A Mechanistic and Preclinical Assessment of BioRestore Bioactive Glass as a Synthetic Bone Graft Extender and Substitute for Osteoinduction and Spine Fusion

Preclinical animal study. Evaluate the osteoinductivity and bone regenerative capacity of BioRestore bioactive glass. BioRestore is a Food and Drug Administration (FDA)-approved bone void filler that has not yet been evaluated as a bone graft extender or substitute for spine fusion. In vitro and in...

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Published in:	Clinical spine surgery Vol. 37; no. 7; pp. 315 - 321
Main Authors:	Fred, Elianna J, Minardi, Silvia, Goodwin, Alyssa M, Nandurkar, Tejas S, Plantz, Mark A, Lyons, Joseph G, Paul, Jonathan T, Foley, James P, Wintring, Allison J, Furman, Andrew A, Jeong, Soyeon, Yun, Chawon, Stock, Stuart R, Hsu, Wellington K, Hsu, Erin L
Format:	Journal Article
Language:	English
Published:	United States 01-08-2024
Subjects:	Animals Biocompatible Materials - pharmacology Bone Substitutes - pharmacology Bone Transplantation Female Glass - chemistry Humans Osteogenesis - drug effects Rats Rats, Inbred F344 Spinal Fusion - methods
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Summary:	Preclinical animal study. Evaluate the osteoinductivity and bone regenerative capacity of BioRestore bioactive glass. BioRestore is a Food and Drug Administration (FDA)-approved bone void filler that has not yet been evaluated as a bone graft extender or substitute for spine fusion. In vitro and in vivo methods were used to compare BioRestore with other biomaterials for the capacity to promote osteodifferentiation and spinal fusion. The materials evaluated (1) absorbable collagen sponge (ACS), (2) allograft, (3) BioRestore, (4) Human Demineralized Bone Matrix (DBM), and (5) MasterGraft. For in vitro studies, rat bone marrow-derived stem cells (BMSC) were cultured on the materials in either standard or osteogenic media (SM, OM), followed by quantification of osteogenic marker genes ( Runx2, Osx, Alpl, Bglap, Spp1 ) and alkaline phosphatase (ALP) activity. Sixty female Fischer rats underwent L4-5 posterolateral fusion (PLF) with placement of 1 of 5 implants: (1) ICBG from syngeneic rats; (2) ICBG+BioRestore; (3) BioRestore alone; (4) ICBG+Allograft; or (5) ICBG+MasterGraft. Spines were harvested 8 weeks postoperatively and evaluated for bone formation and fusion via radiography, blinded manual palpation, microCT, and histology. After culture for 1 week, BioRestore promoted similar expression levels of Runx2 and Osx to cells grown on DBM. At the 2-week timepoint, the relative ALP activity for BioRestore-OM was significantly higher ( P <0.001) than that of ACS-OM and DBM-OM ( P <0.01) and statistically equivalent to cells grown on allograft-OM. In vivo, radiographic and microCT evaluation showed some degree of bridging bone formation in all groups tested, with the exception of BioRestore alone, which did not produce successful fusions. This study demonstrates the capacity of BioRestore to promote osteoinductivity in vitro. In vivo, BioRestore performed similarly to commercially available bone graft extender materials but was incapable of producing fusion as a bone graft substitute. Level V.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	2380-0186 2380-0194 2380-0194
DOI:	10.1097/BSD.0000000000001597