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Chinese Journal of Reparative and Reconstructive Surgery logoLink to Chinese Journal of Reparative and Reconstructive Surgery
. 2022 Nov;36(11):1327–1334. [Article in Chinese] doi: 10.7507/1002-1892.202206060

骨盆解锁复位装置复位不稳定骨盆后环损伤多中心研究

A multicenter retrospective study assessing pelvic unlocking closed reduction device for reducing unstable pelvic posterior ring disruption

Hua CHEN 1, Qun ZHANG 1,, Ming HAO 1,, Jiantao LI 1,, Hongzhe QI 2,, Chengla YI 3,, Xiaodong GUO 4,, Shicai FAN 5,, Jiandong WANG 6,, Longpo ZHENG 7,, Yue FANG 8,, Shuquan GUO 9,, Gang LÜ 10,, Xuefeng ZHOU 2,, Yan ZHUANG 11,, Zhanying SHI 12,, Dapeng ZHOU 13,, Peifu TANG 1,*
PMCID: PMC9681597  PMID: 36382448

Abstract

Objective

To explore the application value and effectiveness of pelvic unlocking closed reduction device for the treatment of unstable pelvic posterior ring disruption.

Methods

A retrospective analysis of clinical data of 243 cases of unstable pelvic posterior ring disruption treated with pelvic unlocking closed reduction device in 13 orthopaedic trauma centers across the country between December 2018 and June 2020 was performed. There were 139 males and 104 females; the age ranged from 18 to 92 years, with an average age of 48.5 years. The cause of injury included 132 cases of traffic accident injuries, 102 cases of falling from height, and 9 cases of crushing injuries. According to AO/Orthopaedic Trauma Association (AO/OTA) classification, there were 5 cases of type 61-B1, 13 cases of type 61-B2, 32 cases of type 61-C1.1, 47 cases of type 61-C1.2, 89 cases of type 61-C1.3, 35 cases of type 61-C2, and 22 cases of type 61-C3. The time from injury to operation was 2-121 days, with a median of 10 days. Preoperative preparation time, installation time of unlocking closed reduction device, fracture reduction time, intraoperative fluoroscopy times, intraoperative blood loss, and surgical complications were recorded, and Matta scoring standard was used to evaluate the quality of fracture reduction. According to Matta evaluation results, the patients were divided into two subgroups: excellent-good group and fair-poor group. The differences in gender, age, time from injury to operation, AO/OTA classification, and perioperative clinical indicators were compared between the two groups, and the effects of baseline data and perioperative indicators on the quality of fracture reduction were studied.

Results

Pelvic unlocking closed reduction device did not interfere with the display of the pelvic structure and fracture displacement direction during the intraoperative fluoroscopy, effectively correcting the displacement of the pelvic ring. The preoperative preparation time was 17-60 minutes, with an average of 30 minutes; installation time of unlocking closed reduction device was 10-32 minutes, with an average of 21 minutes; intraoperative fracture reduction time was 15-205 minutes, with an average of 49.2 minutes; intraoperative fluoroscopy times were 41-420 times, with an average of 132 times; intraoperative blood loss was 40-1 500 mL, with an average of 71.5 mL. The reduction quality of pelvic fracture was evaluated according to Matta score immediately after operation. The results were excellent in 153 cases, good in 61 cases, fair in 24 cases, and poor in 5 cases. The excellent and good rate was 88.1%. Further subgroup analysis showed that there was no significant difference in other indexes (P>0.05) between the excellent-good group and the fair-poor group except for the time from injury to operation and AO/OTA classification (P<0.05). Among them, the excellent-good reduction rate was 92.2% (119/129) in patients with injury-to-operation time less than 10 days, and the fair-poor reduction rate was 25.7% (9/35) and 40.9% (9/22) in patients with AO/OTA 61-C2 and 61-C3 types, respectively. There was no surgery-related complication due to the application of the pelvic unlocked reduction device, no secondary iliac fractures, vascular, or nerve injuries, and postoperative CT showed that all channel screws were located in the osseous channel.

