Background: 

Previous observational studies and meta-analyses have recommended augmentation with a fibular allograft (FA) during the treatment of proximal humeral fractures with locking plates (LPs). However, to our knowledge, randomized controlled trials comparing open reduction and internal fixation (ORIF) with and without FA have not been performed to date.

Methods: 

This was a randomized controlled trial in which adults with a medial column comminuted proximal humeral fracture were randomly allocated to undergo ORIF with an LP (the LP group) or with an LP augmented with an FA (the FA group). Patients were followed for 24 months. The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) score at 12 months after the surgical procedure. The secondary outcomes included the DASH score at other time points, shoulder function, pain score, satisfaction, complications, and changes in neck-shaft angle and humeral head height.

Results: 

From October 20, 2016, to December 24, 2019, 80 patients were randomized. There were 52 women (65%), and the mean patient age (and standard deviation) was 65 ± 14 years. Of the 80 patients, 39 were allocated to the FA group and 41 were allocated to the LP group. At the primary time point (12 months), the unadjusted mean between-group difference in DASH score was −1.2 (95% confidence interval [CI], −7.3 to 5.0; p = 0.71) favoring the FA group, and, with adjustment for smoking, alcohol drinking, and diabetes, the between-group difference was −1.4 (95% CI, −7.7 to 5.0; p = 0.67) favoring FA. No significant differences between the 2 groups were found among the secondary outcomes.

Conclusions: 

No additional benefit was found for FA augmentation in treating medial column comminuted proximal humeral fractures.

Level of Evidence: 

Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

中文翻译：

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同种异体腓骨移植物对内侧柱粉碎性肱骨近端骨折的影响：一项随机对照试验

背景： 

之前的观察性研究和荟萃分析建议在使用锁定钢板 (LP) 治疗肱骨近端骨折期间使用腓骨同种异体移植物 (FA) 进行增强。然而，据我们所知，迄今为止尚未进行比较切开复位内固定 (ORIF) 有无 FA 的随机对照试验。

方法： 

这是一项随机对照试验，其中患有内侧柱粉碎性近端肱骨骨折的成年人被随机分配接受带 LP 的 ORIF（LP 组）或 LP 加 FA 增强的 LP（FA 组）。患者随访 24 个月。主要结果是手术后 12 个月的手臂、肩部和手部残疾 (DASH) 评分。次要结果包括其他时间点的 DASH 评分、肩功能、疼痛评分、满意度、并发症以及颈干角和肱骨头高度的变化。

结果： 

从 2016 年 10 月 20 日到 2019 年 12 月 24 日，80 名患者被随机分组​​。有 52 名女性 (65%)，平均患者年龄（和标准差）为 65 ± 14 岁。80 例患者中，39 例分配至 FA 组，41 例分配至 LP 组。在主要时间点（12 个月），DASH 评分的未调整平均组间差异为 −1.2（95% 置信区间 [CI]，−7.3 至 5.0；p = 0.71）有利于 FA 组，并且经过调整对于吸烟、饮酒和糖尿病，FA 的组间差异为 −1.4（95% CI，−7.7 至 5.0；p = 0.67）。在次要结果中，两组之间没有发现显着差异。

结论： 

未发现 FA 增强治疗内侧柱粉碎性肱骨近端骨折有额外益处。

证据等级： 

治疗二级。有关证据等级的完整描述，请参阅作者须知。