三叶加强型颈椎前路钉板系统的研制以及生物力学研究与初步临床应用  

New PRUNUS spine plate system and its biomechanical research and preliminary clinical application

作　　者：齐德泰 赵晓峰[1] 赵轶波[1] 陆向东[1] 杨旭 王晓楠 周润田 靳元璋 赵斌[1] Qi Detai;Zhao Xiaofeng;Zhao Yibo;Lu Xiangdong;Yang Xu;Wang Xiaonan;Zhou Runtian;Jin Yuanzhang;Zhao Bin(Department of Orthopaedics,the Second Hospital,Shanxi Medical University,Taiyuan 030001,China)

机构地区：[1]山西医科大学第二医院骨科,太原030001

出　　处：《中华骨科杂志》2019年第24期1496-1506,共11页Chinese Journal of Orthopaedics

基　　金：山西省应用基础自然科学基金(201801D121080)。

摘　　要：目的研制一种三叶加强型颈椎前路钉板系统(PRUNUS钉板系统)并测试其生物力学特性,通过临床初步应用观察其临床疗效。方法采用12具新鲜山羊颈椎标本,应用高精度数显光栅位移传感器系统,比较PRUNUS钉板系统与Atlantis钉板系统的稳定性、疲劳试验和抗拔出力。选取2015年1月至2018年1月收治的92例采用颈椎前路减压、cage或钛网植骨融合、PRUNUS钉板系统或Atlantis钉板系统内固定治疗的颈椎疾病患者,通过对比术中出血量、手术时间、手术前后颈椎Cobb角、疼痛视觉模拟评分(visual analogue scale,VAS)及日本骨科协会(Japanese Orthopaedic Association Scores,JOA)评分,并计算神经功能改善率,应用Frankel分级评价患者手术前后脊髓神经损害恢复情况,从而综合评价PRUNUS钉板系统的初步临床疗效。结果生物力学测试表明:①应用PRUNUS钉板系统固定后的前屈、后伸、左侧弯、右侧弯、左旋转、右旋转ROM分别为1.02°±0.13°、1.32°±0.11°、0.96°±0.23°、1.03°±0.19°、1.37°±0.17°、1.05°±0.08°,Atlantis钉板系统固定后的ROM分别为0.99°±0.11°、1.08°±0.23°、0.83°±0.21°、0.82°±0.13°、1.18°±0.43°、1.17°±0.17°,两组的差异均无统计学意义;②PRUNUS钉板和Atlantis钉板疲劳寿命分别为6.3×10^5、6.1×10^5,疲劳强度分别为512.72 Mpa、502.85 Mpa,两组的差异均无统计学意义;③PRUNUS钉板系统的最大拔出力为(483.62±39.14)N,Atlantis钉板系统为(396.55±22.79)N,两组的差异有统计学意义。临床应用:PRUNUS钉板系统组手术时间平均为(102.8±13.6)min,术中出血量(56.8±14.1)ml;Atlantis钉板系统组手术时间平均为(132.8±15.7)min,术中出血量(76.8±19.1)ml,两组差异均有统计学意义。PRUNUS钉板系统组VAS评分由术前(7.21±0.53)分下降至术后1周时(1.58±0.44)分,术前JOA评分(8.13±1.26)分改善至末次随访时为(14.71±1.16)分;Atlantis钉板系统组VAS评分由术前(6.94.±1.06)�Objective To develop a new type of triple-leaf-enhanced cervical spine plate system,to study its biomechanical properties,perform clinical preliminary applications,and observe clinical effects.Methods Twelve fresh goat specimens were used,and the high-precision digital display grating displacement sensor system was used to compare the stability,fatigue strength and tensile strength of the fixation of the anterior nailing of the new type of triple-leaf-enhanced cervical spine plate system.All of 92 patients with cervical spondylosis who underwent cervical anterior decompression,cage or titanium mesh fusion,with new PRUNUS spine plate system or Atlantis spine plate system internal fixation were selected from January 2015 to January 2018.Comparative study recorded intraoperative blood loss,operative time,preoperative cervical Cobb angle,pain visual analogue scale(VAS),and Japanese Orthopaedic Association(JOA)spinal function score,and neurological improvement ratewas calculated.Frankel grading was used to evaluate pre and postoperative functional status of the anterior and posterior nerves,so as to comprehensively evaluate the initial clinical efficacy of the new PRUNUS spine plate system.Results The biomechanical tests showed that:1)The flexion,extension,left bending,right bending,left rotation and right rotation ROM after fixing with the new PRUNUS spine plate system were 1.02°±0.13°,1.32°±0.11°,0.96°±0.23°,1.03°±0.19°,1.37°±0.17°and 1.05°±0.08°.ROM after fixation of Atlantis spine plate system were 0.99°±0.11°,1.08°±0.23°,0.83°±0.21°,0.82°±0.13°,1.18°±0.43°,1.17°±0.17°,respectively.There was no significant statistical difference between the two groups;2)The fatigue life of the new PRUNUS spine plate system and Atlantis spine plate system were 6.3×10^5 and 6.1×10^5,and the fatigue strengths were 512.12 Mpa and 502.85 Mpa respectively.There was no statistical difference between the two groups.3)The maximum pull-out force of the new PRUNUS spine plate system was 483.62±39.14 N,a

关 键 词：颈椎 内固定器 生物力学 治疗效果 

分 类 号：R68[医药卫生—骨科学]