Fitzgerald Anita, McCool Rachael, Carr Emma, Miller Paul, Reddish Katie, Lohr Cynthia C, Annoni Elena, Lawrence Brandon
York Health Economics Consortium, Enterprise House, University of York, York, United Kingdom.
Medtronic, Office of Medical Affairs, Memphis, TN, United States.
N Am Spine Soc J. 2025 Jan 11;21:100579. doi: 10.1016/j.xnsj.2024.100579. eCollection 2025 Mar.
Degenerative disc disease (DDD) is associated with chronic lower back pain that may have impacts on individual's quality of life and functional ability. Lumbar interbody fusion can be carried out with a variety of bone grafting products, the choice depends on several factors including the patient, site, procedure, cost and indication. This systematic review (SR) intends to validate and consolidate the existing evidence base supporting bone graft materials related to lumbar interbody fusion procedures for DDD, specifically anterior lumbar interbody fusion (ALIF) and oblique lumbar interbody fusion (OLIF).
An SR was conducted in February 2023. Clinical and economic studies of adults with DDD in regions L2 to S1 undergoing lumbar interbody fusion with Infuse™, allograft, synthetic bone grafts, demineralized bone matrices or cell-based matrices were eligible for inclusion.
Twenty-one studies (reported in 25 publications) were included in the review. Eighteen studies (reported in 22 publications) reported clinical outcomes, while 4 studies reported economic outcomes. Nine studies (in 5 publications) investigated Infuse™, including 3 randomized controlled trials (RCTs), one cohort study and 4 case series. Ten studies investigated allograft bone, bone harvested from the vertebral spur combined with apacerum powder, or tricalcium phosphate soaked in autologous bone marrow aspirate, including one RCT, 2 cohort studies, and 7 case series.
The SR shows that Infuse™ offers comparable results to iliac crest bone graft with the benefit of not requiring harvested bone and offers significant benefits in surgical time and blood loss. There is a lack of comparative evidence for any other bone grafts identified in this SR, highlighting the need for further well-designed studies to be conducted in this area.
椎间盘退变疾病(DDD)与慢性下腰痛相关,这可能会影响个人生活质量和功能能力。腰椎椎间融合术可使用多种骨移植产品,其选择取决于多个因素,包括患者、手术部位、手术方式、成本和适应症。本系统评价(SR)旨在验证和巩固现有的证据基础,以支持与DDD腰椎椎间融合手术相关的骨移植材料,特别是前路腰椎椎间融合术(ALIF)和斜外侧腰椎椎间融合术(OLIF)。
于2023年2月进行了一项系统评价。纳入L2至S1区域患有DDD且接受Infuse™、同种异体骨、合成骨移植、脱矿骨基质或基于细胞的基质进行腰椎椎间融合术的成年人的临床和经济研究。
该评价纳入了21项研究(发表于25篇出版物)。18项研究(发表于22篇出版物)报告了临床结果,4项研究报告了经济结果。9项研究(发表于5篇出版物)调查了Infuse™,包括3项随机对照试验(RCT)、1项队列研究和4个病例系列。10项研究调查了同种异体骨、取自椎骨棘突并结合acerum粉末的骨或浸泡在自体骨髓抽吸物中的磷酸三钙,包括1项RCT、2项队列研究和7个病例系列。
该系统评价表明,Infuse™与髂嵴骨移植效果相当,且无需采集骨,在手术时间和失血量方面具有显著优势。本系统评价中确定的任何其他骨移植缺乏比较证据,这突出表明该领域需要进一步开展精心设计的研究。