Conclusion

The pelvic unlocking reduction device can effectively help to reduce the unstable pelvic posterior ring and maintain reduction, meet the needs of different projection angles of pelvic fracture with intraoperative C-arm fluoroscopy. The system facilitate the operation of pelvic reduction and precise fixation.

Keywords: Pelvic unstable posterior ring disruption, minimally invasive internal fixation, pelvic unlocking closed reduction device


骨盆骨折发生率占全身骨折的3%~8%,多为高能量损伤所致,常合并其他部位损伤,如四肢骨折(85%)、胸部损伤(70%)、腹部损伤(60%)、头颅损伤(60%)等[1-6]。由于经典切开复位内固定手术存在切口暴露大、出血多等不足,对于严重移位、不稳定骨盆骨折患者往往需要推迟手术,待血流动力学稳定、伤后7~10 d血肿相对机化以后才能进行,大大增加了骨折复位难度。因此,此类患者通过不切开或者小切口实现严重移位骨盆骨折闭合复位、通过通道螺钉完成骨盆环的稳定,在很多临床医生中已达成共识[7-12]。本团队率先在国内探讨如何闭合复位严重移位骨盆骨折,提出“解锁复位”理念,并设计了骨盆解锁复位装置[913-14]。在国家骨科与运动康复临床医学研究中心组建的“环骨盆微创救治联盟”推动下,我们对严重移位骨盆骨折闭合复位手术开展的必要条件进行了规范[12-13],并在全国推广。现回顾分析2018年12月—2020年6月全国13个骨创伤中心收治的243例骨盆骨折患者临床资料,探讨骨盆解锁复位装置对不稳定骨盆后环损伤复位和维持复位的效果。报告如下。

1. 临床资料

1.1. 骨盆解锁复位装置

骨盆解锁复位装置(专利号:CN201510543929.3;石家庄高新区亿成科技有限公司),需要和带硬性连接牵引的全透视手术床、铅板、透视机(影像增强器>9英寸)一起使用。如果没有全透视牵引手术床,可使用自制木质手术床替代,包括躺板、支臂板,衔接处有加固三角、加固横梁,加固横梁窄于躺板,躺板左右边缘需留出50 mm空间,以安装骨盆解锁复位装置。硬性连接牵引可用股骨转子间骨折手术牵引床与木床串联替代,牵引通过尼龙绳与患者股骨髁上牵引的牵引弓相连,以提供严重移位骨盆骨折复位的纵向牵引力。见图1

图 1.

Layout of pelvic unlocking closed reduction device and other equipment in the operation room

骨盆解锁复位装置使用手术室布局

a. 带硬性连接牵引的全透视手术床以及骨盆解锁复位装置;b. 木质手术床模式图及对应尺寸说明;c. 木质手术床的三视图;d. 手术床、骨盆解锁复位装置、股骨转子间骨折手术牵引床、透视机和天玑骨科机器人在手术室术中摆位

a. Complete radiolucent surgical table with rigid traction arc and pelvic unlocking closed reduction device; b. Diagram of wooden operating bed and description of corresponding dimensions; c. Three views of the wooden operating table; d. Layout of operating table, pelvic unlocking closed reduction device, surgical traction table for intertrochanteric fracture, fluoroscopy machine, and TiRobot system in the operating room

图 1

1.2. 一般资料

纳入标准:① 年龄>18岁;② 不稳定骨盆后环损伤(纵向稳定、旋转不稳定或纵向、旋转均不稳定),骨折或脱位最大位移>1 cm;③ 采用骨盆解锁复位装置闭合复位。排除合并严重心脑血管、肝、肾和造血系统疾病及精神病者。

本组男139例,女104例;年龄18~92岁,平均48.5岁。致伤原因:交通事故伤132例,高处坠落伤102例,压砸伤9例。单侧骨盆骨折移位186例,其中左侧96例、右侧90例;双侧57例。骨折按国际内固定研究协会/美国骨创伤协会(AO/OTA)分型:61-B1型5例,61-B2型13例,61-C1.1型32例,61-C1.2型 47例,61-C1.3型 89例,61-C2型35例,61-C3型22例。受伤至手术时间2~121 d,中位时间10 d;其中≤10 d 129例,>10 d 114例。术前摄骨盆正位、出口位、入口位X线片,并行CT平扫及三维重建检查,评估骨折移位情况。

