The function of bone marrow in the incorporation of a bone graft.

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Abstract

[Indexed for MEDLINE] 10. J Funct Biomater. 2023 Jul 21;14(7):384. doi: 10.3390/jfb14070384. Comparative Evaluation of Mineralized Bone Allografts for Spinal Fusion Surgery. Hubbell PJ(1), Roth B(2), Block JE(3). Author information: (1)Southern Pain and Neurologic, 3939 Houma Blvd., Building 2, Suite 6, Metairie, LA 70006, USA. (2)AZ Pain Doctors, 14420 W Meeker Blvd., Building A, Ste. 211, Sun City West, AZ 85375, USA. (3)Independent Consultant, 2210 Jackson Street, Suite 401, San Francisco, CA 94115, USA. 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 minimal manipulation and homologous use, 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 minimal manipulation and homologous use 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. DOI: 10.3390/jfb14070384 PMCID: PMC10381653