锁骨远端骨折新分型的建立及临床应用效果评价

Establishment of a new classification system for distal clavicle fracture and its clinical efficiency evaluation

目的建立锁骨远端骨折新分型并评估其临床应用效果。方法采用回顾性病例系列研究分析南京医科大学第一附属医院2015年1月至2022年3月收治的101例锁骨远端骨折患者的临床资料,其中男57例,女44例;年龄19~86岁[(53.8±14.0)岁]。治疗前,常规摄双侧肩关节正位X线片,测量骨折块长度、喙锁间距和肩锁间距。根据骨折线位置和喙锁韧带止点关系将锁骨远端骨折分为三型:Ⅰ型为骨折线位于喙锁韧带区域外侧,Ⅱ型为骨折线位于喙锁韧带区域,Ⅲ型为骨折线位于喙锁韧带区域内侧。根据喙锁韧带和肩锁韧带损伤情况将Ⅰ型进一步细分为ⅠA、ⅠB、ⅠC和ⅠD型;Ⅱ型进一步细分为ⅡA、ⅡB、ⅡC、ⅡD和ⅡE型。由10名高年资和10名低年资肩关节外科医师依据新分型方法对101例患者进行分型,间隔3个月后随机再次分型。采用Kappa系数评价新分型观察者间和观察者内的一致性。52例稳定骨折(ⅠA、ⅠB、ⅡC、ⅡD型)采取非手术治疗;49例不稳定骨折(ⅠC、ⅠD、ⅡA、ⅡB、ⅡE、Ⅲ型)采取手术治疗,其中喙锁韧带解剖重建26例,锁定钢板固定9例,锁骨钩钢板固定8例,锁定钢板固定联合喙锁韧带解剖重建4例,拉力螺钉固定联合喙锁韧带解剖重建2例。记录治疗前及治疗后3、6、12、18个月视觉模拟评分(VAS)及Constant-Murley肩关节评分;在治疗后3、6、12、18个月健侧和患侧肩关节正位X线片上测量喙锁间距和肩锁间距;观察骨折愈合时间及并发症发生情况。结果骨折块长度Ⅰ型骨折患者为12.9(9.7,17.6)mm,Ⅱ型骨折患者为24.7(21.8,27.8)mm,Ⅲ型骨折患者为43.6(41.2,46.9)mm(P<0.01)。ⅠA、ⅠB、ⅡC、ⅡD和Ⅲ型骨折患者患侧喙锁间距和肩锁间距较健侧差异均无统计学意义(P>0.05);ⅠC、ⅡA、ⅡB和ⅡE型骨折患者患侧喙锁间距较健侧均明显增大(P<0.01),而患侧肩锁间距较健侧差异均无统计学意义(P>0.05)。新分型的观察者间和观察者内一致性均良好,其中高年资肩关节外科医师间Kappa值为0.69,高年资肩关节外科医师内Kappa值为0.71;低年资肩关节外科医师间Kappa值为0.61,低年资肩关节外科医师内Kappa值为0.64。患者均获随访18~104个月[28(23,32)个月]。非手术患者治疗后3、6、12、18个月VAS分别为3(2,3)分、2(1,2)分、1(0,1)分、0(0,1)分,均较治疗前的6(5,6)分明显改善(P<0.01);手术患者治疗后3、6、12、18个月VAS分别为3(2,3)分、2(1,2)分、1(1,1)分、0(0,1)分,均较治疗前的6(5,7)分明显改善(P<0.01)。非手术患者治疗后3、6、12、18个月Constant-Murley肩关节评分分别为(76.6±5.3)分、(84.3±5.0)分、(88.4±4.0)分、(91.9±3.8)分,均较治疗前的(42.7±5.2)分明显改善(P<0.01);手术患者治疗后3、6、12、18个月Constant-Murley肩关节评分分别为(77.4±4.6)分、(84.4±4.7)分、(87.6±3.7)分、(91.7±4.0)分,均较治疗前的(42.8±5.3)分明显改善(P<0.01)。治疗后3、6、12、18个月非手术患者患侧喙锁间距较治疗前差异均无统计学意义(P>0.05),而手术患者患侧喙锁间距较治疗前均明显缩小(P<0.01)。非手术和手术患者治疗后3、6、12、18个月健侧喙锁间距及双侧肩锁间距较治疗前均差异无统计学意义(P>0.05)。治疗后12个月骨折均愈合。无肩锁关节脱位或半脱位,未发生内固定失败或内固定物断裂。锁骨钩钢板固定的8例患者术后均出现肩部疼痛伴活动受限,术后12个月均行二次手术取出锁骨钩钢板。结论建立的新型锁骨远端骨折分型综合考虑了骨折线位置、喙锁韧带和肩锁韧带损伤情况及骨折稳定性。此分型具有良好的观察者间和观察者内一致性,且初步临床应用效果较好。

