背景:不对齐是胫骨远端骨折(DTF)的髓内钉(IMN)过程中的常见事件。尽管据报道,半扩展IMN技术,如髌骨上(SP)和髌骨旁(PP)方法可能在防止错位方面更优越,由于关节内受累,这些技术的应用令人担忧。因此,我们开发了一种关节外半扩展髌下(SEIP)方法,该方法利用髌下(IP)空间,同时将膝盖保持在半扩展位置。然而,没有关于SEIP治疗DTFs的安全性和有效性的研究。因此,在这项研究中,检查了SEIP技术,特别是在DTF的潜在对准改进方面,并将该技术与传统的超弯曲髌下(HFIP)手术进行了比较。
方法:这项随机临床试验(RCT)比较了2018年4月至2021年6月在中国I级创伤中心使用HFIP和SEIP技术矫正关节外和非移位关节内DTFs时IMN排列不良。对研究参与者进行了至少12个月的临床和影像学检查随访。术中透视时间,操作时间,失血,住院时间,功能踝关节评分,并对并发症进行了评估。
结果:在88名招募的参与者中,45例(51%)接受传统HFIPIMN,43例(49%)接受SEIPIMN。来自HFIP队列的9例患者(20.0%)和来自SEIP队列的2例患者(4.7%)发生了不对齐(P值=0.030)。此外,SEIPIMN技术显著缩短了术中透视时间,操作时间,与HFIPIMN技术相比,术后踝关节功能得到改善。然而,术中失血,住院时间,感染,延迟联合,骨不连在两个队列之间保持不变。
结论:总之,我们证明,与传统的HFIPIMN手术相比,SEIPIMN可显著增强关节外和非移位的关节内DTF的对齐.所描述的技术代表用于DTF的IMN的有效选项。
方法:二级。试验注册中国临床试验注册中心,ChiCTR2100043673。2021年2月26日注册,追溯注册,http://www。chictr.org.cn/showprojen.aspx?proj=122263。
BACKGROUND: Malalignment is a common event during the intramedullary nailing (IMN) of distal tibia fractures (DTFs). Although it is reported that the semi-extended IMN techniques such as
suprapatellar (SP) and parapatellar (PP) approaches may be superior in preventing malalignment, the application of these techniques is concerning owing to the intra-articular involvement. We thus developed an extra-articular semi-extended infrapatellar (SEIP) approach which utilizes the infrapatellar (IP) space while maintaining the knee in a semi-extended position. However, there are no studies on the safety and efficacy of SEIP in treating DTFs. Therefore, in this study, the SEIP technique was examined, particularly in terms of the potential alignment improvement of DTFs, and this technique was compared with the traditional hyperflexed infrapatellar (HFIP) procedure.
METHODS: This randomized clinical trial (RCT) compared IMN malalignment while correcting extraarticular and nondisplaced intra-articular DTFs between April 2018 and June 2021 using the HFIP and SEIP techniques at a level I trauma center in China. The study participants were clinically and radiographically examined for at least 12 months of follow-ups. Intraoperative fluoroscopy time, operation time, blood loss, hospitalization duration, functional ankle score, and complications were assessed as well.
RESULTS: Among the 88 recruited participants, 45 (51%) underwent traditional HFIP IMN and 43 (49%) underwent SEIP IMN. Malalignment occurred in 9 patients (20.0%) from the HFIP cohort and in 2 patients (4.7%) from the SEIP cohort (P value = 0.030). In addition, the SEIP IMN technique significantly reduced the intraoperative fluoroscopy time, operation time, and improved the postoperative ankle function compared to the HFIP IMN technique. However, the intraoperative blood loss, hospitalization duration, infection, delay union, and nonunion remained the same between the two cohorts.
CONCLUSIONS: In summary, we demonstrated that the SEIP IMN provides markedly enhanced alignment of extraarticular and nondisplaced intra-articular DTFs compared to the traditional HFIP IMN procedure. The described technique represents an effective option for IMN of DTFs.
METHODS: Level 2. Trial registration The Chinese Clinical Trial Registry, ChiCTR2100043673. Registered 26 February 2021, retrospectively registered, http://www.chictr.org.cn/showprojen.aspx?proj=122263.