MagnetOs Preclinical Study

MagnetOs, Vitoss, and Novabone in a Multi-Endpoint Study of Posterolateral Fusion: A True Fusion or Not?

Study Design: This study was a multi-endpoint analysis of bone graft substitutes implanted as a standalone graft in a clinically relevant Ovine model of instrumented posterolateral spinal fusion (PLF).

Objective: The objective of this study was to obtain high-quality evidence on the efficacy of commercial bone graft substitutes compared with autograft in instrumented PLF using a state-of-the-art model with a complete range of assessment techniques.

Summary of Background Data: Preclinical and clinical data on the quality of spinal fusions obtained with bone graft substitutes are often limited. Calcium phosphates with submicron topography have shown promising results in PLF, as these are able to induce bone formation in tissues distant from the host bone, which facilitates bony union.

Methods: Nine female, skeletally mature sheep (4–5 y) underwent posterior pedicle screw/rods instrumented PLF at L2–L3 and L4–L5 using the following bone graft materials as a standalone graft per spinal segment: (1) biphasic calcium phosphate with submicron topography (BCP_<µm), (2) 45S5 Bioglass (BG), and (3) collagen-β-tricalcium phosphate with a 45S5 Bioglass adjunct (TCP/BG). Autograft bone (AB) was used as a positive control treatment. Twelve weeks after implantation, the spinal segments were evaluated by fusion assessment (manual palpation, x-ray, micro-computed tomography, and histology), fusion mass volume quantification (micro-computed tomography), range of motion (ROM) testing, histologic evaluation, and histomorphometry.

Results: Fusion assessment revealed equivalence between AB and BCP_<µm by all fusion assessment methods, whereas BG and TCP/BG led to significantly inferior results. Fusion mass volume was highest for BCP_<µm, followed by AB, BG, and TCP/BG. ROM testing determined equivalence for spinal levels treated with AB and BCP_<µm, while BG and TCP/BG exhibited higher ROM. Histologic evaluation revealed substantial bone formation in the intertransverse regions for AB and BCP_<µm, whereas BG and TCP/BG grafts contained fibrous tissue and minimal bone formation. Histologic observations were supported by the histomorphometry data.

Conclusions: This study reveals clear differences in efficacy between commercially available bone graft substitutes, emphasizing the importance of clinically relevant animal models with multiendpoint analyses for the evaluation of bone graft materials. The results corroborate the efficacy of calcium phosphate with submicron topography, as this was the only material that showed equivalent performance to autograft in achieving spinal fusion.

Citation: van Dijk LA, Barrère-de Groot F, Rosenberg AJWP, Pelletier M, Christou C, de Bruijn JD, Walsh WR. MagnetOs, Vitoss, and Novabone in a Multi-endpoint Study of Posterolateral Fusion: A True Fusion or Not? Clin Spine Surg. 2020;33(6):E276-E287. DOI: 10.1097/BSD.0000000000000920. PMID: 31977334; PMCID: PMC7337107.

Disclaimer: Results from in vitro or in vivo laboratory testing may not be predictive of clinical experience in humans. Please refer to the Instructions for Use for a full list of indications, contraindications, precautions and warnings. For important safety and intended use information please visit kurosbio.com/eifu. MagnetOs is not cleared by the FDA or TGA as an osteoinductive bone graft.

PROMO/MAG/GL/024-20/R00