Study design: The bone-bonding characteristic of the new artificial intervertebral disc consisting of bioceramic-coated three-dimensional fabric was evaluated mechanically and histologically in an in vivo sheep model.
Objectives: To investigate the mechanical properties and the histologic appearance of the interface between the three-dimensional fabric disc and the vertebral body, and to evaluate these alterations in vivo under a spinal segmentally mobile condition.
Summary of background data: Bone ingrowth to the bioceramic-coated three-dimensional fabric surface had been demonstrated already under a stable environment in preliminary animal studies.
Methods: For this study, 20 sheep underwent two-level lumbar intervertebral disc replacement with three-dimensional fabric discs (Group I) or bioceramic spacers as a comparative material (Group II). All operative segments were stabilized temporarily with spinal instrumentation for the initial ingrown phase. Four animals each were killed at 4, 6, 15, and 24 months in Group I and at 6 months in Group II, and the operative segments were subjected to either a detachment test or histologic evaluation.
Results: The interfacial tensile strength at 6 months was significantly higher in Group I than in Group II. No significant decrease in tensile strength was detected until 24 months after surgery in Group I. Histologically, bone ingrowth to the three-dimensional fabric surface was observed 4 months after surgery, and no aseptic loosening occurred until 24 months after surgery.
Conclusions: The findings show that the three-dimensional fabric disc was firmly fixed to the vertebral body by bone ingrowth, and that this biologic fixation was preserved even under the spinal segmentally mobile condition.