Hubbell Paul J, Roth Brandon, Block Jon E
Southern Pain and Neurologic, 3939 Houma Blvd., Building 2, Suite 6, Metairie, LA 70006, USA.
AZ Pain Doctors, 14420 W Meeker Blvd., Building A, Ste. 211, Sun City West, AZ 85375, USA.
J Funct Biomater. 2023 Jul 21;14(7):384. doi: 10.3390/jfb14070384.
The primary objective of this review is to evaluate whether the degree of processing and the clinical utility of commercially available mineralized bone allografts for spine surgery meet the 2020 US Food and Drug Administration's (FDA) guideline definitions for and , respectively. We also assessed the consistency of performance of these products by examining the comparative postoperative radiographic fusion rates following spine surgery. Based on the FDA's criteria for determining whether a structural allograft averts regulatory oversight and classification as a drug/device/biologic, mineralized bone allografts were judged to meet the Agency's definitional descriptions for and when complying with the American Association of Tissue Banks' (AATB) accredited guidelines for bone allograft harvesting, processing, storing and transplanting. Thus, these products do not require FDA medical device clearance. Radiographic fusion rates achieved with mineralized bone allografts were uniformly high (>85%) across three published systematic reviews. Little variation was found in the fusion rates irrespective of anatomical location, allograft geometry, dimensions or indication, and in most cases, the rates were similar to those for autologous bone alone. Continued utilization of mineralized bone allografts should be encouraged across all spine surgery applications where supplemental grafts and/or segmental stability are required to support mechanically solid arthrodeses.
本综述的主要目的是评估市售矿化骨移植材料用于脊柱手术的加工程度和临床效用是否分别符合2020年美国食品药品监督管理局（FDA）对[具体内容1]和[具体内容2]的指南定义。我们还通过检查脊柱手术后的比较性术后影像学融合率来评估这些产品性能的一致性。根据FDA确定结构性移植材料是否可避免监管审查并归类为药物/器械/生物制品的标准，当矿化骨移植材料符合美国组织银行协会（AATB）认可的骨移植采集、加工、储存和移植指南时，判断其符合该机构对[具体内容1]和[具体内容2]的定义描述。因此，这些产品不需要FDA医疗器械批准。在三项已发表的系统评价中，矿化骨移植材料实现的影像学融合率均较高（>85%）。无论解剖位置、移植材料几何形状、尺寸或适应症如何，融合率几乎没有差异，并且在大多数情况下，这些比率与单独使用自体骨时的比率相似。对于所有需要补充移植材料和/或节段稳定性以支持机械稳固性关节融合术的脊柱手术应用，应鼓励继续使用矿化骨移植材料。
