Comparative Efficacy of Commonly Available Human Bone Graft Substitutes as Tested for Posterolateral Fusion in an Athymic Rat Model

Bhamb, Neil; Kanim, Linda E.A.; Drapeau, Susan; Mohan, Suneeth; Vasquez, Erick S.; Shimko, Dan; McKay, William F.; Bae, Hyun

doi:10.14444/6059

Cited by 20 publications

(22 citation statements)

References 76 publications

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“…There were large variations in fusion performance for seven commercially available DBF and DBM products in an established preclinical fusion model. These data agree well with previous reports using the athymic rat spinal fusion model (13)(14)(15)(16)(17)(18)(20)(21)(22)(23)(24). Among different 100% DBF products with no carrier present, there were significant differences in fusion outcomes, suggesting that composition alone does not guarantee performance.…”

Section: Discussionsupporting

confidence: 91%

“…Because of this challenging environment, the reported fusion rates for DBM products tested in this model at 4 weeks vary considerably, which makes it a robust model to discern differences in product performance. Previous studies have evaluated fusion performance of commercial DBM putties and/or gels composed of different carriers and reported fusion rates of 0-100% in the same preclinical fusion model as the current study (13)(14)(15)(16)(17)(18)(20)(21)(22)(23)(24). In studies by the Wang group (14,15), substantial variability in performance was measured between different DBM products from different manufacturers, while Bae et al (17), further showed substantial variability between various lots of the same DBM material.…”

Section: Discussionsupporting

confidence: 49%

“…The athymic rat spinal fusion model is well-characterized and has been used extensively to test human DBM products (13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24). In this model, DBM and DBF grafts can be tested in an unaltered "off-the-shelf " form, as would be available for use in human spine surgery.…”

Section: Discussionmentioning

confidence: 99%

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In-vivo Performance of Seven Commercially Available Demineralized Bone Matrix Fiber and Putty Products in a Rat Posterolateral Fusion Model

et al. 2020

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Introduction: Demineralized bone matrix (DBM) is a widely used bone graft in spinal fusion. Most commercial DBMs are composed of demineralized bone particles (∼125-800 microns) suspended in a carrier that provides improved handling but dilutes the osteoinductive component. DBM fibers (DBF) provide improved osteoconductivity and do not require a carrier. It has been suggested that 100% DBF may offer improved performance over particulate-based DBMs with carrier.Study Design: Seven commercially available DBM products were tested in an athymic rat posterolateral fusion model. There were four 100% DBFs, two DBFs containing a carrier, and one particulate-based DBM containing carrier.Objective: The study objectives were to evaluate the in vivo performance: (1) compare fusion rate and fusion maturity of six commercially available DBFs and one particulate-based DBM, and (2) assess the effect of carrier on fusion outcomes for DBFs in a posterolateral fusion model. Methods:The DBF/DBM products evaluated were: Strand TM Family, Propel ® DBM Fibers, Vesuvius ® Demineralized Fibers, Optium ® DBM Putty, Grafton ® DBF, Grafton Flex, and DBX ® Putty. Single-level posterolateral fusion was performed in 69 athymic rats. Fusion was assessed bilaterally after 4 weeks by manual palpation, radiograph and CT for bridging bone. Fusion mass maturity was assessed with a CT maturity grading scale and by histology. Statistical analysis was performed using Fishers Exact Test for categorical data and Kruskal-Wallis Test for non-parametric data.Results: Strand Family achieved 100% fusion (18/18) by manual palpation, radiographic and CT evaluation, significantly higher than Propel Fibers, Vesuvius Fibers, Optium Putty, and DBX Putty, and not statistically higher than Grafton DBF and Grafton Flex. Strand Family provided the highest fusion maturity, with CT maturity grade of 2.3/3.0 and 89% mature fusion rate. Fusion results suggest a detrimental effect of carrier on fusion performance. Russell et al. Performance of Demineralized Bone FibersConclusions: There were large variations in fusion performance for seven commercially available DBM products in an established preclinical fusion model. There were even significant differences between different 100% DBF products, suggesting that composition alone does not guarantee in vivo performance. In the absence of definitive clinical evidence, surgeons should carefully consider available data in valid animal models when selecting demineralized allograft options.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionsupporting

confidence: 49%

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In-vivo Performance of Seven Commercially Available Demineralized Bone Matrix Fiber and Putty Products in a Rat Posterolateral Fusion Model

et al. 2020

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“…Autologous iliac cres bone graft (ICBG) remains the gold standard for spinal fusion, but its harvest is associated with long‐term donor site pain in up to 25% of patients 3 . A variety of alternative bone graft options are available (allograft, demineralized bone matrix, and cellular bone matrices), but none have proven to be suitable and effective substitutes for ICBG in the posterolateral spine 4,5 . Alternatively, biologic bone grafts substitutes such as bone morphogenetic protein (BMP) can be used either as an adjunct to autograft/allograft or it can be used as a standalone osteoinductive agent.…”

