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MagnetOs Clinical Whitepaper

Use of Novel Biphasic Calcium Phosphate with Submicron Surface Topography as Extender to Autograft in Posterolateral Spine Fusion

Introduction: In recent years, spinal arthrodesis surgeries have increased in the United States (U.S.), with the number of cases expected to continue to rise.1 One challenging complication of spinal arthrodesis is a pseudarthrosis of an operated segment. Recent literature reports the pseudarthrosis rate at approximately 17%, resulting in 149,000 non-unions in the U.S. per year.1,2 Over half of these nonunions are revised at the index level, leading to 92,000 revisions per year.3

One important factor in obtaining a solid fusion is the bone graft chosen for the procedure.2 Autograft bone in the form of Iliac Crest Bone Graft (ICBG) is the gold standard, but there is limited supply and co-morbidities with harvesting, such as pain at the donor site.4 Additionally, there is significant variability in autograft bone due to age, metabolic disease, or other factors.5 As a result, multiple products have entered the market as an alternative or adjunct to bone autograft. Synthetic calcium phosphate bone graft usage has increased due to its efficacy, reasonable cost, low incidence of adverse reactions, and reduced need to harvest large amounts of autologous bone.6-8

Harnessing the power of osteoimmunology, or the relationship between the body’s immune system and skeletal system, leads to more predictable bony fusions in spinal arthrodesis procedures.9-14 Macrophages are among the first responders of the immune system after tissue trauma, and polarizing macrophages toward the pro-healing M2 phenotype versus the proinflammatory M1 phenotype can activate bony healing.15,16 MagnetOs is a biphasic calcium phosphate (BCP) bone graft that grows bone in soft tissue without added cells or growth factors, thanks to its unique NeedleGrip™ surface technology, which provides traction for the body’s vitally important pro-healing immune cells (M2 Macrophages).†9,13 This, in turn, unlocks previously untapped potential to stimulate stem cells and form new bone throughout the graft.10-12

Non-unions are challenging for the surgeon and patient alike, and can lead to poorer clinical outcomes, continued spinal instability at the affected level, and the need for revision surgery. The purpose of this case series is to assess radiographic success, functional outcomes, and pain scores following on-label use of MagnetOs in posterolateral fusion as an extender to bone autograft.

Conclusion: This case series review demonstrates the efficacy of MagnetOs as an extender to autograft in a retrospective cohort of patients undergoing posterolateral fusion.