Fujibayashi Shunsuke, Takemoto Mitsuru, Nakamura Takashi, Matsushita Tomiharu, Kokubo Tadashi, Sasaki Kiyoyuki, Mori Shigeo, Matsuda Shuichi
Department of Orthopedic Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Department of Biomedical Sciences, College of Life and Health Sciences, Chubu University, Kasugai, Japan.
Asian Spine J. 2021 Jun;15(3):373-380. doi: 10.31616/asj.2020.0231. Epub 2020 Sep 22.
The purpose of this study was to introduce our patient-specific bioactive porous titanium implant manufactured using selective laser melting (SLM) and to establish the efficacy and safety of the implant for stand-alone anterior cervical discectomy and fusion (ACDF) based on a prospective clinical trial. We designed a customized ACDF implant using patient-specific data and manufactured the implant using SLM. We produced a bioactive surface through a specific chemical and thermal treatment. Using this implant, we surgically treated four patients with cervical degenerative disc disease and evaluated the clinical and radiological results. We achieved successful bony union in all but one patient without autologous bone grafting within 1 year. We observed no implant subsidence during the follow-up period, and all clinical parameters improved significantly after surgery, with no reported implant-related adverse effects. Our customized bioactive porous titanium implant is a safe and promising implant for stand-alone ACDF.
本研究的目的是介绍我们使用选择性激光熔化（SLM）制造的患者特异性生物活性多孔钛植入物，并基于一项前瞻性临床试验确定该植入物用于单纯前路颈椎间盘切除融合术（ACDF）的有效性和安全性。我们使用患者特异性数据设计了定制的ACDF植入物，并使用SLM制造了该植入物。我们通过特定的化学和热处理产生了生物活性表面。使用这种植入物，我们对4例颈椎间盘退变疾病患者进行了手术治疗，并评估了临床和放射学结果。除1例患者外，其余患者均在1年内成功实现骨融合，无需自体骨移植。在随访期间，我们未观察到植入物下沉，术后所有临床参数均显著改善，未报告与植入物相关的不良反应。我们定制的生物活性多孔钛植入物是一种用于单纯ACDF的安全且有前景的植入物。