1.3. 手术方法

参照文献 [9] 方法进行手术。患者于全身麻醉下仰卧于全透视手术床上,上肢外展、伸直置于支臂板上,腰骶部垫枕。常规消毒铺单,安装骨盆解锁复位装置,将其通过夹具固定于全透视手术床上。单侧骨盆骨折移位、健侧结构完整时,以健侧作为复位基准,即在健侧骨盆上分别植入髋臼上横行螺钉(直径6 mm,长度40 cm)和LC-2螺钉,将钉尾通过夹头固定于骨盆解锁复位装置上;健侧骨盆和复位装置通过连接形成稳定体。借助患侧的髋臼上横行螺钉、LC-2螺钉、股骨髁上牵引以及髂嵴顶棒等多种手段,实现骨盆骨折在三维空间的整体复位。其中,通过推拉髋臼上横行螺钉可纠正骨盆内、外翻移位,配合球形顶棒推压,可实现位置维持和微调;通过内外或上下旋转LC-2螺钉可纠正骨盆内外、上下旋转移位;患者下肢股骨髁上沿肢体长轴方向牵引可同时纠正骨盆后环的上下移位。术中实时透视骨盆正位、侧位、入口位和出口位,判断骨盆环是否复位;然后通过相应通道螺钉恢复骨盆环的稳定。

1.4. 术后处理

术后口服利伐沙班片10 mg,每日1次,连续35 d,防止下肢深静脉血栓形成。术后第1天允许患者在床上行肌肉等长收缩练习,每日1次极限被动屈髋、屈膝练习(屈髋、屈膝均>90°),防止关节僵硬。术后根据X线片显示的骨折愈合情况决定患者负重锻炼时间。

1.5. 疗效观测指标

记录术前准备时间、骨盆解锁复位装置安装时间、术中骨折复位时间、术中透视次数、术中出血量,观察手术并发症发生情况。术后摄骨盆正位、出口位、入口位X线片,并行CT平扫及三维重建检查,采用Matta评分标准评价骨折复位质量。将患者按Matta评价结果分为优良和可差两个亚组,比较两组患者性别、年龄、受伤至手术时间、AO/OTA分型及各围术期临床指标的差异,研究患者基线资料及围术期临床指标对骨折复位质量的影响。

1.6. 统计学方法

采用SPSS23.0统计软件进行分析。计量资料行正态性检验,符合正态分布的数据以均数±标准差表示,组间比较采用独立样本t检验;计数资料采用频数表示,组间比较采用χ² 检验;等级资料比较采用秩和检验。检验水准取双侧α=0.05。

2. 结果

在骨盆后环损伤闭合复位、维持复位及通道螺钉完成骨盆环稳定过程中,骨盆解锁复位装置不干扰透视机(影像增强器>9英寸)对骨盆解剖结构、骨折块移位方向的显示,如骨盆正位、出口位、入口位,髂骨斜位,骶髂关节入口正位、骶髂关节出口正位、髂骨翼正位等(图2)。股骨转子间手术牵引床与木质手术床串联在一起,可与股骨髁上牵引弓相连,为纠正骨盆纵向移位复位提供牵引力,达到与带硬性连接牵引的全透视手术床一样的效果。

图 2.

A 34-year-old male patient with AO/OTA type 61-C1.2, pelvic unlocking closed reduction device did not interfere with intraoperative fluoroscopic visualization of pelvic structure and the direction of fracture displacement

