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MagnetOs Clinical Whitepaper

Use of novel biphasic calcium phosphate with submicron surface topography in interbody fusion

Introduction: The number of people ≥ 60 years of age is predicted to rise from 90 million to 2 billion by the year 2050 (WHO 2019). As expected, the number of spine fusion procedures continues to increase proportionately with the aging population.1,2 The average age for spinal fusion has increased in recent years as has the number of spinal fusion procedures performed annually.3 Interbody fusion is an effective surgical treatment option to address back pain through the stabilization of painful motion segments. A common obstacle associated with spine surgery is the lack of available local autograft. As a result, surgeons continue to search for the most advanced and affordable bone graft in order to achieve successful spine fusion without the well-known co-morbidities related to harvesting autograft.4 Synthetic calcium phosphate bone graft usage has increased in recent years as these have demonstrated support of bone formation and reduced the need to harvest large amounts of autologous bone.5,6 This class of bone graft closely resembles the composition of human cancellous bone and has proven to be cost-effective with a very low incidence of adverse reactions and graft-related complications.7 The body’s natural response to spinal surgery is the upregulation of macrophages, especially the proinflammatory M1 phenotype.8,9 This can lead to the formation of scar tissue and ultimately, a non-union. MagnetOs is a biphasic calcium phosphate (BCP) bone graft with a unique submicron surface topography. Its submicron needle-shaped surface features have been shown, using in vitro studies of human-derived
monocytes, to promote attachment and spreading of M2 macrophages, reliably leading to the formation of bone instead of scar tissue.10 In preclinical studies, MagnetOs has been shown to promote bone formation; even in soft tissue, without the need for added cells or growth factors.11 MagnetOs is designed to mimic the porous, trabecular structure of cancellous bone. Clinically-relevant animal models demonstrate that bone formation takes place throughout MagnetOs simultaneously, leading to uniform, solid and stable fusions.12-14 The purpose of this evaluation of a consecutive case series was to assess radiographic success, functional and pain outcomes following interbody fusion using a novel biphasic calcium phosphate bone graft with a unique submicron topography (MagnetOs, Kuros Biosciences, B.V.).

Conclusion: This case series review demonstrates successful fusion results in an aged and bone density challenged group. It shows that MagnetOs directs bone formation early in the healing process and the graft resorbs at a physiologically balanced rate, thus supporting the transition from woven to trabecular bone and the development of a uniform, stable and solid fusions. These outcomes further substantiate the results from preclinical studies that MagnetOs is an ideal bone graft for use in spine fusion.

PROMO_MAG_EU_048-21_R00

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