Abstract
Background
Radiofrequency Kyphoplasty (RFK) provides a new minimally invasive procedure to treat vertebral compression fractures (VCF).
Purpose
The purpose of this study was to investigate the functional outcomes, safety and radiographic outcomes after the treatment of painful osteolytic vertebral fractures treated with a novel minimally invasive procedure, RFK.
Material and Methods
88 patients (50 females and 38 males) with 158 osteolytic vertebral fractures were treated with RFK using the StabiliT Vertebral Augmentation System (Dfine Inc, San Jose, CA). The StabiliT System provides a navigational osteotome to create a site and size specific cavity prior to delivering ultrahigh viscosity cement with an extended working time (done by applying radiofrequency energy to the cement immediately prior to entering the patient). 12 months follow up in 60 patients (36 females and 24 males) with 110 treated vertebrae are reported. Pre- and postoperative, 3, 6 and 12 months clinical parameters (Visual Analogue Scale, Oswestry Disability Index score), and radiological parameters (vertebral height and kyphotic angle) were measured.
Results
The median pain scores (VAS) (p<0.001) and the Oswestry Disability Score (p<0.001) improved significantly from pre- to post-treatment and maintained at 3, 6 and 12 months follow up. Postoperative, 3,6 and 12 months follow-up RFK restored and stabilized the vertebral height and avoided further kyphotic deformity.
No symptomatic cement leaks or serious adverse events were seen in the RFK group during 3-months of follow up. In 7 out of 158 vertebrae (4.4%) a cement leakage into the disc or lateral wall could be determined by radiograph postoperatively.
Conclusion
Radiofrequency Kyphoplasty is a very safe and effective minimally invasive procedure for the treatment of osteolytic vertebral fractures. Radiofrequency Kyphoplasty shows excellent clinical and radiological results in the 3 and 6 months follow up. Site specific cavity creation and delivery of ultra-high viscosity cement in RF Kyphoplasty with extended working time resulted in the added benefits of height restoration and lower cement leakages intra-operatively.
