摘要
背景:股骨转子间骨折行髓内钉内固定时,手术医师难以实时、准确判断股骨颈导针置入的前倾角度,目前临床缺乏可以实现该功能的手术器械。目的:研发一种可配合常见股骨转子间骨折髓内钉内固定手术器械使用,可在术中实时监测并指示股骨颈导针前倾角度的测量仪器,辅助手术医师精准完成股骨颈导针置入。方法:根据Brunner法原理,设计股骨颈前倾角测量器并3D打印实体模型。用等比例人体股骨模型构建手术模型,模拟在牵引床上行转子间骨折闭合复位髓内钉内固定的手术过程。使用3D打印模型对3组股骨模型进行辅助置入导针实验,记录实验数据并进行统计分析。优化设计、制作仪器实物。选择20例股骨转子间骨折患者进行临床试验,试验组及对照组各10例,试验组用前倾角测量仪置入导针,对照组由同一组医师用传统方式置入导针。记录两组试验数据并统计分析,确定该仪器效能。结果与结论:①新型前倾角测量器(专利号:ZL202120806525.X)可以实时测量髓内钉近端导向架的前倾角度;②新型前倾角测量器可以真实反映Brunner法测得的股骨颈前倾角,并指示股骨颈导针置入时所需的髓内钉近端导向架的前倾角度;③临床试验结果显示,与对照组相比,试验组患者手术时间更短(P=0.042)、股骨颈导针偏差角度更小(P=0.001)、透视次数更少、导针置入重复次数更少、导针置入时间更短(P<0.05);④提示新型前倾角测量器可以在术中实时、准确测量并指示股骨颈导针置入的前倾角度,可配套多种股骨近端髓内钉内固定器械系统使用,不直接接触人体,无附加损伤,有临床推广价值。
BACKGROUND:During intramedullary nailing fixation for intertrochanteric femoral fractures,surgeons encounter challenges in real-time assessment of the anteversion angle during femoral neck guide needle placement.Current clinical practice lacks specialized instrumentation for this specific functionality.OBJECTIVE:To develop a measurement device compatible with common surgical instruments that enables real-time intraoperative monitoring and indication of the femoral neck guide needle anteversion angle,thereby assisting surgeons in achieving rapid and precise placement.METHODS:Based on Brunner's method for measuring femoral neck anteversion,a digital model of the femoral anteversion angle measuring device was designed and 3D-printed.A surgical model was constructed using anatomically scaled human femur phantoms and auxiliary structures to simulate intertrochanteric fracture fixation for intertrochanteric fractures on a traction bed.The 3D-printed prototype was utilized to assist guide needle insertion.Three groups of femur models were tested,with experimental data recorded and statistically analyzed.The device design was optimized,and a physical prototype was produced.Twenty patients with intertrochanteric femoral fractures were prospectively enrolled(trial group:n=10,control group:n=10).The trial group underwent guide needle placement assisted by the measurement device,while the control group received conventional treatment by the same surgical team.Comparative analysis of surgical parameters was conducted to evaluate device efficacy and clinical utility.RESULTS AND CONCLUSION:(1)The novel femoral neck anteversion angle measurement device(Patent No.ZL202120806525.X)enables real-time measurement of the anteversion angle of the proximal guide frame during intramedullary nailing.(2)The novel anteversion angle measurement device can accurately reflect the femoral neck anteversion measured by Brunner's method and indicate the required proximal guide frame angle for guide needle insertion.(3)Clinical trial results showed that compared with the control group,the trial group had shorter surgical time(P=0.042),less femoral neck guide wire deviation(P=0.001),fewer fluoroscopy sessions,fewer repeated guide wire placements,and shorter guide wire placement time(P<0.05).(4)The novel anteversion angle measurement device can accurately measure and indicate the anteversion angle of the femoral neck guide wire during real-time intraoperative use.It can be used with a variety of proximal femoral intramedullary nail fixation device systems,does not directly contact the human body,and does not cause additional damage,making it valuable for clinical promotion.
作者
王树方
康晓琴
刘志
沈冰
张峰
宋远征
张率功
Wang Shufang;Kang Xiaoqin;Liu Zhi;Shen Bing;Zhang Feng;Song Yuanzheng;Zhang Shuaigong(First Department of Orthopedics and Traumatology,Tengzhou Central People’s Hospital,Tengzhou 277500,Shandong Province,China)
出处
《中国组织工程研究》
北大核心
2026年第15期3885-3896,共12页
Chinese Journal of Tissue Engineering Research
关键词
股骨颈前倾角
测量器
股骨转子间骨折
术中测量
手术器械
自制仪器
femoral neck anteversion
measurement device
intertrochanteric fracture
intraoperative measurement
surgical instruments
homemade instrument
