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

Q4 Medicine
Detai Qi, Xiaofeng Zhao, Yi-Bo Zhao, Xiang-dong Lu, Xu Yang, Xiao-nan Wang, Run-tian Zhou, Yuan-zhang Jin
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引用次数: 0

Abstract

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 6.3×105 and 6.1×105, 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, and the maximum pull-out force of the Atlantis spine plate system was 396.55±22.79 N. The difference between the two groups was statistically significant. In the clinical application, the new PRUNUS spine plate system was used, the average operation time was 102.8±13.6 min, and the average blood loss was 56.8±14.1 ml. Using the Atlantis spine plate system, the average operation time was 132.8±15.7 min, and the average blood loss was 76.8±19.1 ml. The difference between the two groups was statistically significant; Using the new PRUNUS spine plate system, the VAS score was reduced from 5.42±1.17 before surgery to 1.58±0.44, the preoperative JOA score was 8.13±1.26, and the JOA score was 14.71±1.16 at the last follow-up. Using the Atlantis spine plate system, the VAS score was 6.94±1.06 before surgery. dropped to 1.75±0.35, the preoperative JOA score was 9.26±1.32, and the JOA score was 14.96±1.56 at the last follow-up. There was no significant difference between the two groups. Conclusion The new PRUNUS spine plate system has good biomechanical properties and has a good effect on the stability of the cervical vertebra, especially for the postoperative renovations and osteoporosis patients. The operation is simple and convenient, safe and effective, and worthy of clinical promotion. Key words: Cervical vertebrae; Internal Fixators; Biomechanics; Treatment outcome
新型PRUNUS脊柱钢板系统及其生物力学研究与初步临床应用
目的研制一种新型三叶增强颈椎钢板系统,研究其生物力学性能,进行临床初步应用,观察临床效果。方法采用12只新鲜山羊标本,采用高精度数显光栅位移传感器系统,比较新型三叶增强颈椎钢板系统前钉固定的稳定性、疲劳强度和抗拉强度。选取2015年1月至2018年1月间行颈椎前路减压、cage或钛网融合、新型PRUNUS脊柱钢板系统或Atlantis脊柱钢板系统内固定的92例颈椎病患者。对比研究记录术中出血量、手术时间、术前颈椎Cobb角、疼痛视觉模拟评分(VAS)、日本骨科协会(JOA)脊柱功能评分,并计算神经系统改好率。采用Frankel分级法评价前后神经的术前和术后功能状态,综合评价新型PRUNUS脊柱钢板系统的初步临床疗效。结果生物力学试验表明:1)新型PRUNUS脊柱钢板系统固定后屈伸、左屈、右屈、左旋、右旋ROM分别为1.02°±0.13°、1.32°±0.11°、0.96°±0.23°、1.03°±0.19°、1.37°±0.17°和1.05°±0.08°。Atlantis脊柱钢板系统固定后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°。两组间差异无统计学意义;2)新型PRUNUS脊柱板系统和Atlantis脊柱板系统的疲劳寿命分别为6.3×105和6.1×105,疲劳强度分别为512.12 Mpa和502.85 Mpa。两组间无统计学差异。3)新型PRUNUS脊柱钢板系统的最大拔出力为483.62±39.14 N, Atlantis脊柱钢板系统的最大拔出力为396.55±22.79 N,两组差异有统计学意义。在临床应用中,采用新型PRUNUS脊柱钢板系统,平均手术时间为102.8±13.6 min,平均出血量为56.8±14.1 ml。采用Atlantis脊柱钢板系统,平均手术时间为132.8±15.7 min,平均出血量为76.8±19.1 ml,两组差异有统计学意义;使用新型PRUNUS脊柱钢板系统,VAS评分由术前的5.42±1.17降至1.58±0.44,术前JOA评分为8.13±1.26,末次随访时JOA评分为14.71±1.16。采用Atlantis脊柱钢板系统,术前VAS评分为6.94±1.06。术前JOA评分为9.26±1.32,末次随访时JOA评分为14.96±1.56。两组间无显著差异。结论新型PRUNUS脊柱钢板系统具有良好的生物力学性能,对颈椎的稳定性有良好的效果,尤其适用于术后修复和骨质疏松患者。操作简单方便,安全有效,值得临床推广。关键词:颈椎;内部固定器;生物力学;治疗结果
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来源期刊
中华骨科杂志
中华骨科杂志 Medicine-Surgery
CiteScore
0.80
自引率
0.00%
发文量
8153
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