Morita Kohei, Ohashi Hiroki, Oikawa Katsuhiro, Tani Satoshi, Karagiozov Kostadin, Murayama Yuichi
The Department of Neurosurgery, The Jikei University School of Medicine, Tokyo, Japan.
GLOBERIDE, Inc., Higashikurume, Japan.
N Am Spine Soc J. 2025 Mar 27;22:100608. doi: 10.1016/j.xnsj.2025.100608. eCollection 2025 Jun.
Carbon fiber-reinforced plastic (CFRP) has been used in many medical devices, including rods for posterior spinal fixation devices, owing to its superior radiolucency and durability compared with titanium alloys. However, the strength of the existing short fiber type CFRP does not surpass that of metals. Recently, the use of innovative technologies for manufacturing long fiber type CFRP has dramatically improved their strength. In this study, we developed a rod for posterior spinal fixation using long fiber type CFRP technology and evaluated its strength, durability, and radiolucency against rods made of titanium alloy, cobalt chrome, short fiber CFRP, and polyaryletherketone (PEEK).
Comparison tests were conducted on the strength, durability, and image evaluation of long fiber type CFRP rods and titanium alloy rods. In addition, a series of tests required for regulatory approval and clinical use were conducted.
The long fiber type CFRP rod showed 120% of the strength of the titanium alloy rod, 102% of that of the cobalt chrome rod, and approximately 20 times the strength of the short fiber type CFRP and PEEK, demonstrating durability that remarkably exceeded that of the titanium alloy. Moreover, artifacts in the radiographic images were smaller than those observed with titanium alloy. Biosafety and magnetic resonance safety tests also yielded satisfactory results, supporting approval for clinical use.
This study introduces a new type of long fiber type CFRP rod for spinal surgery that is stronger, lasts longer, and causes fewer imaging problems than current titanium rods, and may prevent complications such as rod breakage. The long fiber type CFRP rod may improve the safety and outcomes of spinal surgeries.
碳纤维增强塑料（CFRP）因其与钛合金相比具有更高的射线透过性和耐用性，已被用于许多医疗设备，包括后路脊柱固定装置的棒材。然而，现有的短纤维型CFRP的强度并未超过金属。最近，用于制造长纤维型CFRP的创新技术的使用显著提高了它们的强度。在本研究中，我们使用长纤维型CFRP技术开发了一种用于后路脊柱固定的棒材，并评估了其与钛合金、钴铬合金、短纤维CFRP和聚芳醚酮（PEEK）制成的棒材相比的强度、耐用性和射线透过性。
对长纤维型CFRP棒材和钛合金棒材进行了强度、耐用性和图像评估的对比测试。此外，还进行了监管批准和临床使用所需的一系列测试。
长纤维型CFRP棒材的强度为钛合金棒材的120%，钴铬合金棒材的102%，约为短纤维型CFRP和PEEK强度的20倍，显示出显著超过钛合金的耐用性。此外，X射线图像中的伪影比钛合金观察到的要小。生物安全性和磁共振安全性测试也取得了满意的结果，支持临床使用批准。
本研究介绍了一种新型的用于脊柱手术的长纤维型CFRP棒材，它比目前的钛棒更强、更耐用，且成像问题更少，并可能预防诸如棒材断裂等并发症。长纤维型CFRP棒材可能会提高脊柱手术的安全性和疗效。
