Medical Student Northwestern University Feinberg School of Medicine
Introduction: Synthetic bone grafts have rapidly become a common alternative to often difficult-to-harvest autologous bone grafts in spinal fusion. While groups have individually assessed the comparative clinical efficacy of synthetic bone grafts, a consolidated analysis of the characteristics of such studies is lacking. An understanding of studies’ clinical outcomes in the context of their funding sources (private vs. industry-funded) stands to further our understanding of potential innovation in the space.
Methods: A systematic review was performed in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement. PubMed, Embase, and Scopus were searched, identifying randomized control studies assessing spinal fusion outcomes with reported use of demineralized bone matrix (DBM), tricalcium phosphate, and/or hydroxyapatite synthetic bone grafts. Clinical outcomes of interest included fusion rate after one-year, visual analog score (VAS), and Oswestry Disability Index (ODI). Studies were categorized as industry sponsored if any author of the study reported funding from or being associated with a third-party entity.
Results: Eight studies met inclusion criteria; seven studies were subsequently classified as industry sponsored and one as privately sponsored. On average across all studies, 51.3 patients composed the synthetic bone graft cohort and 47.6 patients the non-synthetic cohort. There was no statistically significant difference in fusion rate among industry sponsored studies (OR: 1.04, CI: 0.52 to 2.10) or privately sponsored studies (OR: 2.57 CI: 0.19 to 34.47). ODI and VAS postoperative scores improved amongst all studies.
Conclusion : Industry and privately sponsored synthetic bone graft studies were both not associated with a difference in fusion rates. Limited literature fitting inclusion criteria restricted analysis of additional clinical outcomes shaped by varying study infrastructures. Nonetheless, more privately funded and institution-driven studies are necessary to mitigate bias that may inherently promote the use of specific grafts and to increase diversity of patient demographic representation.
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