Study design: Evaluation of a novel, leakage-free vertebroplastic instrumentation by fresh cadaveric studies.
Objectives: To compare Vessel-X, a novel percutaneous bone void filling container system, with conventional kyphoplasty in restoring strength, stiffness, and height in experimentally induced vertebral compressive fractures and morphologically determine the cement distribution.
Summary of background data: Clinically, both vertebroplasty and kyphoplasty perform well in reinforcement and pain relief. One of the shortcomings, however, is the risk of cement leakage. Vessel-X is a novel bone expander and bone void filler combined instrumentation for vertebral augmentation requiring evaluation.
Methods: A total of 28 fresh-frozen vertebral specimens were randomly assigned to 4 groups for testing: unipedicular kyphoplasty, bipedicular kyphoplasty, unipedicular Vessel-X, and bipedicular Vessel-X. Compressive fractures were experimentally created on each vertebra after determining the bone mineral density. Kyphoplasty and Vessel-X were performed using bioactive bone cement (SrHAC) under C-arm fluoroscopy and compared by compression testing to measure the effects of augmentation. Morphologic observations were also performed to determine the cement distribution and vertebral height restoration.
Results: There was no significant difference in bone mineral density, initial strength, and stiffness in any of the groups. Furthermore, no significant difference was observed in total cement volume in intragroup comparison within the unipedicular or bipedicular groups. Vessel-X bone filler container could expand well and contain most of the cement. The height restoration ranged from 88.5% to 96.4% in all groups. The augmented strength with unipedicular and bipedicular injections reached 3651.57 N and 4833.73 N, respectively. Stiffness with bipedicular injection was significantly higher than that of unipedicular injection.
Conclusion: Vessel-X was comparable to kyphoplasty in restoring the mechanical properties and height of the fractured vertebrae. Interestingly, Vessel-X instrumentation showed considerably less cement leakage and better cement placement in the vertebral body. Therefore, it could be a leakage controllable technique in percutaneous vertebral augmentation.