钢板固定与非手术治疗移位型锁骨中段骨折的多中心随机对照试验
Plate Fixation Compared with Nonoperative Treatment for Displaced Midshaft Clavicular Fractures: A Multicenter Randomized Controlled Trial.
作者信息
Woltz Sarah, Stegeman Sylvia A, Krijnen Pieta, van Dijkman Bart A, van Thiel Tom P H, Schep Niels W L, de Rijcke Piet A R, Frölke Jan Paul M, Schipper Inger B
机构信息
1Leiden University Medical Center, Leiden, the Netherlands 2Flevo Hospital, Almere, the Netherlands 3Koningin Beatrix Hospital, Winterswijk, the Netherlands 4Maasstad Hospital, Rotterdam, the Netherlands 5IJsselland Hospital, Capelle a/d IJssel, the Netherlands 6Radboud University Medical Center, Nijmegen, the Netherlands.
出版信息
J Bone Joint Surg Am. 2017 Jan 18;99(2):106-112. doi: 10.2106/JBJS.15.01394.
BACKGROUND
The use of operative treatment for clavicular fractures is increasing, despite varying results in previous studies. The aim of this study was to compare plate fixation and nonoperative treatment for displaced midshaft clavicular fractures with respect to nonunion, adverse events, and shoulder function.
METHODS
In this multicenter, prospective, randomized controlled trial, patients between 18 and 60 years old with a displaced midshaft clavicular fracture were randomized between nonoperative treatment and open reduction with internal plate fixation. The primary outcome was evidence of nonunion at 1 year. Other outcomes were secondary operations, arm function as measured with the Constant shoulder score and Disabilities of the Arm, Shoulder and Hand (DASH) score, pain, cosmetic results, and general health status. Outcomes were recorded at 6 weeks, 3 months, and 1 year following trauma.
RESULTS
One hundred and sixty patients were randomized. The rate of nonunion was significantly higher in the nonoperatively treated group than in the operatively treated group (23.1% compared with 2.4%; p < 0.0001), as was the rate of nonunion for which secondary plate fixation was performed (12.9% compared with 1.2%; p = 0.006). The rate of secondary operations was 27.4% in the operatively treated group (16.7% for elective plate removal) and 17.1% in the nonoperatively treated group (p = 0.18). Nineteen percent of the patients in the operatively treated group had persistent loss of sensation around the scar. No difference was found between the groups with respect to the Constant and DASH scores at all time points.
CONCLUSIONS
For patients with a diaphyseal fracture of the clavicle displaced at least 1 shaft width, plate fixation improves the chances that the bone will heal; however, the rate of patients who need a second operation is considerable. In addition, the procedure does not improve shoulder function or general symptoms, and it does not decrease limitations compared with nonoperative treatment in a sling.
LEVEL OF EVIDENCE
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
背景
尽管先前研究结果各异，但锁骨骨折手术治疗的应用仍在增加。本研究的目的是比较钢板固定与非手术治疗移位型锁骨中段骨折在骨不连、不良事件及肩部功能方面的差异。
方法
在这项多中心、前瞻性、随机对照试验中，年龄在18至60岁之间的移位型锁骨中段骨折患者被随机分为非手术治疗组和切开复位内固定钢板治疗组。主要结局是1年时骨不连的证据。其他结局包括二次手术、用Constant肩部评分和上肢、肩部和手部功能障碍（DASH）评分评估的上肢功能、疼痛、美容效果及总体健康状况。在创伤后6周、3个月和1年记录结局。
结果
160例患者被随机分组。非手术治疗组的骨不连发生率显著高于手术治疗组（分别为23.1%和2.4%；p<0.0001），需要进行二次钢板固定的骨不连发生率也是如此（分别为12.9%和1.2%；p = 0.006）。手术治疗组的二次手术率为27.4%（其中16.7%为择期取出钢板），非手术治疗组为17.1%（p = 0.18）。手术治疗组19%的患者在瘢痕周围存在持续性感觉丧失。在所有时间点，两组在Constant和DASH评分方面均未发现差异。
结论
对于锁骨骨干骨折移位至少1个骨干宽度的患者，钢板固定可提高骨折愈合的几率；然而，需要二次手术的患者比例相当高。此外，与使用吊带的非手术治疗相比，该手术并未改善肩部功能或总体症状，也未减少功能受限情况。
证据水平
治疗性I级。有关证据水平的完整描述，请参阅作者指南。
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