MagnetOs Basic Science Article

Physico-Chemical Characteristics and Posterolateral Fusion Performance of Biphasic Calcium Phosphate with Submicron Needle-Shaped Surface Topography Combined with a Novel Polymer Binder

Abstract:

A biphasic calcium phosphate with submicron needle-shaped surface topography combined with a novel polyethylene glycol/polylactic acid triblock copolymer binder (BCP-EP) was investigated in this study. This study aims to evaluate the composition, degradation mechanism and bioactivity of BCP-EP in vitro, and its in vivo performance as an autograft bone graft (ABG) extender in a rabbit Posterolateral Fusion (PLF) model. The characterization of BCP-EP and its in vitro degradation products showed that the binder hydrolyses rapidly into lactic acid, lactide oligomers and unaltered PEG (polyethylene glycol) without altering the BCP granules and their characteristic submicron needle-shaped surface topography. The bioactivity of BCP-EP after immersion in SBF revealed a progressive surface mineralization. In vivo, BCP-EP was assessed in a rabbit PLF model by radiography, manual palpation, histology and histomorphometry up to 12 weeks post-implantation. Twenty skeletally mature New Zealand (NZ) White Rabbits underwent single-level intertransverse process PLF surgery at L4/5 using (1) autologous bone graft (ABG) alone or (2) by mixing in a 1:1 ratio with BCP-EP (BCP-EP/ABG). After 3 days of implantation, histology showed the BCP granules were in direct contact with tissues and cells. After 12 weeks, material resorption and mature bone formation were observed, which resulted in solid fusion between the two transverse processes, following all assessment methods. BCP-EP/ABG showed comparable fusion rates with ABG at 12 weeks, and no graft migration or adverse reaction were noted at the implantation site nor in distant organs.

Citation: Belluomo R, Arriola-Alvarez I, Kucko NW, Walsh WR, de Bruijn JD, Oliver RA, Wills D, Crowley J, Wang T, Barrère-de Groot F. Physico-Chemical Characteristics and Posterolateral Fusion Performance of Biphasic Calcium Phosphate with Submicron Needle-Shaped Surface Topography Combined with a Novel Polymer Binder. Materials (Basel). 2022;11;15(4):1346. DOI: 10.3390/ma15041346. PMID: 35207887; PMCID: PMC8880136.

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. MagnetOs is not cleared by the FDA or TGA as an osteoinductive bone graft. MagnetOs Easypack Putty is only commercially available in the United States.

PROMO/MAG/GL/105-22/R00