患者,男,34岁,AO/OTA 61-C1.2型,骨盆解锁复位装置不干扰术中透视对骨盆结构和骨折移位方向的显示

a. 骨盆正位,耻骨联合点状复位钳复位后克氏针临时稳定,双侧髋臼上横行螺钉和LC-2螺钉完成对双侧髂骨的把持;b. 骨盆入口位,骨盆双侧闭口重叠,耻骨联合分离前后方向移位被纠正;c. 骨盆出口位,耻骨联合与S2椎体重合,脱位的耻骨联合上下方向移位被纠正;d. 髂骨斜位,显示LC-2螺钉通道上下方向和髋臼上横行螺钉植入深度,螺钉深度穿过骨盆内壁皮质1个螺纹;e. 骶髂关节入口正位,显示LC-2螺钉通道内外方向,骶髂关节间隙,LC-2螺钉避免穿入骶髂关节或突破髂骨翼外板皮质;f. 骨盆入口位,骶髂关节螺钉通道(骶骨岬前侧皮质重叠),骶髂关节前后方向移位被纠正,右侧骶髂关节间隙轻度增宽;g. 骨盆出口位,骶髂关节上下方向移位被纠正;h. 骨盆正位,骨盆环内外旋转被纠正;i. 髂骨翼正位,骶髂关节螺钉的钉尾紧贴髂骨翼外板皮质

a. Anteroposterior view, Kirschner wire temporarily stabilized pubic symphysis after reduction of pubic symphysis with pointed reduction forceps, then bilateral supra-acetabular transverse screws and LC-2 screws were placed for control of bilateral iliac bones; b. In-let view, bilateral obturator disappeared, the displacement of the pubic symphysis separation in the anterior and posterior directions was corrected; c. Out-let view, the pubic symphysis merged with the S2 vertebral body, and the displacement of the pubic symphysis separation in the upper and lower directions was corrected; d. Iliac oblique view, the upper and lower directions of the LC-2 channel and the supra-acetabular transverse screw insertion depth, the screw passing through the inner cortex of the pelvis by 1 thread; e. Down-the-sacro-iliac-joint view (inlet), the internal and external directions of the LC-2 channel, the sacroiliac joint space, and the LC-2 screw to avoid penetrating through the sacroiliac joint or breaking through the cortex of the outer plate of the iliac wing; f. In-let view, the sacroiliac joint screw channel (anterior sacral promontory cortex overlapping), sacroiliac joint anterior-posterior displacement corrected, slight widening of the right sacroiliac joint space; g. Out-let view, the displacement of the sacroiliac joint in the upper and lower directions was corrected; h. Anteroposterior view, internal and external rotational displacement of the pelvic ring corrected; i. Down-the-iliac-wing-view, the screw tail of the sacroiliac joint screw was close to the outer plate of the iliac wing

图 2

本组术前准备时间17~60 min,平均30 min;骨盆解锁复位装置安装时间10~32 min,平均21 min;术中骨折复位时间15~205 min,平均49.2 min;术中透视次数41~420次,平均132次;术中出血量40~1 500 mL,平均71.5 mL。骨盆解锁复位装置能够有效矫正骨盆后环损伤移位。术后即刻,按Matta评分标准评价骨盆骨折复位,获优153例、良61例、可24例、差5例,优良率88.1%。进一步亚组分析显示,优良组和可差组间除受伤至手术时间及AO/OTA分型比较差异有统计学意义(P<0.05)外,其余指标比较差异均无统计学意义(P>0.05)。见表1。其中,受伤至手术时间≤10 d的患者优良率达92.2%(119/129),AO/OTA 61-C2和61-C3 型患者复位可差率分别为25.7%(9/35)和40.9%(9/22)。

表 1.

Comparison of clinical data between Matta score excellent-good group and fair-poor group

Matta评分优良组和可差组各临床资料比较

变量
Variable
优良组(n=214)
Excellent-good
group (n=214)
可差组(n=29)
Fair-poor
group (n=29)
统计值
Statistic
性别
 男 121(56.5%) 18(62.1%) χ²=0.319
P=0.690
 女 93(43.5%) 11(37.9%)
年龄(岁) 49.25±15.19 48.03±14.45 t=0.408
P=0.658
受伤至手术时间(d)
 ≤10 119(55.6%) 10(34.5%) χ²=4.576
 >10 95(44.4%) 19(65.5%) P=0.046
术前准备时间(min) 29.76±5.90 29.90±2.97 t=0.121
P=0.904
复位装置安装时间(min) 20.56±3.46 20.07±2.05 t=0.741
P=0.460
术中骨折复位时间(min) 49.37±30.00 47.69±29.20 t=0.284
P=0.777
术中透视次数(次) 126.96±58.55 125.48±62.39 t=0.127
P=0.899
术中出血量(mL) 72.72±147.87 62.17±104.51 t=0.371
P=0.711
AO/OTA分型
 61-B1 5(2.3%) 0(0) Z=–5.346
P<0.001
 61-B2 13(6.1%) 0(0)
 61-C1.1 31(14.5%) 1(3.4%)
 61-C1.2 47(22.0%) 0(0)
 61-C1.3 79(36.9%) 10(34.5%)
 61-C2 26(12.1%) 9(31.0%)
 61-C3 13(6.1%) 9(31.0%)

