Department of Orthopedic Surgery, Division of Spine Surgery, University of Michigan, Ann Arbor, MI.
Clin Spine Surg. 2020 Dec;33(10):400-407. doi: 10.1097/BSD.0000000000001026.
Systematic review.
To review the current clinical use of 3-dimensional printed (3DP) patient-specific implants in the spine.
Additive manufacturing is a transformative manufacturing method now being applied to spinal implants. Recent innovations in technology have allowed the production of medical-grade implants with unprecedented structure and customization, and the complex anatomy of the spine is ideally suited for patient-specific devices. Improvement in implant design through the process of 3DP may lead to improved osseointegration, lower subsidence rates, and faster operative times.
A comprehensive search of the literature was conducted using Ovid MEDLINE, EMBASE, Scopus, and other sources that resulted in 1842 unique articles. All manuscripts describing the use of 3DP spinal implants in humans were included. Two independent reviewers (N.W. and N.E.S.) assessed eligibility for inclusion. The following outcomes were collected: pain score, Japanese Orthopedic Association (JOA) score, subsidence, fusion, Cobb angle, vertebral height, and complications. No conflicts of interest existed. No funding was received for this work.
A total of 17 studies met inclusion criteria with a total of 35 patients. Only case series and case reports were identified. Follow-up times ranged from 3 to 36 months. Implant types included vertebral body replacement cages, interbody cages, sacral reconstruction prostheses, iliolumbar rods, and a posterior cervical plate. All studies reported improvement in both clinical and radiographic outcomes. 11 of 35 cases showed subsidence >3 mm, but only 1 case required a revision procedure. No migration, loosening, or pseudarthrosis occurred in any patient on the basis of computed tomography or flexion-extension radiographs.
Results of the systematic review indicate that 3DP technology is a viable means to fabricate patient-matched spinal implants. The effects on clinical and radiographic outcome measures are still in question, but these devices may produce favorable subsidence and pseudoarthrosis rates. Currently, the technology is ideally suited for complex tumor pathology and atypical bone defects. Future randomized controlled trials and cost analyses are still needed.
IV-systematic review.
系统评价。
回顾目前在脊柱中使用三维打印（3DP）患者特异性植入物的临床应用。
增材制造是一种变革性的制造方法，现已应用于脊柱植入物。技术的最新创新使得能够生产具有前所未有的结构和定制化的医疗级植入物，而脊柱的复杂解剖结构非常适合患者特异性装置。通过 3DP 进行植入物设计的改进可能导致更好的骨整合、更低的沉降率和更快的手术时间。
使用 Ovid MEDLINE、EMBASE、Scopus 和其他来源对文献进行全面搜索，共产生 1842 篇独特的文章。所有描述 3DP 脊柱植入物在人类中应用的手稿均被纳入。两名独立的审查员（N.W. 和 N.E.S.）评估了纳入的标准。收集了以下结果：疼痛评分、日本矫形协会（JOA）评分、沉降、融合、Cobb 角、椎体高度和并发症。没有利益冲突。这项工作没有收到任何资金。
共有 17 项研究符合纳入标准，共 35 名患者。仅确定了病例系列和病例报告。随访时间从 3 到 36 个月不等。植入物类型包括椎体置换笼、椎间笼、骶骨重建假体、髂腰棒和颈椎后路板。所有研究均报告了临床和影像学结果的改善。35 例中有 11 例出现沉降 >3mm，但只有 1 例需要进行修正手术。根据计算机断层扫描或屈伸位 X 线片，没有发生迁移、松动或假关节形成。
系统评价的结果表明，3DP 技术是制造患者匹配脊柱植入物的可行方法。其对临床和影像学结果测量的影响仍存在疑问，但这些装置可能产生有利的沉降和假关节发生率。目前，该技术非常适合复杂的肿瘤病理学和非典型骨缺损。仍需要未来的随机对照试验和成本分析。
IV-系统评价。
