背景:髓内钉(IMN)是骨科创伤中必不可少的关键微创“武器”之一,而远端锁定对外科医生来说仍然具有挑战性。虽然有各种发明和技术来改进锁定程序,仍然存在定位不准确等问题,过度的辐射暴露,首次成功率低,学习曲线长。因此,设计了一种新型的激光引导导航装置,并与传统的徒手(FH)技术在股骨IMN远端锁定中进行了比较。
方法:这项随机对照单盲试验招募了股骨干骨折患者。自行设计的激光导航装置(激光组)和徒手技术(FH组)用于IMN的远端锁定。将入选患者随机分为FH组和激光组,所有手术均由两名级别相同的外科医生进行.比较两组在辐射照射时间,手术时间,第一成功率,失血,视觉模拟评分(VAS),Harris评分和愈合时间。
结果:32名患者结束研究期间,每组16名患者。结果表明,激光组在远端锁定时间方面优于FH组(10(9/11)vs19.5(17.25/21)min,Z=4.83,P<0.001),远端锁定辐射暴露时间(46.5(41.25/51.75)vs105(88.25/140)s,Z=4.807,P<0.001),首次成功率(30/32vs20/32,χ2=9.143,P=0.002)和失血量(60(50-100)vs150(105-192.5)mL,Z=3.610,P=0.0003)。哈里斯得分没有差异,VAS评分,或两组间骨折愈合时间。
结论:与FH技术相比,新型股骨IMN远端锁定激光导引导航装置具有手术时间短,更少的辐射暴露和更高的首次成功率。试验注册中国临床试验注册中心,ChiCTR2200060236。2022年5月23日注册,https://www。chictr.org.cn/showprojen.aspx?proj=169130。
BACKGROUND: Intramedullary nail (IMN) is one of the key essential minimally invasive \"weapons\" in orthopaedic trauma, while the distal locking is still challenging for surgeons. Although there are various inventions and technologies to improve the locking procedure, there are still problems such as inaccurate positioning, excessive radiation exposure, low first success rate and long learning curve. Therefore, a new laser guiding navigation device was designed and compared with the traditional freehand (FH) technique in the distal locking of femoral IMN.
METHODS: This randomized controlled single-blind trial recruited patients with femoral diaphyseal fracture. The self-designed laser navigation device (laser group) and freehand technique (FH group) were used in the distal locking of the IMNs. The patients enrolled were randomized into FH group and laser group, all operations were performed by two surgeons of the same level. The differences between the two groups were compared in terms of radiation exposure time, operative time, first success rate, blood loss, visual analogue score (VAS), Harris score and healing time.
RESULTS: 32 patients ended the study period and 16 patients in each group. The results showed that the laser group was better than the FH group in terms of distal locking time (10(9/11) vs 19.5 (17.25/21) min, Z = 4.83, P < 0.001), distal locking radiation exposure time (46.5 (41.25/51.75) vs 105 (88.25/140) s, Z = 4.807, P < 0.001), first success rate (30/32 vs 20/32, χ2 = 9.143, P = 0.002) and blood loss (60 (50-100) vs 150 (105-192.5) mL, Z = 3.610, P = 0.0003). There was no difference in Harris score, VAS score, or fracture healing time between the two groups.
CONCLUSIONS: Compared with the FH technique, the novel laser guiding navigation device for distal locking of femoral IMN has the advantages of shorter operative time, less radiation exposure and higher first success rate. Trial registration Chinese Clinical Trial Registry, ChiCTR2200060236. Registered 23 May 2022, https://www.chictr.org.cn/showprojen.aspx?proj=169130.