of Trauma Surgery, Leiden University Medical Center, Leiden, the Netherlands.
出版信息
J Bone Joint Surg Am. 2017 Jun 21;99(12):1051-1057. doi: 10.2106/JBJS.16.01068.
BACKGROUND
The aim was to analyze whether patients with a displaced midshaft clavicular fracture are best managed with plate fixation or nonoperative treatment with respect to nonunion, secondary operations, and functional outcome, by evaluating all available randomized controlled trials (RCTs) on this subject.
METHODS
A systematic search of electronic databases (PubMed, MEDLINE, Embase, and Web of Science) was performed to identify RCTs comparing nonoperative treatment with plate fixation for displaced midshaft clavicular fractures. Risk of bias of the studies was assessed. Outcomes evaluated were nonunion, shoulder function (Constant score and Disabilities of the Arm, Shoulder and Hand [DASH] score), and secondary operations.
RESULTS
Six RCTs (614 patients) were included. The risk of nonunion was lower in the operatively treated patients (relative risk [RR] = 0.14, 95% confidence interval [CI] = 0.06 to 0.32). One-third of the patients with a nonunion did not receive further treatment. Secondary operations for adverse events were performed less often in the operatively treated patients (RR = 0.42, 95% CI = 0.25 to 0.71). When plate removal operations were also included, a secondary operation was performed in 17.6% in the operative group and 16.6% in the nonoperative group (RR = 1.01, 95% CI = 0.64 to 1.59). Constant and DASH scores after 1 year were somewhat better after plate fixation, with mean differences of 4.4 points (95% CI, 0.9 to 7.9 points) and 5.1 points (95% CI, 0.1 to 10.1 points), respectively.
CONCLUSIONS
Plate fixation significantly reduces the risk of nonunion, but does not have a clinically relevant advantage regarding final functional outcome. Secondary operations are common after both treatments. Overall, there is not enough evidence to support routine operative treatment for all patients with a displaced midshaft clavicular fracture.
LEVEL OF EVIDENCE
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
背景
通过评估关于该主题的所有可用随机对照试验（RCT），旨在分析移位型锁骨中段骨折患者采用钢板固定还是非手术治疗在骨不连、二次手术及功能结局方面哪种治疗方式最佳。
方法
对电子数据库（PubMed、MEDLINE、Embase和科学网）进行系统检索，以识别比较非手术治疗与钢板固定治疗移位型锁骨中段骨折的RCT。评估研究的偏倚风险。评估的结局指标为骨不连、肩部功能（Constant评分和上肢、肩部和手部功能障碍[DASH]评分）以及二次手术情况。
结果
纳入6项RCT（614例患者）。手术治疗患者的骨不连风险较低（相对风险[RR]=0.14，95%置信区间[CI]=0.06至0.32）。三分之一的骨不连患者未接受进一步治疗。手术治疗患者因不良事件进行二次手术的频率较低（RR=0.42，95%CI=0.25至0.71）。当也包括取出钢板手术时，手术组二次手术率为17.6%，非手术组为16.6%（RR=1.01，95%CI=0.64至1.59）。钢板固定后1年的Constant和DASH评分稍好，平均差异分别为4.4分（95%CI，0.9至7.9分）和5.1分（9%CI，0.1至10.1分）。
结论
钢板固定显著降低骨不连风险，但在最终功能结局方面无临床相关优势。两种治疗后二次手术均常见。总体而言，没有足够证据支持对所有移位型锁骨中段骨折患者进行常规手术治疗。
证据级别
治疗性I级。有关证据级别的完整描述，请参阅作者指南。
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