Preclinical Safety of a 3D-Printed Hydroxyapatite-Demineralized Bone Matrix Scaffold for Spinal Fusion. Issue 1 (1st January 2022)

• Record Type: Journal Article
• Authors: Plantz, Mark; Lyons, Joseph; Yamaguchi, Jonathan T.; Greene, Allison C.; Ellenbogen, David J.; Hallman, Mitchell J.; Shah, Vivek; Yun, Chawon; Jakus, Adam E.; Procissi, Daniele; Minardi, Silvia; Shah, Ramille N.; Hsu, Wellington K.; Hsu, Erin L.
• Is Part Of: Spine. Volume 47:Issue 1(2022)
• Publication Date: 2022-01-01
• Subjects: 3D printing -- bone morphogenetic protein-2 -- demineralized bone matrix -- host inflammatory response -- hydroxyapatite -- spinal fusion; Spine -- Abnormalities -- Periodicals; Spine -- Diseases -- Periodicals; Spine -- Surgery -- Periodicals; 616.73005
• DOI: 10.1097/BRS.0000000000004142
• Languages: English
• ISSNs: 0362-2436

Abstract

Abstract : Study Design: Prospective, randomized, controlled preclinical study. Objective: The objective of this study was to compare the host inflammatory response of our previously described hyperelastic, 3D-printed (3DP) hydroxyapatite (HA)-demineralized bone matrix (DBM) composite scaffold to the response elicited with the use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in a preclinical rat posterolateral lumbar fusion model. Summary of Background Data: Our group previously found that this 3D-printed HA-DBM composite material shows promise as a bone graft substitute in a preclinical rodent model, but its safety profile had yet to be assessed. Methods: Sixty female Sprague-Dawley rats underwent bilateral posterolateral intertransverse lumbar spinal fusion using with the following implants: 1) type I absorbable collagen sponge (ACS) alone; 2) 10 μg rhBMP-2/ACS; or 3) the 3DP HA-DBM composite scaffold (n = 20). The host inflammatory response was assessed using magnetic resonance imaging, while the local and circulating cytokine expression levels were evaluated by enzyme-linked immunosorbent assays at subsequent postoperative time points (N = 5/time point). Results: At both 2 and 5 days postoperatively, treatment with the HA-DBM scaffold produced significantly less soft tissue edema at the fusion bed site relative to rhBMP-2-treated animals as quantified on magnetic resonance imaging. At every postoperative time point evaluated, the level of soft tissue edema in HA-DBM-treated animals was comparable to that of the ACS control group. At 2 days postoperatively, serum concentrations of tumor necrosis factor-α and macrophage chemoattractant protein-1 were significantly elevated in the rhBMP-2 treatment group relative to ACS controls, whereas these cytokines were not elevated in the HA-DBM-treated animals. Conclusion: The 3D-printed HA-DBM composite induces a significantly reduced host inflammatory response in a preclinical spinal fusion model relative to rhBMP-2. Level of Evidence: N/A Abstract : We previously developed a 3D-printed HA-DBM composite scaffold that exhibits promise as a potential bone graft substitute. In this study, we demonstrate the lack of a hyperinflammatory host response to this material in vivo using an established preclinical rat spinal fusion model.