National Spinal Injuries Unit, Mater Misericordiae University Hospital, Dublin, Ireland.
School of Medicine and Medical Science, University College Dublin, Dublin, Ireland.
Eur Spine J. 2024 Jan;33(1):253-263. doi: 10.1007/s00586-023-07941-9. Epub 2023 Sep 23.
Despite successful fusion rates with iliac crest bone graft (ICBG), donor-site morbidity and increased operating time remain a considerable limitation and drive the search for alternatives. In this systematic review, grafts with additional cellular supplementation were compared with ICBG for spinal arthrodesis. We compared safety, efficacy and long-term outcomes, thus providing the current and relevant evidence for orthopaedic surgeons to make informed choices regarding this rapidly developing field.
An electronic literature search was conducted according to the PRISMA guidelines by two independent reviewers for articles published up to 1st March 2023 using PubMed, EMBASE and the Cochrane Central Register of Controlled Trial. Cellular allografts were not included. The following data were extracted: Number of patients, type of graft, fusion assessment method, follow-up duration, fusion rates, clinical outcomes and complications. The methodological quality of evidence (MQOE) was assessed using the Risk of Bias 2 (RoB-2) tool and Risk of Bias In Non-Randomised Studies (ROBINS) tool developed by Cochrane for evaluating bias in randomised and non-randomised studies.
Ten studies fulfiled the inclusion criteria, including 465 patients. The mean number of patients per study was 43.8 (std dev. 28.81, range 12-100). Two studies demonstrated cell-based therapy to be significantly more successful in terms of fusion rates compared to ICBG. However, the remaining eight demonstrated equivocal results. No study found that cell-based therapy was inferior. No difference was seen between the two groups in three studies who focused on degenerative cohorts. No difference in functional outcome scores was seen between the groups. A number of different preparation techniques for cell-based grafts were used throughout the studies.
Cell-based therapy offers a promising alternative to ICBG in spinal fusion surgery, which could help reduce the associated morbidity to patients. This review found that cell-based therapy is non-inferior to iliac crest bone graft and may offer patients an alternative treatment option with fewer complications and reduced post-operative pain. However, the literature to date is limited by heterogeneity of the cell preparation and grafting process. Future research with a unified approach to the cell preparation process is required to fully delineate the potential advantages of this technology.
尽管髂嵴骨移植物(ICBG)的融合率很高,但供区并发症和手术时间延长仍然是一个相当大的限制因素,促使人们寻找替代物。在这项系统评价中,我们比较了具有附加细胞补充的移植物与 ICBG 在脊柱融合中的效果。我们比较了安全性、疗效和长期结果,从而为骨科医生提供了有关这一快速发展领域的当前相关证据,以便他们做出明智的选择。
根据 PRISMA 指南,两位独立的审查员使用 PubMed、EMBASE 和 Cochrane 对照试验中心注册库,对截至 2023 年 3 月 1 日发表的文章进行了电子文献检索。未包括细胞同种异体移植物。提取的数据包括:患者人数、移植物类型、融合评估方法、随访时间、融合率、临床结果和并发症。使用 RoB-2 工具和 Cochrane 为评估随机和非随机研究偏倚而开发的 ROBINS 工具评估证据的方法学质量(MQOE)。
10 项研究符合纳入标准,包括 465 名患者。每项研究的平均患者人数为 43.8(标准差 28.81,范围 12-100)。两项研究表明,细胞治疗在融合率方面明显优于 ICBG。然而,其余八项研究则得出了模棱两可的结果。没有研究表明细胞治疗是劣效的。在关注退行性队列的三项研究中,两组之间在融合率方面没有差异。两组在功能结局评分方面没有差异。在研究中使用了多种不同的细胞移植物制备技术。
细胞治疗为脊柱融合手术提供了一种有前途的 ICBG 替代物,有助于减少患者的相关并发症。本综述发现,细胞治疗与髂嵴骨移植物非劣效,并且可能为患者提供一种并发症更少、术后疼痛减轻的替代治疗选择。然而,目前的文献受到细胞制备和移植物处理过程异质性的限制。需要使用统一的细胞制备方法进行未来的研究,以充分阐明这项技术的潜在优势。