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锁骨钩钢板与接骨板治疗移位性锁骨中段骨折的随机临床试验。

Sling compared with plate osteosynthesis for treatment of displaced midshaft clavicular fractures: a randomized clinical trial.

机构信息

Department of Orthopaedics and Traumatology, Helsinki University Central Hospital and University of Helsinki, Topeliuksenkatu 5, 00260 Helsinki, Finland.

出版信息

J Bone Joint Surg Am. 2012 Sep 5;94(17):1546-53. doi: 10.2106/JBJS.J.01999.

DOI:10.2106/JBJS.J.01999
PMID:22832887
Abstract

BACKGROUND

Few randomized controlled trials have compared operative with nonoperative treatment of clavicular fractures.

METHODS

Patients with displaced midshaft clavicular fractures were randomized either to nonoperative treatment with a sling or to operative treatment with a stainless steel 3.5-mm reconstruction plate. Outcome measures were the Constant shoulder score, DASH (Disabilities of the Arm, Shoulder and Hand) score, pain, fracture-healing, and complications. The null hypothesis was that the Constant and DASH scores would not differ between the groups at the one-year follow-up evaluation.

RESULTS

In accordance with the power analysis, we included sixty patients in the study; thirty-two were randomized to the nonoperative group and twenty-eight to the operative group. We found no difference in the Constant score (p = 0.75), the DASH score (p = 0.89), or pain (p = 0.98) between the groups at the one-year follow-up evaluation. All fractures in the operative group healed, but six nonunions (24%) occurred in the nonoperative group.

CONCLUSIONS

One year after a displaced midshaft clavicular fracture, nonoperative treatment resulted in a higher nonunion rate but similar function and disability compared with operative treatment.

摘要

背景

比较锁骨骨折手术与非手术治疗的随机对照试验较少。

方法

将移位的锁骨中段骨折患者随机分为非手术治疗(吊带固定)或手术治疗(不锈钢 3.5mm 重建板)。主要的结局评估指标是 Constant 肩关节评分、DASH(上肢功能障碍)评分、疼痛、骨折愈合情况和并发症。零假设是两组在一年随访时 Constant 和 DASH 评分无差异。

结果

根据功效分析,我们纳入了 60 例患者,其中 32 例被随机分为非手术组,28 例被随机分为手术组。我们发现两组在一年随访时 Constant 评分(p=0.75)、DASH 评分(p=0.89)和疼痛评分(p=0.98)均无差异。手术组所有骨折均愈合,但非手术组有 6 例(24%)发生骨折不愈合。

结论

对于移位的锁骨中段骨折,一年后非手术治疗的骨折不愈合发生率更高,但功能和残疾情况与手术治疗相似。

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