微创弹性钉与传统切口钢板治疗锁骨中段骨折的前瞻性随机对照研究

Intramedullary nailing versus plate fixation for midshaft clavicular fractures:a prospective randomized controlled trial

目的比较微创弹性钉内固定与传统切口钢板内固定治疗成人锁骨中段骨折的临床疗效。方法采用随机数字表法将2013年1月至2017年12月收治的113例成人锁骨中段骨折患者分为2组,分别采用微创弹性钉和传统切口钢板内固定治疗。其中微创弹性钉组58例,男37例,女21例,年龄17~64岁,平均42岁;传统切口钢板组55例,男34例,女21例,年龄20~63岁,平均41岁。记录并比较两组患者手术切口总长度、手术时间、骨折愈合时间、Constant-Murley肩关节功能评分、臂肩手残疾评分(DASH)、并发症发生情况。结果所有患者术后获得13~26个月随访。术后1年微创弹性钉组与传统切口钢板组Constant-Murley肩关节功能评分及DASH评分差异均无统计学意义(P>0.05)。微创弹性钉组手术切口总长度[(4.3±1.2)cm]、手术时间[(41.3±21.2)min]均较传统切口钢板组[(11.8±2.6)cm]、[(75.4±19.6)min]短,差异具有统计学意义(P<0.05)。微创弹性钉组骨折愈合时间[(12.3±2.4)周]较传统切口钢板组[(15.6±2.8)周]短,差异具有统计学意义(P<0.05)。微创弹性钉组与传统切口钢板组并发症发生率分别为12.1%(7/58)、9.1%(5/55),差异无统计学意义(P>0.05)。结论微创弹性钉内固定治疗锁骨中段骨折可获得与传统切口钢板内固定相当的术后疗效,但手术瘢痕明显小且软组织损伤轻,同时并发症发生率与传统切口钢板内固定也无明显差异。

Objective To compare the clinical outcome of intramedullary nailing versus plate fixation for treatment of midshaft clavicular fractures.Methods A prospective randomized,controlled trial was performed between January 2013 and December 2017,which finally included113 patients with acute displaced midshaft clavicular fractures.They were randomly divided into 2 groups to receive either intramedullary nailing(n=58)or open reduction and plate fixation(n=55).Fifty eight patients were allocated in the minimally intramedullary nail group,37 males and 21 females,with an average of 42 years old(range,17 to 64 years);55 patients in the plate fixation group,34 males and 21 women,with an average age of 41 years old(range,20 to 63 years).The total length of surgical incision,operation duration,fracture union period,Constant-Murley shoulder function score,disabilities of the arm,shoulder and hand(DASH)score of the shoulder,and complications were recorded and compared between both groups.Results All patients were followed up for 13 to 26 months after operation.There was no significant difference in the Constant-Murley shoulder function scores and DASH scores after surgery(P>0.05).In the minimally intramedullary nailing group,the incision lengths and operation duration were 4.3±1.2 cm and 41.3±21.2 min,respectively,which were significantly shorter than those of the plate fixation group(11.8±2.6 cm,75.4±19.6 min)(P<0.05).The fracture union period of the minimally intramedullary nail group(12.3±2.4 weeks)was significantly shorter than that of the plate fixation group(15.6±2.8 weeks)(P<0.05).The incidence of complications in the minimally intramedullary nail group and the plate fixation group were 12.1%(7/58)and 9.1%(5/55),respectively,and there was no significant difference(P>0.05).Conclusion Minimally intramedullary nailing can be used to treat midshaft clavicular fractures with the same functional scores as plate fixation,with comparable incidence of complications,shorter incisions and less soft tissue damage.