本组未发生因应用骨盆解锁复位装置导致的手术相关并发症,未继发髂骨骨折、血管和神经损伤。采用INFIX稳定骨盆前环的210例患者中,45例出现一过性股前外侧皮神经损伤,伴有股前外侧皮肤麻木症状,术后6个月自行恢复。患者术后均行CT检查示所有通道螺钉均位于骨性通道内。见图3

图 3.

A 36-year-old female patient with pelvic fracture caused by traffic accident (AO/OTA type 61-C1.2)

患者,女,36岁,交通事故伤致骨盆骨折(AO/OTA 61-C1.2型)

a、b. 术前X线片和CT三维重建示右侧骶髂关节骨折脱位、垂直向移位(新月型),合并右侧耻骨支和坐骨支骨折、左侧耻骨联合骨折;c. 采用骨盆解锁复位装置闭合复位,并用天玑手术机器人辅助植入穿S2的骶髂关节贯穿螺钉固定;d. 手术切口外观;e~g. 术中骨盆正位、出口位和入口位透视示骨盆结构复位并采用穿骶骨骶髂关节全长螺钉、前环INFIX和耻骨联合螺钉固定恢复骨盆环的稳定;h~j. 术后CT三维重建和冠状位、横断位断层影像示骨盆骨折复位达优,螺钉均位于骨质内,未穿出皮质

a, b. Preoperative X-ray film and CT three-dimensional reconstruction showed crescent fracture-dislocation of the right sacroiliac joint, combined with fractures of the right pubic ramus and ischial ramus, and left symphysis pubis; c. Closed reduction was performed using pelvic unlocking closed reduction device, and fixation was performed with a transiliac-transsacral screw inserted into the sacroiliac joint assisted by a TiRobot system; d. The appearance of the surgical incision; e-g. Intraoperative pelvic anteroposterior, out-let, and in-let fluoroscopy showed the reduction of pelvic structures and the stabilization of the pelvic ring with full-length screws through the sacroiliac joint, anterior ring INFIX and pubic symphysis screws; h-j. Postoperative CT three-dimensional reconstruction and coronal and transverse tomographic images showed that the reduction of pelvic fractures was excellent, and the screws were all located in the osseous bone without passing through the cortex

图 3

3. 讨论

骨盆骨折多为高能量损伤,常合并严重脏器损伤,有极高的死亡率和致残率。在兼顾损伤控制[15-16]的原则下,采用骨盆解锁复位装置闭合复位、维持复位及通道螺钉固定骨盆的治疗策略,可实现骨盆骨折早期外科精准治疗。骨盆解锁复位装置可有效复位不稳定骨盆后环损伤的移位并维持复位,满足术中C臂X线机对骨盆骨折不同透视投照角度的需求,方便术者实施骨折复位、精准固定手术。本组总体复位优良率达88.1%,受伤至手术时间≤10 d的患者复位优良率可达92.2%。

国家骨科与运动康复临床医学研究中心牵头成立的“环骨盆微创救治联盟”,对骨盆微创治疗理念和技术不断推广,使得骨盆微创治疗技术已实现向全国医院辐射[1117-25]。在没有碳纤维全透视牵引手术床的医院,使用自制木质手术床、配合骨盆解锁复位装置,可以实现严重移位骨盆骨折闭合复位和复位维持,然后使用通道螺钉完成骨盆环的稳定固定,具有良好效果。手术床为木质材料,结构简单,全透视,实用性强,规格尺寸基于手术操作过程的经验总结和术中常用C臂X线机的结构参数,既方便复位装置安装,又能保证术中不同透视角度进行投照,给予医生足够的操作空间实施骨盆微创手术,也可配合天玑骨科机器人使用。本研究显示骨盆解锁复位装置的安装只需要平均21 min,手术复位时间平均49.2 min,并不增加手术时间,也未发生因安装复位装置导致的手术相关并发症。

