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移位型锁骨中段骨折的治疗:8字绷带与前路钢板内固定术:一项随机对照试验

Treatment of Displaced Midshaft Clavicle Fractures: Figure-of-Eight Harness Versus Anterior Plate Osteosynthesis: A Randomized Controlled Trial.

作者信息

Tamaoki Marcel Jun Sugawara, Matsunaga Fabio Teruo, Costa Adelmo Rezende Ferreira da, Netto Nicola Archetti, Matsumoto Marcelo Hide, Belloti Joao Carlos

机构信息

1Department of Orthopedics and Traumatology, Universidade Federal de São Paulo-Escola Paulista de Medicina (Unifesp-EPM), São Paulo, Brazil.

出版信息

J Bone Joint Surg Am. 2017 Jul 19;99(14):1159-1165. doi: 10.2106/JBJS.16.01184.

DOI:10.2106/JBJS.16.01184
PMID:28719554
Abstract

BACKGROUND

Most midshaft clavicle fractures affect the economically active population, which is negatively impacted by transient limb impairment during the treatment. There is still debate about the advantages and disadvantages of surgical treatment for these fractures.

METHODS

In this prospective randomized controlled trial, 117 patients were allocated to 1 of 2 groups: nonsurgical treatment with a figure-of-eight harness or surgical treatment with anteroinferior plate osteosynthesis. The primary outcome was upper-limb limitation measured with the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire at 6 months. Other outcomes included pain, radiographic findings, satisfaction with the cosmetic result, complications, and time to return to previous work and activities. Participants were assessed at 6 weeks, 6 months, and 1 year after the intervention.

RESULTS

No difference between the 2 groups was detected in the DASH score at any time point (p = 0.398, 0.403, and 0.877 at 6 weeks, 6 months, and 1 year, respectively), pain levels measured with a visual analogue scale (VAS), time to return to previous activities, or dissatisfaction with the cosmetic result. Seven patients (14.9%) developed nonunion after nonsurgical treatment, a nonunion rate that was significantly higher than that in the surgical group, in which all fractures had healed (p = 0.004). The patients in the nonsurgical group had radiographic evidence of greater clavicle shortening (p < 0.001) and more of the patients in that group answered "yes" when asked if their clavicle felt short (p < 0.001) and if they felt bone prominence (p < 0.001). More patients answered "yes" when asked if they felt paresthesia in the surgical group (7; 13.7%) than in the nonsurgical group (1; 2.1%) (p = 0.036).

CONCLUSIONS

This study did not demonstrate a difference in limb function between patients who underwent surgical treatment and those nonsurgically treated for a dislocated midshaft clavicle fracture. Meanwhile, surgical treatment decreased the likelihood of nonunion.

LEVEL OF EVIDENCE

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

摘要

背景

大多数锁骨中段骨折影响经济活跃人群,治疗期间的短暂肢体功能障碍会对其产生负面影响。对于这些骨折的手术治疗利弊仍存在争议。

方法

在这项前瞻性随机对照试验中,117例患者被分配到以下两组之一:采用“8”字绷带进行非手术治疗或采用前下钢板接骨术进行手术治疗。主要结局指标是在6个月时使用手臂、肩部和手部功能障碍(DASH)问卷测量的上肢功能受限情况。其他结局指标包括疼痛、影像学检查结果、对外观效果的满意度、并发症以及恢复至先前工作和活动的时间。在干预后6周、6个月和1年对参与者进行评估。

结果

在任何时间点,两组之间的DASH评分均未检测到差异(6周、6个月和1年时分别为p = 0.398、0.403和0.877),采用视觉模拟量表(VAS)测量的疼痛程度、恢复至先前活动的时间或对外观效果的不满意程度也无差异。7例患者(14.9%)在非手术治疗后发生骨不连,该骨不连发生率显著高于手术组,手术组所有骨折均已愈合(p = 0.004)。非手术组患者有影像学证据显示锁骨缩短更明显(p < 0.001),当被问及锁骨是否感觉短(p < 0.001)以及是否感觉有骨突出(p < 0.001)时,该组更多患者回答“是”。当被问及是否感觉有感觉异常时,手术组回答“是”的患者(7例;13.7%)多于非手术组(1例;2.1%)(p = 0.036)。

结论

本研究未证明锁骨中段骨折脱位接受手术治疗和非手术治疗的患者在肢体功能上存在差异。同时,手术治疗降低了骨不连的可能性。

证据级别

治疗性I级。有关证据级别的完整描述,请参阅作者须知。

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