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

Supporting

Mentioning

Contrasting

Order By: Relevance

“…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

View full text Add to dashboard Cite

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).

show abstract

Section: Discussionmentioning

confidence: 99%

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

et al. 2021

View full text Add to dashboard Cite

show abstract

“…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

View full text Add to dashboard Cite

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.

show abstract

“… 15 In a randomized trial comparing 2 bone graft substitutes in combined posterolateral and interbody fusion, the uni- and/or bilateral fusion rate increased from 53% to 56% at 1 year to 80% at 2-year follow-up. 26 Recently, Kim et al demonstrated the significance of facet joint fusion and increase of these fusions between 6 and 12 months after PLF. An additional interbody fusion procedure negatively influenced PLF, probably due to the associated facetectomies.…”

Section: Discussionmentioning

confidence: 99%

Increasing Fusion Rate Between 1 and 2 Years After Instrumented Posterolateral Spinal Fusion and the Role of Bone Grafting

Lehr

Öner

Delawi

et al. 2020

Spine

View full text Add to dashboard Cite

show abstract

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

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

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

Increasing Fusion Rate Between 1 and 2 Years After Instrumented Posterolateral Spinal Fusion and the Role of Bone Grafting

Contact Info

Product

Resources

About