Early Clinical Outcomes Comparing Porous PEEK, Smooth PEEK, and Structural Allograft Interbody Devices for Anterior Cervical Discectomy and Fusion

Clint P. Hill, K. Br, on Strenge
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引用次数: 7

Abstract

Background: Recently, material surface advancements have been promoted to improve spinal implant osseointegration. While rough and porous titanium implants have gained traction due to their osteoconductive properties, polyetheretherketone (PEEK) devices have remained popular due to their radiographic properties and similar modulus of elasticity to bone. However, traditional smooth PEEK devices elicit fibrous tissue responses leading to poor implant osseointegration. Recently, PEEK implants have been developed with surface porosity allowing for direct bone in-growth. Despite preclinical data suggesting implant osseointegration with porous PEEK implants, comparative clinical results between implants with and without porous surface architecture are heretofore reported. The objective of this single-site retrospective study was to comparatively evaluate early clinical efficacy in patients undergoing ACDF treated with porous PEEK interbody implants to patients treated with structural allograft or traditional smooth PEEK implants. Methods: 167 consecutive patients presenting with cervical degenerative disc disease and radiculopathy underwent ACDF using one of three implants (porous PEEK (Cohere®, NuVasive Inc., San Diego, CA), structural allograft, or smooth PEEK). After preop evaluation and surgery, patients were followed per standard of care 0.5, 1.5, 3, 6, and 12 months post-op. At each time, patient outcomes were measured by disability (Neck Disability Index) and pain (visual analogue score (VAS) neck/arm pain). Results: Patients treated with porous PEEK implants achieved significantly greater NDI and neck pain improvement by 6 weeks post-op when compared to patients receiving structural allograft or smooth PEEK devices. These significantly greater NDI and neck pain improvements for patients treated with porous PEEK devices compared to structural allograft and smooth PEEK were sustained through 12 months post-op. Conclusion: 12 month follow-up data in patients with degenerative disc disease and radiculopathy demonstrates a clear benefit of porous PEEK in promoting improved early outcomes over structural allograft and smooth PEEK in ACDF procedures.
多孔PEEK、光滑PEEK和结构型同种异体移植物椎间盘融合术的早期临床疗效比较
背景:近年来,材料表面的进步已被促进,以改善脊柱植入物的骨整合。虽然粗糙和多孔的钛植入物由于其骨传导特性而获得了牵引力,但聚醚醚酮(PEEK)装置由于其射线照相特性和与骨骼相似的弹性模量而仍然很受欢迎。然而,传统的光滑PEEK装置会引起纤维组织反应,导致种植体骨整合不良。最近,PEEK植入物已经被开发出具有表面孔隙率,允许直接骨生长。尽管临床前数据表明植入物与多孔PEEK植入物骨结合,但迄今为止,有报道称具有和不具有多孔表面结构的植入物之间的比较临床结果。这项单点回顾性研究的目的是比较评估接受多孔PEEK椎体间植入物治疗的ACDF患者与接受结构同种异体移植物或传统光滑PEEK植入物治疗患者的早期临床疗效。方法:167例连续出现颈椎退行性椎间盘疾病和神经根病的患者使用三种植入物之一(多孔PEEK(Cohere®,NuVasive股份有限公司,加利福尼亚州圣地亚哥)、结构同种异体移植物或光滑PEEK)进行ACDF。术前评估和手术后,患者在术后0.5、1.5、3、6和12个月按照标准护理进行随访。每次,通过残疾(颈部残疾指数)和疼痛(视觉模拟评分(VAS)颈部/手臂疼痛)来衡量患者的结果。结果:与接受结构同种异体移植物或光滑PEEK装置的患者相比,接受多孔PEEK植入物治疗的患者在术后6周时获得了显著更大的NDI和颈部疼痛改善。与结构同种异体移植物和光滑PEEK相比,使用多孔PEEK装置治疗的患者的NDI和颈部疼痛改善显著更大,手术后12个月持续。结论:退行性椎间盘疾病和神经根病患者12个月的随访数据表明,在ACDF手术中,多孔PEEK在促进早期结果改善方面明显优于结构同种异体移植物和光滑PEEK。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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