基于Mimics软件下一种可调式数字化空心钉导向器的研制验证和临床初步运用

目的:评价自行设计的可调式空心钉导向器的有效性,为临床治疗经颈型股骨颈骨折加压空心钉倒三角排列提供了有效的辅助工具。方法:先用Solidworks软件画出该器械的草图,生产后获得实体产品。利用Mimics软件获取数据结合该导向器首先在22具尸体骨上使用,22具干燥尸体骨,男12例,女10例。接着通过X线片评价导针的分布,分别用不同的方式测量股骨头颈的解剖大小和螺钉距离,并进行统计学比较。自2018年1月至2020年6月选取股骨颈骨折患者45例,根据是否用该器械分为新式导向器组(22例)和徒手置钉组(23例),记录并比较两组患者临床资料和手术情况。结果:X线测量、三维和实体测量解剖数据结果差异无统计学意义(P>0.05),实体测量和三维测量螺钉距离比较,差异无统计学意义(P>0.05)。螺钉间距离进针点设计为等腰三角形(r=0.992 8,P<0.000 1),但由于股骨前倾角和扭转角的存在,在股骨颈内为近似等腰三角形(r=0.824 1,P<0.000 1)。两组患者获得平均2年随访,新式导向器组与徒手置钉组透视次数、穿刺次数比较,差异无统计学意义(P>0.05),螺钉平行度更好,手术时间更短,差异有统计学意义(P<0.05)。但两组患者最终的Harris评分以及并发症的发生率比较差异无统计学意义(P>0.05)。结论:自制股骨颈空心钉导向器结合Mimics软件的术前规划有利于空心钉的倒三角排列的置入,但在后期大规模使用过程中仍需不断改良和随访。

Development and clinical application of an adjustable digital cannulated nail guide based on Mimics software

Objective: To evaluate effectiveness of self-designed adjustable cannulated screw guide,and to provide an effective auxiliary tool for inverted triangular arrangement of compression cannulated screws in clinical treatment for transcervical femoral neck fractures.Methods: The sketch of instrument was drawn with Solidworks software,and physical product was obtained after production. The data were obtained by Mimics software. Combined with the guide,it was first used on 22 cadaveric bones,22 dry cadaveric bones,including 12 males and 10 females. Then the distribution of guide pins was evaluated by X-ray film. The anatomical size and screw distance of femoral head and neck were measured in different ways,and statistically compared. From January 2018 to June 2020,45 hospitalized patients with femoral neck fracture were selected and divided into new guide group (22 patients) and free hand nail group (23 patients) according to whether the instrument was used or not. The clinical data and operation conditions between two groups were recorded and compared.Results: The anatomical data of X-ray,three-dimensional and physical measurement were basically the same,whlie had no difference (P>0.05). There was no significant difference between physical measurement and three-dimensional measurement (P>0.05). The distance between screws and needle entry point was designed as an isosceles triangle (r=0.992 8,P<0.000 1),but due to the existence of femoral anteversion and torsion angle,it was an approximate isosceles triangle in the femoral neck (r=0.824 1,P<0.000 1). The patients between two groups were followed up for an average of 2 years. There was no significant difference in the number of fluoroscopy and puncture between new guide group and free hand nail group(P>0.05). The screw parallelism was better and operation time was shorter which had statistically difference(P<0.05). However,there was no significant difference in final Harris score and incidence of complications between two groups(P>0.05).Conclusion: Self-made femoral neck cannulated screw guide combined with preoperative planning of Mimics software is conducive to placement of inverted triangular arrangement of cannulated screws,but it still needs to be improved and followed up in the later large-scale use.