A Prospective, Randomized, Multicenter Study Comparing Silicated Calcium Phosphate versus BMP-2 Synthetic Bone Graft in Posterolateral Instrumented Lumbar Fusion for Degenerative Spinal Disorders

Coughlan, Marc; Davies, Mark; Mostert, Adriaan K.; Nanda, Dharmin; Willems, Paul; Rosenberg, Geoffrey; Ferch, Richard

doi:10.1097/brs.0000000000002678

Cited by 14 publications

(11 citation statements)

References 24 publications

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“…At the cellular level, it can trigger a healing cascade, induce MSCs to differentiate into osteoblasts or chondroblasts, and promote osteoblast proliferation [ 295 , 296 ]. Accordingly, it has been frequently incorporated into scaffolds for applications ranging from spinal fusion [ 297 , 298 ] to dental and craniofacial regeneration [ [299] , [300] , [301] ]. However, a few studies have found that the direct delivery of cytokines to bone defects could cause individual differences in repair effects.…”

Section: Bioactive Molecular Delivery Based On Bone-healing Mechanismmentioning

confidence: 99%

Bone physiological microenvironment and healing mechanism: Basis for future bone-tissue engineering scaffolds

Zhu

Zhang

Miao

et al. 2021

Bioactive Materials

208

160

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Bone-tissue defects affect millions of people worldwide. Despite being common treatment approaches, autologous and allogeneic bone grafting have not achieved the ideal therapeutic effect. This has prompted researchers to explore novel bone-regeneration methods. In recent decades, the development of bone tissue engineering (BTE) scaffolds has been leading the forefront of this field. As researchers have provided deep insights into bone physiology and the bone-healing mechanism, various biomimicking and bioinspired BTE scaffolds have been reported. Now it is necessary to review the progress of natural bone physiology and bone healing mechanism, which will provide more valuable enlightenments for researchers in this field. This work details the physiological microenvironment of the natural bone tissue, bone-healing process, and various biomolecules involved therein. Next, according to the bone physiological microenvironment and the delivery of bioactive factors based on the bone-healing mechanism, it elaborates the biomimetic design of a scaffold, highlighting the designing of BTE scaffolds according to bone biology and providing the rationale for designing next-generation BTE scaffolds that conform to natural bone healing and regeneration.

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Section: Bioactive Molecular Delivery Based On Bone-healing Mechanismmentioning

confidence: 99%

Bone physiological microenvironment and healing mechanism: Basis for future bone-tissue engineering scaffolds

Zhu

Zhang

Miao

et al. 2021

Bioactive Materials

208

160

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“…The OstP material studied here contains silicated calcium phosphate granules with much higher levels of silicon/silicate substituted in the apatite structure than other silicated calcium phosphate bone grafts that have been used clinically [33,34], but also a much smaller grain size. These properties have not been correlated with in vivo bone formation in this system, but studies on other systems such as tricalcium phosphate (b-TCP) and biphasic calcium phosphate (BCP) materials have shown that bone formation can be positively affected by relatively small decreases in grain size [3,5,26].…”

Section: Discussionmentioning

confidence: 99%

The efficacy of a nanosynthetic bone graft substitute as a bone graft extender in rabbit posterolateral fusion