Objective To establish a new classification system for distal clavicle fracture and evaluate its clinical effectiveness.Methods A retrospective case series study was conducted to analyze the clinical data of 101 patients with distal clavicle fracture admitted to First Affiliated Hospital of Nanjing Medical University from January 2015 to March 2022,including 57 males and 44 females,aged 19-86 years[(53.8±14.0)years].Before treatment,patients were routinely subjected to bilateral anteroposterior radiography of the shoulder joints to measure the length of the fractured fragments,coracoclavicular distance,and acromioclavicular distance.According to the correlation between the location of the fracture line and the insertion of the coracoclavicular ligament,distal clavicle fracture was divided into three types:type I,with the fracture line lateral to the coracoclavicular ligament region;type II,with the fracture line in the coracoclavicular ligament region;type III,with the fracture line medial to the coracoclavicular ligament region.According to the injury severity of the coracoclavicular ligament and acromioclavicular ligament,type I was further subdivided into type IA,IB,IC and ID,and type II fracture was further subdivided into type IIA,IIB,IIC,IID and IIE.All the 101 patients were classified and randomly reclassified at an interval of 3 months by 10 senior and 10 junior shoulder surgeons according to the new classification method.Kappa coefficients were used to evaluate the inter-and intra-observer consistency of the new classification.Fifty-two patients with stable fracture(types IA,IB,IIC,and IID)were treated non-surgically,while 49 patients with unstable fracture(types IC,ID,IIA,IIB,IIE,and III)were treated surgically,including 26 patients with anatomic coracoclavicular ligament reconstruction,9 with locking plate fixation,8 with clavicle hook plate fixation,4 with anatomic coracoclavicular ligament reconstruction combined with locking plate fixation,and 2 with anatomic coracoclavicular ligament reconstruction combined with tension screw fixation.The patients were assessed using the visual analogue scale(VAS)and Constant-Murley shoulder score before treatment and at 3,6,12,and 18 months after treatment.The coracoclavicular distance and acromioclavicular distance on the anteroposterior radiographs of the healthy and affected shoulder joints were measured at 3,6,12,and 18 months after treatment,and fracture healing time and complications were observed.Results The length of the fractured fragments was 12.9(9.7,17.6)mm in patients with type I fracture,24.7(21.8,27.8)mm in patients with type II fracture,and 43.6(41.2,46.9)mm in patients with type III fracture(P<0.01).There were no significant differences in the coracoclavicular distance and acromioclavicular distance of the affected and healthy shoulders among the patients with types IA,IB,IIC,IID,and III fracture(P>0.05);For the patients with types IC,IIA,IIB and IIE fracture,the coracoclavicular distance of the affected shoulder was significantly increased compared with that of the healthy shoulder(P<0.01),while there was no significant difference in the acromioclavicular distance of the affected and healthy shoulders(P>0.05).Both of the inter-and intra-observer consistency of the new classification was good.The inter-and intra-observer Kappa values were 0.69 and 0.71 respectively among the senior shoulder surgeons,and 0.61 and 0.64 respectively among the junior shoulder surgeons.All the patients were followed up for 18-104 months[28(23,32)months].At 3,6,12 and 18 months after treatment,the VAS scores of non-surgical patients were 3(2,3)points,2(1,2)points,1(0,1)points and 0(0,1)points respectively,significantly decreased compared with 6(5,6)points before treatment(P<0.01);the VAS scores of surgical patients were 3(2,3)points,2(1,2)points,1(1,1)points and 0(0,1)points respectively,significantly decreased compared with 6(5,7)points before treatment(P<0.01);the Constant-Murley shoulder scores of non-surgical patients were(76.6±5.3)points,(84.3±5.0)points,(88.4±4.0)points and(91.9±3.8)points respectively,significantly higher than(42.7±5.2)points before treatment(P<0.01);the Constant-Murley shoulder scores of surgical patients were(77.4±4.6)points,(84.4±4.7)points,(87.6±3.7)points and(91.7±4.0)points respectively,significantly higher than(42.8±5.3)points before treatment(P<0.01).At 3,6,12 and 18 months after treatment,the coracoclavicular distance of the affected shoulder in non-surgical patients was not significantly different from that before treatment(P>0.05),while the acromioclavicular distance of the affected shoulder in surgical patients was significantly reduced compared with that before treatment(P<0.01).There were no significant differences in the coracoclavicular distance of the healthy shoulder or bilateral acromioclavicular distance in non-surgical and surgical patients at 3,6,12,and 18 months after treatment compared with those before treatment(P>0.05).Fractures were healed within 12 months after treatment in all the patients,without dislocation or subluxation of the acromioclavicular joint,internal fixation failure or internal fixator breakage.Eight patients treated with clavicular hook plate fixation had shoulder pain associated with limited mobility after operation,and all underwent a second operation to remove the clavicular hook plate at 12 months after operation.Conclusions The new classification system for distal clavicle fracture is established,which comprehensively considers the position of the fracture line,injury of the coracoclavicular and acromioclavicular ligaments,and fracture stability.The new classification system exhibits good inter-and intra-observer consistency,and the effectiveness of its preliminary clinical application is satisfactory.