TY - JOUR
T1 - Biphasic calcium phosphate with submicron surface topography in an Ovine model of instrumented posterolateral spinal fusion
AU - van Dijk, Lukas A.
AU - Duan, Rongquan
AU - Luo, Xiaoman
AU - Barbieri, Davide
AU - Pelletier, Matthew
AU - Christou, Chris
AU - Rosenberg, Antoine J.W.P.
AU - Yuan, Huipin
AU - Barrèrre-de Groot, Florence
AU - Walsh, William R.
AU - de Bruijn, Joost D.
N1 - Funding Information:
information Horizon 2020, Grant/Award Number: 674282This study was supported by the European Union's Horizon 2020 Research and Innovation program (grant agreement no. 674282) and Kuros Biosciences BV. H.Y., F.B. de G., W.W., J.D. de B.: Research Design. L. van D., R.D., X.L., D.B., M.P., C.C., H.Y., W.W.: Data acquisition and analysis. L. van D., H.Y., F.B. de G., W.W., J.D. de B.: Data interpretation. L. van D., H.Y., F.B. de G., J.D. de B., A.R.: Drafting paper or revising it critically. All authors have read and approved the final submitted manuscript.
Publisher Copyright:
© 2018 The Authors. JOR Spine published by Wiley Periodicals, Inc. on behalf of Orthopaedic Research Society
PY - 2018/12
Y1 - 2018/12
N2 - As spinal fusions require large volumes of bone graft, different bone graft substitutes are being investigated as alternatives. A subclass of calcium phosphate materials with submicron surface topography has been shown to be a highly effective bone graft substitute. In this work, a commercially available biphasic calcium phosphate (BCP) with submicron surface topography (MagnetOs; Kuros Biosciences BV) was evaluated in an Ovine model of instrumented posterolateral fusion. The material was implanted stand-alone, either as granules (BCPgranules) or as granules embedded within a fast-resorbing polymeric carrier (BCPputty) and compared to autograft bone (AG). Twenty-five adult, female Merino sheep underwent posterolateral fusion at L2-3 and L4-5 levels with instrumentation. After 6, 12, and 26 weeks, outcomes were evaluated by manual palpation, range of motion (ROM) testing, micro-computed tomography, histology and histomorphometry. Fusion assessment by manual palpation 12 weeks after implantation revealed 100% fusion rates in all treatment groups. The three treatment groups showed a significant decrease in lateral bending at the fusion levels at 12 weeks (P < 0.05) and 26 weeks (P < 0.001) compared to the 6 week time-point. Flexion-extension and axial rotation were also reduced over time, but statistical significance was only reached in flexion-extension for AG and BCPputty between the 6 and 26 week time-points (P < 0.05). No significant differences in ROM were observed between the treatment groups at any of the time-points investigated. Histological assessment at 12 weeks showed fusion rates of 75%, 92%, and 83% for AG, BCPgranules and BCPputty, respectively. The fusion rates were further increased 26 weeks postimplantation. Similar trends of bone growth were observed by histomorphometry. The fusion mass consisted of at least 55% bone for all treatment groups 26 weeks after implantation. These results suggest that this BCP with submicron surface topography, in granules or putty form, is a promising alternative to autograft for spinal fusion.
AB - As spinal fusions require large volumes of bone graft, different bone graft substitutes are being investigated as alternatives. A subclass of calcium phosphate materials with submicron surface topography has been shown to be a highly effective bone graft substitute. In this work, a commercially available biphasic calcium phosphate (BCP) with submicron surface topography (MagnetOs; Kuros Biosciences BV) was evaluated in an Ovine model of instrumented posterolateral fusion. The material was implanted stand-alone, either as granules (BCPgranules) or as granules embedded within a fast-resorbing polymeric carrier (BCPputty) and compared to autograft bone (AG). Twenty-five adult, female Merino sheep underwent posterolateral fusion at L2-3 and L4-5 levels with instrumentation. After 6, 12, and 26 weeks, outcomes were evaluated by manual palpation, range of motion (ROM) testing, micro-computed tomography, histology and histomorphometry. Fusion assessment by manual palpation 12 weeks after implantation revealed 100% fusion rates in all treatment groups. The three treatment groups showed a significant decrease in lateral bending at the fusion levels at 12 weeks (P < 0.05) and 26 weeks (P < 0.001) compared to the 6 week time-point. Flexion-extension and axial rotation were also reduced over time, but statistical significance was only reached in flexion-extension for AG and BCPputty between the 6 and 26 week time-points (P < 0.05). No significant differences in ROM were observed between the treatment groups at any of the time-points investigated. Histological assessment at 12 weeks showed fusion rates of 75%, 92%, and 83% for AG, BCPgranules and BCPputty, respectively. The fusion rates were further increased 26 weeks postimplantation. Similar trends of bone growth were observed by histomorphometry. The fusion mass consisted of at least 55% bone for all treatment groups 26 weeks after implantation. These results suggest that this BCP with submicron surface topography, in granules or putty form, is a promising alternative to autograft for spinal fusion.
KW - biphasic calcium phosphate
KW - posterolateral spinal fusion
KW - sheep
KW - submicron
KW - surface topography
UR - http://www.scopus.com/inward/record.url?scp=85059651008&partnerID=8YFLogxK
U2 - 10.1002/jsp2.1039
DO - 10.1002/jsp2.1039
M3 - Article
AN - SCOPUS:85059651008
SN - 2572-1143
VL - 1
JO - JOR spine
JF - JOR spine
IS - 4
M1 - e1039
ER -