et al. 2021

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BACKGROUND CONTEXT: Synthetic bone graft substitutes are commonly used in spinal fusion surgery. Preclinical data in a model of spinal fusion to support their efficacy is an important component in clinical adoption to understand how these materials provide a biological and mechanical role in spinal fusion. PURPOSE: To evaluate the in vivo response of a nanosynthetic silicated calcium phosphate putty (OstP) combined with autograft compared to autograft alone or a collagen-biphasic calcium phosphate putty (MasP) combined with autograft in a rabbit spinal fusion model. STUDY DESIGN: Efficacy of a nanosynthetic silicated calcium phosphate putty as an extender to autograft was studied in an experimental animal model of posterolateral spinal fusion at 6, 9, 12 and 26 weeks, compared to a predicate device. METHODS: Skeletally mature female New Zealand White rabbits (70) underwent single level bilateral posterolateral intertransverse process lumbar fusion, using either autograft alone (AG), a nanosynthetic silicated calcium phosphate putty (OstP) combined with autograft (1:1), or a collagen-biphasic calcium phosphate putty (MasP) combined with autograft (1:1). Iliac crest autograft was harvested for each group, and a total of 2 cc of graft material was implanted in the posterolateral gutters per side. Fusion success was assessed at all time points by manual palpation, radiographic assessment, micro-CT and at 12 weeks only using nondestructive range of motion testing. Tissue response, bone formation and graft resorption were assessed by decalcified paraffin histology and by histomorphometry of PMMA embedded sections. RESULTS: Assessment of fusion by manual palpation at the 12 week endpoint showed 7 out of 8 (87.5%) bilateral fusions in the OstP extender group, 4 out of 8 (50%) fusions in the MasP extender group, and 6 out of 8 (75%) fusions in the autograft alone group. Similar trends were observed with fusion scores of radiographic and micro-CT data. Histology showed a normal healing response in all groups, and increased bone formation in the OstP extender group at all timepoints compared to the MasP extender group. New bone formed directly on the OstP granule surface within the fusion mass while this was not a feature of the Collagen-Biphasic CaP material. After 26 weeks the OstP FDA device/drug status: Osteo 3 ZP Putty (Approved for this indication), Mastergraft Putty (Approved for this indication).

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“…For the present study, a commercially available, granular silicon substituted hydroxyapatite matrix (SiHA) was used. SiHA has been described as a promising scaffold for bone defect healing and for spinal fusion surgery [ 21 , 22 ]. However, based on the results of our current study, induction of ectopic bone formation in subcutaneous tissue by SiHA alone (group B/B irrad) seems to be rather poor.…”

Section: Discussionmentioning

confidence: 99%

Free Transplantation of a Tissue Engineered Bone Graft into an Irradiated, Critical-Size Femoral Defect in Rats

Rottensteiner-Brandl

Bertram

Lingens

et al. 2021

Cells

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Healing of large bone defects remains a challenge in reconstructive surgery, especially with impaired healing potential due to severe trauma, infection or irradiation. In vivo studies are often performed in healthy animals, which might not accurately reflect the situation in clinical cases. In the present study, we successfully combined a critical-sized femoral defect model with an ionizing radiation protocol in rats. To support bone healing, tissue-engineered constructs were transferred into the defect after ectopic preossification and prevascularization. The combination of SiHA, MSCs and BMP-2 resulted in the significant ectopic formation of bone tissue, which can easily be transferred by means of our custom-made titanium chamber. Implanted osteogenic MSCs survived in vivo for a total of 18 weeks. The use of SiHA alone did not lead to bone formation after ectopic implantation. Analysis of gene expression showed early osteoblast differentiation and a hypoxic and inflammatory environment in implanted constructs. Irradiation led to impaired bone healing, decreased vascularization and lower short-term survival of implanted cells. We conclude that our model is highly valuable for the investigation of bone healing and tissue engineering in pre-damaged tissue and that healing of bone defects can be substantially supported by combining SiHA, MSCs and BMP-2.

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A Prospective, Randomized, Multicenter Study Comparing Silicated Calcium Phosphate versus BMP-2 Synthetic Bone Graft in Posterolateral Instrumented Lumbar Fusion for Degenerative Spinal Disorders

Abstract: 2.

Cited by 14 publications

References 24 publications

Bone physiological microenvironment and healing mechanism: Basis for future bone-tissue engineering scaffolds

Bone physiological microenvironment and healing mechanism: Basis for future bone-tissue engineering scaffolds

The efficacy of a nanosynthetic bone graft substitute as a bone graft extender in rabbit posterolateral fusion

Free Transplantation of a Tissue Engineered Bone Graft into an Irradiated, Critical-Size Femoral Defect in Rats

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