Development of AOSpine BOnE (Bone Osteobiologics and Evidence) Classification

Abstract

Study Design: Classification development. Objectives: The aim of our study was to develop a 3-tier classification for the levels of evidence for osteobiologics and provide a description of the principles by which osteobiologics can be evaluated. BOnE (Bone Osteobiologics and Evidence) classification evaluates each osteobiologic based on the available evidence, and if the published evidence is based on clinical, in vivo or in vitro studies. Methods: The process of establishing the BOnE classification included 5 face-to-face meetings and 2 web calls among members of the AOSpine Knowledge Forum Degenerative. Results: The 3 levels of evidence were determined based on the type of data on osteobiologics: level A for human studies, level B for animal studies, and level C for in vitro studies, with level A being the highest level of evidence. Each level was organized into 4 subgroups (eg, A1, A2, A3, and A4). Conclusions: The use and the variety of osteobiologics for spine fusion has dramatically increased over the past few decades; however, literature on their effectiveness is inconclusive. Several prior systematic reviews developed by AOSpine Knowledge Forum Degenerative reported low level of evidence primarily due to the high risk of bias, small sample size, lack of control groups, and limited patient-reported outcomes. BOnE classification will provide a universal platform for research studies and journal publications to classify a new or an existing product and will allow for creating decision-making algorithms for surgical planning.

Recombinant human bone morphogenetic protein-2 in spine surgery: recommendations for use and alternative bone substitutes—a narrative review

“…The most up-to-date level of evidence classification system for osteobiologics is the AOSpine BOnE (Bone Osteobiologics and Evidence) Classification ( 56 ). This BOnE classification has three tiers of evidence: level A, human studies; level B, animal studies; and level C, in vitro studies.…”

“…No osteoinductive agent has been more extensively studied in animals and humans than rhBMP-2. Although there are other osteoinductive products (allograft-based DBMs) with A2 evidence ( 56 ), the volume and level of evidence is not as robust as for rhBMP-2.…”

“…Currently, the level of evidence supporting the use of different commercially available bone graft substitutes varies greatly. Many marketed products are supported by only minimal evidence of efficacy ( 56 ). A comprehensive review of all aspects of alternative graft materials is beyond the scope of this manuscript; the following presents a brief summary of current alternatives.…”

Existing clinical evidence on the use of cellular bone matrix grafts in spinal fusion: updated systematic review of the literature

“…As such, the level of evidence across all existing clinical literature on the use of CBMs in spinal fusion remains quite low (Table 1). 47 There also appear to be no studies comparing costs, either between available CBM products or between CBMs and other allograft alternatives.…”

Research Practices and Needs Among Spine Surgeons Worldwide

“…AO Spine, a clinical division of the AO Foundation, is an international community of spine surgeons and researchers focused on improving spine care worldwide. [2][3][4][5][6][7] In this study, we utilized the AO Spine network of spine surgeons and researchers to obtain their opinions and insights to help identify research priorities. To this end, we conducted a cross-sectional survey with the purpose of understanding the research practices and needs of spine surgeons and to identify regional variations and similarities.…”