48 - Radiofrequency-Kyphoplasty (DFine) versus Conventional Balloon-Kyphopl...

#48 Radiofrequency-Kyphoplasty (DFine) versus Conventional Balloon-Kyphoplasty (Medtronic). A Prospective Study with Regard to Efficiency and Safety

MIS Techniques and Outcomes

Poster Presented by: A. Licht


A.W. Licht (1)

(1) Asklepios Kliniken Kandel, Orthopedic Surgery/Spine-Center, Kandel, Germany


Introduction: Vertebroplasty (VP) and conventional Balloon-Kyphoplasty (BKP) are established minimally invasive procedures for the treatment of osteoporosis and traumatic vertebral body compression fractures (VCFs). Since the introduction of BKP, many innovations in terms of kyphoplasty instruments with different augmentation systems have been developed. The main complication is cement extravasation which has been observed in a rate of 4,8 % up to > 70 % depending on used procedure and cement viscosity. New methods require to provide comparable or even better efficiency in vertebral body height restoration and pain reduction as well as to prevent extravasation. This 3 year study analyses advantages and disadvantages of BKP versus RFK.

Material/Methods: Included were all patients with osteoporotic and traumatic VCF, excluded vertebral collapse due to benign or malign lesions. Between 1/2009 and 12/2011 randomly distributed N=55 patients (age: Ø 68,9 y) with n=73 VCFs were treated using conventional BKP (Medtronic©). In the same period N=103 patients with n=160 VCFs (age: Ø 75,2 y) underwent RFK (DFine©). Both groups have been evaluated in a prospective study with a subgroup analysis related to age of fracture (old VCFs: ≥6 weeks, BKP/RFK n = 32/86 VCFs vs. fresh VCFs: < 6 weeks, BKP/RFK n=41/74 VCFs). Vertebral body height restoration, pain reduction and rate of complications/extravasation following the procedure were analysed using Wilcoxon Test.

Results: In BKP cement leakage rate was on average 17,8% (fresh VCFs 17,07%, old VCFs 18.75%) and height restoration was Ø 6,1 mm in fresh and Ø 4,42 mm in old VCFs (p< 0,001). In this 3-years period two major complications were noted with one cement extravasation posterior resulting in spinal cord compression and incomplete paraplegia and one case of pulmonary cement embolization. The group of patients with RFK intervention showed fracture reduction of Ø 6,89 mm in fresh and Ø 5,72 mm in old VCF (p< 0,001) and rate of cement leakage was 13,75% ( fresh VCFs 10,46%, old VCFs 17,56%) with no complications observed.

Conclusion: RFK reveals similar results with regard to vertebral body height restoration and pain reduction in VAS- Score (1 to 10 points) compared to BKP but lower cement extravasation rate and over all complications. In addition and especially in multilevel treatment shortened intervention time appears beneficial. Due to the extended working time using RFK cement, augmentation is more controlled and directed. Furthermore remote controlled cement delivery permitted reduction in radiation exposure to medical staff.