Behrbalk Eyal, Ofir Uri, Maman David, Engel Itzhak, Folman Yoram
Department of Orthopaedic Surgery, Hillel Yaffe M.C., 3100 Hadera, Israel.
Orthopedics, Technion - Israel Institute of Technology, Haifa, Israel.
Indian J Orthop. 2024 Oct 30;59(1):62-68. doi: 10.1007/s43465-024-01255-8. eCollection 2025 Jan.
To present the clinical result of spinal fixation system made entirely of Carbon-Fiber-Reinforced (CFR)-Hybrid Polyaryl-Ether-Ether-Ketone (PEEK).
Fusion surgery has been used to treat chronic low back pain caused by degenerative disk disease (DDD). The traditional pedicle screw system made of titanium, though biocompatible, can lead to complications, such as stress shielding and implant failure.
Fifty-two patients with one-level degenerative disc disease, with or without spinal stenosis, were treated with a stand-alone novel pedicular screw system (PSS) made entirely of CFR-PEEK composite biomaterial. Forty-six were followed for 24 months. Changes in pain and disability were evaluated using a 0-10-point visual analog scale (VAS) and a 0-90 (after omitting the question related to sex life) Oswestry Disability Index (ODI), respectively. Imaging evaluations of fusion were performed with standard and dynamic radiographs.
Mean age was 58.4 ± 12.7 years. The mean operating time was 114.9 ± 22.7 min; X-ray exposure was 38.5 ± 18.1 s. No operative problems or complications were encountered. Three patients were lost to follow-up and three patients were re-operated. Forty-six patients completed follow-up of 24 months; the mean VAS was 6.49 points for lower back pain and 6.54 for leg pain, and the mean ODI by 41.6. No screw breakage or loosening was reported. Radiological consolidation was observed in all patients within 12 months. No clinical symptoms or radiological signs of adjacent degenerative disc disease were observed up to 24 months.
The all CFR-PEEK PSS is user friendly, safe, and compatible with modern imaging techniques. Its mechanical strength lessens the risk of implant failure, while its bone matching elastic modules seem to contribute in the short term to fusion, and in the long term to potential prevention of adjacent disk disease.
介绍一种完全由碳纤维增强（CFR）-混杂聚芳醚酮（PEEK）制成的脊柱固定系统的临床结果。
融合手术已用于治疗由退行性椎间盘疾病（DDD）引起的慢性下腰痛。传统的钛制椎弓根螺钉系统虽然具有生物相容性，但可能导致诸如应力遮挡和植入物失败等并发症。
52例患有单节段退行性椎间盘疾病、伴或不伴有椎管狭窄的患者，接受了一种完全由CFR-PEEK复合生物材料制成的独立新型椎弓根螺钉系统（PSS）治疗。46例患者接受了24个月的随访。分别使用0-10分视觉模拟量表（VAS）和0-90（省略与性生活相关的问题后）Oswestry功能障碍指数（ODI）评估疼痛和功能障碍的变化。采用标准和动态X线片对融合情况进行影像学评估。
平均年龄为58.4±12.7岁。平均手术时间为114.9±22.7分钟；X线暴露时间为38.5±18.1秒。未遇到手术问题或并发症。3例患者失访，3例患者再次手术。46例患者完成了24个月的随访；下腰痛的平均VAS评分为6.49分，腿痛为6.54分，平均ODI为41.6。未报告螺钉断裂或松动情况。所有患者在12个月内均观察到影像学融合。至24个月时，未观察到相邻节段退行性椎间盘疾病的临床症状或影像学征象。
全CFR-PEEK PSS使用方便、安全，且与现代成像技术兼容。其机械强度降低了植入物失败的风险，而其与骨匹配的弹性模量似乎在短期内有助于融合，长期来看可能预防相邻节段椎间盘疾病。