术中透视技术是严重移位骨盆骨折闭合复位、通道螺钉植入过程的关键,透视角度多达13个。在该复位装置推广应用过程中,透视遇到了很多困难:① 骨科手术床均存在床边两侧的金属遮挡,影响骨盆结构和移位的显示,特别是骨盆各种斜位角度的显示,如闭孔斜位像、髂骨斜位像、LC-2长轴像(LC-2通道正位像)、泪滴位像(LC-2通道轴位像)、闭孔出口位像、髂骨入口位像、骶髂关节入口正位像、骶髂关节出口正位像、髂骨翼正位像等。② 骨盆结构显露范围有限。目前国内大多数医院采购透视机影像增强器多为9英寸(很少医院为12英寸)。为了显露足够大骨盆视野,患者仰卧位时,透视机影像增强器位于患者上方,需要通过上升或者下降调整透视机高度或升降手术床,使影像增强器与骨盆贴近[26]。但临床中我们发现,透视机已降至最低、床升至最高,仍无法满足临床需要。国内医院使用的透视机,影像增强器离地高度多数在1 300~1 750 mm、影像增强器和射线发射球管距离为70~80 cm,考虑不同患者骨盆的前后径长度及腹部软组织厚度,我们建议手术床升降高度最低设计为1 100 mm、床面宽度为50~53 cm,这使得骨盆结构正好在影像增强器的高度范围内,且存在较大范围可调整缓冲区,从而满足不同透视体位的投照要求。本研究中,术中操作时间和透视时间与既往报道的采用全透视手术牵引床配合骨盆复位架的研究无显著差异[927],可见木质手术床可最大限度满足骨盆闭合复位和透视投照的操作要求。

骨盆解锁复位装置成功构建了严重移位骨盆骨折闭合复位体系,其优势在于:① 骨盆骨折闭合复位和复位维持、经皮通道螺钉固定稳定,术中不切开暴露骨折部位,大大减少了由于出血和创面暴露带来的手术风险。② 将骨盆精确固定手术的时间窗最早提前至伤后24~48 h,只要患者血流动力学稳定就可以进行手术。本组有15例患者为严重多发伤、在ICU救治,采用气管插管、呼吸机辅助呼吸,经综合救治生命体征平稳,于伤后24~72 h完成骨折闭合复位和固定手术。既往这类患者需要等7~10 d才能进行切开复位和固定治疗。

综上述,骨盆解锁复位装置可有效复位不稳定骨盆后环损伤并维持复位,满足术中C臂X线机透视对骨盆骨折不同透视投照角度的需求,方便术者实施骨折复位、精准固定。本研究不足在于缺乏对照,未关注患者远期功能,下一步将开展多中心前瞻性对照研究。

利益冲突 在课题研究和文章撰写过程中不存在利益冲突;经费支持没有影响文章观点和对研究数据客观结果的分析及其报道

伦理声明 研究方案经中国人民解放军总医院伦理委员会批准(伦审第S2020-088-01号);患者均知情同意

作者贡献声明 陈华、张群、齐红哲、易成腊、郭晓东、樊仕才、王建东、郑龙坡、方跃、郭书权、吕刚、周雪峰、庄岩、石展英、周大鹏:手术实施,临床数据收集,文章撰写及修改;陈华、齐红哲、郝明、李建涛:数据整理及分析;唐佩福:研究总体设计、指导,对文章提出总体修改意见

Funding Statement

国家重点研发计划资助项目(2021ZD0140410、2017YFC0114002、2016YFE0126200);军队后勤科技成果扩试项目(145BHQ090003074X);军队医学科技青年培育计划(21QNPY131)

National Key Research & Development Program of China (2021ZD0140410, 2017YFC0114002, 2016YFE0126200); Military Logistics Science and Technology Achievements Expansion Project (145BHQ090003074X); Military Medical Science and Technology Youth Training Program (21QNPY131)

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