Section: Introductionmentioning

confidence: 99%

The temporal and spatial expression of sclerostin and Wnt signaling factors during the maturation of posterolateral lumbar spine fusions

et al. 2020

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The bone healing environment in the posterolateral spine following arthrodesis surgery is one of the most challenging in all of orthopedics and our understanding of the molecular signaling pathways mediating osteogenesis during spinal fusion is limited. In this study, the spatial and temporal expression pattern of Wnt signaling factors and inhibitors during spinal fusion was assessed for the first time. Bilateral posterolateral spine arthrodesis with autologous iliac crest bone graft was performed on 21 New Zealand White rabbits. At 1-, 2-, 3-, 4-, and 6-weeks, the expression of sclerostin and a variety of canonical and noncanonical Wnts signaling factors was measured by qRT-PCR from tissue separately collected from the transverse processes, the Outer and Inner Zones of the fusion mass, and the adjancent paraspinal muscle. Immunohistochemistry for sclerostin protein was also performed. Sclerostin and many Wnt factors, especially Wnt3a and Wnt5a, were found to have distinct spatial and temporal expression patterns. For example, harvesting ICBG caused a significant increase in sclerostin expression. Furthermore, the paraspinal muscle immediately adjacent to the transplanted ICBG also had significant increases in sclerostin expression at 3 weeks, suggesting new potential mechanisms for pseudarthroses following spinal arthrodesis. The presented work is the first description of the spatial and temporal expression of sclerostin and Wnt signaling factors in the developing spine fusion, filling an important knowledge gap in the basic biology of spinal fusion and potentially aiding in the development of novel biologics to increase spinal fusion rates.

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“…30 Importantly, the concentration of native BMP in DBM products differs significantly by manufacturer, donor lot, and batch, making it difficult to study the efficacy of DBM in clinical trials. [30][31][32][33] In an athymic rat model, Bae et al 34 observed significant lot-to-lot variability of a single DBMbased product, commercially available ''off-theshelf'' with regard to BMP concentrations and associated in vivo bone formation for fusion rates. 35 Therefore, it is important to note the efficacy of DBM's osteoconduction and osteoinduction properties in clinical studies is limited by mainly narrative study designs with limited levels of evidence, small sample size, and lack of appropriate controls.…”

Section: Allo-bone Graft: Cortico-cancellous Allograftmentioning

confidence: 99%

Allografts and Spinal Fusion

et al. 2021

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Background: Back pain is a common chief complaint within the United States and is caused by a multitude of etiologies. There are many different treatment modalities for back pain, with a frequent option being spinal fusion procedures. The success of spinal fusion greatly depends on instrumentation, construct design, and bone grafts used in surgery. Bone allografts are important for both structural integrity and providing a scaffold for bone fusion to occur.Method: Searches were performed using terms 'allografts' and 'bone' as well as product names in peer reviewed literature Pubmed, Google Scholar, FDA-510k approvals, and clinicaltrials.gov.Results: This study is a review of allografts and focuses on currently available products and their success in both animal and clinical studies.Conclusion: Bone grafts used in surgery are generally categorized into 3 main types: autogenous (from patient's own body), allograft (from cadaveric or living donor), and synthetic. This paper focuses on allografts and provides an overview on the different subtypes with an emphasis on recent product development and uses in spinal fusion surgery.

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Comparative Efficacy of Commonly Available Human Bone Graft Substitutes as Tested for Posterolateral Fusion in an Athymic Rat Model

Cited by 20 publications

References 76 publications

In-vivo Performance of Seven Commercially Available Demineralized Bone Matrix Fiber and Putty Products in a Rat Posterolateral Fusion Model

In-vivo Performance of Seven Commercially Available Demineralized Bone Matrix Fiber and Putty Products in a Rat Posterolateral Fusion Model

The temporal and spatial expression of sclerostin and Wnt signaling factors during the maturation of posterolateral lumbar spine fusions

Allografts and Spinal Fusion

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