Department of Spine Surgery, Honghui-Hospital, Xi'an Jiaotong University, Xi'an, 710054, China.
Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China.
Biomed Eng Online. 2023 Sep 23;22(1):95. doi: 10.1186/s12938-023-01156-1.
While lumbar spinal fusion using rigid rods is a prevalent surgical technique, it can lead to complications such as adjacent segment disease (ASDis). Dynamic stabilization devices serve to maintain physiological spinal motion and alleviate painful stress, yet they are accompanied by a substantial incidence of construct failure and subsequent reoperation. Compared to traditional rigid devices, Isobar TTL semi-rigid stabilization devices demonstrate equivalent stiffness and effective stabilization capabilities. Furthermore, when contrasted with dynamic stabilization techniques, semi-rigid stabilization offers improved load distribution, a broader range of motion within the fixed segment, and reduced mechanical failure rates. This paper will review and evaluate the clinical and biomechanical performance of Isobar TTL semi-rigid stabilization devices. A literature search using the PubMed, EMBASE, CNKI, Wanfang, VIP, and Cochrane Library databases identified studies that met the eligibility criteria. Twenty-eight clinical studies and nine biomechanical studies were included in this systematic review. The VAS, the ODI, and Japanese Orthopedic Association scoring improved significantly in most studies. UCLA grading scale, Pfirrmann grading, and modified Pfirrmann grading of the upper adjacent segments improved significantly in most studies. The occurrence rate of ASD was low. In biomechanical studies, Isobar TTL demonstrated a superior load sharing distribution, a larger fixed segment range of motion, and reduced stress at the rod-screw/screw-bone interfaces compared with titanium rods. While findings from mechanical studies provided promising results, the clinical studies exhibited low methodological quality. As a result, the available evidence does not possess sufficient strength to substantiate superior outcomes with Isobar semi-rigid system in comparison to titanium rods. To establish more conclusive conclusions, further investigations incorporating improved protocols, larger sample sizes, and extended follow-up durations are warranted.
虽然使用刚性棒进行腰椎脊柱融合术是一种常见的手术技术，但它可能导致并发症，如邻近节段疾病（ASDis）。动态稳定装置用于维持生理脊柱运动并减轻疼痛应激，但它们伴随着相当高的器械失效和随后的再次手术发生率。与传统的刚性器械相比，Isobar TTL 半刚性稳定装置具有等效的刚度和有效的稳定能力。此外，与动态稳定技术相比，半刚性稳定装置提供了改善的负荷分布、固定节段内更广泛的运动范围和降低的机械失效率。本文将回顾和评估 Isobar TTL 半刚性稳定装置的临床和生物力学性能。使用 PubMed、EMBASE、CNKI、Wanfang、VIP 和 Cochrane 图书馆数据库进行文献检索，确定符合入选标准的研究。这项系统综述纳入了 28 项临床研究和 9 项生物力学研究。大多数研究中，VAS、ODI 和日本矫形协会评分显著改善。大多数研究中，UCLA 分级、Pfirrmann 分级和改良 Pfirrmann 分级的上邻近节段均显著改善。ASD 的发生率较低。在生物力学研究中，与钛棒相比，Isobar TTL 表现出更优越的负荷分布、更大的固定节段运动范围和减少了杆-螺钉/螺钉-骨界面的应力。虽然机械研究的结果提供了有希望的结果，但临床研究的方法学质量较低。因此，现有证据不足以证明与钛棒相比，Isobar 半刚性系统具有更优越的结果。为了得出更具结论性的结论，需要进一步进行研究，包括改进方案、更大的样本量和更长的随访时间。
