In Vitro and In Vivo Characterization of BiFORM Bioactive Moldable Matrix
Posterolateral Rabbit Spinal Fusion Study
I. Introduction
Autologous bone has long been the gold standard for bone graft substitute in spinal fusion procedures. The limited supply and morbidity associated with using autologous graft material led to the development of alternative bone grafting materials. Bioactive glass has a long history of biomedical use and has been shown to facilitate mineral deposition in vitro2,3. In order to take advantage of the surface bioactivity of bioactive glass and minimize the use of autograft, we have developed a Bioactive Glass Collagen Anorganic Bone Composite (BiFORM® Bioactive Moldable Matrix).
II. Objective
The objective of the study was to evaluate the safety and effectiveness of using BiFORM® Bioactive Moldable Matrix + BMA to facilitate fusion between L4-L5 transverse processes in a rabbit posterolateral spinal fusion model in comparison with Vitoss® BA + BMA and BiFORM® Bioactive Moldable Matrix + autograft in comparison with autograft as positive control.
III. Materials & Methods
BiFORM® Bioactive Moldable Matrix is composed of 30% 45S5 bioactive glass, 20% bovine Type I collagen, and 50% bovine anorganic bone mineral. Vitoss® BA is composed of 80% β-TCP + bioactive glass and 20% collagen.
36 New Zealand white rabbits were assigned into four study groups summarized in Figure 1.
Figure 1. Summary of Study Groups