New PRUNUS spine plate system and its biomechanical research and preliminary clinical application
10.3760/cma.j.issn.0253-2352.2019.24.002
- VernacularTitle: 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
- Author:
Detai QI
1
;
Xiaofeng ZHAO
;
Yibo ZHAO
;
Xiangdong LU
;
Xu YANG
;
Xiaonan WANG
;
Runtian ZHOU
;
Yuanzhang JIN
;
Bin ZHAO
Author Information
1. Department of Orthopaedics, the Second Hospital, Shanxi Medical University, Taiyuan 030001, China
- Publication Type:Clinical Trail
- Keywords:
Cervical vertebrae;
Internal Fixators;
Biomechanics;
Treatment outcome
- From:
Chinese Journal of Orthopaedics
2019;39(24):1496-1506
- CountryChina
- Language:Chinese
-
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.
