Evaluation of a novel, leakage-free vertebroplastic instrumentation by fresh cadaveric studies.
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.
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.
A total of 28 fresh-frozen vertebral specimens were randomly assigned to 4 groups for testing: unipedicular kyphoplsty, bipedicular kyphoplsty, 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.
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.
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.
Vessel-X bone void filling container system was a novel technique for fractured vertebrae augmentation. Vessel-X bone cement container expanded well in the vertebrae and showed effective cement leakage control. This fresh cadaveric study indicated that Vessel-X was comparable to kyphoplasty in fractured vertebrae mechanical properties and height restoration.
From the *Department of Orthopaedics and Traumatology, University of Hong Kong, Hong Kong, China; and †Department of Spine Surgery, First Affiliated Hospital of Sun Yat-sen University, Guang-zhou, China.
Acknowledgment date: November 29, 2006. First revision date: January 31, 2007. Second revision date: March 22, 2007. Acceptance date: March 23, 2007.
Supported in part by the University of Hong Kong Strategic Research Area Fund on Biomedical Engineering, Hong Kong ITF Fund ITS/064/06, and A-SPINE Co., Ltd.
The legal regulatory status of the device(s)/drug(s) that is/are the subject of this manuscript is not applicable in my country.
Corporate/Industry and Institutional funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.
Address correspondence and reprint requests to William W. Lu, PhD, Department of Orthopaedics and Traumatology, Room 907, Lab Block, 21 Sassoon Road, Pokfulam, University of Hong Kong, Hong Kong; E-mail: email@example.com