Osteobiologics and Value-Based Care: Challenges and Opportunities.

Abstract

Autologous bone grafts, sourced from the iliac crest, are the gold standard for bone substitution in spine surgery. However, harvesting autografts increases the risk of postoperative complications. Bone allografts are another popular source of graft material, but their use is rapidly surpassing their availability. There has been considerable interest in manufactured bone graft substitutes, commonly referred to as osteobiologics, which mimic the properties of autologous bone and may be osteoconductive, osteoinductive, osteogenic, or a combination. Osteobiologics have been developed to mimic the properties of autologous bone, but their high cost and variable effectiveness raise questions about their value. This article explores the challenges and opportunities associated with the use of osteobiologics used to aid in bone healing in spinal fusion surgery within a value-based care framework. Spinal fusion treatments such as bone morphogenetic proteins, platelet-rich plasma, autologous conditioned serum, demineralized bone matrix, biomaterial scaffolds, stem cells, and cellular bone matrices are compared. Bone morphogenetic proteins are highly effective but often associated with serious risks; platelet-rich plasma shows promising results but lacks standardization in research protocols. Autologous conditioned serum is inconclusive and cost-effective, while demineralized bone matrix has variable effectiveness and limited data to use in anterior spinal fusions. Biomaterial scaffolds have limited application in the anterior spine but demonstrate high efficacy when it comes to spinal fusion. Stem cells demonstrate improved postsurgical outcomes but have low yield from bone marrow and potential risks associated with genetic engineering and cell therapy. Cellular bone matrices show promising results and have high fusion rates, yet there is currently no US Food and Drug Adminstration requirement for preclinical or clinical data before commercial usage. Although osteobiologics have considerable potential, their high price and uncertain efficiency raise questions concerning their usefulness in spinal fusion surgery. To ensure better patient outcomes, extensive research is needed to explore their utilization within a value-based care framework.