Abstract
Introduction
Vertebral compression fractures (VCF) are an increasing problem. Common surgical treatments are vertebroplasty and kyphoplasty. Both are mainly performed with PMMA bone cement. Recently a new elastomer (VK100) was developed as optional material for kyphoplasty instead of PMMA. This study investigated the outcome and safety of balloon kyphoplasty performed with the VK100 Vertebral Augmentation System over a follow-up period of 12 months.
Material and Methods
The study includes patients with osteoporotic fractures of one or two vertebrae. All patients were treated with balloon kyphoplasty using VK100 (Bonwrx, Lansing, Michigan, USA) instead of PMMA. VK100 is a radio opaque, bone adherent, non-exotermic elastomer, which is less stiff as PMMA and therefore more comparable to the natural bone. VAS and ODI of all patients was measured preoperative, postoperative, at 12 months. Additional cement leakage and additional fractures were documented.
Results
82 patients were included in the study (age: 63.69 ± 7.54). VAS improved significantly from preoperative 82.9 ± 10 mm to postoperative 18.3 ± 10.2 mm (p = 0.0015) and improved significantly from postoperative to 8.92 ± 11.5 mm at the 12 months follow up (p = 0.0163). ODI improved significantly from preoperative 72.92 ± 14.6% to postoperative 47.08 ± 16.35% (p = 0.0015) and from postoperative to 20.15 ± 7.56 at 12 months (p = 0.0022). There were no complications due to leakage. Patients showed no additional fractures within the follow up period.
Conclusion
VK100 showed good results in terms of VAS and ODI improvement and occurrence of adverse events. VK100 is an alternative to PMMA bone cement augmentation. Further studies are needed for longer implantation years.