AI Article Synopsis
- The study was a randomized, controlled experiment using rabbits to test the performance of a new bone graft substitute called SiCaP EP against the standard iliac crest autograft.
- The research aimed to evaluate SiCaP EP in three different modes: as a stand-alone, with bone marrow aspirate, and in combination with autograft.
- Results indicated that SiCaP EP performed comparably to traditional iliac crest autograft in promoting spinal fusion across various evaluation metrics.
Article Abstract
Study Design/setting: Randomized, controlled study in a laboratory setting. Blinded observations/assessment of study outcomes.
Objective: The purpose of this study is to determine the performance characteristics of a novel silicate-substituted hydroxyapatite bone graft substitute (BGS), SiCaP EP (Baxter Healthcare/ ApaTech, Elstree, UK), in a stand-alone mode, a stand-alone with bone marrow aspirate (BMA) mode, and an extender mode with iliac crest autograft (ICBG) in a rabbit posterolateral spine fusion model. The investigational BGS is compared to a standard iliac crest autograft (ICBG) control.
Summary Of Background Data: The rabbit posterolateral fusion model is an established environment for testing of fusion efficacy. It offers the opportunity to obtain radiographic, histological, and biomechanical data on novel bone graft substitutes.
Methods: One hundred and twenty rabbits were entered into the study with 116 used for analysis. Bilateral posterolateral lumbar intertransverse fusions were performed at L5-L6. The lateral two thirds of the transverse processes were decorti cated and covered with graft material in the following five groups: ICBG, SiCaP EP stand-alone, SiCaP EP with BMA (1:0.5 by volume), and SiCaP EP with ICBG (1:3 by volume). Rabbits were necropsied at 4, 8, and 12-week time points and fusion rate, quantity, and quality was evaluated based on manual palpation, mechanical stiffness testing, pqCT, and histological assessment.
Results: SiCaP EP, ICBG+SiCaP EP (3:1), and SiCaP EP+BMA (1:0.5) compare favorably to iliac crest autologous bone by multiple metrics in this rabbit posterolateral fusion model. Fusion efficacy via manual palpation and mechanical stiffness testing metrics indicate that all SiCaP EP groups had similar group-to-group performance, and were not significantly different than the ICBG control at each time period evaluated.
Conclusions: In this commonly used rabbit posterolateral fusion model, SiCaP EP utilized as a stand-alone, as a stand-alone with BMA, and as an autograft (ICBG) extender produces results that are clinically and radiographically similar to ICBG.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3748888 | PMC |
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